Division of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy -
Division of Cardiology, Città della Salute e Scienza, University of Turin, Turin, Italy.
Minerva Cardiol Angiol. 2023 Aug;71(4):431-437. doi: 10.23736/S2724-5683.22.06144-0. Epub 2023 Feb 27.
In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach.
OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization.
A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%.
A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.
在 ST 段抬高型心肌梗死（STEMI）患者中，罪犯病变的经皮冠状动脉介入治疗（PCI）显著降低了心血管死亡风险。然而，多支血管病变患者的非罪犯病变的处理在这种情况下仍存在争议。目前尚不清楚形态学 OCT 指导的方法，识别冠状动脉斑块不稳定，是否与标准的血管造影/功能方法相比提供更具针对性的治疗。
OCT-Contact 是一项前瞻性、多中心、开放标签、非劣效性随机对照试验。在成功进行罪犯病变的直接 PCI 后，将 STEMI 患者纳入研究。如果在指数血管造影期间发现除罪犯病变（与狭窄程度≥50%相关）以外的临界冠状动脉病变，则患者符合入选标准。患者将以 1:1 的比例随机分为 OCT 指导的非罪犯病变 PCI 组（A 组）和完全 PCI 组（B 组）。A 组 PCI 将根据斑块易损性标准进行，而 B 组将根据操作者的判断使用血流储备分数。主要不良心血管事件（MACE）是全因死亡率、非致死性心肌梗死（MI）（不包括围手术期 MI）、计划外血运重建和纽约心脏协会（NYHA）IV 级心力衰竭的复合终点。MACE 的单一成分以及心血管死亡率是次要终点。安全性终点包括肾功能恶化、手术并发症和出血。患者将在随机分组后随访 24 个月。
需要 406 例患者（每组 203 例）的样本量，才能在主要终点检测到非劣效性，具有 80%的功效，α误差设定为 0.05，非劣效性限值为 4%。
与标准血管造影/功能方法相比，形态学 OCT 指导的方法在 STEMI 患者的非罪犯病变中可能是一种更具针对性的治疗方法。
