Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.
Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.
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心血管疾病患者的肠涂层与未涂层的阿司匹林的有效性和安全性：对适应性随机临床试验的次要分析。
DOI：
10.1001/jamacardio.2023.3364
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发表时间：
2023-11-01
期刊：
影响因子：
24
通讯作者：
Hernandez, Adrian F.
中科院分区：
文献类型：
--
作者：
Sleem, Amber;Effron, Mark B.;Stebbins, Amanda;Wruck, Lisa M.;Marquis-Gravel, Guillaume;Munoz, Daniel;Re, Richard N.;Gupta, Kamal;Pepine, Carl J.;Jain, Sandeep K.;Girotra, Saket;Whittle, Jeffrey;Benziger, Catherine P.;Farrehi, Peter M.;Knowlton, Kirk U.;Polonsky, Tamar S.;Roe, Matthew T.;Rothman, Russell L.;Harrington, Robert A.;Jones, W. Schuyler;Hernandez, Adrian F.
阿司匹林肠溶包衣降低心血管疾病患者的疗效还是增加其安全性？在对来自ADAPTABLE随机临床试验的10678例动脉粥样硬化性心血管疾病参与者进行的事后次要分析中，主要有效性无显著差异（死亡、心肌梗死住院或卒中住院）或安全性在参与者中，肠溶阿司匹林和未包衣阿司匹林之间的（大出血）终点，无论他们被分配的阿司匹林剂量如何。这些结果表明，阿司匹林的肠溶包衣与阿司匹林用于心血管事件二级预防的有效性或安全性变化无关，允许患者确定阿司匹林制剂。临床医生推荐肠溶阿司匹林在冠状动脉疾病的二级预防中减少胃肠道出血，即使研究表明肠溶阿司匹林与未包衣阿司匹林制剂相比血小板抑制作用降低。评估接受肠溶包衣与未包衣阿司匹林是否与有效性或安全性结局相关。这是对ADAPTABLE（阿司匹林给药：一项评估获益和长期有效性的以患者为中心的试验）的事后次要分析，ADAPTABLE是一项对15076例动脉粥样硬化性心血管疾病患者进行的实用研究，其数据来自国家以患者为中心的临床研究网络。患者于2016年4月19日至2020年6月30日入组，并随机分配接受高剂量（325 mg）与低剂量（81 mg）每日阿司匹林。本分析评估了在基线时报告阿司匹林制剂的受试者中肠溶包衣与未包衣阿司匹林的有效性和安全性。分析了2019年11月11日至2023年7月3日的数据。ADAPTABLE参与者根据基线时自我报告的阿司匹林制剂进行重新分组，中位（IQR）随访时间为26.2（19.8-35.4）个月。主要有效性终点是心肌梗死、卒中或全因死亡复合终点的累积发生率，主要安全性终点是大出血事件（因使用血液制品或颅内出血导致出血事件住院）。使用未校正和多变量考克斯比例风险模型，比较服用肠溶包衣或未包衣阿司匹林的受试者中位随访时主要有效性和主要安全性终点的累积发生率。所有分析均针对意向治疗人群进行。ADAPTABLE中10678例受试者（中位[IQR]年龄为68.0 [61.3-73.7]岁; 7285例男性[68.2%]）自我报告基线阿司匹林制剂，其中7366例（69.0%）服用肠溶阿司匹林，3312例（31.0%）服用未包衣阿司匹林。有效性无显著差异（校正风险比[AHR]，0.94; 95% CI，0.80-1.09; P = .40）或安全性（AHR，0.82; 95% CI，0.49-1.37; P = 0.46），在肠溶阿司匹林和未包衣阿司匹林队列中，阿司匹林剂量与疗效无关（肠溶包衣阿司匹林AHR，1.13; 95% CI，0.88-1.45和未包衣阿司匹林AHR，0.99; 95% CI，0.83-1.18;相互作用P = 0.41）或安全性（肠溶包衣阿司匹林AHR，2.37; 95% CI，1.02-5.50和未包衣阿司匹林AHR，0.89; 95% CI，0.49-1.64;相互作用P = 0.07）。在这项ADAPTABLE随机临床试验的事后次要分析中，与未包衣阿司匹林相比，肠溶阿司匹林与心肌梗死、卒中或死亡的风险显著升高或出血风险降低无关，无论剂量如何，尽管不能排除肠溶阿司匹林减少出血的可能性。需要更多的研究来证实肠溶阿司匹林制剂或新制剂是否会改善这一人群的结局。ClinicalTrials.gov 标识符：NCT 02697916这项随机临床试验的事后次要分析比较了肠溶阿司匹林与未包衣阿司匹林在动脉粥样硬化性心血管疾病患者中的有效性和安全性。
Does enteric coating on aspirin reduce effectiveness or increase safety in patients with cardiovascular disease? In this post hoc secondary analysis of 10 678 participants with atherosclerotic cardiovascular disease from the ADAPTABLE randomized clinical trial, there were no significant differences in the primary effectiveness (death, hospitalization for myocardial infarction, or hospitalization for stroke) or safety (major bleeding) end points between enteric-coated aspirin and uncoated aspirin among participants, regardless of which dose of aspirin they were assigned. These findings suggested that enteric coating on aspirin is not associated with changes in the effectiveness or safety of aspirin for secondary prevention of cardiovascular events, allowing patients to determine the aspirin formulation. Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulations. To assess whether receipt of enteric-coated vs uncoated aspirin is associated with effectiveness or safety outcomes. This is a post hoc secondary analysis of ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic study of 15 076 patients with atherosclerotic cardiovascular disease having data in the National Patient-Centered Clinical Research Network. Patients were enrolled from April 19, 2016, through June 30, 2020, and randomly assigned to receive high (325 mg) vs low (81 mg) doses of daily aspirin. The present analysis assessed the effectiveness and safety of enteric-coated vs uncoated aspirin among those participants who reported aspirin formulation at baseline. Data were analyzed from November 11, 2019, to July 3, 2023. ADAPTABLE participants were regrouped according to aspirin formulation self-reported at baseline, with a median (IQR) follow-up of 26.2 (19.8-35.4) months. The primary effectiveness end point was the cumulative incidence of the composite of myocardial infarction, stroke, or death from any cause, and the primary safety end point was major bleeding events (hospitalization for a bleeding event with use of a blood product or intracranial hemorrhage). Cumulative incidence at median follow-up for primary effectiveness and primary safety end points was compared between participants taking enteric-coated or uncoated aspirin using unadjusted and multivariable Cox proportional hazards models. All analyses were conducted for the intention-to-treat population. Baseline aspirin formulation used in ADAPTABLE was self-reported for 10 678 participants (median [IQR] age, 68.0 [61.3-73.7] years; 7285 men [68.2%]), of whom 7366 (69.0%) took enteric-coated aspirin and 3312 (31.0%) took uncoated aspirin. No significant difference in effectiveness (adjusted hazard ratio [AHR], 0.94; 95% CI, 0.80-1.09; P = .40) or safety (AHR, 0.82; 95% CI, 0.49-1.37; P = .46) outcomes between the enteric-coated aspirin and uncoated aspirin cohorts was found. Within enteric-coated aspirin and uncoated aspirin, aspirin dose had no association with effectiveness (enteric-coated aspirin AHR, 1.13; 95% CI, 0.88-1.45 and uncoated aspirin AHR, 0.99; 95% CI, 0.83-1.18; interaction P = .41) or safety (enteric-coated aspirin AHR, 2.37; 95% CI, 1.02-5.50 and uncoated aspirin AHR, 0.89; 95% CI, 0.49-1.64; interaction P = .07). In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteric-coated aspirin cannot be excluded. More research is needed to confirm whether enteric-coated aspirin formulations or newer formulations will improve outcomes in this population. ClinicalTrials.gov Identifier: NCT02697916 This post hoc secondary analysis of a randomized clinical trial compares the effectiveness and safety of enteric-coated aspirin vs uncoated aspirin among patients with atherosclerotic cardiovascular disease.
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影响因子：
3.3
作者：
Karkossa, Frank;Klein, Sandra
通讯作者：
Klein, Sandra
耐药性和伪耐药性：肠涂层阿司匹林的意外结果。
影响因子：
37.8
作者：
Grosser T;Fries S;Lawson JA;Kapoor SC;Grant GR;FitzGerald GA
通讯作者：
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影响因子：
158.5
作者：
Mehta, Shamir R.;Bassand, Jean-Pierre;Yusuf, Salim
通讯作者：
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DOI：
10.1161/circoutcomes.121.008190
发表时间：
2021-12-01
影响因子：
6.9
作者：
Marquis-Gravel, Guillaume;Hammill, Bradley G.;Jones, W. Schuyler
通讯作者：
Jones, W. Schuyler
影响因子：
2.1
作者：
THIESSEN, JJ;GRAD, H;SPINO, M
通讯作者：
SPINO, M