TY - JOUR
T1 - First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation
T2 - The Massy study group vs. the PREVAIL JAPAN trial
AU - Watanabe, Yusuke
AU - Hayashida, Kentaro
AU - Takayama, Morimasa
AU - Mitsudo, Kazuaki
AU - Nanto, Shinsuke
AU - Takanashi, Shuichiro
AU - Komiya, Tatsuhiko
AU - Kuratani, Toru
AU - Tobaru, Tetsuya
AU - Goto, Tsuyoshi
AU - Lefèvre, Thierry
AU - Sawa, Yoshiki
AU - Morice, Marie Claude
N1 - Funding Information:
The authors would like to thank Mrs Catherine Dupic for her assistance in the preparation of this manuscript. The PREVAIL JAPAN trial was funded by Edwards Lifesciences Limited ; ClinicalTrials.gov number, NCT01113983 .
Publisher Copyright:
© 2014 Japanese College of Cardiology.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - Background: The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Methods and results: Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m2 vs. 1.72±0.18m2; p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91). Conclusions: Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort.
AB - Background: The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Methods and results: Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m2 vs. 1.72±0.18m2; p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91). Conclusions: Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort.
KW - Aortic stenosis
KW - Clinical outcome
KW - Transcatheter aortic valve implantation
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U2 - 10.1016/j.jjcc.2014.05.001
DO - 10.1016/j.jjcc.2014.05.001
M3 - Article
C2 - 24927855
AN - SCOPUS:84922782345
SN - 0914-5087
VL - 65
SP - 112
EP - 116
JO - Journal of Cardiology
JF - Journal of Cardiology
IS - 2
ER -