Heart Centre, Medical School, University of Pécs, Pécs, Hungary.
Heart and Vascular Centre, Semmelweis University, Budapest, Hungary.
Eur Heart J Cardiovasc Pharmacother. 2023 Nov 2;9(7):608-616. doi: 10.1093/ehjcvp/pvad027.
Clinical guidelines recommend de-escalation antiplatelet strategies to reduce bleeding risk in acute coronary syndrome (ACS) patients, albeit with a weak recommendation. This substudy of the TROPICAL-ACS trial aimed to determine the impact of body mass on the efficacy of a platelet function testing-guided de-escalation regimen in ACS patients after percutaneous coronary intervention.
Patients were randomized to prasugrel (control group) or a platelet function testing-guided regimen with clopidogrel or prasugrel defined after 1-week clopidogrel. The primary endpoint was the net clinical benefit [cardiovascular death, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) 2-5 bleeding] for 12 months. Overweight was defined as a body mass index >25 kg/m2.Patients without overweight showed a significant net clinical benefit from the de-escalation strategy, while in overweight cases de-escalation was comparable to prasugrel treatment [hazard ratio (HR): 0.52; 95% confidence interval (CI): 0.31-0.88; P = 0.013 and HR: 0.95; 95% CI: 0.69-1.31, P = 0.717, P-non-inferiority = 0.03, respectively, P-interaction = 0.053]. The benefit of de-escalation in terms of the risk of bleeding or of the ischaemic events did not reach statistical significance. Bleeding events with de-escalation were less frequent in non-overweight patients but comparable in overweight patients (HR: 0.55; 95% CI: 0.30-1.03; P = 0.057 and HR: 0.95; 95% CI: 0.64-1.41, respectively, P-interaction = 0.147). Non-overweight patients had lower ischaemic event rates with de-escalation, while overweight cases had slightly less (HR: 0.47; 95% CI: 0.18-1.25; P = 0.128 and HR: 0.89; 95% CI: 0.53-1.50, respectively, P-interaction = 0.261).
The strategy of guided dual antiplatelet therapy de-escalation was associated with a significant net clinical benefit in non-overweight patients, while the two strategies were equivalent in overweight patients.
临床指南推荐降级抗血小板策略以降低急性冠状动脉综合征（ACS）患者的出血风险，尽管推荐强度较弱。本 TROPICAL-ACS 试验的子研究旨在确定体重对 ACS 患者经皮冠状动脉介入治疗后血小板功能检测指导的降级方案疗效的影响。
患者被随机分配接受普拉格雷（对照组）或血小板功能检测指导的氯吡格雷或普拉格雷方案，在 1 周氯吡格雷后确定。主要终点是 12 个月时的净临床获益[心血管死亡、心肌梗死、卒中和出血学术研究联合会（BARC）2-5 级出血]。超重定义为体重指数>25 kg/m2。在无超重的患者中，从降级策略中获得了显著的净临床获益，而在超重患者中，降级与普拉格雷治疗相当[风险比（HR）：0.52；95%置信区间（CI）：0.31-0.88；P=0.013 和 HR：0.95；95% CI：0.69-1.31，P=0.717，P-非劣效性=0.03，P 交互=0.053]。在出血风险或缺血事件方面，降级的获益没有达到统计学意义。在非超重患者中，降级的出血事件发生率较低，但在超重患者中相当（HR：0.55；95% CI：0.30-1.03；P=0.057 和 HR：0.95；95% CI：0.64-1.41，P 交互=0.147）。非超重患者的缺血事件发生率较低，而超重患者则略低（HR：0.47；95% CI：0.18-1.25；P=0.128 和 HR：0.89；95% CI：0.53-1.50，P 交互=0.261）。
在非超重患者中，指导双联抗血小板治疗降级策略与显著的净临床获益相关，而在超重患者中，两种策略等效。
