Equivalent Outcomes With Corevalve and Sapien Transcatheter Aortic Valves

January 17, 2013

MILAN, Italy — A head-to-head comparison of the CoreValve (Medtronic, Minneapolis, MN) and Sapien (Edwards, Irvine, CA) transcatheter aortic-valve implantation (TAVI) systems suggests there is no major difference between the two commercially available devices. At 30 days, there was no difference in the rate of all-cause mortality, cardiovascular mortality, MI, stroke, or device success, as well as no major difference in the rate of major vascular complications or life-threatening bleeding events.

In addition, there was no major difference in the rate of all-cause or cardiovascular mortality at one year.

The Medtronic CoreValve was associated with a higher rate of permanent pacemaker implantation, with 22.5% of patients requiring a pacemaker compared with 5.9% of patients treated with the Edwards Sapien/Sapien XT devices (hazard ratio [HR] 4.6; p<0.001).

"Overall, our results are encouraging, showing no difference between commercially available valve types except for a greater need for a [permanent pacemaker] PPM with the [Medtronic CoreValve], but clearly longer-term follow-up in the setting of an adequately powered randomized clinical trial is needed," state Dr Alaide Chieffo (San Raffaele Scientific Institute, Milan, Italy) and colleagues in their report, published online January 16, 2013 in the Journal of the American College of Cardiology.

Speaking with heart wire , Dr J Jeffrey Marshall (Northeast Georgia Heart Center, Gainesville), the president of the Society of Cardiovascular Angiography and Interventions, said the findings are in line with expectations, with clinicians well aware that the CoreValve, because of its self-expanding design, is associated with an increased risk of a need for a permanent pacemaker.

"Any time you have to have another procedure performed, it's not something you'd prefer, but it doesn't occur in a huge number of patients," said Marshall. "The need for a permanent pacemaker implantation is not something that's associated with a lot of complications in and of itself, so it's not that great an issue, although there is an extra cost, obviously."

Marshall noted that the incidence of aortic regurgitation was equal with both valves, a finding he said was reassuring, considering that previous trials suggested there might be differences between the valves in terms of aortic insufficiency following the procedure.

The PRAGMATIC Plus Initiative

The study, known as the PRAGMATIC Plus Initiative, included data from four experienced European centers. In total, 793 patients underwent TAVI, including 453 patients treated with the Medtronic CoreValve and 340 patients treated with the Edwards Sapien/Sapien XT devices. The 18-F sheath-compatible CoreValve was used in all but five cases (in these five cases the 21-F device was used) and the Sapien system used 22-/24-F sheaths until 2010, when the Sapien XT device offered the option of 18-/19-F sheath sizes. The average patient age was 82 years.

As noted, there was no significant difference in the 30-day and one-year clinical outcomes between the two TAVI systems. Because there were differences in the baseline characteristics of patients, the analysis was based on 204 propensity-score-matched patients.

Clinical Outcomes in the Propensity-Matched Patients

Outcome CoreValve, n=204 (%) Sapien/Sapien XT, n=204 (%) p
30 d      
All-cause mortality 8.8 6.4 0.352
Cardiac mortality 6.9 6.4 0.842
MI 0.5 1.5 0.339
Major stroke 2.9 1.0 0.174
Major vascular complications 9.3 12.3 0.340
Major bleeding 18.1 22.1 0.324
1 y      
All-cause mortality 16.2 12.3 0.266
Cardiac mortality 8.3 7.4 0.713
Moderate to severe aortic regurgitation 5.2 2.8 0.302

In the US, the only commercially available TAVI system is the Edwards Sapien transcatheter aortic valve. For Marshall, who was not involved in the study, this is a major issue.

"As an American cardiologist, the US regulatory body, the Food and Drug Administration, is actually preventing some of these newer, and I think safer, devices being given to our patients," he told heartwire. "It's a patient-centered issue, and the FDA is going so slowly on this. The newest device, the current commercially available Sapien device, is the only device available if you're not in a clinical trial, and it's a 22-F device. In Europe, you can get a 14-F device with the Sapien 3. I just think that for patient safety that's something the FDA would want to move along with a little faster. It's a little frustrating."

With the smaller sheaths, more patients would be suitable for TAVI, as Marshall said it's often the size of the iliac artery that prevents some of the older patients from getting the procedure. The larger the tube in a 90-year-old patient, the greater the chance of "iliac on a stick," a complication that occurs after an inadvertent iliac artery rupture and the intima is pulled or torn out. With the lack of small sheaths, and the subsequent risk posed to some patients, Marshall said he believes that these patients might resort to traveling to Europe or Canada for the newer aortic valves.

Marshall said the stroke rates in the present analysis are also in line with previous studies, noting that stroke typically occurs in patients if there is a problem with the valve, such as it being set too low, with a second valve needing to be implanted. In these elderly patients, excessive manipulation can lead to the increase risk of stroke.