Corevalve Evolut R (Medtronic) and Edwards Sapien 3 (Edward Lifesciences) Valves Reveal Equivalence in Transcatheter Aortic Valve Implantation (TAVI) in a Head-to-Head Comparison Results From The SOLVE-TAVI Trial Presented at the 30th Annual 2018 TCT Conference

Results from an open-label, multi-center, 2×2 factorial design randomized trial powered for equivalence, comparing the self-expanding Corevalve Evolut R valve to balloon expandable Edwards Sapien 3 valve, have shown that the two valves were equivalent to each other in terms of decreasing all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation (p=0.02). Trial results presented at the 2018 TCTMD conference held at San Diego, California, also showed equivalence in a comparison between general anesthesia vs local anesthesia (with conscious sedation) in terms of decreasing all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury (p=0.02).

“In patients with symptomatic aortic stenosis undergoing transfemoral TAVR the self-expanding Corevalve Evolut R valve is equivalent to the balloon-expandable Edwards Sapien 3 with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. There may be a higher stroke rate with the balloon-expandable valve. The event rates were similar in patients enrolled in both arms of the trial. With respect to the valvle strategy, for the majority of patients both are very good third-generation valves.”-Dr. Holger Thiele, M.D. discussed with Dr. Tarek Nafee reporting live from TCT 2018, San Diego, California.

 

Transcatheter aortic valve implantation (TAVI) has emerged as a life-saving rescue strategy in patients with severe aortic valve stenosis who are considered to be high-risk surgical candidates. The SOLVE-TAVI trial, which compared two valve and two anesthesia strategies, enrolled 447 patients suffering from severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1 cm² or 0.6 cm²/m². All patients were ≥ 75 years of age, and/or had a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20%, indicating that all participants were high-risk surgical patients. The patients were randomized in a 1:1 fashion, with both the self-expanding Evolut group and the balloon-expandable Sapien 3 group enrolling 219 patients in each group with a mean age 82 years. Almost half the patients in each group were males. A transfemoral approach was used to do the valve replacement. Interestingly, the investigators were surprised by a higher pacemaker implantation rate (18%) for both the Evolut R strategy and for the Sapien 3 strategy than previously reported. Overall mortality was equivalently low among both groups, given the high-risk patient population. More patients assigned the balloon-expandable valve had a stroke vs. those assigned the self-expanding valve, when tested for superiority (4.7% vs. 0.5%; p for equivalence = .003; p for superiority = .01). The rationale of comparing general vs local anesthesia (with conscious sedation) stems from the belief that general anesthesia is safer while performing TAVI; the results from SOLVE-TAVI show that both general and local anesthesia are equally safe, and a minimalist approach can be adopted while managing this high-risk patient population.