Transcatheter Aortic Valve Implantation With the Edwards SAPIEN Versus the Medtronic CoreValve Revalving System Devices: A Multicenter Collaborative Study: The PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration)

Study Questions:

What is the comparative safety and efficacy of the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis?


The authors pooled data from four large-volume European centers of patients undergoing transfemoral transcatheter aortic valve implantation. Due to differences in baseline clinical characteristics of patients treated with the two valves, propensity score matching was performed. The outcome of interest was Valve Academic Research Consortium outcomes at 30 days and 1 year.


Of the 793 patients who underwent transcatheter aortic valve implantation at these institutions, 453 (57.1%) were treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV 8.8% vs. ESV 6.4%; hazard ratio [HR], 1.42; 95% confidence interval [CI], 0.677-2.984; p = 0.352), cardiovascular mortality (MCV 6.9% vs. ESV 6.4% ), myocardial infarction (MCV 0.5% vs. ESV 1.5%), stroke (MCV 2.9% vs. ESV 1.0%), or device success (MCV 95.6% vs. ESV 96.6%). Additionally, there were no differences in major vascular complications (MCV 9.3% vs. ESV 12.3%; HR, 0.735; 95% CI, 0.391-1.382; p = 0.340) or life-threatening bleeding (MCV 13.7% vs. ESV 8.8%; HR, 1.644; 95% CI, 0.878-3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR, 4.634; 95% CI, 2.373-9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV 16.2% vs. ESV 12.3%; HR, 1.374; 95% CI, 0.785-2.407; p = 0.266) or cardiovascular (MCV 8.3% vs. ESV 7.4%; HR, 1.145; 95% CI, 0.556-12.361; p = 0.713) mortality. There was no difference in the valve area or postprocedural aortic regurgitation.


In this observational study, no differences were observed between the two commercially available transfemoral transcatheter aortic valve implantation devices, except for a greater need for permanent pacemakers with the MCV.


This study confirms that both of the currently used transcatheter heart valves have similar safety and efficacy, other than the increased risk of permanent pacemakers with MCV. Although the small size of the study and the observational design prevent any definitive conclusions, these results should prove reassurance to both patients and physicians that either one of the valves provides a similar clinical benefit with acceptable safety.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Physicians, Risk, Myocardial Infarction, Stroke, Cardiovascular Diseases, Pacemaker, Artificial, Heart Valve Prosthesis Implantation, Angioplasty, Balloon, Coronary

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