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(Circulation. 2003;108:1078.)
© 2003 American Heart Association, Inc.

Clinical Investigation and Reports

Safety of an Aspirin-Alone Regimen After Intracoronary Stenting With a Heparin-Coated Stent

Final Results of the HOPE (HEPACOAT and an Antithrombotic Regimen of Aspirin Alone) Study

Roxana Mehran, MD; Eve D. Aymong, MD, MS; Dale T. Ashby, MD; Tim Fischell, MD; Hall Whitworth, Jr, MD; Robert Siegel, MD; William Thomas, MD; S. Chiu Wong, MD; Raj Narasimaiah, MD; Alexandra J. Lansky, MD; Martin B. Leon, MD

From the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY (R.M., D.A., E.A., R.N., A.L., M.L.); Borgess Medical Center, Kalamazoo, Mich (T.F.); Florida Heart Institute, Orlando (H.W.); Advanced Cardiovascular Specialists, Gilbert, Ariz (R.S.); Medical College of Ohio, Toledo (W.T.); and New York Presbyterian Hospital, New York, NY (S.C.W.).

Correspondence to Roxana Mehran, MD, Cardiovascular Research Foundation, 55 East 59th St, 6th Floor, New York, NY 10021. E-mail rmehran{at}crf.org

Received November 8, 2002; de novo received April 29, 2003; revision received June 12, 2003; accepted June 12, 2003.

Background— Stent thrombosis is an infrequent complication of intracoronary stenting that often has devastating clinical consequences. This study assesses the additional benefit of heparin coating with the BX VELOCITY Balloon-Expandable Stent with HEPACOAT, Carmeda end-point attached heparin (HEPACOAT) in patients with de novo or restenotic native coronary artery lesions treated with aspirin monotherapy after optimal stenting.

Methods and Results— This was a multicenter, prospective, nonrandomized, pilot study. Two hundred patients (69% men; mean age, 64.1±11.2 years) meeting the eligibility criteria were treated with the HEPACOAT stent and aspirin alone after stenting. Any other antiplatelet or anticoagulation therapy was not permitted. Procedural success was achieved in all patients. There were 3 postprocedural non–Q-wave myocardial infarctions. The primary end point of stent thrombosis at 30 days occurred in 2 of 200 patients (1%): in one after blunt chest trauma and in the other in the setting of essential thrombocytosis. Major adverse cardiac events (death, myocardial infarction, target lesion revascularization, and coronary artery bypass grafting) were observed at 30 days in 5 of 200 (2.5%) patients.

Conclusions— The BX VELOCITY stent with HEPACOAT and aspirin alone after the procedure was safe in select patients with de novo or restenotic lesions in native coronary arteries. Heparin coating provides additional protection against stent thrombosis.

Key Words: stents • heparin • thrombosis • angioplasty

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