Piedmont Heart Institute, Atlanta, GA (D.E.K.).
Leicester Biomedical Research Centre, University Hospitals of Leicester, University of Leicester, United Kingdom (A.H.G.).
Circ Cardiovasc Interv. 2018 Oct;11(10):e007007. doi: 10.1161/CIRCINTERVENTIONS.118.007007.
Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion.
The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36).
Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels.
URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.
左主干(LM)冠状动脉远端分叉病变增加了经皮冠状动脉介入治疗(PCI)的程序复杂性,并且与孤立的开口/干病变相比,其预后更差。LM 远端病变的最佳治疗策略尚未确定。我们旨在确定在使用临时 1 支架与计划的 2 支架技术治疗 LM 远端分叉病变后,其 PCI 的结果是否受到影响,以及如果存在差异,这种差异是否取决于 LM 分叉病变的复杂性。
在 EXCEL 试验(XE- cience 与冠状动脉旁路移植术治疗左主干血运重建效果的评估)中,比较了接受计划 LM 远端 PCI 的患者中,使用临时 1 支架与计划 2 支架技术的患者的临床和血管造影特征、程序方法和结果,以及 3 年随访期间的临床事件。在接受计划 LM 远端 PCI 的 529 例患者中,344 例(65.0%)和 185 例(35.0%)分别接受了预期的 1 支架临时和计划 2 支架技术治疗。在 3 年时,死亡、心肌梗死或卒中的主要复合终点发生率在接受临时 1 支架治疗的患者中明显低于接受计划 2 支架治疗的患者(14.1%对 20.7%;调整后的危险比,0.55;95%CI,0.35-0.88;P=0.01),差异主要归因于心血管死亡(3.3%对 8.3%,P=0.01)和心肌梗死(7.7%对 12.8%,P=0.06)。在临时组中,LM 复合体缺血驱动的血运重建的 3 年率也较低(7.2%对 16.3%,P=0.001)。在 342 例未累及两个主要分支血管的 LM 远端分叉病变患者中,与计划的 2 支架技术相比,临时 1 支架治疗的 3 年主要终点较低(13.8%对 23.3%,P=0.04),而在 182 例累及两个侧支血管的 LM 远端分叉病变患者中,这两种方法无显著差异(14.3%对 19.2%,P=0.36)。
在 EXCEL 试验中随机接受 PCI 治疗的 LM 远端分叉病变患者中,与计划的 2 支架治疗相比,3 年不良结局更差,这一差异仅限于 LM 侧支血管无主要受累的患者。
网址:https://www.clinicaltrials.gov。唯一标识符:NCT01205776。