News | Atrial Fibrillation | March 29, 2020

POPULAR TAVR Shows Oral Anticoagulants Alone in AF Patients Reduces Bleeding Post TAVR

ACC late-breaker shows OAC can be used safely in 30 percent of TAVR patients with atrial fibrillation

POPULAR TAVR trial Shows Oral Anticoagulants Alone in atrial fibrillation  (AF) Patients Reduces Bleeding Post TAVR, transcatheter aortic valve replacement. #ACC20 #ACC2020

March 29, 2020 — Patients with atrial fibrillation (AF) who took oral anticoagulants alone after undergoing transcatheter aortic valve replacement (TAVR) had a lower rate of bleeding complications without an increased risk of clotting-related complications compared to patients who took antiplatelet medication in addition to oral anticoagulants. This was the outcome of the POPULAR TAVR trial, presented as a late-breaking session at the American College of Cardiology (ACC) 2020 Scientific Session.[1]

About 30 percent of patients who undergo TAVR have AF, and there have not been any guidelines on how to treat these patients, who require anticoagulation therapy to prevent AF-caused stroke. This trial offers new data on how these patients can be managed.

The new study, antiplatelet therapy for Patients undergoing Transcatheter Aortic Valve Implantation (POPular-TAVI), is the first randomized trial designed to assess the safety of oral anticoagulants alone as compared to using antiplatelet drugs alongside oral anticoagulants for managing TAVR complication risks in these patients. Anticoagulants work by interfering with proteins involved in the formation of blood clots, while antiplatelet drugs prevent platelets, a type of blood cell, from clumping together.

“The rates of complications for TAVR — especially complications related to bleeding — remain high,” said Vincent Nijenhuis, M.D., from the cardiology department at St. Antonius Hospital in Nieuwegein, Netherlands, and the study’s lead author. “This study helps physicians to better understand the risks of adding antiplatelet therapy to oral anticoagulants—namely, that doing so leads to more bleeding without reducing the rate of ischemic events. I think once physicians are aware of this, they will not treat patients undergoing TAVR so aggressively, leading to better outcomes.”

Both bleeding and clotting-related complications (such as stroke and heart attack) can be life threatening, especially among patients undergoing TAVR, who are generally older, have multiple comorbid conditions and are frailer than those who undergo open heart valve replacement. In focusing on patients with atrial fibrillation, who typically take oral anticoagulants for many years, the trial sought to address how best to balance the risk of clots against the increased risk of bleeding that comes with any anticoagulant or antiplatelet therapy.

Researchers enrolled 313 patients with atrial fibrillation undergoing TAVR at 17 sites in four European countries. Half were assigned to take oral anticoagulants alone and half took the antiplatelet drug clopidogrel for three months after TAVR in addition to oral anticoagulants.

At 12 months, those taking oral anticoagulants alone were significantly less likely to suffer bleeding complications than those who took oral anticoagulants plus clopidogrel, meeting the trial’s prespecified composite primary endpoint. The first component of the composite primary endpoint, all bleeding as  assessed with the Valve Academic Research Consortium (VARC) definition, occurred in 21.7 percent of those receiving only oral anticoagulants and 34.6 percent of those receiving clopidogrel. The second component, nonprocedural bleeding as assessed with the Bleeding Academic Research Consortium (BARC) criteria, occurred in 21.7 percent of those receiving only oral anticoagulants and 34 percent of those receiving clopidogrel. This reflects a 43 percent reduction in the rate of bleeding complications among those taking oral anticoagulants alone.

In a secondary analysis, patients taking oral anticoagulants alone did not show an increased risk of clotting-related complications, meeting the trial’s prespecified secondary endpoint for non-inferiority. A composite of cardiovascular death, ischemic stroke and heart attack occurred in 13.4 percent of those receivingonly oral anticoagulants and 17.3 percent of those receiving clopidogrel, while a composite of those outcomes plus non-procedural bleeding occurred in 31.2 percent of patients receiving only oral anticoagulants and 45.5 percent of patients receiving clopidogrel.

“The results suggest it would be beneficial to not give clopidogrel — in fact, it’s safer because it does not lead to as many bleeding events,” Nijenhuis said.

The study is limited by its open label design, which means patients and doctors were aware of which patients had been randomized to receive clopidogrel versus oral anticoagulants alone, although outcomes were adjudicated by independent evaluators who were blinded to patients’ treatment status. In addition, Nijenhuis said that the study’s findings are only applicable to patients with atrial fibrillation. The researchers are assessing antiplatelet management in patients without atrial fibrillation in a separate cohort of the ongoing POPular TAVI study. Other studies are underway to assess other types of anticoagulation medications such as direct oral anticoagulants.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The trial was funded by The Netherlands Organization for Health Research and Development

 

Find more news from ACC 2020.

 

Reference:

1. Vincent J. Nijenhuis, M.D., Jorn Brouwer, M.D., Ronak Delewi, et al. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. NEJM. Published online March 29, 2020. DOI: 10.1056/NEJMoa1915152.

Related Content

The American College of Cardiology (ACC) released a list of the latest practice-changing presentations at the ACC.20 annual meeting March 28-30, 2020, in Chicago. This includes five late-breaking clinical trial (LBCT) sessions and three featured clinical research sessions. There also are two LBCT deep-dive sessions where the experts will break down the hottest trials and attendees can find out what the impact might be on the practice of cardiology and patients.
Feature | ACC | April 09, 2020 | Dave Fornell, Editor
Here is the list of American College of Cardiology (ACC) practice-
ACC Cancels 2020 Conference Amid Coronavirus Concerns. #COVID19 #coronavirus #2019nCoV
Feature | ACC | March 09, 2020 | Dave Fornell, Editor
March 9, 2020 — Less than week after the American College of Cardiolog...
American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair

Image courtesy of Massachusetts General Hospital

News | ACC | October 08, 2019
Douglas Drachman, M.D., FACC, has been selected as the next vice chair of the American College of Cardiology’s (ACC)...
SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions. FFR in the cath lab.

SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions.

Feature | ACC | March 27, 2019 | Greg Freiherr, Contributing Editor
The fingerprints of value-added medicine were all over products and works-in-progress on the exhibit floor of the a

The opening late-breaking trial at ACC 2019 is the Apple Heart Study, a large-scale, app-based study to identify atrial fibrillation using a smartwatch. Earlier, smaller trials showed this approach might be used in a population health application to proactively identify AFib patients earlier.

Feature | ACC | March 19, 2019
The American College of Cardiology (ACC) released a list of the late
A patient who received HeartMate III LVAD system at ACC.18. The HeartMate 3 was the topic of of the the key late-breaking trials at #ACC18

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC.18. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at this year's conference.

Feature | ACC | March 27, 2018 | Dave Fornell
There were several notable presentations of new data on cardiovascular technologies at the recent 2018 American Colle
Drug Stops Dangerous Bleeding in Patients Taking Factor Xa Inhibitors

Connolly 

News | ACC | March 22, 2018
March 22, 2018 — The experimental drug...
Videos | ACC | March 21, 2018
DAIC Editor Dave Fornell takes a tour of some of the most interesting new technologies on the expo floor at
ACC 2018 Late-Breaking Trials Announced
News | ACC | March 21, 2018
Here is a list of the American College of Cardiology (ACC) 2018 annual meeting late-breaking clinical trials presente
Inhaled Therapy Ineffective in Difficult-to-Treat Heart Failure at ACC 2018.

Image from presentation, "Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF: The INDIE-HFpEF Trial," Borlaug

News | ACC | March 20, 2018
March 20, 2018 — Four weeks of treatment with a novel inhaled medication failed to improve exercise capacity, daily a