A-54 | Efficacy and Safety of P2Y12 Inhibitor Monotherapy After Complex PCI: A Collaborative Systematic Review and Meta-Analysis

BackgroundComplex percutaneous coronary intervention (C-PCI) is associated with increased risk of ischemic and bleeding complications. The safety and efficacy of a short dual antiplatelet therapy (DAPT) regimen followed by P2Y12 inhibitor monotherapy after C-PCI remain controversial. We sought to evaluate the safety and efficacy of P2Y12 inhibitor monotherapy versus DAPT in patients undergoing C-PCI.MethodsWe conducted a collaborative meta-analysis of randomized trials comparing a short DAPT regimen (≤3 months) followed by P2Y12 inhibitor monotherapy with a prolonged DAPT regimen (³12 months) in patients undergoing C-PCI. C-PCI and the co-primary bleeding and ischemic outcomes were determined according to each trial's definitions. Secondary outcomes included major bleeding, all-cause death, myocardial infarction, and stent thrombosis. We used hazard ratios (HRs) and 95% confidence interval (CI) as a metric of choice for treatment effects with random-effects models.ResultsAmong 8,205 screened items, 5 randomized trials fulfilled the inclusion criteria. In the pooled population of 35,614 patients, 8,818 (24.8%) underwent C-PCI. As compared with prolonged DAPT, a short DAPT regimen followed by P2Y12 inhibitor monotherapy after C-PCI reduced the bleeding risk in C-PCI (HR: 0.66, 95% CI: 0.44-0.98) and non-C-PCI (HR: 0.60, 95% CI: 0.45-0.79) patients (p-interaction=0.735). Overall, no differences were observed in terms of the primary ischemic endpoint, although the risk was significantly reduced in C-PCI patients in the subgroup analysis evaluating ticagrelor as P2Y12 inhibitor monotherapy.ConclusionsCompared with a prolonged DAPT, a shortened DAPT regimen followed by P2Y12 inhibitor monotherapy reduced bleeding complications after C-PCI, without increasing the risk of ischemic events.PROSPERO-registered (CRD42021259271)DisclosuresR. Mehran: Abbott: institutional research payments; Abiomed: institutional research payments; Alleviant Medical: institutional research payments; AM-Pharma: institutional research payments; Applied Therapeutics: institutional research payments and Ownership Interests: Stocks, Stock Options; Arena: institutional research payments; AstraZeneca: institutional research payments; BAIM: institutional research payments; Bayer: institutional research payments; Beth Israel Deaconness: institutional research payments; Biosensors: institutional research payments; Biotronik: institutional research payments; Boston Scientific Corp.: institutional research payments; Bristol-Myers Squibb: institutional research payments; CardiaWave: institutional research payments; CellAegis: institutional research payments; CeloNova: institutional research payments; CERC: institutional research payments; Chiesi: institutional research payments; Concept Medical: institutional research payments; CSL Behring: institutional research payments; DSI: institutional research payments; Duke University: institutional research payments; Element Science: institutional research payments; Humacyte: institutional research payments; Insel Gruppe AG: institutional research payments; Janssen: Consulting and institutional research payments; Magenta: institutional research payments; Medtronic: institutional research payments; Novartis: institutional research payments; OrbusNeich: institutional research payments; Philips: institutional research payments; Vivasure: institutional research payments; Zoll: institutional research payments; Boston Scientific Corp.: Consulting; California Institute for Regenerative Medicine (CIRM): Consulting; Cine-Med Research: Consulting; WebMD: Consulting; Idorsia Pharmaceuticals: consulting fees paid to institution; U. Baber: Amgen and AstraZeneca: Honoraria; J. Nicolas Nothing to disclose. M. Chiarito Nothing to disclose. C. A. Pivato Nothing to disclose. A. Spirito Nothing to disclose. D. Cao Nothing to disclose. G. Guistino Nothing to disclose. F. Beerkens Nothing to disclose. A. Camaj Nothing to disclose. B. Vogel Nothing to disclose. S. Sartori Nothing to disclose. K. Yamamoto Nothing to disclose. T. Kimura Nothing to disclose. B. K. Kim Nothing to disclose. G. D. Dangas Nothing to disclose. BackgroundComplex percutaneous coronary intervention (C-PCI) is associated with increased risk of ischemic and bleeding complications. The safety and efficacy of a short dual antiplatelet therapy (DAPT) regimen followed by P2Y12 inhibitor monotherapy after C-PCI remain controversial. We sought to evaluate the safety and efficacy of P2Y12 inhibitor monotherapy versus DAPT in patients undergoing C-PCI. Complex percutaneous coronary intervention (C-PCI) is associated with increased risk of ischemic and bleeding complications. The safety and efficacy of a short dual antiplatelet therapy (DAPT) regimen followed by P2Y12 inhibitor monotherapy after C-PCI remain controversial. We sought to evaluate the safety and efficacy of P2Y12 inhibitor monotherapy versus DAPT in patients undergoing C-PCI. MethodsWe conducted a collaborative meta-analysis of randomized trials comparing a short DAPT regimen (≤3 months) followed by P2Y12 inhibitor monotherapy with a prolonged DAPT regimen (³12 months) in patients undergoing C-PCI. C-PCI and the co-primary bleeding and ischemic outcomes were determined according to each trial's definitions. Secondary outcomes included major bleeding, all-cause death, myocardial infarction, and stent thrombosis. We used hazard ratios (HRs) and 95% confidence interval (CI) as a metric of choice for treatment effects with random-effects models. We conducted a collaborative meta-analysis of randomized trials comparing a short DAPT regimen (≤3 months) followed by P2Y12 inhibitor monotherapy with a prolonged DAPT regimen (³12 months) in patients undergoing C-PCI. C-PCI and the co-primary bleeding and ischemic outcomes were determined according to each trial's definitions. Secondary outcomes included major bleeding, all-cause death, myocardial infarction, and stent thrombosis. We used hazard ratios (HRs) and 95% confidence interval (CI) as a metric of choice for treatment effects with random-effects models. ResultsAmong 8,205 screened items, 5 randomized trials fulfilled the inclusion criteria. In the pooled population of 35,614 patients, 8,818 (24.8%) underwent C-PCI. As compared with prolonged DAPT, a short DAPT regimen followed by P2Y12 inhibitor monotherapy after C-PCI reduced the bleeding risk in C-PCI (HR: 0.66, 95% CI: 0.44-0.98) and non-C-PCI (HR: 0.60, 95% CI: 0.45-0.79) patients (p-interaction=0.735). Overall, no differences were observed in terms of the primary ischemic endpoint, although the risk was significantly reduced in C-PCI patients in the subgroup analysis evaluating ticagrelor as P2Y12 inhibitor monotherapy. Among 8,205 screened items, 5 randomized trials fulfilled the inclusion criteria. In the pooled population of 35,614 patients, 8,818 (24.8%) underwent C-PCI. As compared with prolonged DAPT, a short DAPT regimen followed by P2Y12 inhibitor monotherapy after C-PCI reduced the bleeding risk in C-PCI (HR: 0.66, 95% CI: 0.44-0.98) and non-C-PCI (HR: 0.60, 95% CI: 0.45-0.79) patients (p-interaction=0.735). Overall, no differences were observed in terms of the primary ischemic endpoint, although the risk was significantly reduced in C-PCI patients in the subgroup analysis evaluating ticagrelor as P2Y12 inhibitor monotherapy. ConclusionsCompared with a prolonged DAPT, a shortened DAPT regimen followed by P2Y12 inhibitor monotherapy reduced bleeding complications after C-PCI, without increasing the risk of ischemic events.PROSPERO-registered (CRD42021259271) Compared with a prolonged DAPT, a shortened DAPT regimen followed by P2Y12 inhibitor monotherapy reduced bleeding complications after C-PCI, without increasing the risk of ischemic events.