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Shortened DAPT After PCI With Third-Generation DES
Quick Takes
- Among a predominantly male cohort of South Korean patients, 3-6 months of DAPT was noninferior to 12 months of DAPT with respect to NACE (composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, or major bleeding).
- Findings persisted regardless of presentation (NSTE-ACS vs. stable ischemic heart disease).
Study Questions:
Is a shorter duration (3-6 months) of dual antiplatelet therapy (DAPT) noninferior to a 12-month strategy after drug-eluting stent (DES) implantation with ultrathin struts and advanced polymer technology?
Methods:
Patient undergoing percutaneous coronary intervention (PCI) using the Orsiro biodegradable-polymer sirolimus-eluting stents (SES) or the Coroflex ISAR polymer-free SES at 37 centers in South Korea were randomized in an open-label fashion. Patients with ST-segment elevation myocardial infarction (STEMI) were excluded. Patients were randomized to receive either 3-6 months or 12 months of DAPT after PCI. The choice of antiplatelet medications was at the physician's discretion. The primary outcome was a net adverse clinical event (NACE), a composite of cardiac death, target vessel myocardial infarction (TVMI), clinically driven target lesion revascularization (CD-TLR), stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure (TLF), a composite of cardiac death, TVMI, CD-TLR, and major bleeding.
Results:
A total of 2,013 patients (mean age 65.7 ± 10.5 years, 1,487 males [73.9%], 1,110 [55.1%] presented with acute coronary syndrome [ACS]) were randomized to 3-6 months of DAPT (n = 1,002) or 12 months of DAPT (n = 1,011). The primary outcome occurred in 37 (3.7%) patients in the 3-6 month DAPT group and 41 (4.1%) in the 12-month DAPT group. The noninferiority of the 3-6 month DAPT group to the 12-month DAPT group was met (absolute risk difference, -0.4% [1-sided 95% confidence interval (CI), -∞% to 1.1%; p < 0.001 for noninferiority]). There were no significant differences in TLF (hazard ratio [HR], 0.98; 95% CI, 0.56-1.71; p = 0.94) or major bleeding (HR, 0.82; 95% CI, 0.41-1.61; p = 0.56) between the two groups. Across various subgroups, the treatment effect of 3-6 months of DAPT was consistent for NACE.
Conclusions:
Among patients undergoing PCI using third-generation DES, 3-6 months of DAPT was noninferior to 12 months of DAPT for NACE. Further research is needed to generalize this finding to other populations and to determine the ideal regimen for 3-6 months of DAPT.
Perspective:
The authors present data on antiplatelet therapy duration among South Korean patients undergoing DES PCI using third-generation DES (ultrathin struts with advanced polymer technology). Among this predominantly male cohort of patients, 3-6 months of DAPT was noninferior to 12 months of DAPT with respect to NACE (composite of cardiac death, TVMI, CD-TLR, stent thrombosis, or major bleeding). The findings persisted regardless of presentation (NSTE-ACS vs. stable ischemic heart disease).
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Vascular Medicine, Chronic Angina
Keywords: Acute Coronary Syndrome, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Non-ST Elevated Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Sirolimus, Stents, Thrombosis
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