BACKGROUND:Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES). METHODS: The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non-insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year. RESULTS:Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; P(superiority) = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11). CONCLUSION: In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
RCT Entities:
BACKGROUND:Diabeticpatients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabeticpatients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES). METHODS: The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non-insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year. RESULTS:Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; P(superiority) = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11). CONCLUSION: In this prospective, randomized trial in a high-risk group of diabeticpatients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
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: Damian Kawecki; Beata Morawiec; Janusz Dola; Wojciech Wańha; Grzegorz Smolka; Aleksandra Pluta; Kamil Marcinkiewicz; Andrzej Ochała; Ewa Nowalany-Kozielska; Wojciech Wojakowski Journal: Med Sci Monit Date: 2015-10-27
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