A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discussed European requirements that apply to DES. This article discusses the new guideline, other stent guidelines, ...

INTRODUCTION AND OBJECTIVES Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary art...

OBJECTIVES To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. DESIGN Mixed treatment comparison meta-analysis. DATA SOURCES AND STUDY SELECTION PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (s...

BACKGROUND Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents. METHOD...

BACKGROUND The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. METHODS AND RESULTS Study stents included BMS, paclitaxel-eluting (PES), siroli...

Bare metal stents have a proven safety record, but limited long-term efficacy due to in-stent restenosis. First-generation drug-eluting stents successfully countered the restenosis rate, but were hampered by concerns about their long-term safety. Second generation drug-eluting stents have combined the low restenosis rate of the first generation with improved long-term safety. We review the evol...

BACKGROUND Recent studies have questioned the safety of drug-eluting stents because of a higher incidence of late stent thrombosis, raising the possibility that drug-eluting stents may be associated with an increased mortality. The effect of drug-eluting stents on mortality in African-Americans is unknown. METHODS We evaluated 628 African-American patients (354 patients treated with drug-elut...

BACKGROUND Numerous studies have compared the outcomes of coronary artery bypass grafting (CABG) surgery and coronary stenting for the treatment of multivessel coronary disease. In 2003, drug-eluting stents were introduced with the hope of reducing restenosis. However, limited information exists on the comparison of drug-eluting stents and CABG surgery. The long-term outcome of drug-eluting ste...

BACKGROUND Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or ba...

BACKGROUND Although effective coverage of challenging coronary lesions has warranted the use of overlapping drug-eluting stents, the histopathological response to stent overlap is unknown. METHODS AND RESULTS The arterial reaction to overlapping Cypher or Taxus drug-eluting stents was examined in rabbits with bare metal stents, BxVelocity or Express, serving as controls. Single iliac artery b...