麻豆传媒

NEW ORLEANS -- Procedural bivalirudin (Angiomax) failed to beat unfractionated heparin in transfemoral transcatheter aortic valve replacement (TAVR) no matter the valve received or whether patients had atrial fibrillation (Afib), according to two BRAVO 3 analyses.

The BRAVO 3 trial of high-risk TAVR included 332 Afib patients randomized to bivalirudin (n=177) or unfractionated heparin (n=155). This group wasn't more likely to have 30-day events than the non-Afib cohort. Consistent with overall trial results, bivalirudin gave this group no added benefit as well, reported Usman Baber, MD, of Mount Sinai Health System in New York City, and colleagues.

However, stroke rates were up more than fourfold for those who developed Afib after TAVR (10.5% versus 2.6% for non-Afib, unadjusted OR 4.49, 95% CI, 1.37-14.67), he said, based on his group's post hoc analysis presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting.

This means clinicians should be vigilant of new-onset Afib after TAVR, Baber said: "There's a need for monitoring and maintaining of sinus rhythm, and strategies to mitigate risk."

Case in point: of the Afib cohort in the trial -- conducted at mostly German and French sites -- just over half were discharged on anticoagulation.

"What I see of this, is that's a lot of people with Afib not on anticoagulation, and that's a dangerous situation," commented SCAI session panelist Spencer B. King, MD, of Emory Saint Joseph's Hospital in Atlanta.

Separately, a secondary BRAVO 3 analysis found that valve design appeared to interact with anticoagulation strategy for one outcome.

Whether balloon-expandable or self-expanding valves were used did not change bivalirudin's lack of superiority for 30-day major bleeds, death, stroke, or MI, reported Roxana Mehran, MD, also of Mount Sinai Health System.

However, her group discovered in their pre-specified study that patients who got balloon-expandable valves were less likely to experience major vascular complications on bivalirudin in lieu of unfractionated heparin (7.9% versus 14.1%, P-interaction=0.039), she said.

"Here, I don't think we can say anything about bivalirudin making an important impact in TAVR," Mehran maintained. "I would say heparin is just fine. Bivalirudin doesn't have a place in TAVR at the moment."

The trial was not powered to evaluate outcomes according to valve type, she emphasized, nor is it generalizable to TAVR with non-femoral cases. Importantly, BRAVO 3 investigators lacked data on post-TAVR pacemaker rates as well.

Comprising two-thirds of the total BRAVO 3 population, balloon-expandable valve recipients tended to be slightly younger and were more likely to have diabetes on baseline.