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Comparative Trial of Local Pharmacotherapy with L-Arginine, r-Hirudin, and Molsidomine to Reduce Restenosis after Balloon Angioplasty of Stenotic Rabbit Iliac Arteries¹

¹ From the Department of Diagnostic Radiology, Philipps-University Hospital, Marburg, Germany (M.K., H.A., S.B., K.J.K., H.J.W.); and Boston Scientific, Natick, Mass (J.J.B.). Received August 8, 2000; revision requested September 20; final revision received January 2, 2001; accepted January 11. Address correspondence to H.J.W., Department of Radiology, University of Wisconsin Hospital and Clinics, D4/356 Clinical Science Center, 600 Highland Ave, Madison, WI 53792-3252 (e-mail: hwagner@mail.radiology.wisc.edu). J.J.B. is vice president, Center for Molecular Interventions for Boston Scientific.

PURPOSE: To determine if local application of L-arginine, r-hirudin, or molsidomine significantly reduces restenosis after balloon angioplasty in stenotic rabbit iliac arteries.

MATERIALS AND METHODS: Thirty-one male cholesterol-fed New Zealand white rabbits underwent balloon dilation of both common iliac arteries to induce arterial stenosis. Four weeks later, one stenotic iliac artery was simultaneously dilated and received local application of L-arginine (210 mg/mL, n = 7), r-hirudin (0.5 mg/mL, n = 8), or molsidomine (0.2 mg/mL, n = 8) with a channeled balloon catheter. On the contralateral side, 0.9% saline was injected as a control. In eight sham animals, saline was applied to one iliac artery and balloon dilation to only the contralateral artery. Six weeks after local treatment, vessels were harvested, and computerized morphometric and immunohistologic analyses were performed.

RESULTS: Application of drugs resulted in a significant reduction of neointimal area as follows: 53% with L-arginine (1.01 mm² vs 2.17 mm², P < .05), 43% with molsidomine (1.04 mm² vs 1.89 mm², P < .05), and 20% with r-hirudin (1.79 mm² vs 2.24 mm², P < .05). Infusion of saline led to a significant increase (50%, 1.21 mm² vs 1.93 mm², P < .05) in neointimal area compared with balloon dilation alone. Immunohistologic findings showed a significant reduction of macrophages (5.0% vs 10.2%, P < .05) and proliferating cells (6.2% vs 10.6%, P < .05) in the neointima after local application of L-arginine.

CONCLUSION: Reduction of neointimal area was significant for L-arginine and molsidomine but not for r-hirudin. Saline infusion caused significant arterial trauma, resulting in additional neointimal proliferation.

Index terms: Arteries, iliac, 984.721 • Arteries, stenosis or obstruction, 984.721 • Arteries, transluminal angioplasty, 984.1279, 984.1282 • Interventional procedures, experimental, 984.1279, 984.1282

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