Data Presented From SURTAVI and NOTION Trials of TAVR
May 18, 2017—Findings from the randomized SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial showed that patients at intermediate risk for surgery have a lower risk of early neurologic complications, including stroke, with transcatheter aortic valve replacement (TAVR) than with surgical aortic valve replacement. The study data were presented at the EuroPCR 2017 conference in Paris, France.
The SURTAVI trial randomized 1,660 patients with severe symptomatic aortic stenosis who were at intermediate surgical risk to aortic valve replacement with TAVR (using the CoreValve or Evolut R systems [Medtronic]) or surgery. A neurologist or stroke specialist evaluated any patient who had a suspected neurologic event after their procedure.
The incidence of early stroke at 30 days was significantly lower in patients undergoing TAVR (3.3%) than in those having surgical aortic valve replacement (5.4%; P = .031). Stroke incidence remained lower at 2 years with TAVR compared to surgery (6.3% vs 8%; P = .143). One-year mortality was similar for TAVR and surgery patients with stroke or encephalopathy at 30 days.
Further results showed that quality of life, based on the 36-Item Short Form Health Survey, was lower at 30 days for all patients with early stroke compared to those not having a stroke. Quality of life improved quicker in TAVR patients with stroke but was similar by 6 months regardless of procedure type.
Pieter Kappetein, MD, the Lead Author of the SURTAVI trial, commented in the press release for the presentation, “As TAVR moves into lower-risk patients, it’s important to understand the relative risk for neurological complications following surgical aortic value replacement and TAVR.” Dr. Kappetein is professor of cardiothoracic surgery at Erasmus Medical Center in Rotterdam, the Netherlands.
Dr. Kappetein continued, “Surgical aortic valve replacement carries a higher risk in intermediate-risk patients and TAVR might be the preferred treatment in patients with aortic stenosis. This is the first time we have observed a lower stroke rate with TAVI compared to surgery."
Also at EuroPCR, long-term results from the physician-initiated, real-world NOTION trial (Nordic Aortic Valve Intervention Trial) demonstrated excellent clinical outcomes for TAVR at 4 years with the CoreValve platform versus surgery. Key outcomes included similar rates for TAVR versus surgery in all-cause mortality (20% vs 23%; P = .56), stroke (6.8% vs 7.3%; P = .85) and myocardial infarction (7.7% vs 7.8%; P = .87).
Additionally, strong hemodynamic performance was sustained through 4 years and was superior for TAVR patients versus SAVR (P ≤ .001). Late complications after both procedures were rare, while procedural complications after TAVR, including pacemaker implantation and aortic regurgitation, did not significantly affect mortality.