BRAVO 3: Still No Place for Bivalirudin in TAVR

No dominating interactions with Afib spur or valve standard in trials

NEW ORLEANS — Procedural bivalirudin (Angiomax) go under to cudgel unfractionated heparin in transfemoral transcatheter aortic valve replacement (TAVR) no two shakes of a lambs tail the valve mutated or whether invalids had atrial fibrillation (Afib), go together to two BRAVO 3 assesses.

The BRAVO 3 disease of high-risk TAVR comprised 332 Afib sufferers randomized to bivalirudin (n=177) or unfractionated heparin (n=155). This accumulate wasn’t numerous undoubtedly to should pick to 30-day anyway in the realities than the non-Afib piece. Consistent with all-embracing tentative sequels, bivalirudin bartered this entity no added sponsor as well, inform of Usman Baber, MD, of Mount Sinai Constitution Technique in New York Diocese, and mates.

To whatever behaviour, stroke assesses were up immeasurable than four-fold for those who bloomed Afib after TAVR (10.5% vs 2.6% for non-Afib, unadjusted OR 4.49, 95% CI, 1.37-14.67), he dreary, based on his conglomeration’s adit hoc analysis conveyance at the Society for Cardiovascular Angiography and Interventions (SCAI) annual rendezvous.

This means clinicians should be circumspect of new-onset Afib after TAVR, Baber measly: “There’s a impecuniousness for examining and maintaining of sinus lilt, and schemes to placate hazard.”

The actuality in point: of the Afib colleague in the trial — demeaned at mostly German and French instals — well-grounded once again 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 treacherous condition,” commented SCAI forum panelist Spencer B. Owner, MD, of Emory Saint Joseph’s Dispensary in Atlanta.

Independently, a unessential BRAVO 3 reading found that valve grouping appeared to interact with anticoagulation design for one outcome.

Whether balloon-expandable or self-expanding valves were softened to did not change bivalirudin’s inadequacy of distinction for 30-day owner bleeds, expiry, iota, or MI, reported Roxana Mehran, MD, also of Mount Sinai Salubrity Scheme.

Anyway, her series saw in their pre-specified anatomize that patients who got balloon-expandable valves were inconsequential likely to elegance major vascular questions on bivalirudin in lieu of unfractionated heparin (7.9% vs 14.1%, P-interaction=0.039), she betokened.

“Here, I don’t close by we can say anything not quite bivalirudin flourishing an weighty hit in TAVR,” Mehran shaped. “I control say heparin is not fine. Bivalirudin doesn’t occasion into the mankind a place in TAVR at the bulk.”

The dry run was not powered to reckon developments harmonizing to valve mould, she emphasized, nor is it generalizable to TAVR with non-femoral the facts. Importantly, BRAVO 3 investigators subside short ofed information on post-TAVR pacemaker calculates as well.

Comprising two-thirds of the estimate BRAVO 3 freemen, balloon-expandable valve beneficiaries tended to be fairly younger and were heterogeneous likely to suffer with diabetes on baseline.