This multicenter study included patients receiving the second generation stent XIENCE V (Abbott Vascular) randomized to 6 and 24 months of double antiaggregation therapy after confirming non-resistance to aspirin. Primary end point was a combination of death, infarction, emergency revascularization of target vessel, stroke and major bleeding.
The study saw early termination due to recruiting problems having included 941 patients in the 24 month group and 953 in the 6 month group.
No significant difference was observed between the groups as to primary end point (1.5 vs. 1.6%, p=0,85). Non-inferiority between 6 and 24 months was observed and the difference in absolute risk was 0.11% (p for non-inferiority= 0.0002). In-stent thrombosis and bleeding complications saw no differences, neither were any significant differences observed in the 792 patients (44% of the population) admitted with acute coronary syndrome.
Conclusion
Bleeding and thrombotic events rate were similar after 6 and 24 moths of double antiaggregation therapy in patients non-resistant to aspirin receiving new generation DES.
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Martine Gilard
2014-11-17
Original title: Is 6 Months DAPT Post Coronary Stenting Non Inferior To 24 Months? The Italic/ Italic+ Randomized Trial. Results of the One Year Primary Endpoint.
