European Study Compares Medtronic and Edwards TAVI Devices

January 16, 2013—Results from the PRAGMATIC Plus Initiative (Pooled-Rotterdam-Milano-Toulouse In Collaboration) were published online ahead of print by Alaide Chieffo, MD, et al in the Journal of the American College of Cardiology.

The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV; Medtronic, Inc., Santa Rosa, CA) versus the Edwards Sapien/Sapien XT (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (ESV) for severe aortic stenosis. No large matched comparison study has been conducted so far evaluating both commercially available devices, noted the investigators.

The investigators concluded that no differences were observed between the two commercially available transfemoral transcatheter aortic valve implantation devices at the adjusted analysis in Valve Academic Research Consortium outcomes, except for the need for permanent pacemakers with the MCV.

As summarized in the Journal of the American College of Cardiology, the data from databases of four experienced European centers were pooled and analyzed. Because of differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year.

The study included 793 patients, of whom 453 (57.1%) were treated with the MCV and 340 (42.9%) were treated with the ESV. After propensity matching, 204 patients were identified in each group.

The investigators found that at 30 days, there were no differences in all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, or device success. Additionally, there were no differences in major vascular complications or life-threatening bleeding. MCV was associated with more permanent pacemakers. At 1 year, there were no differences in all-cause or cardiovascular mortality.

Specifically, the results showed rates of all-cause mortality (MCV, 8.8% vs ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI], 0.677 to 2.984; P = .352), cardiovascular mortality (MCV, 6.9% vs ESV, 6.4%; HR: 1.083; 95% CI, 0.496 to 2.364; P = .842), myocardial infarction (MCV, 0.5% vs ESV, 1.5%; HR: 0.33; 95% CI, 0.034 to 3.2; P = .339), stroke (MCV, 2.9% vs ESV, 1%; HR: 3.061; 95% CI, 0.61 to 15.346; P = .174), device success (MCV, 95.6% vs ESV, 96.6%; HR: 0.77; 95% CI, 0.281 to 2.108; P = .611), major vascular complications (MCV, 9.3% vs ESV, 12.3%; HR: 0.735; 95% CI, 0.391 to 1.382; P = .340), and life-threatening bleeding (MCV, 13.7% vs ESV, 8.8%; HR: 1.644; 95% CI, 0.878 to 3.077; P = .12). At 1 year, the devices showed equivalent rates of all-cause mortality (MCV, 16.2% vs ESV, 12.3%; HR: 1.374; 95% CI, 0.785 to 2.407; P = .266) and cardiovascular mortality (MCV, 8.3% vs ESV, 7.4%; HR: 1.145; 95% CI, 0.556 to 12.361; P = .713).

The one observed difference was that MCV compared to ESV was associated with more permanent pacemakers (22.5% vs 5.9%; HR: 4.634; 95% CI: 2.373 to 9.05; P < .001), reported the investigators in the Journal of the American College of Cardiology.