randomized comparison between sirolimus (cypher)/sirolimus-analogous (xience; promus) vs. paclitaxel...
DESCRIPTION
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clinical outcome of Taxus vs. Conor vs. Cypher/Xience in all comers patients planned to be enrolled May 2007 Conor was withdrawn from the market 359 patients enrolled between May 2006 and May 2007 and randomized 1:1.1 Group 3 n=120 Group 3 n=120 Group 1 n=120 Group 1 n=120 Group 2 n=119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=120TRANSCRIPT
““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
Alaide Chieffo, Enrico Romagnoli, Angela Ferrari, Alaide Chieffo, Enrico Romagnoli, Angela Ferrari, Flavio Airoldi, Renata Rogacka, Valeria Magni, Flavio Airoldi, Renata Rogacka, Valeria Magni,
Matteo Montorfano, Mauro Carlino, Iassen Matteo Montorfano, Mauro Carlino, Iassen Michev, Azeem Latib, Tiziana C Aranzulla, Alfredo Michev, Azeem Latib, Tiziana C Aranzulla, Alfredo
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
Group 1Limusn=120
Group 2Taxusn=119
Group 3Conorn=120
Age, ys 63.1±10.2
64.4±9.2 64.6±10.0
LVEF,% 52.7±10.6
52.7±9.4 52.6±10.2
UA 23(19.2%)
18(15.1%) 22(18.3%)
Hypertension
88(73.3%)
90(75.6%) 81(67.5%)
Hyperchol 80(66.7%)
84(70.6%) 77(64.2%)
Smoking 69(57.5%)
67(56.3%) 62(51.6%)
Baseline Lesion CharacteristicsBaseline Lesion Characteristics
Group 1Limusn=175
Group 2Group 2TaxusTaxusn=204n=204
Group 3Group 3ConorConorn=173n=173
Complex Complex lesionslesions
129(73.7%)
156(76.5156(76.5%)%)
118(68.2%)
CTO 26(14.8%) 42 (20.6%)
27(15.6%)
Bifurcations 40(19.0%) 39(19.1%) 32(18.5%)Number Number stent/lesstent/les
1.171.17±0.4±0.4 1.191.19±0.5±0.5 1.161.16±0.4±0.4
Stent lengthStent length 29.629.6±13.9±13.9 29.129.1±16.6±16.6 28.4±±14.9Vess diameter 2.742.74±0.5±0.5 2.672.67±0.6±0.6 2.62±0.6±0.6
p = NS for all comparisonsp = NS for all comparisons
In Hospital MACE
MI TVR Death MACE
3.0
2.0
1.0
%
Limus n=120 ptsTaxus n=119 ptsConor n=120 pts
1.6
2.5
0.8 0.8 0.8
1.6
2.5
1.7
n=2
n=3
n=1
n=1
n=1
n=2
n=3
n=2
1 Taxus pt had a definite ST with MI and TVR
0
5
10
15
20
TLR MI Death MACE
Six Month Clinical Follow-UpCumulative (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=13n=12
n=2 n=1 n=1n=4
n=1
n=17
n=6 n=7
P=0.028
P=0.055
P=NS
Limus n=120 ptsTaxus n=119 ptsConor n=120 pts
1.7%
n=1
Definite ST in Conor stent at 10 and 169 days following DAT discontinuation
Predictors of TLR0.01 0.1 1 5 10 15100
0.01 0.1 1 5 10 15100
Conor
Diabetes
OR=3.3; 95%CI, 1.47-7.66, p=0.004
OR=3.7; 95%CI, 1.56-8.77, p=0.003
OR=5.8; 95%CI, 2.3-14.7,p=0.002Bifurcation
Stent Thrombosis<1 Month
n=359> 1 month
n=358Total
Definite 2 (0.5%)1 Taxus1 Conor*
1 (0.3%)1 Conor*
3 (0.8%)
Probable
1 (0.3%) 1 Cypher
0 1 (0.3%)
Possible
0 2 (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….