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