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March 29, 2020

POPular-TAVI Trial Evaluates Risk of Antiplatelet Drugs for TAVR Patients With Atrial Fibrillation

March 29, 2020—Patients with atrial fibrillation 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 in the POPular-TAVI trial presented by Vincent Nijenhuis, MD, at the virtual American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).

Dr. Nijenhuis, the study's lead author, and Jurrien ten Berg, MD, the study's principal investigator, are from the cardiology department at St. Antonius Hospital in Nieuwegein, the Netherlands. The trial was funded by The Netherlands Organization for Health Research and Development.

The study was simultaneously published online in The New England Journal of Medicine.

According to the ACC announcement, the POPular-TAVI randomized trial of antiplatelet therapy for patients undergoing transcatheter aortic valve implantation is 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.

By 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.

Dr. Nijenhuis commented in the press release, “The rates of complications for TAVR—especially complications related to bleeding—remain high. 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.”

As summarized in the ACC announcement, the POPular-TAVI investigators enrolled 313 patients with atrial fibrillation undergoing TAVR at 17 sites in four European countries. Half of these patients were assigned to take oral anticoagulants alone and half took the antiplatelet drug clopidogrel for 3 months after TAVR in addition to oral anticoagulants.

At 12 months, the patients taking oral anticoagulants alone were significantly less likely to experience 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 definition—occurred in 21.7% of those receiving only oral anticoagulants and 34.6% of those receiving clopidogrel.
  • The second component—nonprocedural bleeding as assessed with the Bleeding Academic Research Consortium criteria—occurred in 21.7% of those receiving only oral anticoagulants and 34% of those receiving clopidogrel. This reflects a 43% 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 noninferiority.

  • A composite of cardiovascular death, ischemic stroke, and heart attack occurred in 13.4% of those receiving only oral anticoagulants and 17.3% of those receiving clopidogrel.
  • A composite of those outcomes plus nonprocedural bleeding occurred in 31.2% of patients receiving only oral anticoagulants and 45.5% 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,” stated Dr. Nijenhuis.

The study is limited by its open-label design, although outcomes were adjudicated by independent evaluators who were blinded to patients’ treatment status. In addition, Dr. Nijenhuis advised that the study’s findings are only applicable to patients with atrial fibrillation. The investigators 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, noted the ACC announcement.

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