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



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).



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.).
Osaka University Graduate School of Medicine.
Yoshiki
Y
Sawa
Sakakibara Heart Institute.
Morimasa
M
Takayama
Kurashiki Central Hospital.
Tsuyoshi
T
Goto
Sakakibara Heart Institute.
Shuichiro
S
Takanashi
Kurashiki Central Hospital.
Tatsuhiko
T
Komiya
Sakakibara Heart Institute.
Tetsuya
T
Tobaru
Osaka University Graduate School of Medicine.
Koichi
K
Maeda
Osaka University Graduate School of Medicine.
Toru
T
Kuratani
Osaka University Graduate School of Medicine.
Yasushi
Y
Sakata
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D011183:Postoperative Complications / Q000401:mortality*; D011446:Prospective Studies; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods*
Aortic stenosis; Transcatheter aortic valve replacement