New-Onset A-fib After TAVR Linked to Increased Risk of Early Stroke

NEW ORLEANS, LA—One-third of TAVR patients have atrial fibrillation that is either present at baseline on develops as a complication after the procedure, according to a post-hoc analysis from the BRAVO-3 trial. The study, presented here in a late-breaking session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions, also found that patients in the new-onset group had a nearly fivefold increased risk of stroke at 30 days.

“We found that preexisting AF or new-onset AF did not associate significantly at least with increased risk [of adverse events] compared with those patients without AF,” said Usman Baber, MD (Icahn School of Medicine at Mount Sinai, New York, NY). “However, in exploratory analyses, new-onset AF did associate with higher risk for stroke, as has been noted by other investigators previously.”

As previously reported by TCTMD, BRAVO-3 randomized 802 high-risk TAVR patients at 31 sites in seven countries to treatment with bivalirudin (Angiomax, The Medicines Company; n = 404), given as a bolus of 0.75 mg/kg plus continuous IV infusion at 1.75 or 1.4 or 1 mg/kg/h depending on renal function, or to a weight-adjusted bolus of unfractionated heparin (n = 398). The primary endpoint of Bleeding Academic Research Consortium (BARC) type 3b bleeding at 48 hours was no different between groups for the primary study results.

New-Onset Strokes Concerning

For the current analysis, investigators looked at differences between the 294 BRAVO-3 patients who had A-fib at baseline, the 38 with new-onset A-fib after TAVR, and the 470 had no A-fib.

Of note, Baber said, despite the high prevalence of A-fib and high CHA2DS2-VASc scores, only 65% were discharged home on some form of anticoagulant, with the choice of agent being “quite variable across the population” and demonstrating lack of uniform approach in this patient population.

A lot of people with atrial fib are not on anticoagulants when they go home, and this seems like a very dangerous situation. Spencer B. King

For BARC ≥ 3 bleed, death, stroke, MACE, net adverse clinical events, and major vascular complications, patients with A-fib had a numerically higher number of events compared with those lacking A-fib, although none of these differences achieved statistical significance.

Similar to the main trial results, there were no major differences in bleeding or ischemic outcomes by preprocedural randomization to bivalirudin or heparin regardless of AF status. However, in the group of patients with A-fib (either established or new onset), there were numerically fewer strokes with heparin versus bivalirudin, with an opposite trend seen in the absence of A-fib.

Comparison of patients with established versus new-onset TAVR also showed that the latter group had numerically more strokes, MI, MACE, and net adverse clinical events. While patients with no A-fib had a 30-day stroke rate of 2.6% and those with prior A-fib had a rate of 3.1%, new-onset A-fib patients had a rate of 10.5%.

“Certainly the new-onset AF . . . patients are at very high risk,” Baber said in a press conference prior to his presentation. “Now, is that because AF is just a marker of something untoward that happens, or is there a causal relationship? I don’t think we’ve figured that out quite yet. But I think this speaks to perhaps a need for monitoring, trying to maintain sinus rhythm, and trying to get a better sense of what [we can do] to mitigate that risk.”

Panelist Spencer B. King, MD (Emory University School of Medicine, Atlanta, GA), commented: “The main thing I get out of this is that a lot of people with atrial fib are not on anticoagulants when they go home, and this seems like a very dangerous situation.”