Peverill William T, Incani Alexander, Worthley Stephen G, Singbal Yash, Garrahy Paul J, McCann Andrew B, Cox Stephen V, Moore Peter T, Lim Richard Y Y, Fetahovic Taufik, Connors Gerard W, Hall Cindy, Sieg Charmaine, Camuglia Anthony C
Department of Cardiology, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.
University of Queensland, Brisbane, QLD 4102, Australia.
Int J Cardiol Heart Vasc. 2020 Sep 25;30:100643. doi: 10.1016/j.ijcha.2020.100643. eCollection 2020 Oct.
The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required.
From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis.
All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina.
The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).
本研究是一项前瞻性观察性单臂临床研究，并进行了平行的实验室测试，旨在研究采用锥形球囊挤压改良T（CFCT）分叉支架技术的技术可行性、安全性和临床结果。分叉经皮冠状动脉介入治疗（PCI）仍是一个程序不断发展的领域。需要更广泛适用且可重复的技术。
从2018年4月至2019年3月，连续20例患者使用CFCT技术及含生物可吸收聚合物的铂铬依维莫司药物洗脱支架进行分叉PCI。在12个月随访时进行运动负荷超声心动图检查。主要结局是心脏相关死亡、心肌梗死、靶病变/血管血运重建和中风的复合结局。安全性次要终点包括出血、全因死亡和支架血栓形成。
所有患者均成功进行了CFCT分叉手术，至30天随访无并发症。1例患者在9个月时因稳定型心绞痛达到主要终点，需要进行靶病变血运重建。该队列中无其他主要或次要结局事件。随访期间无中风、死亡、支架血栓形成或心肌梗死。平均加拿大心血管学会（CCS）评分从2.25改善至0.25（p<0.0001）。光学相干断层扫描（OCT）和实验室测试结果表明，侧支开口覆盖最佳，新嵴处多余的支架材料最少。
CFCT技术似乎是治疗冠状动脉分叉病变的一种安全、有效且可行的策略。需要扩大数据集并进行长期随访的随机研究，以进一步探索并证实该可行性数据。（澳大利亚和新西兰临床试验注册中心编号：ACTRN12618001145291）
