TAXUS WOMAN

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TAXUS WOMAN

• A Pooled Analysis of Outcomes with
  Paclitaxel-eluting Stents in Women and Men
• Simon Corbett
• Interventional Fellow
• St Marys Hospital

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Background (1)

• Previous trial and registry data have
  consistently shown worse outcomes in women
  compared to men undergoing coronary
  revascularisation
• This is usually attributed to an adverse risk
  profile in women they tend to be older, smaller
  and have more diabetes, hypertension and heart
  failure

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Background (2)

• The efficacy of drug-eluting stents in reducing
  clinical restenosis across a wide range of lesion
  subsets is well-established
• However, the efficacy of DES in women is assumed,
  not proven

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Aim of this Study

• To assess the safety and efficacy of the
  paclitaxel-eluting TaxusTM stent in women

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Methodology

• Pooled analysis of the Results from the TAXUS II,
  IV, V and VI randomized, controlled trials

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The TAXUSTM Trial Program
Study Inclusion Criteria Exclusion Criteria Patients Endpoints Results
TAXUS II Colombo, Circ 2003 Single de novo lesion, length 12 mm, diameter 3.0 mm and 3.5 mm AMI, LVEF lt30, left main stenosis 536 (24.4 ?) 131 Taxus SR 135 Taxus MR 270 Bare metal 1o stent obstructed on IVUS 2o MACE at 1, 6 and 12 months obstruction PES SR 7.9 PES MR 7.8 BMS 23.2 Plt0.0001
TAXUS IV Stone, NEJM 2004 Single de novo lesion, length 28 mm, diameter 2.6 mm and 3.5 mm AMI, LVEF lt25, renal failure, left main, CTO, ostial, bifurcation, calcified 1314 (27.9 ?) 662 Taxus SR 652 Bare metal 1o TVR at 9 months 2o none specified TVR at 9 months Taxus SR 4.7 BMS 12.0 Plt0.001
TAXUS V Stone, JAMA 2005 Single de novo lesion, length 46 mm, diameter 2.25 mm and 4.0 mm AMI, LVEF lt25, renal failure, CVA, left main, CTO, ostial, bifurcation, calcified 1156 (30.5 ?) 577 Taxus SR 579 Bare metal 1o TVR at 9 months 2o angiographic restenosis TVR at 9 months Taxus SR 12.1 BMS 17.3 Plt0.001
TAXUS VI Dawkins, Circ 2005 Single de novo lesion, length 40 mm, diameter 2.5 mm and 3.75 mm AMI, LVEF poor, left main, CTO, ostial, bifurcation, calcified 446 (23.8 ?) 219 Taxus MR 227 Bare metal 1o TVR at 9 months 2o none specified TVR at 9 months Taxus MR 9.1 BMS 19.4 P0.0027
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Results

• Between June 2001 and March 2004, 3445 patients
  were enrolled into the TAXUS II, IV, V and VI
  trials
• Women comprised 27.7 (955 patients)
• Stents received Taxus 480, 475 bare metal
• Men comprised 72.3 (2490 patients)
• Stents received Taxus 1238, 1252 bare metal
• Follow-up is complete to 3 years for TAXUS II and
  IV, 2 years for TAXUS VI and 1 year for TAXUS V

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Baseline Patient Characteristics
Overall Overall Overall Taxus Taxus Taxus Control (BMS) Control (BMS) Control (BMS)
Variable Women Men P-value Women Men P-value Women Men P-value
Patients (n955) (n2490) (n480) (n1238) (n475) (n1252)
Age (years) 65.4 10.9 61.0 10.4 lt0.0001 65.3 10.6 61.1 10.5 lt0.0001 65.5 10.5 60.9 10.3 lt0.0001
Body Surface Area 1.80 0.19 2.05 0.20 lt0.0001 1.80 0.18 2.05 0.20 lt0.0001 1.79 0.19 2.04 0.20 lt0.0001
Heart Failure 8.8 5.5 0.0008 9.0 4.8 0.0014 8.7 6.3 0.0903
Risk Factors
Hypertension 78.0 65.1 lt0.0001 78.8 65.8 lt0.0001 77.3 64.5 lt0.0001
Hyperlipidemia 68.5 71.1 0.1439 69.5 70.5 0.6805 67.5 71.7 0.0974
Smoker 20.0 22.7 0.0882 19.2 23.6 0.0606 20.7 21.8 0.6458
Diabetes 30.4 21.0 lt0.0001 32.1 19.8 lt0.0001 28.6 22.3 0.0067
P-valuenon-significant for all comparisons
between the Taxus and Control groups in women and
men (data not shown)
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Baseline Lesion and Procedural Characteristics
Overall Overall Overall Taxus Taxus Taxus Control (BMS) Control (BMS) Control (BMS)
Variable Women Men P-value Women Men P-value Women Men P-value
Patients (n955) (n2490) (n480) (n1238) (n475) (n1252)
Number of stents 1.23 0.49 1.22 0.51 0.8560 1.23 0.53 1.23 0.49 0.8018 1.22 0.45 1.22 0.53 0.9987
Stent length (mm) 24.5 11.1 24.4 11.3 0.8172 24.8 11.4 24.5 11.2 0.6432 24.2 10.8 24.3 11.4 0.8854
Gp IIb-IIIa use 40.8 41.3 0.8166 40.4 41.8 0.6236 41.3 40.9 0.9128
Type C lesion 29.9 34.0 0.0356 30.2 33.4 0.2631 29.6 34.6 0.0739
LAD lesion 41.4 42.0 0.7576 39.8 42.6 0.3004 42.9 41.4 0.5848
Calcification 26.4 26.0 0.8513 25.4 25.7 0.9467 27.3 26.3 0.7422
RVD (mm) 2.63 0.46 2.78 0.52 lt0.0001 2.63 0.46 2.78 0.52 lt0.0001 2.63 0.47 2.77 0.52 lt0.0001
MLD (mm) 0.89 0.35 0.91 0.36 0.0917 0.88 0.34 0.91 0.35 0.1363 0.89 0.36 0.91 0.37 0.3643
Diameter stenosis () 66.4 11.1 67.2 11.1 0.0585 66.6 10.8 67.3 10.8 0.2463 66.2 11.4 67.2 11.4 0.1308
Lesion length (mm) 14.8 7.8 15.3 8.0 0.1413 15.2 8.1 15.2 7.9 0.9550 14.5 7.5 15.4 8.2 0.0366
P-valuenon-significant for all comparisons
between the Taxus and Control groups in women and
men (data not shown)
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Clinical Outcomes at 30 days
Taxus Taxus Control Control
Variable Women (1) Men (2) Women (3) Men (4) P-value (1) vs (2) P-value (3) vs (4) P-value (1) vs (3) P-value (2) vs (4)
Patients (n480) (n1238) (n475) (n1252)
MACE 4.6 (22) 3.8 (47) 3.6 (17) 3.4 (43) 0.4936 0.8835 0.5139 0.6682
All death 0 0.2 (2) 0 0.4 (5) 1.0000 0.3312 0.4525
Cardiac death 0 0.2 (2) 0 0.4 (5) 1.0000 0.3312 0.4525
MI 4.2 (20) 3.6 (45) 3.4 (16) 3.0 (38) 0.5763 0.7571 0.6110 0.4355
Stent thrombosis 0 0.6 (8) 0.2 (1) 0.6 (8) 0.1153 0.4585 0.4974 1.0000
TLR 0.2 (1) 0.6 (7) 0.2 (1) 0.6 (7) 0.4555 0.4581 1.0000 1.0000
TVR 0.6 (3) 0.6 (7) 0.4 (2) 0.6 (8) 1.0000 0.7365 1.0000 1.0000
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Clinical Outcomes at 1 year
Taxus Taxus Control Control
Variable Women (1) Men (2) Women (3) Men (4) P-value (1) vs (2) P-value (3) vs (4) P-value (1) vs (3) P-value (2) vs (4)
Patients (n480) (n1238) (n475) (n1252)
MACE 15.6 13.2 24.0 21.7 0.2139 0.3320 0.0015 lt0.0001
All death 1.5 1.7 1.5 1.8 0.8341 0.6852 1.0000 0.8794
Cardiac death 0.4 1.1 1.3 1.1 0.2593 0.8031 0.1758 1.0000
MI 5.0 4.4 5.9 4.4 0.6056 0.2078 0.5708 1.0000
Stent thrombosis 0 1.0 0.2 0.8 0.0251 0.3076 0.4974 0.6747
TLR 8.1 6.7 17.5 16.4 0.2972 0.6129 lt0.0001 lt0.0001
TVR 11.7 9.7 20.0 18.3 0.2489 0.4477 0.0005 lt0.0001
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Conclusions

• The Taxus stent is as effective at reducing
  repeat revascularization in women as men
• The Taxus stent is safe in women
• Long-term clinical outcomes in women and men
  treated in these contemporary PCI studies are
  equivalent despite the adverse risk profile of
  women at baseline
• Women treated with the Taxus stent have a lower
  rate of late stent thrombosis than men