Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Cardiac & Cardiovascular Systems, Cardiovascular System & Cardiology, bifurcation, angioplasty, drug-eluting balloon, stent, PACLITAXEL-COATED BALLOON, CORONARY, RESTENOSIS, EFFICACY, SAFETY, OUTCOMES, RISK, Aged, Analysis of Variance, Angioplasty, Balloon, Coronary, Cardiovascular Agents, Chi-Square Distribution, Coronary Angiography, Coronary Artery Disease, Coronary Restenosis, Coronary Vessels, Drug-Eluting Stents, Europe, Feasibility Studies, Female, Humans, Male, Metals, Middle Aged, Myocardial Infarction, Paclitaxel, Predictive Value of Tests, Prosthesis Design, Risk Factors, Single-Blind Method, Stents, Time Factors, Treatment Outcome, 1102 Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, 3201 Cardiovascular medicine and haematology

Abstract:

BACKGROUND: Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES. METHODS: In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization). RESULTS: The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively. CONCLUSIONS: Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS. © 2012 Wiley Periodicals, Inc.