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One-Year Results of the CRISTAL Trial, a Randomized Comparison of Cypher Sirolimus-Eluting Coronary Stents versus Balloon Angioplasty for Restenosis of Drug-Eluting Stents.
MedLine Citation:
PMID:  22994863     Owner:  NLM     Status:  Publisher    
Objectives : We compared the efficacy of the Cypher Select™ (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus™ or Taxus Liberté™ paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Background : Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. Methods : Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. Results : 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. Conclusions : In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed Abstract Optimal treatment strategies have not been identified for sirolimus- (SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES. (J Interven Cardiol 2012;**:1-10).
Bernard Chevalier; Robert Moulichon; Emmanuel Teiger; Philippe Brunel; Jean-Philippe Metzger; Michel Pansieri; Didier Carrie; Hans-Peter Stoll; Kristel Wittebols; Christian Spaulding; Jean Fajadet
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-20
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  -     ISSN:  1540-8183     ISO Abbreviation:  J Interv Cardiol     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
©2012, Wiley Periodicals, Inc.
Institut Cardiovasculaire Paris-Sud, Massy, France Clinique Saint Pierre, Perpignan, France Centre Hospitalier Henri Mondor, Assistance Publique Hôpitaux de Paris, Creteil, France Nouvelles Cliniques Nantaises-Site Saint-Henri, Nantes, France Centre Hospitalier Universitaire Pitié-Salpêtrière, Assistance Publique Hôpitaux de Paris, Paris, France Centre Hospitalier Henri Duffaut, Avignon, France Centre Hospitalier Universitaire Rangeuil, Toulouse, France Cordis Corporation (Johnson and Johnson), Waterloo, Belgium and Bridgewater, New Jersey Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris and INSERM U 970, Paris Descartes University, Paris, France Unité de Cardiologie Interventionnelle, Clinique Pasteur, Toulouse, France.
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