• Balram Bhargava, N Krishna Reddy, Ganesan Karthikeyan, Raghava Raju, Sundeep Mishra, Sandeep Singh, Ron Waksman, Renu Virmani, and B Somaraju.
• All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
• Catheter Cardiovasc Interv. 2006 May 1; 67 (5): 698-702.

ObjectivesWe aimed to evaluate the response of porcine coronary arteries to a novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt chromium stent.BackgroundPolymer based drug-eluting stents significantly reduce restenosis. However, the indefinite presence of polymer is thought to initiate and sustain inflammation and contribute to the occurrence of late complications.MethodsSixteen carbon-carbon coated, nonpolymeric cobalt chromium stents with two different doses of paclitaxel (eight of each) were implanted in porcine coronary arteries. In addition, eight cobalt chromium stents coated with a biodegradable polymer were also studied. Animals were sacrificed 6 weeks after stent implantation and histomorphometric analysis was performed. Results were compared among the three groups of stents.ResultsThe cobalt chromium stents coated with carbon-carbon with low and medium doses of paclitaxel both showed acceptable performance characteristics, with respect to endothelialization, neointimal hyperplasia, percentage diameter stenosis, inflammatory response, and tendency to fibrin deposition, when compared to historical data with the Cypher stent. On the other hand, the stents coated with poly(lactide) and poly(lactide-co-glycolide) biodegradable polymers and 0.7 microg/mm2 paclitaxel showed poor performance. There was a significant tendency to poor endothelialization, greater neointimal hyperplasia, percentage diameter stenosis, greater inflammatory response, and tendency to fibrin deposition (P < 0.01 for all parameters).ConclusionsThis preclinical evaluation demonstrates the safety and efficacy of a novel cobalt chromium stent with a carbon-carbon coating and low and medium doses of paclitaxel.(c) 2006 Wiley-Liss, Inc.

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