替格瑞洛在接受经皮冠状动脉介入治疗的急性冠状动脉综合征患者中的有效性和安全性：丹麦西部的一项队列研究

Effectiveness and Safety of Ticagrelor Implementation in Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention: A Cohort Study in Western Denmark.

作者信息

Thrane Pernille Gro, Olesen Kevin Kris Warnakula, Würtz Morten, Gyldenkerne Christine, Madsen Morten, Jensen Lisette Okkels, Raungaard Bent, Sørensen Henrik Toft, Thim Troels, Kristensen Steen Dalby, Maeng Michael

机构信息

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

出版信息

Lancet Reg Health Eur. 2022 Jan 25;14:100301. doi: 10.1016/j.lanepe.2021.100301. eCollection 2022 Mar.

BACKGROUND

Ticagrelor was introduced in Denmark in 2011 after randomised data showed its superiority over clopidogrel for patients with acute coronary syndrome (ACS). We assessed the effectiveness and safety of ticagrelor implementation in ACS patients undergoing percutaneous coronary intervention (PCI).

METHODS

We identified PCI-treated ACS patients in Western Denmark who redeemed a P2Y12 inhibitor prescription within 14 days. Using Danish health registries, 1-year outcomes were compared before (2007-2010) and after (2012-2015) introduction of ticagrelor. Outcomes were MACE (death, myocardial infarction, and ischaemic stroke) and hospitalisation for bleeding. Inverse probability of treatment weights were used to estimate weighted incidence rate ratios (wIRRs).

FINDINGS

We included 14,450 patients; 7,102 were treated in the earlier time period (99·9% clopidogrel) and 7,348 in the later time period (87·8% ticagrelor). Ticagrelor implementation was not associated with a clinically relevant difference in 1-year risk of MACE with 413 events in the ticagrelor period vs. 424 events in the clopidogrel period (cumulative incidence percentage [CIP] 5·6% vs. 6·0%; wIRR 1·06, 95% CI 0·92-1·22). The 1-year risk of bleeding was also similar between groups with 335 bleedings requiring hospitalisation in the ticagrelor period vs. 309 events in the clopidogrel period (CIP 4·6% vs. 4·4%; wIRR 1·05, 95% CI 0·89-1·23). Results were robust in patients above and below 70 years of age.

INTERPRETATION

Implementation of ticagrelor was not associated with changes in risks of ischaemic or bleeding events in Danish PCI-treated ACS patients.

背景

随机数据显示替格瑞洛在急性冠状动脉综合征（ACS）患者中优于氯吡格雷后，丹麦于2011年引入了替格瑞洛。我们评估了替格瑞洛在接受经皮冠状动脉介入治疗（PCI）的ACS患者中的有效性和安全性。

方法

我们在丹麦西部确定了接受PCI治疗的ACS患者，这些患者在14天内兑换了P2Y12抑制剂处方。利用丹麦健康登记系统，比较了替格瑞洛引入之前（2007 - 2010年）和之后（2012 - 2015年）的1年结局。结局指标为主要不良心血管事件（MACE，包括死亡、心肌梗死和缺血性卒中）以及因出血住院。采用治疗权重的逆概率来估计加权发病率比（wIRRs）。

结果

我们纳入了14450例患者；7102例在较早时间段接受治疗（99.9%使用氯吡格雷），7348例在较晚时间段接受治疗（87.8%使用替格瑞洛）。替格瑞洛的应用与1年MACE风险的临床相关差异无关，替格瑞洛组有413例事件，氯吡格雷组有424例事件（累积发生率百分比[CIP]分别为5.6%和6.0%；wIRR为1.06，95%CI为0.92 - 1.22）。两组之间1年出血风险也相似，替格瑞洛组有335例因出血需住院，氯吡格雷组有309例事件（CIP分别为4.6%和4.4%；wIRR为1.05，95%CI为0.89 - 1.23）。在70岁及以上和70岁以下患者中结果均稳健。