Twelve Versus Six Months of Clopidogrel to Reduce Major Cardiac Events in Patients Undergoing γ-Radiation Therapy for In-Stent Restenosis

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Abstract
Background— Intracoronary γ-radiation reduces recurrent in-stent restenosis (ISR). Late thrombosis was attenuated with 6 months of aspirin and clopidogrel. We aimed to find out whether 12 months of aspirin plus clopidogrel is superior to a strategy of 6 months after radiation therapy for patients with ISR. Methods and Results— One hundred twenty consecutive patients with diffuse ISR in native coronaries and vein grafts with lesions 192 Ir seeds was positioned to cover the treated site, and a dose of 14 Gy to 2 mm was prescribed. Patients were discharged with clopidogrel and aspirin for 12 months and followed up clinically. The cardiac clinical event rates at 15 months were compared with the γ-treated (n=120) patients of the WRIST PLUS study (only 6 months of antiplatelet therapy). Whereas the late thrombosis rates were similar (3.3% for the group given 12 months of antiplatelet therapy versus 4.2% for the group given 6 months, P =0.72), the group treated with 12 months of antiplatelet therapy had a rate of 21% for major adverse cardiac events and 20% for target-lesion revascularization compared with 36% ( P =0.01) and 35% ( P =0.009), respectively, in patients who were treated with only 6 months of clopidogrel. Conclusions— Twelve months of clopidogrel is superior to 6 months in reducing overall major cardiac events and revascularization rates at 15 months for patients with ISR treated with γ-radiation. At least 12 months of clopidogrel therapy should be recommended for patients undergoing radiation therapy for ISR.