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

• Published in: JACC. Cardiovascular interventions Vol. 3; no. 5; pp. 486 - 494
• Main Authors: Steinberg, Daniel H, Mintz, Gary S, Mandinov, Lazar, Yu, Alan, Ellis, Steven G, Grube, Eberhard, Dawkins, Keith D, Ormiston, John, Turco, Mark A, Stone, Gregg W, Weissman, Neil J
• Format: Journal Article
• Language: English
• Published: United States 01.05.2010
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiovascular Agents - administration & dosage; Cardiovascular Diseases - diagnostic imaging; Cardiovascular Diseases - etiology; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel - administration & dosage; Prospective Studies; Prosthesis Design; Stents; Thrombosis - diagnostic imaging; Thrombosis - etiology; Time Factors; Treatment Outcome; Ultrasonography, Interventional
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2010.03.007

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events. The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable. 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. 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. 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.