August 26, 2026Journal of the American College of Cardiology356 citationsOpen Access
6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin
Resultado clave
6-month DAPT was noninferior to 24-month DAPT for the composite of death, MI, urgent revascularization, stroke, and major bleeding (1.6% vs 1.5%; P=0.0002 for noninferiority).
Puntos clave
- To determine whether 6-month dual antiplatelet therapy is noninferior to 24-month therapy in aspirin-sensitive patients receiving everolimus-eluting stents.
- Multicenter, randomized trial (NCT01476020) conducted across 70 European and Middle Eastern centers in patients with confirmed aspirin nonresistance undergoing everolimus-eluting stent placement.
- Enrolled 2,031 patients randomly assigned to receive either 6-month (n=953) or 24-month (n=941) dual antiplatelet therapy, assessing a primary composite endpoint at 12 months post-stenting.
- The primary composite endpoint of death, myocardial infarction, urgent target vessel revascularization, stroke, or major bleeding occurred in 1.6% of the 6-month group versus 1.5% of the 24-month group (risk difference: 0.11%, 95% CI: -1.04% to 1.26%; P=0.0002 for noninferiority; P=0.85 for superiority).
- Rates of stent thrombosis and bleeding did not differ significantly between arms, including among 792 patients with acute coronary syndrome (HR: 1.7, 95% CI: 0.519 to 6.057; p=0.361).
Diseño del estudio
Tipo
RCT (n=1,894)
Multicéntrico
Sí
PICO estructurado
Does 6-month DAPT compared to 24-month DAPT prevent adverse clinical events in aspirin-sensitive patients undergoing everolimus-eluting stent implantation?
P
Población
1,894 aspirin-sensitive patients undergoing implantation of everolimus-eluting stents, randomized to 6- or 24-month DAPT and evaluated at 12 months post-stenting.
I
Intervención
6-month dual antiplatelet therapy (DAPT)
C
Comparador
24-month dual antiplatelet therapy (DAPT)
O
Resultado
Composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stentingcomposite
In aspirin-sensitive patients receiving everolimus-eluting stents, 6-month DAPT is noninferior to 24-month DAPT for ischemic and bleeding outcomes.
Resultado numérico
Estimación del efecto: Absolute risk difference 0.11% (95% CI -1.04 to 1.26)
Tasa de eventos absoluta: 1.6% vs 1.5%
Reducción absoluta del riesgo: -0.11%
valor p: p=0.0002 for noninferiority
Limitaciones
- Prematurely terminated due to recruitment problems
Resumen
BACKGROUND: The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). OBJECTIVES: This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. METHODS: A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. RESULTS: A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 95% confidence interval: 0.519 to 6.057; p = 0.361). CONCLUSIONS: Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel ITALICplus; NCT01476020).
Cite This Study
Gilard et al. (Mon,) conducted a rct in Aspirin-sensitive patients undergoing implantation of everolimus-eluting stents (n=1,894). 6-month dual antiplatelet therapy (DAPT) vs. 24-month DAPT was evaluated on Composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting (Absolute risk difference 0.11%, 95% CI -1.04 to 1.26, p=0.0002 for noninferiority). 6-month DAPT was noninferior to 24-month DAPT for the composite of death, MI, urgent revascularization, stroke, and major bleeding (1.6% vs 1.5%; P=0.0002 for noninferiority).