randomized comparison between sirolimus (cypher)/sirolimus-analogous (xience; promus) vs. paclitaxel...

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Study Design DESIGN: Prospective, randomized, three-arm, single- center clinical evaluation of sirolimus(Cypher)/sirolimus- analogous (Xience or Promus)- vs. paclitaxel (Taxus vs. Costar)-eluting stents. Patients were stratified according to the presence of DM, unprotected LM and ISR. OBJECTIVE: To evaluate 1, 6 and 12 month- clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers. DESIGN: Prospective, randomized, three-arm, single- center clinical evaluation of sirolimus(Cypher)/sirolimus- analogous (Xience or Promus)- vs. paclitaxel (Taxus vs. Costar)-eluting stents. Patients were stratified according to the presence of DM, unprotected LM and ISR. OBJECTIVE: To evaluate 1, 6 and 12 month- clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers patients planned to be enrolled May 2007 Conor was withdrawn from the market 359 patients enrolled between May 2006 and May 2007 and randomized 1:1.1 Group 3 n=120 Group 3 n=120 Group 1 n=120 Group 1 n=120 Group 2 n=119 Group 2 n=119 Limus n= Cypher 23 Xience/Promus Taxus n=119 Conor n=120

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Randomized Comparison between Sirolimus (Cypher)/Sirolimus-analogous (Xience; Promus) vs. Paclitaxel (Taxus vs.Costar) Eluting Stents in Coronary Lesions: a Single Center Experience The ABSOLUTE Trial Alaide Chieffo, Enrico Romagnoli, Angela Ferrari, Flavio Airoldi, Renata Rogacka, Valeria Magni, Matteo Montorfano, Mauro Carlino, Iassen Michev, Azeem Latib, Tiziana C Aranzulla, Alfredo Castelli, Cosmo Godino, Antonio Colombo. San Raffaele Hospital, Milan, Italy The authors have nothing to disclose regarding this presentation Study Design DESIGN: Prospective, randomized, three-arm, single- center clinical evaluation of sirolimus(Cypher)/sirolimus- analogous (Xience or Promus)- vs. paclitaxel (Taxus vs. Costar)-eluting stents. Patients were stratified according to the presence of DM, unprotected LM and ISR. OBJECTIVE: To evaluate 1, 6 and 12 month- clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers. DESIGN: Prospective, randomized, three-arm, single- center clinical evaluation of sirolimus(Cypher)/sirolimus- analogous (Xience or Promus)- vs. paclitaxel (Taxus vs. Costar)-eluting stents. Patients were stratified according to the presence of DM, unprotected LM and ISR. OBJECTIVE: To evaluate 1, 6 and 12 month- clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers patients planned to be enrolled May 2007 Conor was withdrawn from the market 359 patients enrolled between May 2006 and May 2007 and randomized 1:1.1 Group 3 n=120 Group 3 n=120 Group 1 n=120 Group 1 n=120 Group 2 n=119 Group 2 n=119 Limus n= Cypher 23 Xience/Promus Taxus n=119 Conor n=120 Study Endpoints Primary End-point Target lesion Revascularization at 6 months Secondary End-points Major Adverse Cardiac Events (defined as death, MI, target lesion and vessel revascularization) at 1, 6 and 12 months COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial Results from The COSTAR II trial comparing the Conor CoStar stent with the Taxus Express(2) paclitaxel drug-eluting stent became available showing inferiority at eight- month follow-up of Conor stent which was withdrawn from the market. 22 May 2007, Barcelona, Spain Baseline Clinical Characteristics I Group 1 Limus n=120 Group 2 Taxus n=119 Group 3 Conor n=120 Diabetes37(30.8%)39(32.7%)37(30.8%) Unprotected LM 6 (5.0%)7 (5.9%)4 (3.3%) ISR21(17.5%)19(15.9%)20(16.6%) Baseline Clinical Characteristics II Group 1 Limus n=120 Group 2 Taxus n=119 Group 3 Conor n=120 Age, ys63.1 10.0 LVEF,%52.7 10.2 UA23(19.2%)18(15.1%)22(18.3%) Hypertension88(73.3%)90(75.6%)81(67.5%) Hyperchol80(66.7%)84(70.6%)77(64.2%) Smoking69(57.5%)67(56.3%)62(51.6%) Baseline Lesion Characteristics Group 1 Limus n=175 Group 2 Taxusn=204 Group 3 Conorn=173 Complex lesions 129(73.7%)156(76.5%)118(68.2%) CTO26(14.8%)42 (20.6%)27(15.6%) Bifurcations40(19.0%)39(19.1%)32(18.5%) Number stent/les 1.17 0.4 Stent length 29.6 16.6 28.414.9 Vess diameter 2.74 0.6 0.6 p = NS for all comparisons In Hospital MACE % Limus n=120 pts Taxus n=119 pts Conor n=120 pts n=2 n=3 n=1 n=2 n=3 n=2 1 Taxus pt had a definite ST with MI and TVR Six Month Clinical Follow-Up Cumulative (30 days +6 months) 14.2% 5.0% 3.3% 0.8% 15.8% 10.9% 10.0% 5.9% 0.8% n=19 n=13 n=12 n=2n=1 n=4 n=1 n=17 n=6 n=7 P=0.028 P=0.055 P=NS Limus n=120 pts Taxus n=119 pts Conor n=120 pts 1.7% n=1 Definite ST in Conor stent at 10 and 169 days following DAT discontinuation Predictors of TLR Conor Diabetes OR=3.3; 95%CI, , p=0.004 OR=3.7; 95%CI, , p=0.003 OR=5.8; 95%CI, ,p=0.002 Bifurcation Stent Thrombosis 1 month n=358 Total Definite2 (0.5%) 1 Taxus 1 Conor* 1 (0.3%) 1 Conor* 3 (0.8%) Probable1 (0.3%) 1 Cypher 01 (0.3%) Possible02 (0.5%) 1 Taxus 1 Conor 2 (0.5%) *premature discontinuation of DAT Conclusions Even in this small single center study a difference in TLR was evident in Conor vs. Limus stents and a trend was observed between Taxus and Conor. These results suggest that dosage and/or release pattern of the drug could play a role. San Raffaele Hospital Thanks all.

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