P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

Abstract

Objective To assess the risks and benefits of P2Y 12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ characteristics. Design Individual patient level meta-analysis of randomised controlled trials. Data sources Searches were conducted in Ovid Medline, Embase, and three websites ( www.tctmd.com , www.escardio.org , www.acc.org/cardiosourceplus ) from inception to 16 July 2020. The primary authors provided individual participant data. Eligibility criteria Randomised controlled trials comparing effects of oral P2Y 12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation. Main outcome measures The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. Results The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y 12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ 2 =0.00) and in 303 (2.94%) with P2Y 12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ 2 =0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y 12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y 12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ 2 =0.03), which was consistent across subgroups, except for type of P2Y 12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y 12 inhibitor rather than clopidogrel was part of the DAPT regimen. Conclusions P2Y 12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT. Registration PROSPERO CRD42020176853.

Clinical outcomes of nicorandil administration in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials

“…The appropriate use of antithrombotic therapy is vital to effectively balance treatment benefit vs risks and improve outcomes. A recent individual patient level meta-analysis by Valgimigli et al showed P2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke and a lower bleeding risk compared with DAPT [ 38 ]. The effects of nicorandil in P2Y12 inhibitor monotherapy need to be explored in future studies.…”

Efficacy and Safety of Aspirin for Primary Cardiovascular Risk Prevention in Younger and Older Age: An Updated Systematic Review and Meta-analysis of 173,810 Subjects from 21 Randomized Studies

“…Conversely, these results do not apply to the context of secondary prevention where aspirin is a standard of care, 3 despite recent trials in the field of percutaneous coronary intervention have challenged this assumption. [34][35][36] The first study of aspirin for primary CVD prevention is dated back in 1988. 37 Since then, the design of aspirin trials has changed significantly, with use of lower doses (75 to 100 mg daily) to improve safety while preserving efficacy, and larger use of statins that may have contributed to lower the baseline residual risk of CVD events.…”

Time series decomposition into dyslipidemia prevalence among urban Chinese population: secular and seasonal trends

“…Given that Shandong is a developed eastern coastal province in China, the residents in Shandong eat more meat that is rich in saturated fat and seafood [ 19 ]. Moreover, dyslipidemia was a serious public health problem in China and globally, and it was a strong risk factor for coronary artery diseases [ 20 , 21 ]. Early intervention of dyslipidemia will contribute to preventing coronary heart disease and improving the prognosis.…”