麻豆传媒

PARIS -- Post-hoc analysis of SURTAVI trial data indicated that, among patients receiving serial neurological evaluations, there was no significant difference at year 2 in cumulative stroke rates between those undergoing surgical versus transcatheter aortic valve replacement (TAVR), researchers said here.

Reported at this year's American College of Cardiology meeting, top-line results from the SURTAVI trial showed that interventions with the CoreValve classic and Evolut R devices were non-inferior to surgical aortic valve replacement (SAVR) for all-cause mortality and disabling stroke at 2 years among intermediate-risk patients with severe, symptomatic aortic stenosis.

But with the analysis limited to SURTAVI participants who got serial evaluations by a neurologist or stroke specialist, the 30-day advantage that TAVR had for fewer strokes (3.3% versus 5.4% for SAVR, log-rank P=0.031) faded to insignificance by 2 years (6.3% versus 8.0%, log-rank P=0.143), according to A. Pieter Kappetein, MD, PhD, of of Thoraxcenter Erasmus Medical Center in the Netherlands, during his late-breaking trial presentation at .

TAVR patients had numerically lower stroke rates at both time points that fell just short of statistical significance (30 days: 1.2% versus 2.4%, P=0.057; 2 years: 2.4% versus 4.5%, P=0.076).

But are these data enough to say that CoreValve TAVR is at least comparable to surgery in this population -- in light of its disadvantages with major vascular complications and permanent pacemaker implantation?

"The follow-up does not appear long enough for strong conclusions in intermediate-risk patients," commented Art Sedrakyan, MD, of Weill Cornell Medical College and the FDA Medical Device Epidemiology Science and Infrastructure Center.

"These patients have much longer life expectancy when compared to high-risk patients. Many intermediate-risk patients are younger than 70 years and we need to be careful with any evidence application in younger patients," Sedrakyan told 麻豆传媒.

Kappetein emphasized that when strokes occurred in the TAVR group, they usually took place within days and in a way less drawn-out than the SAVR experience. Only looking at TAVR patients with early strokes (n=28), then, the investigators found that they trended towards longer procedure times than their peers who also got TAVR but didn't have any strokes (68 min versus 52 min, P=0.07).

Interestingly, the SAVR cohort with strokes (n=43) tended to have a lower history of hypertension than the majority of surgery patients who didn't have strokes (79.1% versus 91%, P=0.01).

A stroke was associated with a longer stay in the ICU after TAVR (88 hours versus 47 hours for stroke-less cohort, P=0.03) and a longer overall stay in the hospital (9 days versus 6 days, P<0.001). These trends were mirrored with SAVR, with a non-significantly longer ICU stay after a stroke (125 hours versus 67 hours, P=0.06) and a statistically-meaningful elongation of hospital stay (13 days versus 10 days, P=0.02).

On baseline, there were no differences between TAVR and SAVR groups.

Kappetein, incidentally, was one of the two European physicians recently barred from entering the U.S. because of previous visits to certain Middle Eastern countries.

Comment