Drug-Eluting stents clinical trials

Mauri L, Hsieh WH, Massaro IM, et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007 356 1020-1029. 

Several smaller studies have also explored the use of bivalirudin with drug-eluting stents, brachytherapy, and in peripheral intervention (40-42). Although lacking optimal comparative design, these studies appear to indicate a safety and efficacy profile comparable to that observed in the randomized clinical trials. 

Although drug-loaded stents have shown beneficial effects on restenosis and thrombosis compared to bare stents in clinical trials and real-world practice, there are still concerns about their long-term safety and efficacy. It has been reported that clinical trials of drug-eluting stents were stopped because of increased (sub)acute thrombosis and neointimal growth or insufficient efficacy. Furthermore, increased late thrombosis has been reported, especially with cytotoxic drug-coated... 

Dawkins KD, Grube E, Guagliumi G, et al. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial support for the use of drug-eluting stents in contemporary clinical practice, Circulation 2005 ... 

The book is comprised of five sections with part I covering systemic and endoluminal therapy with an incisive overview of hemostasis and thrombosis part II covers local therapy with several chapters devoted to drug-eluting stents and restenosis therapies part III covers cell therapy and therapeutic angiogenesis and includes chapters on cell transplantation and clinical trials in cellular therapy part IV covers adjunctive pharmacotherapy with chapters devoted to various patient populations including those with heart failure, diabetes, atrial fibrillation, peripheral artery disease,... 

Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents a metaanalysis of randomized clinical trials. Am J Med 2006 U9(12) 1056-61. 

J.S.W. Kwong, and C.-M. Yu, Clinical outcomes of biodegradable polymer drug-eluting stents for percutaneous coronary intervention An updated meta-analysis of randomized controlled trials, Clin. Cardiol, 37 (7), 440-453,2014. 

Bloomington, Indiana, U.S.A.) coated with escalating doses of paclitaxel (0,2, 0,7, 1.4, and 2.7 jig/mm2 of stent surface area) applied directly to stent surface. In both trials, there was a dose-dependent effect on the angiographic parameters of restenosis (64). However, clinical outcomes at 6 and 12 months were not improved in these studies (65). The subsequent Drug ELuting coronary stent systems in the treatment of patients with de noVo nativE coronaRy lesions... 

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