Fanggiday James C, Stella Pieter R, Guyomi Siyrous Hoseyni, Doevendans Pieter A
Department of Heart and Lung, University Medical Center Utrecht, Utrecht, The Netherlands.
Catheter Cardiovasc Interv. 2008 Apr 1;71(5):629-35. doi: 10.1002/ccd.21452.
To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions.
The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry.
This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months.
The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported.
The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.
评估使用药物洗脱球囊导管（紫杉醇涂层）对冠状动脉分叉病变患者进行经皮冠状动脉介入治疗（PCI）后的疗效。
目前对主支（MB）进行临时支架置入的做法是合理的；然而，分支（SB）治疗的长期结果并不理想。无论植入技术如何，药物洗脱支架的使用都未能改善这些结果，并且可能会导致（晚期）血栓形成事件显著增加。为了评估药物洗脱球囊（DEB）对分叉病变患者进行主支临时支架置入后的短期安全性和有效性，我们建立了DEBIUT注册研究。
该注册研究纳入了20例符合条件的冠状动脉分叉病变患者。患者接受了紫杉醇涂层球囊导管的PCI治疗，随后用裸金属支架对MB进行临时支架置入。在1个月和4个月后进行了急性血管造影和临床随访。
所有患者手术均成功。序贯使用DEB预扩张是安全的且耐受性良好。用DEB治疗后未发生侧支的急性或亚急性闭塞。所有患者均按照临时支架置入技术进行治疗；未在SB置入支架。在4个月的随访中，未报告重大急性冠状动脉事件和亚急性血管闭塞。
在冠状动脉分叉病变患者中，使用药物洗脱球囊在PCI后长达4个月的时间内是有效且安全的。
