Rubboli Andrea, Sciahbasi Alessandro, Briguori Carlo, Saia Francesco, Palmieri Cataldo, Moroni Luigi Andrea, Calabrò Paolo, Leone Antonio Maria, Franco Nicoletta, Valgimigli Marco, Varani Elisabetta, Santi Michela, Pasqualini Paola, Capecchi Alessandro, Piccalò Giacomo, Margheri Massimo, di Pasquale Giuseppe, Galvani Marcello, Bolognese Leonardo, Gonzini Lucio, Maggioni Aldo Pietro
Unità Operativa di Cardiologia, Laboratorio di Cardiologia Interventistica, Ospedale Maggiore, Bologna, Italy.
J Invasive Cardiol. 2013 Apr;25(4):170-6.
The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.
接受冠状动脉支架植入术(PCI-S)的华法林治疗患者的院内管理方式不一,且院内结局尚未完全明确。为确定对当前推荐方案的遵循情况以及不良事件的发生率,我们开展了前瞻性、多中心、观察性的华法林与冠状动脉支架置入(WAR-STENT)注册研究(ClinicalTrials.gov标识符NCT00722319)。意大利37个中心所有接受PCI-S的连续华法林治疗患者均被纳入研究并随访12个月。结局指标包括:主要不良心血管事件(MACE),包括心血管死亡、非致命性心肌梗死、紧急血运重建需求、中风和静脉血栓栓塞,以及严重和轻微出血。在本文中,我们报告院内研究结果。在纳入的411例患者中,92%处于非低(即中度或高度)血栓栓塞风险。分别有61%和60%的病例采用桡动脉入路和裸金属支架。药物洗脱支架主要用于糖尿病患者,反过来,糖尿病又显著预测了药物洗脱支架的植入(比值比[OR],2.02;95%置信区间[CI],1.29 - 3.17;P = 0.002)。院内MACE和严重出血发生率分别为2.7%和2.1%。出院时,76%的患者接受了华法林、阿司匹林和氯吡格雷三联疗法(TT)。非低血栓栓塞风险组TT的处方频率显著更高。反过来,非低血栓栓塞风险是TT处方的显著预测因素(OR,11.2;95%CI,4.83 - 26.3;P < 0.0001)。总之,现实世界中接受PCI-S的华法林治疗患者大多按照当前推荐方案进行管理。因此,院内MACE和严重出血的风险似乎有限且可接受。