Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN)

• Published in: Circulation Journal 2017/07/25, Vol.81(8), pp.1102-1107
• Main Authors: Sawa, Yoshiki, Takayama, Morimasa, Goto, Tsuyoshi, Takanashi, Shuichiro, Komiya, Tatsuhiko, Tobaru, Tetsuya, Maeda, Koichi, Kuratani, Toru, Sakata, Yasushi, on behalf of the PREVAIL JAPAN Investigators
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic stenosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - surgery; Female; Follow-Up Studies; Humans; Japan - epidemiology; Male; Postoperative Complications - mortality; Prospective Studies; Risk Factors; Transcatheter aortic valve replacement; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - methods
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-17-0111

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.)