Larmore Cynthia, Effron Mark B, Molife Cliff, DeKoven Mitch, Zhu Yajun, Lu Jingsong, Karkare Swapna, Lieu Hsiao D, Lee Won Chan, Vetrovec George W
Eli Lilly and Company, US Medical Affairs, Indianapolis, Indiana.
IMS Health, Health Economics and Outcomes Research/Real World Evidence Solutions, Plymouth Meeting, PA.
Catheter Cardiovasc Interv. 2016 Oct;88(4):535-544. doi: 10.1002/ccd.26279. Epub 2015 Nov 18.
The 30-day clinical outcomes with prasugrel or ticagrelor were compared using a US payer database in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Prasugrel and ticagrelor demonstrated superior efficacy with increased non-coronary artery bypass graft major bleeding compared with clopidogrel in randomized clinical trials. No direct randomized or observational studies have compared clinical outcomes between prasugrel and ticagrelor.
Patients hospitalized for ACS-PCI between August 1, 2011 and April 30, 2013 and prescribed prasugrel or ticagrelor were selected. Drug treatment cohorts were propensity matched based upon demographic and clinical characteristics. The primary objective compared 30-day net adverse clinical events (NACE) in prasugrel- and ticagrelor-treated patients using a prespecified 20% noninferiority margin. Secondary objectives included comparisons of major adverse cardiovascular events (MACE) and major bleeding.
Data were available for 16,098 patients (prasugrel, n = 13,134; ticagrelor, n = 2,964). In unmatched cohorts, prasugrel-treated patients were younger with fewer comorbidities than ticagrelor-treated patients, and 30-day NACE rates were 5.6 and 9.3%, respectively (P < 0.001). Following propensity matching, NACE was noninferior (P < 0.001) and 22% lower in prasugrel-treated than in ticagrelor-treated patients (RR, 0.78; 95% CI, 0.64-0.94). A 30-day adjusted MACE (RR, 0.80; 95% CI, 0.64-0.98) and major bleeding (RR, 0.65; 95% CI, 0.45-0.95) were also lower in prasugrel-treated patients compared with ticagrelor-treated patients.
In this "real-world," retrospective, observational study, physicians appear to preferentially use prasugrel in younger patients with lower risk of bleeding or comorbidities compared with ticagrelor. Following adjustment, clinical outcomes associated with prasugrel use appear as good, if not better, than those associated with ticagrelor in ACS-PCI patients. © 2015 Wiley Periodicals, Inc.
利用美国医保数据库,比较普拉格雷或替格瑞洛在接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)患者中的30天临床结局。
在随机临床试验中,与氯吡格雷相比,普拉格雷和替格瑞洛疗效更佳,但非冠状动脉搭桥术相关的大出血发生率更高。尚无直接的随机或观察性研究比较普拉格雷和替格瑞洛的临床结局。
选取2011年8月1日至2013年4月30日因ACS-PCI住院并开具普拉格雷或替格瑞洛处方的患者。根据人口统计学和临床特征对药物治疗队列进行倾向匹配。主要目的是使用预先设定的20%非劣效性界值,比较普拉格雷和替格瑞洛治疗患者的30天净不良临床事件(NACE)。次要目的包括比较主要不良心血管事件(MACE)和大出血情况。
共有16,098例患者的数据可用(普拉格雷组,n = 13,134;替格瑞洛组,n = 2,964)。在未匹配队列中,普拉格雷治疗的患者比替格瑞洛治疗的患者更年轻,合并症更少,30天NACE发生率分别为5.6%和9.3%(P < 0.001)。倾向匹配后,NACE具有非劣效性(P < 0.001),普拉格雷治疗的患者比替格瑞洛治疗的患者低22%(相对危险度,0.78;95%置信区间,0.64 - 0.94)。与替格瑞洛治疗的患者相比,普拉格雷治疗的患者30天调整后MACE(相对危险度,0.80;95%置信区间,0.64 - 0.98)和大出血(相对危险度,0.65;95%置信区间,0.45 - 0.95)也更低。
在这项“真实世界”的回顾性观察研究中,与替格瑞洛相比,医生似乎更倾向于在出血风险较低或合并症较少的年轻患者中使用普拉格雷。调整后,在ACS-PCI患者中,使用普拉格雷的临床结局即便不比使用替格瑞洛更好,也与之相当。© 2015威利期刊公司