TAVR Demonstrates Noniferiority to Surgery in Intermediate-Risk Patients

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Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusions while TAVR had higher rates of residual aortic regurgitation and pacemaker implantation.
Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusions while TAVR had higher rates of residual aortic regurgitation and pacemaker implantation.

WASHINGTON, DC — Transcatheter aortic value replacement (TAVR) was noninferior to surgery in patients with severe aortic stenosis who were at intermediate surgical risk, according to the results of the SURTAVI trial presented at the 66th Annual Scientific Session & Expo of the American College of Cardiology and simultaneously published in the New England Journal of Medicine.1,2

SURTAVI (Surgical Replacement and Transcatheter Aortic Value Implantation; ClincialTrials.gov identifier: NCT01586910) was a multinational, randomized, noninferiority clinical trial. A total of 1746 patients (mean age, 79.8 years) were randomly assigned to undergo TAVR with the use of a self-expanding bioprosthesis or surgery across 87 centers in the United States, Europe, and Canada. Of these, 1660 underwent TAVR or surgery.

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The primary end point was a composite of death from any cause or disabling stroke at 24 months, and secondary end points included major adverse cardiovascular and cerebrovascular events (defined as death from any cause, myocardial infarction, all stroke types, and any reintervention). The researchers used Bayesian analytical methods (margin of 0.07) to assess the noninferiority of TAVR as compared with surgical valve replacement.

At 2 years, the estimated incidence of the primary end point was 12.6% in the TAVR group vs 14% in the surgery group (95% credible interval [Bayesian analysis] for difference –5.2% to 2.3%; posterior probability of noninferiority, >.9999).

Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusions while TAVR had higher rates of residual aortic regurgitation and pacemaker implantation. Lower mean gradients and larger aortic valve areas were a result of TAVR compared with surgery. Neither group had structural valve deterioration at 24 months.

The researchers noted that both SURTAVI and the previously reported PARTNER IIA trial (Placement of Aortic Transcatheter Valves; Clinicaltrial.gov identifier: NCT01314313) achieved their noninferiority end points in intermediate-risk patients. However, the observed-to-expected 30-day surgical mortality ratio was higher in PARTNER IIA than it was in SURTAVI. In fact, SURTAVI had one of the lowest such ratios for surgical mortality that has ever been reported in a randomized study. “We attribute this result to the best practices of our cardiac surgical teams, which underscores the importance of the similar 30-day rates of death in the TAVR group and the surgery group (2.2% and 1.7%, respectively),” the researchers wrote.

They concluded that TAVR was a “statistically noninferior alternative to surgery with respect to death from any cause or disabling stroke at 24 months. However, each procedure had a different pattern of adverse events.”

Study Limitations

  • High number of unplanned withdrawals occurred in the surgical group.
  • The next-generation Evolut R bioprosethesis was used in less than 20% of patients.
  • Longer-term follow-up beyond 2 years is needed.

Disclosures: The study was funded by Medtronic, Inc. Full author disclosures can be viewed online at NEJM.org.

References

  1. Reardon MJ, for the SURTAVI Investigators. Transcatheter aortic valve replacement with a self-expanding bioprosthesis compared with surgical aortic valve replacement in patients at intermediate surgical risk: first results from the SURTAVI clinical trial. Joint ACC/JACC Late-Breaking Clinical Trials. Presented at: the 66th Annual Scientific Session & Expo of the American College of Cardiology. March 17-19, 2017; Washington, DC.
  2. Reardon MJ, Van Mieghem JJ, Kleiman NS, et al; for the SURTAVI Investigators. Surgical or transcatheter aortic valve replacement in intermediate-risk patients [published online March 17, 2017]. N Engl J Med. doi:10.1056/NEJMoa1700456 
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