Five-Year Outcomes Published for Medtronic's CoreValve TAVR System in High-Risk Patients


November 26, 2018—The 5-year outcomes from the randomized United States pivotal high-risk trial of the CoreValve transcatheter aortic valve replacement (TAVR) system (Medtronic) were published by Thomas G. Gleason, MD, et al in Journal of the American College of Cardiology (JACC; 2018;72:2687–2696).

The investigators reported midterm 5-year outcomes of safety, performance, and durability for TAVR compared with surgical aortic valve replacement (SAVR). At 1 year, the trial had demonstrated superior 1-year mortality of TAVR versus SAVR among patients at high operative mortality risk.

In the study, surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding CoreValve bioprosthesis or SAVR. Valve Academic Research Consortium I definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥ 40 mm Hg or a change in gradient ≥ 20 mm Hg or new severe aortic regurgitation.

As summarized in JACC, a total of 797 patients were randomized at 45 centers in the United States, with 750 patients undergoing an attempted implant (TAVR, 391; SAVR, 359). The overall mean age was 83 years, and the Society of Thoracic Surgeons score was 7.4%.

The investigators reported the following at 5 years for TAVR versus SAVR, respectively:

  • All-cause mortality rate, 55.3% vs 55.4%
  • Subgroup analysis showed no differences in mortality
  • Major stroke rate, 12.3% vs 13.2%
  • Mean aortic valve gradients, 7.1 ± 3.6 vs 10.9 ± 5.7 mm Hg
  • No clinically significant valve thrombosis was observed
  • Freedom from severe structural valve deterioration, 99.2% vs 98.3% (P = .32)
  • Freedom from valve reintervention, 97% vs 98.9% (P = .04)
  • Patients implanted with a permanent pacemaker, 33% vs 19.8%

This study shows similar midterm survival and stroke rates in high-risk patients following TAVR or SAVR; additionally, severe structural valve deterioration and valve reinterventions were uncommon, concluded the investigators in JACC.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.