title: Paclitaxel-eluting stents: are they all equal? An analysis of six randomized controlled trials in de novo lesions of 3,319 patients.
abstract: In Germany, four different drug eluting stents (DES) systems are currently commercially available. Whereas sirolimus has been clinically tested in only a single type of stent with a single type of coating in only a single dose, paclitaxel has been tested on various stent designs, in various dose densities, and in various release formulations with or without a polymer carrier. Therefore, the question arises: are all paclitaxel stents equally safe and effective? Six clinical randomized trials investigated the safety and efficacy of paclitaxel-eluting stents in patients with de-novo lesions: TAXUS-I (61 pats), TAXUS-II (536 pats), ASPECT (177 pats), ELUTES (190 pats), DELIVER-I (1041 pats) and TAXUS-IV (1314 pats). In the TAXUS-series, paclitaxel released from the stent was controlled by the Translute polymer. In the other studies, however, no polymer carrier was used. In TAXUS-I, II & IV, the dose density of 1 microg/mm2 significantly reduced angiographic parameters of restenosis and improved clinical outcomes. In ASPECT and ELUTES there was a dose-dependent effect on angiographic parameters of restenosis with the best results for a paclitaxel dose density of approximately 3.0 microg/mm2. Clinical outcomes at 6 and 12 months, however, were not improved in these studies without coating. The studies unanimously show that the paclitaxel-eluting stents are safe, if clopidogrel is added to ASA for 3 to 6 months. The safety of paclitaxel-eluting stents is independent of the stent design, the dose density and the presence or absence of a polymer carrier system. For paclitaxel-eluting stents using a polymer carrier, the dose density of 1 microg/mm2 is highly effective, whereas for paclitaxel-eluting stents without a polymer carrier, the minimal effective dose density is much higher (3 microg/mm2). Despite their improvement of angiographic parameters, paclitaxel-eluting stents without a polymer carrier did not demonstrate a positive effect on clinical outcome. In contrast, polymer-based paclitaxel elution produced significant clinical benefit.
authors: Cardiology Practice in the Dr. Müller Hospital, Munich, Germany. silber@med.de
authors: Sigmund
authors: S
authors: Silber
mesh_terms: D002986:Clinical Trials as Topic; D023903:Coronary Restenosis / Q000517:prevention & control*; D004337:Drug Carriers; D005260:Female; D006131:Growth Inhibitors / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
chemical_list: D004337:Drug Carriers; D006131:Growth Inhibitors; D017239:Paclitaxel