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Dual antiplatelet therapy (DAPT) remains the cornerstone therapy in the prevention of ischemic events following PCI. However, the mandatory duration of DAPT in new-generation drug-eluting stents (DES) remains a matter of debate. We aimed to evaluate efficacy and safety of short-term (≤6 months) versus long-term (≥12 months) duration of DAPT.
PubMed, EMBASE, Cochrane databases, and international meetings were searched for randomized clinical trials (RCT) comparing short versus long DAPT. A systematic review and meta-analyses of major trials was performed with primary outcome: all-cause death, myocardial infarction, stent thrombosis, stroke, and major bleeding.
Nine RCTs with a total number of 19.099 patients were pooled in this meta-analysis. As compared to long DAPT, a short regimen of DAPT was associated with a significant reduction in major bleeding (0.62% vs. 1.10%, Risk Ratio 0.58, 95%-CI 0.39 to 0.86, p<.007, I2=21%), whereas all-cause death (1.65% vs. 1.84%, Risk Ratio 0.90, 95%-CI 0.73 to 1.11, p=.34, I2=0%), myocardial infarction (1.91% vs. 1.68%, Risk Ratio 1.14, 95%-CI 0.92 to 1.40, p=.23, I2=0%), stent thrombosis (0.62% vs. 0.47%, Risk Ratio 1.25, 95%-CI 0.84 to 1.86, p=.27, I2=0%), and stroke (0.60% vs. 0.67%, Risk Ratio 0.91, 95%-CI 0.63 to 1.31, p=.61, I2=0%) were similar.
|Trial||Short- vs. Long DAPT||No. (n)||Design||Time of randomization and follow-up (months)||MACE-endpoint|
|EXCELLENT 2012||6 vs. 12||1443||Non-Inferiority||Index-PCI, 12||All-cause death, MI, stroke, ST(definite or probable), or TIMI-major bleeding|
|PRODIGY 2012||6 vs. 24||1970||Superiority||1 month after Index-PCI, 24||All-cause death, MI, or cerebrovascular accident|
|RESET 2012||3 vs. 12||2117||Non-inferiority||Index-PCI, 12||Cardiovascular death, MI, ST(definite or probable), ischemia-driven target-vessel revascularization, or TIMI-major bleeding|
|OPTIMIZE 2013||3 vs. 12||3119||Non-inferiority||Index-PCI, 12||All-cause death, MI, stroke, major bleeding based on GUSTO/REPLACE-2|
|SECURITY 2014||6 vs. 12||1399||Non-inferiority||Index-PCI, 24||Cardiac death, MI, stroke, ST(definite or probable), or bleeding BARC2/3/5|
|ISAR-SAFE 2015||6 vs. 12||4005||Non-inferiority||6 months after Index-PCI, 15||All-cause death, MI, ST(definite or probable), stroke, TIMI-major bleeding|
|ITALIC 2015||6 vs. 24||2031||Non-inferiority||Index-PCI, 36||All-cause death, MI, stroke, TVR, TIMI-major bleeding|
|I-LOVE-IT 2 2016||6 vs. 12||1829||Non-inferiority||Index-PCI, 18||All-cause death, MI, CVA, Major bleeding BARC≥3|
|IVUS-XPL 2016||6 vs. 12||1400||Superiority||Index-PCI, 12||Cardiac death, MI, stroke, or TIMI major bleeding|
Short DAPT following new-generation DES results in a significant reduction of major bleeding with no apparent increase in all-cause death, ischemic events, stent thrombosis, or stroke. Clinicians should realize the potential drawbacks of DAPT and tailor the duration depending on the ischemic and bleeding risk of the individual patient.