Lee Kyu-Sun, Park Keun-Ho, Park Kyung Woo, Rha Seung-Woon, Hwang Doyeon, Kang Jeehoon, Han Jung-Kyu, Yang Han-Mo, Kang Hyun-Jae, Koo Bon-Kwon, Lee Nam-Ho, Rhew Jay Young, Chun Kook Jin, Lim Young-Hyo, Bong Jung Min, Bae Jang-Whan, Lee Bong Ki, Kim Seok-Yeon, Shin Won-Yong, Lim Hong-Seok, Park Kyungil, Kim Hyo-Soo
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital and Seoul National University College of Medicine, Seoul 03080, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea.
Eur Heart J Cardiovasc Pharmacother. 2023 Apr 10;9(3):262-270. doi: 10.1093/ehjcvp/pvad008.
The aim of this study was to evaluate the efficacy and safety of prasugrel dose de-escalation therapy in patients with diabetes mellitus (DM)-acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).
This was a post-hoc analysis of the HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) randomized trial. The efficacy and safety of prasugrel dose de-escalation therapy (prasugrel 5 mg daily) were compared with conventional therapy (prasugrel 10 mg daily) in patients with DM. The primary endpoint was net adverse clinical events (NACE), defined as a composite of all-cause death, non-fatal myocardial infarction (MI), stent thrombosis (ST), clinically driven revascularization, stroke, and Bleeding Academic Research Consortium (BARC) class ≥2 bleeding events. The secondary ischaemic outcome was major adverse cardiovascular and cerebrovascular events, defined as the composite of cardiac death, non-fatal MI, ST, or ischaemic stroke. Of 2338 patients randomized, 990 had DM. The primary endpoint of NACE occurred in 38 patients (7.6%) receiving prasugrel dose de-escalation and in 53 patients (11.3%) receiving conventional therapy among patients with DM [hazard ratio (HR) 0.66; 95% confidence interval (CI) 0.43-0.99; P = 0.049]. Prasugrel dose de-escalation as compared with conventional therapy did not increase the risk of ischaemic events (HR 1.03; 95% CI 0.56-1.88; P = 0.927) but decreased BARC class ≥2 bleeding in patients with DM (HR 0.44; 95% CI 0.23-0.84; P = 0.012).
Prasugrel dose de-escalation compared with conventional therapy may reduce the risk of net clinical outcomes, mostly driven by a reduction in bleeding without an increase in ischaemic events in patients with DM. Trial Registration: HOST-REDUCE-POLYTECH-ACS, NCT02193971, https://clinicaltrials.gov/ct2/show/NCT02193971.
本研究旨在评估普拉格雷剂量递减疗法在接受经皮冠状动脉介入治疗（PCI）的糖尿病（DM）合并急性冠状动脉综合征（ACS）患者中的疗效和安全性。
这是一项对HOST-REDUCE-POLYTECH-ACS（冠状动脉疾病治疗的优化策略——ACS患者中普拉格雷剂量降低或聚合物技术比较）随机试验的事后分析。将普拉格雷剂量递减疗法（每日5毫克普拉格雷）与常规疗法（每日10毫克普拉格雷）在糖尿病患者中的疗效和安全性进行比较。主要终点是净不良临床事件（NACE），定义为全因死亡、非致命性心肌梗死（MI）、支架血栓形成（ST）、临床驱动的血运重建、中风以及出血学术研究联盟（BARC）≥2级出血事件的综合。次要缺血性结局是主要不良心血管和脑血管事件，定义为心源性死亡、非致命性MI、ST或缺血性中风的综合。在随机分组的2338例患者中，990例患有糖尿病。在糖尿病患者中，接受普拉格雷剂量递减治疗的38例患者（7.6%）和接受常规治疗的53例患者（11.3%）发生了NACE主要终点[风险比（HR）0.66；95%置信区间（CI）0.43 - 0.99；P = 0.049]。与常规治疗相比，普拉格雷剂量递减并未增加缺血事件的风险（HR 1.03；95% CI 0.56 - 1.88；P = 0.927），但降低了糖尿病患者中BARC≥2级出血的发生率（HR 0.44；95% CI 0.23 - 0.84；P = 0.012）。
与常规治疗相比，普拉格雷剂量递减可能降低净临床结局的风险，这主要是由于出血减少，而糖尿病患者的缺血事件并未增加。试验注册：HOST-REDUCE-POLYTECH-ACS，NCT02193971，https://clinicaltrials.gov/ct2/show/NCT02193971 。
