“ “ R R a a ndomized Comparison ndomized Comparison b b etween etween S S ir ir ol ol im im u u s (Cypher)/Sirolimus- s (Cypher)/Sirolimus- analogous (Xience; Promus) vs. analogous (Xience; Promus) vs. Pacli Pacli t t ax ax e e l (Taxus vs.Costar) l (Taxus vs.Costar) Eluting Stents in Coronary Eluting Stents in Coronary Lesions: a Single Center Lesions: a Single Center Experience” Experience” The The ABSOLUTE ABSOLUTE Trial Trial Alaide Chieffo, Enrico Romagnoli, Angela Alaide Chieffo, Enrico Romagnoli, Angela Ferrari, Flavio Airoldi, Renata Rogacka, Ferrari, Flavio Airoldi, Renata Rogacka, Valeria Magni, Matteo Montorfano, Mauro Valeria Magni, Matteo Montorfano, Mauro Carlino, Iassen Michev, Azeem Latib, Tiziana C Carlino, Iassen Michev, Azeem Latib, Tiziana C Aranzulla, Alfredo Castelli, Cosmo Godino, Aranzulla, Alfredo Castelli, Cosmo Godino, Antonio Colombo. Antonio Colombo. San Raffaele Hospital, Milan, Italy San Raffaele Hospital, Milan, Italy
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Randomized Comparison between Sirolimus (Cypher)/Sirolimus-analogous (Xience; Promus) vs. Paclitaxel (Taxus vs.Costar) Eluting Stents in Coronary Lesions:
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clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers patients planned to be enrolled May 2007 Conor was withdrawn from the market 359 patients enrolled between May 2006 and May 2007 and randomized 1:1.1 Group 3 n=120 Group 3 n=120 Group 1 n=120 Group 1 n=120 Group 2 n=119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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““RRaandomized Comparison ndomized Comparison bbetween etween SSirirololimimuus s
(Cypher)/Sirolimus-analogous (Cypher)/Sirolimus-analogous (Xience; Promus) vs. Pacli(Xience; Promus) vs. Paclittaxaxeel l (Taxus vs.Costar) Eluting Stents (Taxus vs.Costar) Eluting Stents
in Coronary Lesions: a Single in Coronary Lesions: a Single Center Experience”Center Experience”The The ABSOLUTEABSOLUTE Trial Trial
Castelli, Cosmo Godino, Antonio Colombo. Castelli, Cosmo Godino, Antonio Colombo.
San Raffaele Hospital, Milan, ItalySan Raffaele Hospital, Milan, Italy
The authors have nothing to disclose regarding this presentation
Study DesignStudy 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.
1500 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 3n=120
Group 1n=120
Group 2n=119
Limus n=12097 Cypher
23 Xience/Promus
Taxus n=119Conor n=120
Study Endpoints
• Primary End-point Target lesion Revascularization at 6 months
• Secondary End-pointsMajor 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 IBaseline Clinical Characteristics I
Group 1Limusn=120
Group 2Taxusn=119
Group 3Conorn=120
Diabetes 37(30.8%) 39(32.7%)
37(30.8%)
Unprotected LM
6 (5.0%) 7 (5.9%) 4 (3.3%)
ISR 21(17.5%) 19(15.9%)
20(16.6%)
Baseline Clinical Characteristics IIBaseline Clinical Characteristics II