Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN)
Yoshiki Sawa, Morimasa Takayama, Tsuyoshi Goto, Shuichiro Takanashi, Tatsuhiko Komiya, Tetsuya Tobaru, Koichi Maeda, Toru Kuratani, Yasushi Sakata, PREVAIL JAPAN Investigators, Yoshiki Sawa, Morimasa Takayama, Tsuyoshi Goto, Shuichiro Takanashi, Tatsuhiko Komiya, Tetsuya Tobaru, Koichi Maeda, Toru Kuratani, Yasushi Sakata, PREVAIL JAPAN Investigators
Abstract
Background: Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8).
Conclusions: The 5-year data from PREVAIL JAPAN show the clinical benefit of TAVR and suggest that balloon-expandable TAVR is an effective treatment option for Japanese patients with severe AS who are not suitable for surgery. (Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.).
Keywords: Aortic stenosis; Transcatheter aortic valve replacement.
Source: PubMed