Luis A. García Rodríguez, Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Almirante 28-2°, E-28004, Madrid, Spain, Tel.: +34 91 531 3404, Fax: +34 91 531 2871, E-mail:
Thromb Haemost. 2013 Dec;110(6):1298-304. doi: 10.1160/TH13-04-0326. Epub 2013 Sep 5.
It was the aim of this study to investigate whether low-dose acetylsalicylic acid (ASA) therapy for secondary cardiovascular prevention should continue, despite the risk of gastrointestinal bleeding. We aimed to make a clinically meaningful benefit-risk assessment regarding the cardiovascular and gastrointestinal consequences of ASA discontinuation.This case-control study usedThe Health Improvement Network UK primary care database to identify patients aged 50-84 years during 2000-2007 with a first ASA prescription for secondary cardiovascular prevention (N = 39,513). New cases of non-fatal myocardial infarction (MI)/coronary death (n = 1,222), ischaemic stroke (IS)/transient ischaemic attack (TIA) (n = 673) and upper gastrointestinal bleeding (UGIB) (n = 169) were identified after a mean follow-up of 3.2, 3.4 and 4.0 years, respectively. ASA discontinuers before the index date were identified. Attributable risks associated with ASA discontinuation were calculated and National Institute for Health and Clinical Excellence annual economic data were used to estimate healthcare costs. The cumulative incidences of non-fatal MI/coronary death, IS/TIA and UGIB among ASA discontinuers within the first year of follow-up were 17, 11 and 1.6 per 1,000 persons, respectively. This corresponds to eight extra cardiovascular events, and a reduction of 0.4 UGIB events per year compared with current ASA users. Extrapolating to the UK population aged over 50 years, avoiding discontinuation of ASA could prevent 12,786 coronary and 7,672 cerebrovascular events/year, at the expense of 1023 extra UGIB events, saving approximately £100 million/year. In conclusion, preventing patients with cardiovascular disease from discontinuing ASA could result in substantial clinical and economic gains.
这项研究旨在探讨在存在胃肠道出血风险的情况下，用于二级心血管预防的低剂量乙酰水杨酸（ASA）治疗是否应该继续。我们旨在对 ASA 停药的心血管和胃肠道后果进行具有临床意义的获益-风险评估。这项病例对照研究使用英国健康改进网络（Health Improvement Network UK）初级保健数据库，于 2000 年至 2007 年期间确定了年龄在 50-84 岁之间、首次开具用于二级心血管预防的 ASA 处方的患者（N=39513）。在平均 3.2、3.4 和 4.0 年的随访后，分别识别出了 1222 例非致命性心肌梗死（MI）/冠状动脉死亡（coronary death）、673 例缺血性中风（IS）/短暂性脑缺血发作（TIA）和 169 例上胃肠道出血（UGIB）新病例。确定了索引日期前的 ASA 停药者。计算了与 ASA 停药相关的归因风险，并使用英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence）的年度经济数据来估算医疗保健成本。在随访的第一年，ASA 停药者的非致命性 MI/冠状动脉死亡、IS/TIA 和 UGIB 的累积发生率分别为每 1000 人 17、11 和 1.6 例。这相当于每年多发生 8 次心血管事件，每年减少 0.4 次 UGIB 事件。根据英国 50 岁以上人群的情况推断，避免 ASA 停药可预防每年 12786 例冠状动脉和 7672 例脑血管事件，但要多发生 1023 例 UGIB 事件，每年可节省约 1 亿英镑。总之，防止患有心血管疾病的患者停止使用 ASA 可能会带来重大的临床和经济效益。
