Uppsala Clinical Research Center, Uppsala University, Sweden.
BMJ. 2011 Jun 17;342:d3527. doi: 10.1136/bmj.d3527.
To evaluate efficacy and safety outcomes in patients in the PLATelet inhibition and patient Outcomes (PLATO) trial who at randomisation were planned for a non-invasive treatment strategy.
Pre-specified analysis of pre-randomisation defined subgroup of prospective randomised clinical trial.
862 centres in 43 countries.
5216 (28%) of 18,624 patients admitted to hospital for acute coronary syndrome who were specified as planned for non-invasive management.
Randomised treatment with ticagrelor (n=2601) versus clopidogrel (2615).
Primary composite end point of cardiovascular death, myocardial infarction, and stroke; their individual components; and PLATO defined major bleeding during one year.
2183 (41.9%) patients had coronary angiography during their initial hospital admission, 1065 (20.4%) had percutaneous coronary intervention, and 208 (4.0%) had coronary artery bypass surgery. Cumulatively, 3143 (60.3%) patients had been managed non-invasively by the end of follow-up. The incidence of the primary end point was lower with ticagrelor than with clopidogrel (12.0% (n=295) v 14.3% (346); hazard ratio 0.85, 95% confidence interval 0.73 to 1.00; P=0.04). Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01). The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.
In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.
Clinical trials NCT00391872.
评估 PLATO 试验中随机分组时计划采用非侵入性治疗策略的患者的疗效和安全性结局。
前瞻性随机临床试验中预先指定的亚组分析。
43 个国家的 862 个中心。
5216 例（28%）急性冠状动脉综合征住院患者，预先指定为接受非侵入性管理。
随机接受替格瑞洛（n=2601）或氯吡格雷（n=2615）治疗。
心血管死亡、心肌梗死和卒中和其各自的组成部分；PLATO 定义的一年期间大出血的主要复合终点。
2183 例（41.9%）患者在初始住院期间接受冠状动脉造影检查，1065 例（20.4%）接受经皮冠状动脉介入治疗，208 例（4.0%）接受冠状动脉旁路移植术。累计有 3143 例（60.3%）患者在随访结束时接受非侵入性治疗。替格瑞洛组的主要终点发生率低于氯吡格雷组（12.0%（n=295）vs. 14.3%（346）；风险比 0.85，95%置信区间 0.73 至 1.00；P=0.04）。总死亡率也较低（6.1%（147）vs. 8.2%（195）；0.75，0.61 至 0.93；P=0.01）。替格瑞洛组的总大出血发生率（11.9%（272）vs. 10.3%（238）；1.17，0.98 至 1.39；P=0.08）和非冠状动脉旁路移植术相关大出血发生率（4.0%（90）vs. 3.1%（71）；1.30，0.95 至 1.77；P=0.10）也高于氯吡格雷组。
在最初计划采用非侵入性治疗的急性冠状动脉综合征患者中，替格瑞洛的获益与总体 PLATO 结果一致，表明无论采用何种治疗策略，替格瑞洛均可广泛抑制 P2Y12 带来获益。
ClinicalTrials.gov NCT00391872。
