There were no observed differences between the transcatheter aortic valve replacement (TAVR) Sapien/Sapien XT and CoreValve devices in an adjusted analysis in Valve Academic Research Consortium (VARC) outcomes, except for the need for permanent pacemakers with the CoreValve. The PRAGMATIC registry analysis was published online Jan. 16 in the Journal of the American College of Cardiology.
The Sapien/Sapien XT and CoreValve devices are both commercially available in Europe. Alaide Chieffo, MD, of the interventional cardiology unit at the San Raffaele Scientific Institute in Milan, Italy, and colleagues undertook the study to compare outcomes after transfemoral TAVR with the CoreValve (Medtronic) versus the Sapien/Sapien XT (Edwards Lifesciences) transcatheter heart valve for severe aortic stenosis, because “so far, no large comparison has been performed to assess differences between currently available valve types.”
While a number of studies have provided a comparison, including the FRANCE 2 (French Aortic National CoreValve and Edwards) registry (N Engl J Med 2012;366:1705–1715) and the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry (J Am Coll Cardiol 2011;58:2130–2138), the study authors pointed out that “it is important to understand that these registries report only unadjusted analyses and do not take into account the significant differences at baseline.”
Thus, the aim of this multicenter collaborative registry was to compare 30-day and one-year VARC outcomes after transfemoral TAVR with CoreValve versus Sapien/Sapien XT. The PRAGMATIC Plus (Pooled-RotterdAm- MilAno-Toulouse In Collaboration) registry is a collaboration of four European institutions with established TAVR experience. Due to differences in baseline clinical characteristics, the researchers performed propensity score matching.
In total, 793 patients were included: 57.1 percent were treated with the CoreValve and 42.9 percent with the Sapien/Sapien XT. After propensity matching, they identified 204 patients in each group.
At 30 days, there were no differences in all-cause mortality (CoreValve, 8.8 percent vs. Sapien/Sapien XT, 6.4 percent), cardiovascular mortality (CoreValve, 6.9 percent vs. Sapien/Sapien XT, 6.4 percent), MI (CoreValve, 0.5 percent vs. Sapien/Sapien XT, 1.5 percent), stroke (CoreValve, 2.9 percent vs. Sapien/Sapien XT, 1 percent) or device success (CoreValve, 95.6 percent vs. Sapien/Sapien XT, 96.6 percent). In addition, there were no differences in major vascular complications (CoreValve, 9.3 percent vs. Sapien/Sapien XT, 12.3 percent) or life-threatening bleeding (CoreValve, 13.7 percent vs. Sapien/Sapien XT, 8.8 percent).
However, Chieffo et al reported that the CoreValve was associated with more permanent pacemakers (22.5 percent vs. 5.9 percent) at 30 days, which the study authors said is “likely related to valve structure and design.”
At one year, there were no differences in all-cause mortality (CoreValve, 16.2 percent vs. Sapien/Sapien XT, 12.3 percent) or cardiovascular mortality (CoreValve, 8.3 percent vs. Sapien/Sapien XT, 7.4 percent).
Due to the nonrandomized and retrospective nature of this study, Chieffo and colleagues acknowledged that the findings are subject to selection bias and confounding with regard to the preprocedural risk of the patient. Also, in an aim to minimize these biases, propensity-score matching was performed; however, hidden bias may remain due to the influences of unmeasured confounders.
Therefore, they concluded that these results need to be confirmed in a randomized trial.