BACKGROUND: Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO). METHODS AND RESULTS: A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up. CONCLUSIONS: The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.
RCT Entities:
BACKGROUND: Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO). METHODS AND RESULTS: A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up. CONCLUSIONS: The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.
Authors: Loes P Hoebers; Bimmer E Claessen; George D Dangas; Truls Råmunddal; Roxana Mehran; José P S Henriques Journal: Nat Rev Cardiol Date: 2014-05-27 Impact factor: 32.419
Authors: Eliano Pio Navarese; Mariusz Kowalewski; David Kandzari; Alexandra Lansky; Bartosz Górny; Lukasz Kołtowski; Ron Waksman; Sergio Berti; Giuseppe Musumeci; Ugo Limbruno; Rene J van der Schaaf; Malte Kelm; Jacek Kubica; Harry Suryapranata Journal: Open Heart Date: 2014-08-21
Authors: Eliano P Navarese; Kenneth Tandjung; Bimmer Claessen; Felicita Andreotti; Mariusz Kowalewski; David E Kandzari; Dean J Kereiakes; Ron Waksman; Laura Mauri; Ian T Meredith; Aloke V Finn; Hyo-Soo Kim; Jacek Kubica; Harry Suryapranata; Toni Mustahsani Aprami; Giuseppe Di Pasquale; Clemens von Birgelen; Elvin Kedhi Journal: BMJ Date: 2013-11-06
Authors: Jong-Hwa Ahn; Jeong Hoon Yang; Cheol Woong Yu; Je Sang Kim; Hyun Jong Lee; Rak Kyeong Choi; Tae Hoon Kim; Ho Joon Jang; Young Jin Choi; Young Moo Roh; Won-Heum Shim; Young Bin Song; Joo-Yong Hahn; Jin-Ho Choi; Sang Hoon Lee; Hyeon-Cheol Gwon; Seung-Hyuk Choi Journal: PLoS One Date: 2016-06-17 Impact factor: 3.240