De Luca Giuseppe, Verdoia Monica, Schaffer Alon, Suryapranata Harry, Parodi Guido, Antoniucci David, Marino Paolo
J Thromb Thrombolysis. 2014 Oct;38(3):388-94. doi: 10.1007/s11239-013-1039-0.
Prasugrel has been shown to be superior to clopidogrel in the setting of ACS patients undergoing coronary angioplasty. However, few data have been reported so far on those patients who switch from clopidogrel to prasugrel after coronary angioplasty. Aim of the current study was to evaluate the safety of prasugrel loading dose administration in ACS patients undergoing PCI and pretreated with high-dose clopidogrel. From May 2010 to December 2011 150 ACS patients undergoing coronary angioplasty and pretreated with high-dose clopidogrel, were switched to prasugrel loading dose soon after the procedure. They were matched (ratio 1:2) according to sex and age with a group of 300 ACS patients undergoing angioplasty and treated with high-dose clopidogrel only from May 2010 to December 2011. All demographic clinical and angiographic were collected. Primary endpoint was the rate of major bleeding complications (according to ACUITY trial definition) at 30-day follow-up. Secondary endpoints were: TIMI major and minor bleeding, definite stent thrombosis, major adverse cardiac events (MACE) and Net adverse cardiac events (NACE) at 30-day followup. The two groups of patients showed similar baseline demographic, and clinical characteristics. Most of the patients had unstable angina or non-ST segment elevation myocardial infarction. Almost (about 95 %) all patients underwent radial approach. No difference was observed in major bleeding complications according to both ACUITY (2.0 vs 2.0 %) and TIMI Major (0.7 vs 1.3 %) definition. No difference between the two groups was observed in terms of in-stent thrombosis, MACE and NACE at 30-day follow-up. Our observational study showed that switching to prasugrel with loading dose soon after angioplasty among ACS patients who were pretreated with clopidogrel seems to be well tolerated without overt evidence of heightened major bleeding. Future large randomized trials are certainly needed to confirm these findings.
普拉格雷已被证明在接受冠状动脉血管成形术的急性冠状动脉综合征(ACS)患者中优于氯吡格雷。然而,迄今为止,关于冠状动脉血管成形术后从氯吡格雷转换为普拉格雷的患者的数据报道很少。本研究的目的是评估在接受经皮冠状动脉介入治疗(PCI)并预先使用高剂量氯吡格雷治疗的ACS患者中给予普拉格雷负荷剂量的安全性。2010年5月至2011年12月,150例接受冠状动脉血管成形术并预先使用高剂量氯吡格雷治疗的ACS患者在手术后不久转换为普拉格雷负荷剂量。根据性别和年龄,将他们与一组仅在2010年5月至2011年12月接受血管成形术并使用高剂量氯吡格雷治疗的300例ACS患者进行匹配(比例为1:2)。收集了所有人口统计学、临床和血管造影资料。主要终点是30天随访时主要出血并发症的发生率(根据急性冠状动脉治疗和干预结果研究(ACUITY)试验定义)。次要终点是:30天随访时的心肌梗死溶栓试验(TIMI)主要和次要出血、明确的支架血栓形成、主要不良心脏事件(MACE)和净不良心脏事件(NACE)。两组患者的基线人口统计学和临床特征相似。大多数患者患有不稳定型心绞痛或非ST段抬高型心肌梗死。几乎所有(约95%)患者采用桡动脉途径。根据ACUITY(2.0%对2.0%)和TIMI主要出血(0.7%对1.3%)定义,主要出血并发症未观察到差异。两组在30天随访时的支架内血栓形成、MACE和NACE方面未观察到差异。我们的观察性研究表明,在预先使用氯吡格雷治疗的ACS患者中,血管成形术后不久转换为普拉格雷负荷剂量似乎耐受性良好,没有明显的主要出血增加的证据。未来肯定需要大型随机试验来证实这些发现。