Maini Aneel S, Abu-Much Arsalan, Redfors Björn, Wollmuth Jason R, Basir Mir B, Faraz Haroon A, Thompson Julia B, Schonning Michael J, Falah Batla, Moses Jeffrey W, O'Neill William W
Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX; Cardiovascular Research Center, New York, NY.
Cardiovascular Research Center, New York, NY.
Am Heart J. 2025 May 22;290:6-16. doi: 10.1016/j.ahj.2025.05.013.
Coronary bifurcation lesions (CBL) are associated with lower procedural success, worse postprocedural outcomes, and greater unplanned repeat revascularization. We sought to better understand the impact of Impella support in patients undergoing percutaneous coronary intervention (PCI) of CBLs.
We used data from the cVAD PROTECT III study (NCT04136392), an FDA-audited, single-arm study of patients undergoing high-risk PCI with Impella support, to examine the outcomes of patients undergoing PCI of CBLs. Patients with a Medina classification of 1.1.1, 1.0.1, or 0.1.1 were considered to have a true CBL, and were compared to patients with nontrue CBLs and/or no CBLs. The primary outcome was the rate of CEC-adjudicated major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days. Cox proportional hazards regression models were adjusted for age, sex, left main disease, and triple vessel disease.
Of 1,044 patients, 523 had at least one true CBL treated. Baseline characteristics were comparable between groups except for age which was higher in patients with CBLs. Patients with CBLs had a significantly higher pre-PCI SYNTAX scores and number of treated lesions, more left main disease and triple vessel disease, and longer procedure duration. There was no difference in post-PCI SYNTAX score, PCI-related complications, or failure to achieve angiographic success. After adjustment for potential confounders, patients with CBLs had similar rates of 90-day MACCE.
While patients with CBLs undergoing Impella-supported high-risk PCI had higher complexity, there were similar rates of PCI-related complications and 90-day MACCE.
Trial Name: The Global cVAD Study (cVAD), ClinicalTrial.gov Identifier: NCT04136392, URL:https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.
冠状动脉分叉病变（CBL）与较低的手术成功率、较差的术后结果以及更高的非计划性重复血运重建相关。我们试图更好地了解Impella支持对接受CBL经皮冠状动脉介入治疗（PCI）患者的影响。
我们使用了cVAD PROTECT III研究（NCT04136392）的数据，这是一项经美国食品药品监督管理局审核的单臂研究，研究对象为接受Impella支持的高危PCI患者，以检查接受CBL PCI患者的结局。Medina分类为1.1.1、1.0.1或0.1.1的患者被认为患有真正的CBL，并与非真正CBL和/或无CBL的患者进行比较。主要结局是90天时CEC判定的主要不良心脑血管事件（MACCE：全因死亡、心肌梗死、中风/短暂性脑缺血发作和重复血运重建的复合事件）发生率。Cox比例风险回归模型根据年龄、性别、左主干病变和三支血管病变进行了调整。
在1044例患者中，523例至少接受了一处真正的CBL治疗。除年龄外，各组间基线特征具有可比性，CBL患者年龄更高。CBL患者PCI术前SYNTAX评分和治疗病变数量显著更高，左主干病变和三支血管病变更多，手术时间更长。PCI术后SYNTAX评分、PCI相关并发症或未实现血管造影成功方面无差异。在对潜在混杂因素进行调整后，CBL患者90天MACCE发生率相似。
虽然接受Impella支持的高危PCI的CBL患者病情更为复杂，但PCI相关并发症发生率和90天MACCE发生率相似。
试验名称：全球cVAD研究（cVAD），ClinicalTrial.gov标识符：NCT04136392，网址：https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2
