Dual antiplatelet therapy duration after percutaneous coronary intervention in high bleeding risk: a meta-analysis of randomized trials

AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) is still debated. The current study, using the totality of existing evidence, evaluated the impact of an abbreviated DAPT regimen in HBR patients. METHODS AND RESULTS: A systematic review and meta-analysis was performed to search randomized clinical trials comparing abbreviated [i.e. very-short (1 month) or short (3 months)] with standard (≥6 months) DAPT in HBR patients without indication for oral anticoagulation. A total of 11 trials, including 9006 HBR patients, were included. Abbreviated DAPT reduced major or clinically relevant non-major bleeding [risk ratio (RR): 0.76, 95% confidence interval (CI): 0.61-0.94; I2 = 28%], major bleeding (RR: 0.80, 95% CI: 0.64-0.99, I2 = 0%), and cardiovascular mortality (RR: 0.79, 95% CI: 0.65-0.95, I2 = 0%) compared with standard DAPT. No difference in all-cause mortality, major adverse cardiovascular events, myocardial infarction, or stent thrombosis was observed. Results were consistent, irrespective of HBR definition and clinical presentation. CONCLUSION: In HBR patients undergoing PCI, a 1- or 3-month abbreviated DAPT regimen was associated with lower bleeding and cardiovascular mortality, without increasing ischaemic events, compared with a ≥6-month DAPT regimen.

Case-fatality rate of major bleeding events in patients on dual antiplatelet therapy after percutaneous coronary intervention: a systematic review and meta-analysis

BACKGROUND: Assessment of the case-fatality rate (CFR) of major bleeding on dual antiplatelet therapy (DAPT) may improve balancing risks and benefits of different durations of DAPT following percutaneous coronary intervention (PCI). OBJECTIVES: To determine the CFR of major bleeding in patients on DAPT after PCI and to compare rates among different durations of DAPT. METHODS: Medline, Embase, and CENTRAL were searched from inception to August 2021 for randomized trials that reported fatal bleeding among patients who were randomized to ≥1 month of DAPT following PCI. Summary estimates for CFRs of major bleeding were calculated using the random-effects inverse-variance method. Statistical heterogeneity was evaluated using the I2 statistic. RESULTS: Of 2777 citations obtained by the search, 15 (48%) of 31 potentially eligible studies were excluded because fatal bleeding was not reported, leaving 16 studies that were included in the analysis. Overall, there were 823 major bleeding events including 91 fatal events in 48,884 patients who were assigned to receive DAPT during study follow-up. The CFR of major bleeding was 10.8% (95% confidence interval [CI], 7.1­ 16.2; I2= 50%) in the entire study population, and 13.8% (95% CI, 6.5­27.1; I2= 28%), 11.2% (95% CI, 6.7­ 18.0; I2= 0%), and 5.8% (95% CI, 3.0­11.1; I2= 0%) in those on short-term (≤6 months; n= 16,553), standard-term (12 months; n= 19,453), and long-term DAPT (>12 months; n= 10,238), respectively. CONCLUSION: Fatal bleeding is not reported in many studies evaluating DAPT after PCI. The CFR of major bleeding on DAPT is substantial and may be higher in the first 12 months of DAPT than during long-term DAPT.

The Mega combo collaboration: an individual patient data pooled analysis of patients undergoing PCI with combo stent

BACKGROUND COMBO (OrbusNeich Medical) is a dual-therapy coro nary stent featuring sirolimus as the antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collabora tion aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI) METHODS Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry, and MASCOT studies were pooled together. The primary end point was 1-year target lesion fail ure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). Event rates were estimated with the Kaplan-Meier method. Predictors of TLF were obtained from multi variate Cox regression, with stepwise selection of candidate variables RESULTS A total of 6,753 patients (median age » 64 years, 23% women) were included. Baseline characteristics are summarized in Figure 1A. At 1 year, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and ID-TLR were 1.3%, 1.8%, and 2.5%, respectively. Independent predictors for TLF are reported in Figure 1B. CONCLUSION This large patient-level pooled analysis provides a comprehensive overview of the safety and efficacy of the dual-ther apy COMBO stent. The rate of TLF observed at 1 year was low, making this stent technology a potential alternative to other contemporary drug-eluting stent platforms.