Long-Term Impact of Routinely Detected Early and Late Incomplete Stent Apposition An Integrated Intravascular Ultrasound Analysis of the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Studies

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 Liberte 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 Liberte), 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. (J Am Coll Cardiol Intv 2010;3:486-94) (C) 2010 by the American College of Cardiology Foundation