Published Online
on July 29, 2002

A more recent version of this article appeared on August 13, 2002

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Submitted on May 29, 2002
Revised on June 24, 2002
Accepted on June 24, 2002

Twelve Versus Six Months of Clopidogrel to Reduce Major Cardiac Events in Patients Undergoing -Radiation Therapy for In-Stent Restenosis. Washington Radiation for In-Stent restenosis Trial (WRIST) 12 Versus WRIST PLUS

Ron Waksman MD^*, Andrew E. Ajani MD, Ellen Pinnow MS, Edouard Cheneau MD, Laurent Leborgne MD, Regina Dieble RN, Anh B. Bui MD, Lowell F. Satler MD, Augusto D. Pichard MD, Kenneth K. Kent MD, and Joseph Lindsay MD

From the Division of Cardiology, Washington Hospital Center, Washington, DC.

^* To whom correspondence should be addressed. E-mail: ron.waksman{at}medstar.net.

Background—Intracoronary -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 <80 mm in length underwent PTCA, laser ablation, or rotational atherectomy. Additional stents were placed in 39 patients (33%). After the intervention, a ribbon with different trains of radioactive ¹⁹²Ir 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 -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 -radiation. At least 12 months of clopidogrel therapy should be recommended for patients undergoing radiation therapy for ISR.

Key words: thrombosis • platelets • restenosis • stents • radioisotopes

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