Analysis of Swiss Registry Compares Medtronic's Evolut R With Earlier-Generation CoreValve TAVR Prosthesis
April 17, 2017—Findings from an analysis of the Swiss TAVI Registry were published by Stephane Noble, MD, et al in the online e-edition of EuroIntervention (2017;12:e2170–e2176). The registry is comparing procedural and clinical outcomes with the new-generation self-expanding Evolut R transcatheter aortic valve replacement (TAVR) prosthesis (Medtronic) versus its predecessor, the CoreValve TAVR system (Medtronic).
In this assessment of the safety and efficacy of the Evolut R device compared with the CoreValve device, the investigators concluded that the 30-day clinical outcomes were favorable and comparable between the Evolut R and the CoreValve bioprostheses.
As summarized in EuroIntervention, this nationwide, prospective, multicenter cohort study investigated outcomes of consecutive transfemoral TAVR patients treated with the Evolut R device from September 2014 to February 2016 and the CoreValve device from February 2011 to February 2016. Events were reported according to the Valve Academic Research Consortium's VARC-2 initiative and adjudicated by a clinical events committee.
During the study period, 317 and 678 consecutive patients underwent TAVR with the Evolut R and CoreValve bioprostheses, respectively. Baseline clinical characteristics between the groups were comparable, although Evolut R patients were lower risk according to the Society of Thoracic Surgeons score (4.8% ± 3.4% vs 6.9% ± 5.0%; P < .001) and logistic EuroSCORE (17.3% ± 13% vs 20.1% ± 13%; P = .009).
Implantation of the Evolut R device was associated with less frequent use of predilatation (48.1% vs 72.4%; P < .001), a shorter procedure time (67.9 ± 36 min vs 76.7 ± 42 min; P = .002), and less contrast dye use during the procedure (155.2 ± 98 mL vs 208 ± 117 mL; P < .001). The postprocedural mean gradient was comparable (7.4 ± 4.7 mm Hg vs 7.5 ± 5.0 mm Hg), as were the 30-day rates of moderate to severe aortic regurgitation (8.5% vs 10.5%), major vascular (9.8% vs 10.3%) and life-threatening bleeding complications (5.4% vs 5.3%), disabling stroke (1.9% vs 1.6%), all-cause mortality (3.2% vs 3.4%), as well as permanent pacemaker implantation (22.1% vs 23.4%), reported the investigators in EuroIntervention.