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Effect of Sacubitril/Valsartan on NT-proBNP in Patients with Heart Failure and Preserved Ejection Fraction: The PARAGON-HF Trial

By: Jonathan Cunningham

Key Points

  • Sacubitril/Valsartan combination is a neprilysin inhibitor and angiotensin receptor blocker
  • PARAGON-HF trial compared Sacubitril/Valsartan vs Valsartan in patients with HF with EF ≥45% and elevated natriuretic peptides with minimum NT-proBNP of >200 pg/ml with HF hospitalization and >300 pg/ml without hospitalization
  • 4,796 patients were enrolled for valsartan and Sacubitril/Valsartan run-in period were randomised in 1:1 ratio. The rate of the primary endpoint; Total rate of hospitalization, cardiovascular death was 13% lower with Sacubitril/Valsartan which never met statistical significance. Women and patient with EF benefited more
  • The objective of the study was to investigate the relationship between NT-proBNP and outcomes in patients with HFpEF, and the effect of sacubitril/valsartan on NT-proBNP
  • Baseline NT-proBNP is strongly predicted total HF hospitalization and CV death.
  • Patients with atrial fibrillation with low NT-proBNP were excluded from the trial and those with NT-proBNP have high rates of atrial fibrillation. The data suggest the higher minimum NT-proBNP criteria for patients with AF in HF clinical trial
  • Non-obese patients showed strong association between NT-proBNP and clinical events and in obese patients this association is weaker
  • NT-proBNP strongly predicted events in HFpEF and risk in atrial fibrillation is lower for a given NT-proBNP
  • Obese patients with low NT-proBNP retain moderate risk
  • Sacubitril/valsartan reduced NT-proBNP by 19% vs Valsartan but NT-proBNP showed similar reduction in men/women and lower/higher LVEF
  • NT-proBNP did not identify patients who benefit more from Sacubitril/Valsartan


Benefit of Dapagliflozin On First and Repeat Events in Patients with HFrEF in DAPA-HF

By: Piotr Ponikowski

Key Points

  • Among patients with heart failure (HF) and reduced ejection fraction the sodium glucose co-transporter 2 (SGLT2) inhibitor Dapagliflozin reduced the risk of cardiovascular (CV) death or worsening HF in the DAPA-HF trial, in a time-to-first event analysis
  • Patient with HF will often experience more than one hospitalization during the course of their disease. Conventional time to first event analysis ignores these repeated hospitalizations
  • Also, time-to-first event analysis of a composite outcome such as CV death or HF hospitalization ignores CV death occurring after a first HF hospitalization
  • Morever, time-to-first event analyses may overestimate treatment benefit if the treatment effect wanes over time or a subgroup of patients does not respond and has multiple recurrent events
  • The objective of the study was to analyse all HF hospitalizations (both first and repeat) experienced by patients in DAPA-HF in this pre-specified secondary analysis
  • The primary endpoint was Cardiovascular death or worsening HF event (unplanned HF hospitalization or an urgent HF visit requiring intravenous therapy)
  • Patients were randomised to placebo (n = 2371) and Dapagliflozin 10 mg once daily (n = 2373) and follow up was done at day 60, day 120 and then after every 120 days, the follow up continues up to 18.2 months
  • Even over a relatively short period of follow-up (median of 18.2 months), a large number of patients experienced recurrent HF hospitalization (32% of all HFH were a second or subsequent event)
  • Patients with HF who had recurrent hospitalizations had more advanced disease and more co-morbidities
  • Dapagliflozin reduced the risk of both first and recurrent HF hospitalizations. The relative and absolute reductions were large
  • The reduction in risk of recurrent HF hospitalizations with Dapagliflozin was more pronounced after accounting for the semi-competing risk of CV death


Contemporary Outcomes with Mitraclip™ (NTR/XTR) System in Primary Mitral Regurgitation: Results from The Global Expand Study

By: D. Scott Lim

Key Points

  • The MitraClip system was FDA approved in 2013 for the treatment of subjects with primary (or degenerative) mitral regurgitation who are at prohibitive risk for mitral valve surgery
  • Since the original EVEREST II trials, no new core-lab adjudicated data on subjects with primary MR have been reported
  • The primary objective of the study was to report on real world, echo core lab and clinical events committee adjudicated outcomes in patients with significant primary mitral regurgitation treated with the next generation MitraClip NTR and XTR systems in the 1000+ patient global EXPAND study
  • The secondary objective was to evaluate MR reduction outcomes as a function of mitral valve anatomic complexity and confirm the safety (including single leaflet device attachments and leaflet injuries) and effectiveness of MR reduction associated with the MitraClip NTR and XTR systems
  • It was a prospective, multicentre, single arm, international, post-market, real world, observational study conducted in United states, Europe and the Middle east
  • 1041 subjects consented and underwent MitraClip implantation and 835 subjects enrolled for adequate imaging for ECL assessment in which 422 patients were with primary or mixed etiology and 413 subjects were with secondary MR etiology
  • This study represents the first contemporary report of ECL and CEC adjudicated 30 day clinical outcomes in patients with primary MR treated with the next generation NTR and XTR MitraClips
  • Approximately one-third of patients had a complex mitral valve anatomy that reflects the difference in patients treated in the real world in comparison to past clinical trials
  • MR ≤ 1+ is being achieved more often with MitraClip NTR and XTR than previously observed in EVEREST II trials
  • MitraClip XTR was associated with greater MR reduction compared to NTR, in more complex anatomies


Edoxaban Versus Warfarin After Surgical Bioprosthetic Valve Implantation or Valve Repair

By: Geu-Ru Hong

Key Points

  • Early postoperative anticoagulation with warfarin is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair
  • However, it is unclear whether direct oral anticoagulant can be an alternative to warfarin in this population
  • The objective of the study was to compare the efficacy and safety of edoxaban with warfarin for 3 months in patients who underwent surgical bioprosthetic valve implantation or valve repair
  • It was a prospective, randomized, open-labelled, clinical trial conducted between Dec 2017 to Sep 2019 with patients between 20 and 85 years of age
  • 285 patients underwent bioprosthetic valve implantation or valve repair and 220 randomised in 1:1 ratio to Edoxaban and warfarin
  • Edoxaban group received dose of 60 mg/30 mg orally once daily in patients with 30-5- mL/min creatinine clearance or no more than 60 kg body weight
  • In Warfarin group, the dose adjustments were done to maintain the INR between 2.0 and 3.0. The INR measurements were performed daily before discharge and at a scheduled outpatient clinic after discharge
  • The primary efficacy outcomes were death, clinical thromboembolic events and asymptomatic intracardiac thrombosis
  • The primary safety outcome was occurrence of major bleeding and secondary safety outcome was composite of major or clinically relevant nonmajor (CRNM) bleeding
  • Edoxaban is noninferior to warfarin for preventing thromboembolism and occurrence of major bleeding in the first 3 months after surgical bioprosthetic valve implantation or valve repair
  • Edoxaban might be an alternative to warfarin in patients early after successful surgical bioprosthetic valve implantation or valve repair


Mavacamten Improves Biomarkers of Myocardial Wall Stress and Injury in Patients with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM): Results from The Phase 2 MAVERICK-HCM Study

By: Carolyn Y. Ho

Key Points

  • Hypertrophic cardiomyopathy (HCM) is a primary myocardial disorder. It is unexplained left ventricular (LV) hypertrophy and often caused by pathogenic variants in sarcomeric genes
  • Approximately 30% of patients have non-obstructive HCM (LVOT gradient <30 mmHg)
  • Cardiac transplantation may be the only option if severe, refractory symptoms were occurred
  • By altering the contractile mechanics of the cardiomyocyte, myosin inhibitors have the potential to modify pathophysiology and improve symptoms associated with non-obstructive HCM
  • Mavacamten is a first in class, selective allosteric inhibitor of cardiac myosin which reduces the number of myosin-actin cross-bridges and thus decreases excessive contractility characteristic of HCM
  • The primary objective of the phase 2, randomised, double-blinded study was the frequency and severity of treatment -emergent adverse events (TEAEs), AEs of special interest and serious adverse events (SAEs)
  • Group 1 received Mavacamten ~200 ng/mL and group 2 received Mavacamten ~500 ng/mL and other group received placebo treated for 16 weeks
  • Mavacamten was generally tolerated in most participants with non-obstructive HCM and no excess of serious adverse events. LVEF decreased by 4 (8)% in the pooled mavacamten group versus 2.3 (5)% in placebo
  • 5 of 40 participants (12.5%) had reversible reductions in LVEF <45% leading to protocol-driven treatment discontinuation
  • Treatment with mavacamten resulted in a dose-dependent reduction in serum levels of NT-proBNP, suggesting physiological benefit
  • Exploratory analyses suggest that patients with more severe disease expression (baseline elevated cTnl or E/e) may benefit more from mavacamten therapy
  • Results set the groundwork for future, larger scale studies in nHCM and potentially in HFpEF


Alirocumab Efficacy and Safety in Adults with Homozygous Familial Hypercholesterolemia (ODYSSEY HoFH)

By: Dirk Blom

Key Points

  • HoFH is characterized by extremely high LDL-C levels and early onset atherosclerotic cardiovascular disease despite treatment with conventional lipid lowering therapy
  • HoFH includes true homozygotes, compound heterozygotes and double heterozygotes
  • HoFH results from severely impaired LDLR function, most commonly due to mutations in both copies of the LDLR gene
  • This is the largest randomized controlled interventional trial in HoFH patients to date
  • The objective of the randomized, double blind, placebo-controlled, parallel group, phase 3 study was to evaluate LDL-C reduction with the PCSK9 inhibitor alirocumab in adult patients with clinically or genetically diagnosed HoFH
  • Patients were randomised in 2:1 ratio to Alirocumab 150 mg (n=45) and placebo (n=24) for 12 weeks in double blind period and Alirocumab 150 mg (n=69) was given in open-label period
  • The primary endpoint was percentage change from baseline in LDL-C vs placebo at week 12
  • Alirocumab showed statistically significant and clinically meaningful reduction in LDL-C at week 12 versus placebo
  • Consistent reductions in LDL-C were observed from baseline to week 12 for all subgroups, including patients on apheresis
  • Alirocumab also significantly reduced ApoB, non-HDL-C, TC and Lp(a)
  • LDL-C respose more variable in patients with HoFH than in other forms of hypercholesterolemia
  • Alirocumab was generally well tolerated with no distinct safety differences versus placebo


Eicosapentaenoic Acid Levels in REDUCE-IT and Cardiovascular Outcomes

By: Deepak L. Bhatt

Key Points

  • In REDUCE IT, 8179 patients were randomised in 1:1 ratio to Icosapent Ethyl (n=4089) and Placebo (n=4090) with continuation of stable statin therapy and follow up for median 4.9 years
  • Patients had controlled LDL-C but consistently elevated triglyceride levels despite statin therapy and patients also had established cardiovascular disease or diabetes with at least one risk factor
  • The primary endpoint was time to first occurrence of composite CV death, nonfatal MI, nonfatal stroke, coronary revascularisation, unstable angina requiring hospitalization from randomization
  • The secondary endpoint was composite of cardiovascular death, MI or stroke
  • Icosapent ethyl 4g/day significantly reduced first and total cardiovascular events by 25% and 305 respectively as compared to placebo. These benefits were beyond what can be explained by the degree of triglyceride or other biomarker changes
  • On-treatment EPA levels via icosapent ethyl strongly correlate with the primary endpoint
  • These data provide a mechanistic underpinning for the large risk reductions seen in multiple endpoints with icosapent ethyl in REDUCE-IT


Natural History of Symptoms and Stress Echo Findings in Patients with Moderate or Severe Ischemia and No Obstructive CAD (INOCA): The NHLBI-funded CIAO Ancillary Study to The ISCHEMIA Trial

By: Harmony R. Reynolds

Key Points

  • Ischemia and No Obstructive Coronary Artery Disease (INOCA) shows signs and symptoms of ischemic heart disease with <50% maximal stenosis on coronary angiography and estimated 3-4 million women and men are affected with it
  • INOCA mechanisms include:
  • Reduced coronary flow reserve
  • Epicardial and/or microvascular coronary spasm
  • INOCA is associated with increased risk of death, MI, HF and stroke and high healthcare costs similar to patients with CAD
  • Persistent symptoms and positive stress testing, eg., stress echocardiography are markers of risk among INOCA patients. However, whether myocardial ischemia is solely responsible for angina in INOCA patients is uncertain
  • The objective of the study was to investigate changes in symptoms and stress testing in INOCA patients over 1 year, leveraging the enrolment process of the international, NHLBI-funded ISCHEMIA trial
  • Stable patient with moderate or severe ischemia were underwent blinded CCTA. The patients with less CCTA were excluded. As the patients were with no obstructive CAD showed screen failure could have considered trail for if they had ischemic symptoms, enrolled after stress echo
  • Angina assessment was done at enrollment, 6 months, 1 year and stress echo repeated at 1 year. Then, comparison between INOCA patients (CIAO) and CAD patients was done
  • Longitudinal assessment was done of CIAO patients from baseline to 1 year
  • Primary endpoint was correlation between change in ischemia and change in angina
  • CIAO participants were enrolled at 39 sites in 11 countries
  • INOCA patients were far more likely to be female, showed largely similar severity of ischemia on stress echo to CAD patients, exhibited more frequent angina but better overall angina related quality of life
  • In half of INOCA patients, stress echo is normal at 1 year, 45%same or worse
  • Angina frequency improve by a clinically meaningful amount in 39% of INOCA pts, despite little change in anti-anginal medication
  • No correlation between change in angina and change in ischemia




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ACC 2.0 World Congress of Cardiology Conference 2020 Day 2 http://digimedupdates.com/acc2020-30-march/ http://digimedupdates.com/acc2020-30-march/#respond Mon, 30 Mar 2020 14:10:56 +0000 http://digimedupdates.com/?p=1978

Antithrombotic Therapy After Transcatheter Aortic Valve Implantation in Patients with A Long-term Indication for Oral Anticoagulation (POPULAR TAVI Trial)

By: Vincent Nijenhuis

Key Points

  • TAVI remains associated with frequent complications such as Major and life threatening bleeding (3-15%) and stroke (1-8%)
  • Approximately 30% of patients have atrial fibrillation (AF). In these patients, the risk of thromboembolic events is higher
  • Patients with AF undergoing TAVI are in need of oral anticoagulation (OAC) to reduce stroke and thromboembolism
  • Antiplatelet therapy in addition to OAC may decrease thromboembolism after TAVI but increases bleeding
  • The trial is investigator initiated, randomised, open label, blinded CEC
  • The primary outcome shows that OAC alone is superior than OAC with clopidogrel in all bleeding. The absolute difference was 0.9% with risk ratio of 0.63 and p= 0.011
  • The co-primary outcome shows that OAC alone is superior than OAC with clopidogrel in non-procedural bleeding. The risk ratio was 0.64 and p=0.015
  • The secondary outcome shows that OAC alone group showed lesser CV mortality, non-procedural bleeding, stroke and MI than OAC with clopidogrel group. The absolute difference was -14.3%
  • In patients with an established indication for OAC undergoing TAVI, OAC alone as compared to OAC with clopidogrel:
  • Reduces the rate of bleeding events, including major, life-threatening or disabling bleeding
  • Does not increase the rate of thrombotic event


Transcatheter Aortic Valve Replacement in Patients with Severe Bicuspid Aortic Valve Stenosis at Low Predicted Risk of Mortality

By: Basel Ramlawi

Key Points

  • TAVR with Evolut supra-annular self-expanding valves has demonstrated excellent outcomes in tricuspid aortic stenosis and is currently approved in the US for patients across all risk classes
  • The objective of the study was to assess the safety and efficacy of TAVR in patients with bicuspid aortic valve stenosis and low surgical risk
  • It is a multicentre, prospective, interventional, single arm study with baseline MSCT to confirm bicuspid morphology
  • Patient’s eligibility was reviewed by local heart team and screening committee
  • Hemodynamics centrally assessed by echocardiographic core laboratory and patient follow up planned for 10 years
  • The study performed at high volume experienced centers and it is non-randomized study design using standardized implant technique with annular sizing and Pre-TAVR balloon dilation
  • It also underwent rigorous adherence to patient selection parameters
  • The primary safety endpoint; all-cause mortality or disabling stroke was 1.3% at 30 days
  • The primary efficacy endpoint was device success such as absence of procedural mortality, correct position of 1 valve in the proper anatomical location and absence of > mild aortic valve regurgitation was 95.3%
  • It shows low rates of AR (no moderate/severe) and consistent hemodynamics across sievers classification
  • In this low risk bicuspid study, early 30-day results showed that TAVR with the Evolut platform was safe and effective
  • The choice between TAVR and surgery should be based on a multidisciplinary heart team discussion that includes anatomic, clinical and patient social factors


Two-year Clinical and Echocardiographic Outcomes from The Partner 3 Low-risk Randomized Trial

By: Michael J. Mack

Key Points

  • Previous PARTNER trials have shown that TAVR was superior to standard therapy in extreme-risk patients and non-inferior to surgery in high and intermediate risk patients with aortic stenosis
  • Results from the PARTNER 3 trial in low-risk patients demonstrated superiority for TAVR vs. surgery for the primary endpoint of death, stroke or rehospitalisation at 1 year
  • The purpose of the study was to report the clinical and echocardiographic outcomes of the PARTNER 3 trial at 2 years for low risk patients with severe symptomatic aortic stenosis treated with the SAPIEN 3 TAVR system vs. surgery
  • PARTNER 3 study design is with low risk patients defined by Heart team (STS < 4%) and 1000 patients were randomised in 1:1 between surgery and TAVR and primary endpoint was composite of all-cause mortality, stroke, or CV re-hospitalization at 1-year post procedure
  • TAVR showed reduced primary endpoint events (37% reduction in death, stroke or CV rehospitalisation) but more death or stroke events was shown in TAVR patients from 1 to 2 years and no significant difference at 2 years
  • Reduced CV rehospitalisation favouring TAVR
  • Increased valve thrombosis events were shown in TAVR patients, esp. from 1 to 2 years
  • Hemodynamic improvements and frequency of moderate or mild paravalvular regurgitation were unchanged between 1 and 2 years in both TAVR and surgery patients


How Long to Continue Aspirin After ACS/PCI in Patients with Atrial Fibrillation? Insights from Augustus

By: John H. Alexander

Key Points

  • AUGUSTUS trial is double blind, open label trial with 4600 patients were randomised to either Apixaban 5 mg BID or Vitamin K antagonist (VKA) and in factorial design the patients were randomised to aspirin or placebo also
  • AUGUSTUS demonstrated that, in patients with atrial fibrillation and recent ACS or PCI on a P2Y12 inhibitor and oral anticoagulant, placebo resulted in significantly less bleeding than aspirin and there was no significant difference between patients assigned aspirin and placebo in the secondary outcomes
  • Assuming that there might be a risk /benefit trade off that changes over time the objective of the study was to explore the balance of risk (bleeding) and benefit (ischemic events) between randomization and 30 days and between 30 days and 6 months, with aspirin and placebo, among patients enrolled in AUGUSTUS
  • The use of aspirin acutely and for up to approximately 30 days results in an equal increase in severe bleeding and reduction in severe ischemic events and after 30 days, aspirin continues to increase bleeding without significantly reducing ischemic events among patients with atrial fibrillation and a recent ACS or PCI receiving a P2Y12 inhibitor and oral anticoagulation with apixaban or warfarin
  • These results should inform patient centric, shared decision making regarding the ideal duration of aspirin after an ACS or PCI in patients with atrial fibrillation receiving oral anticoagulation


Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation: The Venus Trial

By: Miguel Valderrabano

Key Points

  • Catheter ablation of persistent atrial fibrillation (AF) has suboptimal outcomes, with low single procedure success and frequent need for repeat procedures
  • The vein of Marshall (VOM) is an attractive target to improve ablation results, since it contains Pro-fibrillatory innervation, AF triggers and sits in the mitral isthmus critical for perimitral flutter and all of these mechanisms are ablated by VOM ethanol infusion
  • The patients were randomised in 1:1.15 ratio to either catheter ablation or catheter ablation plus VOM ethanol. 15% of patients were intention to treat with VOM ethanol not doable anfd 85% of patients were completed per treatment
  • Patients were followed for 1 month, 3 months, 6 months, 9 months and 12 months. At 6 and 12 months, patient were continuously going for monitoring
  • 350 patients were screened in 12 US centers in which 343 were randomised (158 patients to Catheter ablation only and 185 patients to VOM plus catheter ablation)
  • In persistent AF, vein of Marshall ethanol added to catheter ablation reduces recurrence of AF/AT, reduces AF burden and may produce need for repeat procedures
  • Also it shows some limitations such as VOM ethanol infusion completed in 83.8% of patients and increased the risk of fluid overload


Relationships of Ischemia Severity and Coronary Artery Disease Extent with Clinical Outcomes in The Ischemia Trial

By: David Maron

Key Points

  • In Ischemia trial, patients with moderate or severe ischemia typically underwent blinded coronary computed tomography angiography (CCTA) to identify anatomy eligible for randomisation
  • After randomisation, patients divide into Invasive strategy (OMT + Cath + optimal revascularisation) and Conservative strategy (OMT alone with cath reserved for OMT failure)
  • The primary endpoint was CV death, MI, or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest. There is no statistical evidence of benefit from invasive strategy over a median 3.2 years of follow up
  • Anatomy was more predictive of outcomes than ischemia and there was no association between core laboratory determined ischemia severity and death, but there was a marginal association between ischemia severity and risk of MI in the patients with site determined moderate or severe ischemia
  • There was a strong association between extent and severity of CAD and risk of death and MI
  • There was no statistically significant evidence of a benefit from the invasive strategy on 4-year event rates for any level of ischemia
  • More severe and extensive coronary disease increased risk for death and MI, but an invasive approach did not significantly lower that risk at 4 years
  • This includes the subgroup with severe 3-vessel disease or 2-vessel disease with proximal LAD


Catheter-based Renal Denervation in The Absence of Antihypertensive Medications: Primary Results from The Spyral Htn-off Med Pivotal Trial

By: Michael Boehm

Key Points

  • Over 1 of 3 patients have hypertension (HTN) showed increased risk of cardiovascular events and stroke
  • In Spyral HTN-OFF Med trial, Pilot trial showed proof of principle that renal denervation (RDN) reduces blood pressure and Pivotal trial showed prospectively powered RCT evaluating RDN independent of drug effects and adherence
  • The Spyral Htn-off Med Pivotal Trial was randomized, sham controlled trial. Patients were screened, at visit 1 office BP was measured and after 2-3 weeks safety check, on visit 2 office BP was measured again and 24 hr ABPM was measured and patients were assigned to either Sham control or renal denervation, after 3 months primary endpoint; Office BP, ABPM and drug testing was done
  • Powered trial demonstrates that RDN lowers BP as compared to sham control in uncontrolled hypertensive patients in the absence of medications, in both 24-hr and office BP
  • Clinically meaningful BP reductions was shown at 3 months and treatment is always on for 24 hours, independent of patient adherence to medication, showed consistent BP reduction during nighttime when CV risk is highest
  • Trial showed no major device or procedure related safety events through 3 months
  • Spyral Htn-off Med trial is enrolling


Randomized Clinical Trial of Pre-hospital Sodium Nitrite In Out-of-hospital Cardiac Arrest Patients

By: Francis Kim

Key Points

  • Survival from Out of hospital cardiac arrest (OHCA) is less than 20% and administration of sodium nitrate during resuscitation increased survival by nearly 505 in animal model of cardiac arrest
  • The objective of the trial was to determine whether sodium nitrate given during resuscitation improves outcomes from out of hospital cardiac arrest
  • It is a double blind trial and patients were randomised in 1:1:1 ratio received 60 mg sodium nitrite, 45 mg of sodium nitrite or placebo
  • The trial occurred in 18 months of period. 2264 patients were included in the study, finally 1492 patients were enrolled in which 497 patients received 60mg nitrite, 499 patients received 45 mg nitrite and 496 patients received placebo
  • The primary outcome of the study was survival to hospital admission and secondary outcome was survival to discharge
  • Sodium nitrite for out of hospital cardiac arrest did not significantly improve survival to hospital admission or to discharge
  • Sodium nitrite is not associated with substantive or significant adverse effects on hemodynamics


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ACC 2.0 World Congress of Cardiology Conference 2020 Day 1 http://digimedupdates.com/acc2020/ http://digimedupdates.com/acc2020/#respond Sun, 29 Mar 2020 12:23:04 +0000 http://digimedupdates.com/?p=1959

The VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) Trial

By: Paul Wayne Armstrong

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • Despite optimal guideline based treatment, patients with chronic heart failure (HF) have a substantial risk of death or HF hospitalization after a recent worsening HF event
  • Vericiguat increases sGC activity to improve myocardial and vascular function
  • The objective of the study was to assess whether vericiguat reduces the primary composite outcome of cardiovascular death or first HF hospitalization
  • Secondary outcomes were:
  • Components of the primary composite outcome
  • Total HF hospitalizations; first and recurrent
  • Composite of all-cause mortality or first HF hospitalization
  • All-cause mortality
  • Also, the safety and tolerability of vericiguat in this high risk population with HF with reduced EF (HFrEF) was evaluated
  • VICTORIA enrolled a very high risk HF population with significant unmet needs not well addressed by prior HF studies
  • Vericiguat engages a new therapeutic target by enhancing the cyclic GMP pathway
  • Vericiguat achieved clinically meaningful absolute primary event reduction of 4.2/100 patient-years in the presence of guideline based care
  • NNT for one year to prevent 1 primary outcome event is ~24 patients in this high risk HFrEF population followed for 10.8 months
  • Because vericiguat is a once daily medicine, easy to titrate, generally safe and well tolerated, without the need for monitoring renal function or electrolyte, it may play a useful role in patients with a recent worsening heart failure event


Rivaroxaban for Prevention of Cardiovascular and Limb Events After Lower Extremity Revascularization: Primary Results of the Voyager Pad Randomized Trial

By: Marc P. Bonaca

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • The patients undergoing peripheral revascularization showed high risk of major adverse limb events and outcomes after hospitalization are poor with ~15% disabled or dead
  • Despite the high risk, currently there is no proven antithrombotic strategy that has demonstrated efficacy for reducing major adverse limb and cardiovascular events after peripheral intervention for ischemia
  • The objective of the study was to test whether rivoroxaban 2.5 mg twice daily added to low dose aspirin reduces the risk of major adverse limb and cardiovascular events compared to aspirin alone in PAD (Peripheral artery disease) patients undergoing lower extremity revascularization for ischemic symptoms
  • And to evaluate the safety of rivaroxaban 2.5 mg twice daily added to low dose aspirin compared to aspirin alone
  • In symptomatic PAD after revascularization, ~1 in 5 have acute limb ischemia, major amputation of vascular etiology, MI, ischemic stroke or cardiovascular death at 3 years
  • Rivoraxaban 2.5 mg twice daily with aspirin compared to aspirin alone showed benefits apparent early and continued over time, consistent benefit across major subgroups and broad benefits including reductions in unplanned index limb revascularization
  • In VOYAGER PAD, there was a numerical increase in TIMI major bleeding and significantly increased ISTH major bleeding but no excess in intracranial or fatal bleeding
  • It prevents ~6 times as many ischemic events relative to bleeds caused in PAD patients after revascularization


Clinical Implementation of Clopidogrel Pharmacogenetics: The Tailor PCI Trial

By: Naveen L. Pereira

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • Clopidogrel is the most widely prescribed P2Y12 inhibitor after PCI
  • TAILOR PCI trial was carried out to assess whether does identifying loss of function CYP2C19 allele carriers and altering P2Y12 inhibitor therapy based on CYP2C19 genotype reduce ischemic outcomes
  • Tailor PCI study designed as a two arm, parallel, open label, international, multicentre, randomized superiority clinical trial and patients of ≥18 years of age who underwent PCI and needing 12 months of DAPT were included
  • Primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and severe recurrent ischemia within 1 year after index PCI
  • Secondary endpoint was major or minor bleeding as defined by the TIMI criteria
  • A genotype-guided oral p2Y12 inhibitor strategy compared with conventional clopidogrel therapy without point of care genotyping in CYP2C19 LOF patients with ACS and stable CAD undergoing PCI resulted in no significant difference in reducing ischemic events at 12 months based on the prespecified analysis plan and the 50% treatment effect that the study was powered to detect
  • Potential benefit of genotype-guided therapy appears greatest within 3 months after PCI and for reducing multiple ischemic events per patient


Practice Factors Affecting Cardiologists’ Wellbeing: The American College of Cardiology 2019 Well Being Study

By: Laxmi S. Mehta

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • ACC survey data from 2015 showed that more than 1 crore US cardiologists and fellows in training were burnout where almost 50% were stressed and less than one quarter were not burned out and not highly stressed. The highest level of burnout was among midcore cardiologists
  • The survey was sent to 19,348 ACC members in the 2019. 14,325 cardiologists were included in the survey and only 2,025 (14%) completed it
  • The burnout was assessed by Mini Z survey which included questions regarding medical errors, desire to change jobs
  • In 2019, >1/3 of US cardiologists reported being burned out – This has increased by 32% since 2015 and women and mid-career cardiologists are at higher risk of burnout
  • Burnout rates are higher in cardiologists who work longer hours or in a hectic work environment, plan to leave current practice and among those reporting medical errors
  • Among burned out cardiologist who plan to leave their job, desire to spend more time with family and work related factors (call, RVU, satisfaction scores) are frequently reported


Inclisiran Potently and Durably Reduces Ldl-c in A Pooled Analyses of Phase 3 Studies

By: R. Scott Wright

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • LDL-C lowering is the most effective intervention to change the course of ASCVD and FH yet substantial residual risk remains despite aggressive treatment with statins and other agents
  • Ezetimibe and monoclonal antibodies to PCSK9 are adjunctive strategies to reduce LDL-C and clinical events by multiple treatment guidelines
  • The objective of the study was to assess efficacy and safety of Inclisiran 284 mg compared to placebo in a pooled analysis of all Phase III trials
  • Patients were randomized 1:1 Inclisiran 284 mg vs. placebo with maximally tolerated statins
  • The study has 2 core endpoints; The primary endpoint is changes in LDL-C vs placebo at day 510 and average reduction over days 90-540 and secondary endpoint is change in LDL-C over time and changes in PCSK9 and other lipids
  • The safety and tolerability and exploratory endpoints (cardiovascular events) were also assessed
  • Inclisiran is a novel approach to reduce the level of LDL-C
  • With twice yearly administration, it provides robust and durable LDL-C reduction over 18 months on top of maximally tolerated oral therapies
  • Effects were consistent in patients with heFH, ASCVD, or ASCVD risk-equivalence
  • The safety profile was similar to placebo in a high risk population
  • Twice yearly administration will coincide with typical twice yearly patients visits with health care providers, thereby assuring treatment adherence


Integrating The Effect of Polygenic Scores, Low Density Lipoproteins and Systolic Blood Pressure On the Lifetime Risk of Cardiovascular Disease

By: Brian A. Ference

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • The objective of the study to evaluate how much lifetime risk of cardiovascular disease varies at all levels of a polygenic score (PGS) for CAD depending on difference in lifetime exposure to low-density lipoproteins (LDL) and systolic blood pressure (SBP)
  • To make inferences about how a PGS for CAD can be combined with information about LDL and SBP which are modifiable and the current targets of therapy to reduce risk
  • To directly inform individual screening and treatment decisions
  • To provide a potential framework for incorporating PGS for CAD into clinical medicine
  • 445,556 participants were enrolled in the UK Biobank and primary outcome i.e. major coronary event was assessed in 23,032 patients
  • Lifetime risk of cardiovascular disease varies substantially at all levels of a polygenic score for CAD depending on differences in lifetime exposure to LDL and SBP
  • Therefore, combining information about lifetime exposure to LDL and SBP with a PGS for CAD should more accurately estimate lifetime risk of cardiovascular disease, more accurately identify persons who may benefit from early interventions to reduce risk, and better estimate the potential benefit from early interventions because absolute lifetime risk of cardiovascular disease depends on PGS and lifetime exposure to LDL and SBP and clinical benefit depends on BOTH absolute risk and the absolute reduction in LDL or SBP achieved with treatment
  • When combined with LDL and SBP, a PGS for CAD has the potential to help personalize the prevention of cardiovascular disease by helping to identify persons who may benefit the most from early interventions to minimize the cumulative effects of lifetime exposure to LDL and SBP
  • This implies that the trajectory of cardiovascular risk predicted by a PGS can be reduced by lowering LDL and SBP


The Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes and Cardiovascular Disease: Insights from The Compass Trial

By: Deepak L. Bhatt

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • Prior ischemic events, stable cardiovascular disease increases CV death, MI, or stroke at 4 years as compared to patients with risk factors only
  • In Compass trial, 27,395 patients with stable CAD (Coronary artery disease) or PAD (Peripheral artery disease) were randomized one of three treatments:
  • Rivaroxaban 2.5 mg bid plus Aspirin 100
  • Rivaroxaban 5 mg bid
  • Aspirin 100 mg od
  • The Compass diabetes analysis measured effects in patients with diabetes at baseline versus without diabetes and patients were randomized to rivaroxaban plus aspirin versus placebo plus aspirin
  • Low-dose rivaroxaban plus aspirin reduce major CV events in stable atherosclerosis, irrespective of the presence or absence of diabetes, though absolte risk reductions were numerically larger with diabetes, including for all-cause mortality
  • There was a significant increase in major bleeding, but not in fatal or intracranial bleeding
  • The net clinical benefit when examining irreversible outcomes appeared numerically greater in those with diabetes
  • Use of dual pathway inhibition with low-dose rivaroxaban plus aspirin is particularly attractive in high risk patients such as those with diabetes

Cost-effectiveness of Low-dose Colchicine After Myocardial Infarction in The Colchicine Cardiovascular Outcomes Trial (COLCOT)

By: Michelle Samuel

ACC 2.0 World Congress of Cardiology Conference 2020

Key Points

  • COLCOT is randomized, double blind, placebo controlled trial in which 4,745 patients who had a myocardial infarction ≤30 days were enrolled and randomized 1:1 to low dose colchicine or placebo. Follow up was for 2 years
  • Primary composite endpoints were death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke and urgent hospitalization for angina leading to revascularization
  • The objective of the study was to assess the in-trial period and lifetime cost effectiveness of low dose colchicine compared to placebo in post MI patients on standard of care therapy
  • From the Canadian healthcare system perspective, the addition of low-dose colchicine (0.5 mg daily) to standard of care therapy after MI is economically dominant
  • Mean overall per patient costs reduced by 47% for the in-trial period and 69% for the lifetime period
  • Quality adjusted life years (QALYs) increased
  • From the US Medicare system perspective, low dose colchicine therapy post-MI was cost effective for the in-trial period and economically dominant at a price of <$5 per pill
  • From the US private insurance system perspective, low dose colchicine post-MI was economically dominant at ≤$5 per pill for the in-trial period and $4-6 per pill for the lifetime period
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FDA To Review Safety Assessment of Medications for Type 2 Diabetes http://digimedupdates.com/fda-to-review-safety-assessment-of-medications-for-type-2-diabetes/ http://digimedupdates.com/fda-to-review-safety-assessment-of-medications-for-type-2-diabetes/#respond Fri, 13 Mar 2020 11:27:56 +0000 http://digimedupdates.com/?p=1954

Newsdio, March 12, 2020

The United States Food and Drug Administration (FDA) has published new proposed guidance to the industry on assessing the safety of type 2 diabetes newer medications and withdrawn the 12-year “outdated” conditions for standardized cardiovascular outcome trials (CVOT).

The new proposal guides, “Type 2 Diabetes Mellitus: evaluating the Safety of New Medications to Improve Glycemic Control,” will exchange the December 2008 needs that manufacturers implement CVOT to eliminate an intolerable risk of cardiovascular safety. That alters followed issues expressed at the time about the thiazolidinedione class of glucose-lowering drugs.

Thereafter, the FDA has examined the results of several (CVOTs) conducted to comply with the December 2008 guidance recommendations. According to the federal registry announcement, none of the CVOTs up to now have detected an enhanced risk of ischemic cardiovascular events; some of the CVOTs have found a lower risk for cardiovascular events.

In October 2018, the FDA’s Endocrinological and Metabolic Drug Advisory Committee barely supported (10 to 9) to continue to require CVOT, but the majority of panel members also advised some changes which include more safety data requirements beyond cardiovascular events.

The FDA is examining the recommendations of the December 2008 guideline and is now offering a revised method to analyze the safety of new drugs and biologics to improve the glycemic control, based on CVOT results over the years and the panel’s recommendations, “

The FDA stated that the new draft proposal does not involve a recommendation that the sponsors of all new therapies for type 2 diabetes consistently eliminate a specific degree of risk of ischemic cardiovascular adverse outcomes.

Otherwise, the proposal requires at least 4,000 patient-years of exposure to the new drug in phase 3 trials and incorporation of study subjects with comorbid conditions and/or complications of diabetes, including minimum 500 with stage 3 chronic kidney disease, 4, 600 with determined cardiovascular disease, and minimum 600 over 65 years.

The FDA is requesting stakeholder input on these and other issues, including study duration, topic demographics, specific safety concerns, and event adjudication.

In a statement, Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research, stated that By following prior FDA recommendations, contributors have demonstrated that the new drugs for type 2 diabetes are not extremely risky for ischemic cardiovascular disease, which has granted encouraging cardiovascular safety evidence for millions of diabetes patients. Presently, with this proposed method, more comprehensive and valuable safety information for these medications can be provided.

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Sleep Irregularity and Risk of Cardiovascular Events – The Multi-Ethnic Study of Atherosclerosis http://digimedupdates.com/sleep-irregularity-and-risk-of-cardiovascular-events-the-multi-ethnic-study-of-atherosclerosis/ http://digimedupdates.com/sleep-irregularity-and-risk-of-cardiovascular-events-the-multi-ethnic-study-of-atherosclerosis/#respond Fri, 13 Mar 2020 09:04:06 +0000 http://digimedupdates.com/?p=1942

Huang T. JACC. 2020 Mar;75(9):991-99.

The cardiovascular system showed strong circadian rhythms to retained normal functioning. Irregular sleep schedules, specified by high day-to-day irregularity in sleep period or timing, may show milder however chronic disturbance of the circadian clock that is broadly pertinent over the population. Particularly, individuals who commonly modify their sleep period or sleep timing on a night-to-night basis may have greater cardiometabolic risk because of disturbed circadian functions. An actigraphy was used across several days to estimate sleep timing and duration over multiple nights for evaluation of sleep regularity. Greater irregularity in sleep duration or timing is correlated with unfavourable metabolic profiles, such as higher blood pressure, dysregulated blood lipids, and insulin resistance. Since these adverse metabolic factors are precursors and strong forecasters for CVD, irregular sleep may enhance CVD risk via affecting metabolic health, in addition to its direct effect on the inherent rhythmicity of the cardiovascular system. The general population showed irregular sleep schedules, characterized by high day-to-day irregularity in sleep duration or timing and represent possibly milder however much more common and chronic disturbance of circadian rhythms as compared to shift work. Thus, Huang T et al., conducted a prospective study to analyse the correlation among sleep regularity and risk of cardiovascular disease (CVD).

The data was collected from the MESA (Multi-Ethnic Study of Atherosclerosis) group, a prospective study of clinical and subclinical risk factors for the development of atherosclerosis. 6,814 white (38%), African American (28%), Hispanic (22%), and Chinese American (12%) participants aged 45 to 84 years who were free of clinical CVD were enlisted from 6 field centers across the United States in 2000 to 2002. Participants wore the Actiwatch Spectrum wrist actigraph on their nondominant wrist for 7 continuous days, while also displaying their sleep and wake times in the following sleep diary. 2 SD measures were considered to estimate sleep regularity: 1) 7-day SD in sleep duration; and 2) 7-day SD in sleep-onset timing. Incident cardiovascular occurrences were recognised by telephone interviews held every 9 to 12 months as well as at each MESA follow-up analysis. The primary endpoint was incident total CVD events, which incorporated myocardial infarction, CHD death, resuscitated cardiac arrest, angina followed by revascularization, stroke, stroke death, and other atherosclerotic or CVD deaths. The secondary endpoint was the occurrence of a hard CVD effect that comprised of fatal and nonfatal CHD and stroke. Cox proportional hazards regression was used to analyse HRs and 95% CIs for occurrence CVD in association to quantify sleep regularity.

786 (39.5%) patients showed sleep duration SD of >90 min and 510 (25.6%) had sleep-onset timing SD >90 min from 1,992 MESA participants. A total of 111 incident total CVD occurrences arose after a median follow-up of 4.9 years (including 35 myocardial infarctions, 16 CHD deaths, 30 strokes, 17 other coronary events, and 13 other atherosclerotic or CVD deaths), providing an overall occurrence rate of 11.8 per 1,000 person-years. In unadjusted analysis, after adjustment for CVD risk factors (model 2), the risk for incident CVD enhanced continuously with elevating sleep duration irregularity. Compared with sleep duration SD ≤60 min, the HRs (95% CIs) were 1.07 (0.61 to 1.88) for sleep duration SD 61 to 90 min, 1.54 (0.89 to 2.65) for 91 to 120 min, and 2.02 (1.20 to 3.39) for >120 min. Sleep duration SD as a continuous variable showed that every 1-h rise in sleep duration SD was correlated with 36% greater CVD risk (95% CI: 1.07 to 1.73; p = 0.02). The multivariable-adjusted HRs (95% confidence intervals) for CVD over categories of sleep duration SD were 1.00 (reference) for ≤60 min, 1.09 (0.62 to 1.92) for 61 to 90 min, 1.59 (0.91 to 2.76) for 91 to 120 min, and 2.14 (1.24 to 3.68) for >120 min (p = 0.002). Similarly, the HRs (95% confidence intervals) for CVD, compared with participants with a sleep timing SD ≤30 min, were 1.16 (0.64 to 2.13) for 31 to 60 min, 1.52 (0.81 to 2.88) for 61 to 90 min, and 2.11 (1.13 to 3.91) for >90 min (p = 0.002). The HRs (95% CIs) for CVD, compared with sleep-onset timing SD ≤30 min after adjusting for CVD risk factors and sleep-related factors (model 3) were 1.16 (0.64 to 2.13) for 31 to 60 min, 1.52 (0.81 to 2.88) for 61 to 90 min, and 2.11 (1.13 to 3.91) for >90 min, with 18% higher risk (95% CI: 1.06 to 1.31) for every 1-h rise in sleep-onset timing SD (p = 0.002). (Table 1)

Thus, it was concluded that new risk factors for CVD are variable sleep duration and timing, independent of traditional CVD risk factors and sleep quantity and/or quality.

Table 1: Associations of 7-Day Variability in Sleep Duration and Sleep-Onset Timing with Risk of Total Cardiovascular Disease

Figure 1: Regular and Irregular Sleep Patterns in Relation to Cardiovascular Disease Risk

HR: Hazard ratio; CI: Confidence interval

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Comparison of Prognostic Significance between Serum Fibrinogen and Global Registry of Acute Coronary Events Score for Prognosis of Patients with Non-ST-elevation Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention http://digimedupdates.com/comparison-of-prognostic-significance-between-serum-fibrinogen-and-global-registry-of-acute-coronary-events-score-for-prognosis-of-patients-with-non-st-elevation-acute-coronary-syndromes-undergoing-pe/ http://digimedupdates.com/comparison-of-prognostic-significance-between-serum-fibrinogen-and-global-registry-of-acute-coronary-events-score-for-prognosis-of-patients-with-non-st-elevation-acute-coronary-syndromes-undergoing-pe/#respond Thu, 12 Mar 2020 12:02:35 +0000 http://digimedupdates.com/?p=1936

Song J. Coron Artery Dis. 2020 Mar;31(2):124-129.

Non-ST-elevation acute coronary syndrome (NSTE-ACS) assigns to a range of acute conditions resisting acute myocardial ischemia and infarctions that are common because of a sudden decrease in myocardial coronary blood flow. There is rising evidence that an increased fibrinogen (FIB) level is a predictor of adverse effects of coronary heart disease and is closely associated with cardiovascular disease (CVD) and cardiovascular risk factors. Current studies largely concur that FIB is an independent predictor of long-term prognosis in patients undergoing PCI, however, research is lacking on patients with NSTE-ACS. Thus, Song J et al., conducted a study to evaluate whether FIB is a useful predictor for long-term prognosis in patients with NSTE-ACS undergoing PCI. Furthermore, the prognostic precision of FIB was compared with the GRACE score.

The study was an evaluation of prospective group successive patients with NSTE-ACS who were hospitalized and underwent PCI from 1 January 2015 to 31 December 2016. The venous blood samples of patients were accumulated in a sodium citrate tube and stored at room temperature on the first day after admission (and before each patient underwent PCI); all samples were analysed within 120 minutes of blood collection. Preoperative FIB levels were estimated with the Von Clauss method and ACL-TOP automatic hemagglutination. The left ventricular ejection fraction (LVEF) was calculated by echocardiography during hospitalization. PCI was executed as per the current guideline recommendations after validation of NSTE-ACS. The precision of serum FIB concentrations and the GRACE score for anticipating clinical endpoints were examined according to the area under the ROC (AUC) curve and compared by a nonparametric test. ROC-AUC values of higher than 0.5, 0.75, and 0.93 were contemplated with fair, good, and very good accuracy, respectively.

1211 consecutive patients were selected from a large hospital in northeast China and 84 patients were lost to follow-up. The cutoff value for FIB to anticipate all causes of death was 3.49 with an AUC of 0.71, the sensitivity of 0.92, and specificity of 0.681 by ROC curve analysis (p < 0.001; Figure 1). Hence, the enlisted patients were classified into a low FIB group (n = 826, FIB ≤ 3.49 mg/dL) and a high FIB group (n = 385, FIB > 3.49 mg/dL). Patients with a high serum FIB level exhibited substantially greater rates of hypertension and diabetes, and higher GRACE scores, leukocyte counts, platelet counts, cardiac troponin-I, creatinine, and HbA1c as compared to those with a low serum FIB level. At the one year follow-up, 31 deaths and 43 death/nonfatal reinfarctions arose in the study group. The increased baseline FIB level was a substantial variable in association to death and death/nonfatal reinfarction in patients who underwent PCI in univariate analysis (HR = 1.949, p = 0.001; HR = 1.693, p = 0.003, respectively). The increased baseline FIB level maintained this correlation with a greater rate of death/nonfatal reinfarction after adjusting for covariates (HR = 1.498, 95% CI: 1.030–2.181, p = 0.035). A ROC curve evaluation was executed and the AUC with a 95% CI was obtained to estimate the diagnostic value of serum FIB levels. The ROC-AUC of serum FIB and the GRACE score for anticipating death/nonfatal reinfarction was 0.621 and 0.699, respectively. The serum FIB showed similar prognostic performance to the GRACE system for predicting death or nonfatal reinfarction (C-statistic: z = 1.486, p = 0.14; Figure 2).

Thus, it was concluded that in patients with NSTE-ACS undergoing PCI, the plasma FIB level is a useful biomarker to anticipate death or nonfatal reinfarction within one year. FIB levels show definitive accuracy and an anticipating value as compared to the GRACE score.

Figure 1: Receiver operating characteristic curve of all-cause mortality predicted by fibrinogen

Figure 2: Receiver operating characteristic curves of fibrinogen and the GRACE risk score for death and death/nonfatal reinfarction prediction.

PCI: Percutaneous coronary intervention; GRACE: Global Registry of Acute Coronary Events; ROC: receiver operating characteristic; AUC: Area under the curve; HbA1c: Hemoglobin A1c; HR: Hazard ratio

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Risk Factors, Incidence, and Outcomes of Cardiac Arrhythmia among Autologous Stem Cell Transplant Recipients http://digimedupdates.com/risk-factors-incidence-and-outcomes-of-cardiac-arrhythmia-among-autologous-stem-cell-transplant-recipients/ http://digimedupdates.com/risk-factors-incidence-and-outcomes-of-cardiac-arrhythmia-among-autologous-stem-cell-transplant-recipients/#respond Thu, 05 Mar 2020 13:02:54 +0000 http://digimedupdates.com/?p=1932

Morey C. Biol Blood Marrow Transplant. 2020 Mar;26(3):S148.

The occurrence of arrhythmias has been reported to be as high as 9-27% in an autologous or allogeneic transplant. Thus, Morey C. et al., conducted a retrospective study of only autologous transplant recipients to analyse the occurrence of arrhythmia, predisposing factors and effects in the first 30 days post-transplant. 

959 charts of autologous transplant recipients were reviewed during the years 2010-2015 at the University of Kansas. A Multiple Myeloma, Non-Hodgkin’s Lymphoma, Hodgkin’s Lymphoma, Germ Cell Tumor, and CNS Lymphoma were diagnosed. 

80 patients (8%) developed an arrhythmia in the first 30 days of transplant. 90% of the cases exhibited atrial fibrillation; was most common. Risk factors incorporated age, 51% of patients were 60 years or older. Preexisting conditions showed hypertension in 48% and a history of arrhythmia in 34% of the patients. Other precipitating factors were hypokalemia (41%) and neutropenic fever (46%) between those who progressed arrhythmia. No correlation was shown among the underlying disorder or conditioning regimen with the risk of cardiac arrhythmia in the group. The median length of hospital stay was extended to 20 days among those with cardiac arrhythmia as compared to a median of 14 patients without arrhythmia, inclusive of 11 patients who needed ICU transfer. The overall cost including cardiology consultation was determined which was incurred by patients with arrhythmia.

Thus, it was concluded that autologous transplant recipients exhibited a persistent risk, enhanced morbidity, and extended hospital stay in the modern transplant era. The age, hypertension, electrolyte imbalance and neutropenic fever were the main risk factors. Renal dysfunction was shown as an additional risk factor by other studies. Prospective studies are authorized to organize risk models for arrhythmia and beneficial therapeutic interferences.

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9 Ways to Cut Salt http://digimedupdates.com/9-ways-to-cut-salt/ http://digimedupdates.com/9-ways-to-cut-salt/#respond Wed, 04 Mar 2020 12:42:32 +0000 http://digimedupdates.com/?p=1926
  1. Choose foods wisely

Instead of what numerous people could assume, table salt isn’t the prime culprit. Maximum of the sodium that people eat above 70% adapted from packaged and restaurant foods.

  1. Be label savvy

Take the time to cautiously understand the Nutrition Facts labels on food boxes and compare foods. The quantity of sodium per serving is indicated on most packaging (written as a percentage of the recommended daily amount).  As a global rule, experts suggest selecting products with 5% daily value or less of sodium and avoid or restricting products with a sodium content of 20% or more per serving. Look for alternatives that are “low-sodium,” “no salt added,” “sodium-free” and “unsalted.” 

  1. Be mindful of salt in prepared and restaurant foods

Quick grab-and-go foods, takeout, and restaurant food tend to be high in sodium. When eating outside, don’t hesitate about asking if food can be made with less or no salt. Also, ask for salad dressing to be served on the side. The best chance is to make more meals at home so that people can better control and monitor their sodium intake.

  1. Pick healthy snacks

Try to keep snacks that boost good health. An unlocked bag of chips or other flavourful snack tends to finish quickly, and these salty snacks are packed with sodium. Instead, select fresh fruits and vegetables.

  1. Watch out for canned foods

Canned food items particularly soups are usually packed with salt to conserve color and taste. Some experts suggest rinsing canned foods before eating them, whether beans, tuna or vegetables, to assist removal of some of the sodium.

  1. Spice up your recipes

Do not hesitate to utilize other types of seasonings. Try a bit of herb and spices, squeeze in some fresh lemon or lime, or add some crushed ginger or garlic. These dishes will add flavor to recipes without adding sodium.

  1. Think twice before adding a dash of salt

A salt shaker has always been essential in most kitchens and on tables. Rather than keeping salt shaker close to hand, try locating it in a cabinet out of reach.

  1. Ask your providers about salt substitutes

The jury concerns whether these products are safe for specific people, so ensure to ask before utilizing them. 

  1. Get advice from a nutritionist

If you need support for meal planning and learning more regarding how to reduce sodium intake, consider seeing a nutritionist or dietitian. The DASH diet is also a popular eating plan to help limit salt.

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Statin Therapy is associated with Better Ambulatory Blood Pressure Control: A Propensity Score Analysis http://digimedupdates.com/statin-therapy-is-associated-with-better-ambulatory-blood-pressure-control-a-propensity-score-analysis/ http://digimedupdates.com/statin-therapy-is-associated-with-better-ambulatory-blood-pressure-control-a-propensity-score-analysis/#respond Mon, 02 Mar 2020 13:37:47 +0000 http://digimedupdates.com/?p=1921

Spannella F. J Hypertens. 2020 Mar;38(3):546-552.

Hypercholesterolemia and hypertension normally coexist, serving as the prime alterable cardiovascular risk factors. In order to decrease the load of cardiovascular morbidity and mortality, an efficacious control of hypertension and dyslipidemia should be followed in clinical practice. The long-term advantageous impacts of statins on cardiovascular morbidity and mortality have been clearly showed and statin therapy is a cornerstone therapy of dyslipidemia. In several previous studies, statin therapy was correlated to lower BP values on hypertensive patients in addition with the reduction of blood cholesterol. But, most of these studies considered only office BP values with mixed consequences. But several confounding factors, such as the different antihypertensive drugs taken by patients influenced the relationship among ambulatory BP and statin treatment. Spannella F, et al., conducted a study to analyse the correlation among statin therapy and ambulatory BP control in a wide population of outpatients mentioned to hypertension centre. Also, a propensity score matching analysis was executed to decrease the effect of the possible confounding factors.

1827 consecutive outpatients were enrolled from January 2016 and December 2018 in a retrospective study. The inclusion criteria were as follows: essential hypertensive patients aged at least 18 years, a valid 24-h ambulatory blood pressure monitoring (ABPM), no changes in both antihypertensive and statin therapy in the previous 3 months. The following clinical parameters were analysed: patients’ medical history, laboratory measurements, anthropometric measurements, ABPM parameters and drug therapy. Three sequential oscillometric automatic BP measurements were performed on both arms concurrently with a validated device in the clinical visit. All patients with lipid-lowering therapy took their statin between 1800 and 2200 h. Antihypertensive treatment intensity (ATI) was determined to compare different drug correlations. A propensity score matching was used to compare two equally-sized groups of patients with similar characteristics as per the statin therapy. Matching was executed on log-transformed propensity score in a 1 :1 fashion with a caliper of 0.1, considering the different baseline characteristics among statin and no-statin group.

Mean age of patient was 58.1±13.8 years, with male prevalence (55%). 402 (22.0%) patients were on statin therapy. Patients on statin therapy were older and they had both greater BMI and prevalence of type 2 diabetes mellitus, as compared to no-statin group. They also had greater prevalence of previous CAD (12.7 vs. 0.7%, p<0.001) and TIA/stroke (13.7 vs. 4.1%, p<0.001), as well as lower eGFR, as compared to the no-statin group. Additionally, they took more antihypertensive drugs (2.4±1.3 vs. 1.5±1.2, p<0.001), independently from the pharmaceutical class, and they also had a greater ATI. Hence, patients on statin therapy had lower TC and LDLc. 776 (42.5%) patients had 24-h BP control. In office SBP, no difference was seen among statin and no-statin group (132.5±16.2 vs. 133.3±14.9 mmHg, p=0.354), although statin group had lower office DBP (74.4±9.9 vs. 81.1±10.5mmHg, p<0.001). No correlation was seen between office BP control and statin therapy (67.3 vs. 65.3%, p=0.480). Patients on statin treatment had lower 24-h, daytime and night-time BP as compared to patients who did not take a statin, with a higher difference for DBP (Fig. 1, panels a–c). The statin group also showed higher 24-h PP (55.6±11.9 vs. 51.3±10.2 mmHg, p<0.001). Simultaneously, statin treatment was correlated with a better ambulatory BP control (58.7 vs. 37.9%, p<0.001 for 24-h BP control; 61.7 vs. 43.4%, p<0.001 for daytime BP control; 46.5 vs. 29.8%, p<0.001 for night-time BP control). 369 patients on statin treatment were matched with as many untreated patients. The consequences were confirmed even in the propensity score matched groups. Statin treatment was correlated with lower 24-h, daytime and night-time BP, despite statistical non-significance for 24-h and daytime SBP (Fig. 1, panels d–f). Patients on statin therapy had a greater prevalence of ambulatory BP control as compared to patients not taking statins [60.6 vs. 46.2%, p<0.001, OR 1.8 (95% CI 1.3– 2.4) for 24-h BP control; 63.3 vs. 51.6%, p=0.001, OR 1.6 (95% CI 1.2–2.2) for daytime BP control; 46.2 vs. 33.2%, p<0.001, OR 1.7 (95% CI 1.3–2.3) for night-time BP control].

Thus, it was concluded that statin therapy is correlated with superior ambulatory BP control in essential hypertensive patients. The intensity of the antihypertensive therapy or the evaluation of various cofactors did not influence the consequence.

Figure 1: Ambulatory blood pressure and statin therapy. Panel a: 24-h blood pressure and statin therapy in the study population. Panel b: daytime blood pressure and statin therapy in the study population. Panel c: night-time blood pressure and statin therapy in the study population. Panel d: 24-h blood pressure and statin therapy in propensity score matched groups. Panel e: daytime blood pressure and statin therapy in propensity score matched groups. Panel f: night-time blood pressure and statin therapy in propensity score matched groups.

BP: Blood pressure; BMI: Body mass index; CAD: Coronary artery disease; TIA: Transient ischemic attack; TC: Total cholesterol: LDL-c: Low-density lipoprotein cholesterol; eGFR: estimated Glomerular filtration rate; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; PP: Pulse pressure; OR: Odd ratio; CI: Confidence interval

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Antihypertensive Medication Adherence and Confirmation of True Refractory Hypertension http://digimedupdates.com/antihypertensive-medication-adherence-and-confirmation-of-true-refractory-hypertension/ http://digimedupdates.com/antihypertensive-medication-adherence-and-confirmation-of-true-refractory-hypertension/#respond Fri, 28 Feb 2020 07:39:28 +0000 http://digimedupdates.com/?p=1915

Siddiqui M. Hypertension. 2020 Feb;75(2):510-515.

Refractory hypertension (RfHTN) is a phenotype of antihypertensive therapy failure described as uncontrolled BP (≥130/80 mm Hg), regardless of adequate doses of 5 or more different classes of antihypertensive medications incorporating a long-acting thiazide-like diuretic (chlorthalidone) and a mineralocorticoid receptor antagonist (MRA). Patients with RfHTN are more likely to be female, African-American, and have greater rates of cardiovascular complications as compared to patients with controlled resistant hypertension (RHTN), inclusive of stroke, left ventricular hypertrophy, and congestive heart failure. White coat effect impacting only 6.5% of patients with RfHTN, is unusual in such patients. Medication nonadherence would be inflated in patients with apparent RfHTN, because patients with apparent RfHTN needed at least 5 different antihypertensive class of medications. To test that hypothesis, Siddiqui M et al., conducted a study to analyse antihypertensive medication adherence in patients with apparent RfTHN by estimating urinary drug or drug metabolite levels with high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Patients enlisted between April 2014 and July 2019 was assigned to the UAB Hypertension Clinic for uncontrolled resistant hypertension. Patients were analysed for secondary causes of hypertension, incorporating hyperaldosteronism, pheochromocytoma, and renal artery stenosis as clinically specified. Automated office BP (AOBP) was estimated following at least 5 minutes of quiet rest in a sitting position with the back supported and the arm supported at heart level. The BpTRU device was used to estimate the office BP, which automatically acquires 6 serial BP readings, 1 minute apart, before displaying the average of the last 5 reading. In 24-hour ambulatory blood pressure monitoring (ABPM), 21,22 recordings were made every 20 minutes in the awake (day-time) and every 30 minutes in the night-time (asleep) phases of the 24-hour period. Awake and asleep times were estimated by patient self-report.

Based on uncontrolled AOBP, 54 patients were recruited in the study. Of these, 49 patients had valid 24-hour ABPM readings and 45 patients completed 24-hour urine collections to analyse antihypertensive medication adherence. Out of the 45 patients, 40 (88.9%) patients showed confirmed RfHTN based on an increased AOBP (≥130/80 mm Hg), mean 24-hour ABP (≥125/75 mm Hg), and mean awake (day-time) ABP (≥130/80 mm Hg), while 5 patients showed a white-coat effect. The mean age of patients with RfHTN was 53.0±8.3 years, 65.0% were female and 85.0% were African-American. The mean BMI was 36.0±6.4 kg/m2. The prevalence of dyslipidemia and diabetes mellitus was 52.5% and 50.0%, respectively. The mean serum sodium was 138.3±2.9 mMol/L, serum creatinine was 1.1±0.4 mg/dL, and serum potassium was 4.0±0.5 mMol/L. The mean systolic and diastolic AOBP were 151.1±23.5/89.9±13.8 mmHg. The mean AOBP heart rate were 76.7±12.0 beats/minute. The mean 24-hour systolic and diastolic BP were 157.5±21.4/89.5±13.0 mmHg. The mean 24-hour heart rate was 75.4±11.3 beats/minute. The mean awake (day-time) systolic and diastolic BP were 161.0±21.2/92.4±14.4 mmHg. The mean awake (day-time) heart rate was 76.8±11.4 beats/ minute. The mean asleep (night-time) systolic and diastolic BP were 150.3±23.1/83.7±13.8 mm Hg. The mean asleep (night-time) heart rate was 71.9±12.8 beats/minute. 16 (40.0%) were completely adherent with all of their prescribed antihypertensive medications from the 40 patients with RfHTN who were fully analysed; 18 (45.0%) were partially adherent, taking less than the number of prescribed agents; and 6 (15.0%) were completely nonadherent with any of prescribed medications. From the 18 patients who were partially adherent, 5 (12.5%) were adherent with 5 or more antihypertensive medications, including an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, a calcium channel blocker, chlorthalidone, and MRA. 52.5% patients were adherent with 5 or more antihypertensive medications, inclusive of chlorthalidone and an MRA, accordant with true RfHTN. Altogether, adherence for the different antihypertensive medication classes or agents was 79.2% for angiotensin-converting enzyme inhibitors, 75.0% for angiotensin II receptor blockers, 72.5% for calcium channel blockers, 70.0% for chlorthalidone, 67.5% for MRA (Spironolactone or Eplerenone), 57.1% for α-β blockers, and 64.7% for α-2 agonists. The patients with refractory hypertension were categorised into complete, partial, and nonadherence based on antihypertensive medication adherence. The mean number of antihypertensive medications prescribed was 5.5±0.6, 5.8±0.7, and 6.2±0.8 in the above groups, respectively, while the mean number of antihypertensive medications identifed was 5.5±0.6, 3.8±1.3, and 0 in the above groups, respectively (Figure 1).

Thus, it was concluded that RfHTN is a rare, however true phenotype of antihypertensive treatment failure as 52.5% of patients recognized as having apparent RfHTN, were adherent with at least 5 antihypertensive medications, inclusive of chlorthalidone and a mineralocorticoid receptor antagonist, validating true RfTHN.

Figure 1: Antihypertensive medication adherence in refractory hypertensive patients

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