OBJECTIVES: We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. BACKGROUND: The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable. METHODS: We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials. RESULTS: There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis. CONCLUSIONS: Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
RCT Entities:
OBJECTIVES: We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. BACKGROUND: The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable. METHODS: We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials. RESULTS: There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis. CONCLUSIONS: Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Authors: Francesco Prati; Giulio Guagliumi; Gary S Mintz; Marco Costa; Evelyn Regar; Takashi Akasaka; Peter Barlis; Guillermo J Tearney; Ik-Kyung Jang; Elosia Arbustini; Hiram G Bezerra; Yukio Ozaki; Nico Bruining; Darius Dudek; Maria Radu; Andrejs Erglis; Pascale Motreff; Fernando Alfonso; Kostas Toutouzas; Nieves Gonzalo; Corrado Tamburino; Tom Adriaenssens; Fausto Pinto; Patrick W J Serruys; Carlo Di Mario Journal: Eur Heart J Date: 2012-05-31 Impact factor: 29.983
Authors: Bin Wang; Gary S Mintz; Bernhard Witzenbichler; Cristiano F Souza; D Christopher Metzger; Michael J Rinaldi; Peter L Duffy; Giora Weisz; Thomas D Stuckey; Bruce R Brodie; Mitsuaki Matsumura; Myong-Hwa Yamamoto; Rupa Parvataneni; Ajay J Kirtane; Gregg W Stone; Akiko Maehara Journal: J Am Heart Assoc Date: 2016-12-22 Impact factor: 5.501
Authors: William Wijns; Junya Shite; Michael R Jones; Stephen W L Lee; Matthew J Price; Franco Fabbiocchi; Emanuele Barbato; Takashi Akasaka; Hiram Bezerra; David Holmes Journal: Eur Heart J Date: 2015-08-04 Impact factor: 29.983