““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May 2007 Conor was withdrawn from the market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which was withdrawn from the market.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….