A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: Six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial

作者：Stella Pieter R^*; Belkacemi Anouar; Dubois Christophe; Nathoe Hendrik; Dens Jo; Naber Christoph; Adriaenssens Tom; van Belle Eric; Doevendans Pieter; Agostoni Pierfrancesco

来源：Catheterization and Cardiovascular Interventions, 2012, 80(7): 1138-1146.

DOI：10.1002/ccd.23499

• bifurcation
• angioplasty
• drug-eluting balloon
• stent

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.

• 出版日期2012-12-1