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

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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.

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