S-EPMC10757508 - Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors. - OmicsDI

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Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.

ABSTRACT: Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Methods and Results Participants in ADAPTABLE were stratified according to baseline use of clopidogrel or prasugrel (P2Y12 group). The primary effectiveness end point was a composite of death, myocardial infarction, or stroke; and the primary safety end point was major bleeding requiring blood transfusions. We used multivariable Cox regression to compare the relative effectiveness and safety of aspirin dose within P2Y12 and non-P2Y12 groups. Of 13 815 (91.6%) participants with available data, 3051 (22.1%) were receiving clopidogrel (2849 [93.4%]) or prasugrel (203 [6.7%]) at baseline. P2Y12 inhibitor use was associated with higher risk of the primary effectiveness end point (10.86% versus 6.31%; adjusted hazard ratio [HR], 1.40 [95% CI, 1.22-1.62]) but was not associated with bleeding (0.95% versus 0.53%; adjusted HR, 1.42 [95% CI, 0.91-2.22]). We found no interaction in the relative effectiveness and safety of high- versus low-dose aspirin by P2Y12 inhibitor use. Overall, dose switching or discontinuation was more common in the high-dose compared with low-dose aspirin group, but the pattern was not modified by P2Y12 inhibitor use. Conclusions In this prespecified analysis of ADAPTABLE, we found that the relative effectiveness and safety of high- versus low-dose aspirin was not modified by baseline P2Y12 inhibitor use. Registration https://www.clinical.trials.gov. Unique identifier: NCT02697916.

SUBMITTER: Girotra S

PROVIDER: S-EPMC10757508 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.

Girotra Saket S Stebbins Amanda A Wruck Lisa L Marquis-Gravel Guillaume G Gupta Kamal K Farrehi Peter P Benziger Catherine P CP Effron Mark B MB Whittle Jeffrey J Muñoz Daniel D Kripalani Sunil S Anderson R David RD Jain Sandeep K SK Polonsky Tamar S TS Ahmad Faraz S FS Roe Matthew T MT Rothman Russell L RL Harrington Robert A RA Hernandez Adrian F AF Jones W Schuyler WS

Journal of the American Heart Association 20231013 20

Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Methods and Results Participants in ADAPTABLE were stratified according to baseline use ...[more]

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Project description:ObjectivesTo evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD).DesignA secondary analysis of the randomised controlled trial ADAPTABLE was performed.SettingThe study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA.ParticipantsAmong 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%).InterventionsParticipants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months.Primary and secondary outcomes measuresThe primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion.ResultsEstimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints.ConclusionRace is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race.Trial registration numberNCT02697916.

Project description:BackgroundThe appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.MethodsUsing an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.ResultsA total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).ConclusionsIn this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Project description:AimThe purpose of this systematic review was to evaluate the efficiency of telemedicine on the secondary level of prevention of patients with arteriosclerotic cardiovascular disease (ASCVD), provide evidence for the application of telemedicine in secondary prevention and promote the development of telemedicine in secondary prevention.MethodsA computer-based search was conducted in MEDLINE, Embase, Pubmed, EBSCO, CINAHL, the Cochrane Library, and Web of Science. Randomized controlled trials regarding the effect of telemedicine on secondary prevention of ASCVD were included from inception to May, 2022. Meta-analysis was used to compare the results of the included studies by RevMan5.4 software. The Cochrane Collaboration bias risk tool was used to perform risk of bias assessment in this study. Outcomes included risk factors, physical activity and exercise, muscle function, exercise compliance, medication adherence, healthy diet, depression and anxiety, self-efficacy, knowledge score, economy, and safety endpoints. Subgroup analysis was carried out for different main intervention measures included in the literature.ResultsA total of 32 randomized clinical studies (n = 10 997 participants) were included in the meta-analysis. Compared with usual secondary prevention (USP) group, participants in telemedicine of secondary prevention (TOSP) group showed significant improvement in some risk factors including BMI (MD -0.87, p = 0.002), SBP (MD -4.09, p = 0.007) and DBP (MD -2.91, p = 0.0002) when they use the telephone as the intervention. In physical activity and exercise, Patients in TOSP showed an improvement in VO2 Peak (mL⋅kg-1⋅min-1) (OR 1.58, p = 0.02), 6MWT (MD 21.41, p = 0.001), GSLTPA score (MD 2.89, p = 0.005). Effects on medication adherence, exercise compliance, muscle function, healthy diet, economy and self-efficacy were synthesized narratively. Patients in TOSP did not show a reduction in knowledge score, depression, anxiety and safety endpoints.ConclusionThere is a net benefit of secondary prevention supported by telemedicine (especially when using the telephone as an intervention) in patients with ASCVD in the terms of some risk factors, physical activity and exercise. There are still controversies in the improvement of medication adherence, exercise compliance, muscle function, healthy diet, knowledge score, self-efficacy and economy via telemedicine, which is worth exploring. Larger samples size and longer-term follow-ups are needed in future studies.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=330478], identifier [CRD42022330478].