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 |
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| Authors: | BERNARD CHEVALIER M.D. F.A.C.C. ROBERT MOULICHON M.D. EMMANUEL TEIGER M.D. Ph.D. PHILIPPE BRUNEL M.D. JEAN‐PHILIPPE METZGER M.D. MICHEL PANSIERI M.D. DIDIER CARRIE M.D. HANS‐PETER STOLL M.D. KRISTEL WITTEBOLS M.S. CHRISTIAN SPAULDING M.D. Ph.D. F.A.C.C. JEAN FAJADET M.D. FOR THE CRISTAL INVESTIGATORS |
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| Affiliation: | 1. Institut Cardiovasculaire Paris‐Sud, Massy, France;2. Clinique Saint Pierre, Perpignan, France;3. Centre Hospitalier Henri Mondor, Assistance Publique H?pitaux de Paris, Creteil, France;4. Nouvelles Cliniques Nantaises‐Site Saint‐Henri, Nantes, France;5. Centre Hospitalier Universitaire Pitié‐Salpêtrière, Assistance Publique H?pitaux de Paris, Paris, France;6. Centre Hospitalier Henri Duffaut, Avignon, France;7. Centre Hospitalier Universitaire Rangeuil, Toulouse, France;8. Cordis Corporation (Johnson and Johnson), Waterloo, Belgium and Bridgewater, New Jersey;9. H?pital Européen Georges Pompidou, Assistance Publique H?pitaux de Paris and INSERM U 970, Paris Descartes University, Paris, France;10. Unité de Cardiologie Interventionnelle, Clinique Pasteur, Toulouse, France |
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| Abstract: | 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;25:586–595) |
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