taxus woman

TAXUS WOMANTAXUS WOMAN

A Pooled Analysis of Outcomes with A Pooled Analysis of Outcomes with Paclitaxel-eluting Stents in Women and Paclitaxel-eluting Stents in Women and

MenMen

Simon CorbettSimon CorbettInterventional FellowInterventional FellowSt Mary’s Hospital St Mary’s Hospital

Background (1)Background (1)

Previous trial and registry data have Previous trial and registry data have consistently shown worse outcomes in consistently shown worse outcomes in women compared to men undergoing women compared to men undergoing coronary revascularisationcoronary revascularisation

This is usually attributed to an adverse This is usually attributed to an adverse risk profile in women – they tend to be risk profile in women – they tend to be older, smaller and have more diabetes, older, smaller and have more diabetes, hypertension and heart failurehypertension and heart failure

Background (2)Background (2)

The efficacy of drug-eluting stents in The efficacy of drug-eluting stents in reducing clinical restenosis across a reducing clinical restenosis across a wide range of lesion subsets is well-wide range of lesion subsets is well-establishedestablished

However, the efficacy of DES in However, the efficacy of DES in women is assumed, not provenwomen is assumed, not proven

Aim of this StudyAim of this Study

To assess the safety and efficacy of To assess the safety and efficacy of the paclitaxel-eluting Taxusthe paclitaxel-eluting TaxusTMTM stent in stent in womenwomen

MethodologyMethodology

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

The TAXUSThe TAXUSTMTM Trial Program Trial ProgramStudyStudy Inclusion Inclusion

CriteriaCriteriaExclusion Exclusion CriteriaCriteria

PatientsPatients EndpointsEndpoints ResultsResults

TAXUS IITAXUS II

Colombo, Circ Colombo, Circ 20032003

Single de novo Single de novo lesion, length ≤ lesion, length ≤ 12 mm, diameter 12 mm, diameter ≥ 3.0 mm and ≤ ≥ 3.0 mm and ≤ 3.5 mm 3.5 mm

AMI, LVEF AMI, LVEF <30%, left main <30%, left main stenosisstenosis

536 (24.4% ♀)536 (24.4% ♀)

131 Taxus SR131 Taxus SR

135 Taxus MR135 Taxus MR

270 Bare 270 Bare metalmetal

11oo: % stent : % stent obstructed on obstructed on IVUSIVUS

22oo: MACE at 1, : MACE at 1, 6 and 12 6 and 12 monthsmonths

% obstruction:% obstruction:

PES SR 7.9%PES SR 7.9%

PES MR 7.8%PES MR 7.8%

BMS 23.2%BMS 23.2%

P<0.0001P<0.0001

TAXUS TAXUS IVIV

Stone, NEJM Stone, NEJM 20042004


AMI, LVEF AMI, LVEF <25%, renal <25%, renal failure, left failure, left main, CTO, main, CTO, ostial, ostial, bifurcation, bifurcation, calcifiedcalcified

1314 (27.9% 1314 (27.9% ♀)♀)



11oo: TVR at 9 : TVR at 9 monthsmonths

22oo: none : none specifiedspecified

TVR at 9 TVR at 9 months:months:

Taxus SR 4.7%Taxus SR 4.7%

BMS 12.0%BMS 12.0%

P<0.001P<0.001

TAXUS VTAXUS V

Stone, JAMA Stone, JAMA 20052005


AMI, LVEF AMI, LVEF <25%, renal <25%, renal failure, CVA, left failure, CVA, left main, CTO, main, CTO, ostial, ostial, bifurcation, bifurcation, calcifiedcalcified

1156 (30.5% 1156 (30.5% ♀)♀)




22oo: : angiographic angiographic restenosisrestenosis


Taxus SR Taxus SR 12.1%12.1%

BMS 17.3%BMS 17.3%

P<0.001P<0.001

TAXUS TAXUS VIVI

Dawkins, Circ Dawkins, Circ 20052005


AMI, LVEF AMI, LVEF ‘poor’, left ‘poor’, left main, CTO, main, CTO, ostial, ostial, bifurcation, bifurcation, calcifiedcalcified

446 (23.8% ♀)446 (23.8% ♀)

219 Taxus MR219 Taxus MR



22oo: none : none specifiedspecified


Taxus MR 9.1%Taxus MR 9.1%

BMS 19.4%BMS 19.4%

P=0.0027P=0.0027

ResultsResults

Between June 2001 and March 2004, 3445 Between June 2001 and March 2004, 3445 patients were enrolled into the TAXUS II, IV, V patients were enrolled into the TAXUS II, IV, V and VI trialsand VI trials

Women comprised 27.7% (955 patients)Women comprised 27.7% (955 patients) Stents received: Taxus 480, 475 bare metalStents received: Taxus 480, 475 bare metal

Men comprised 72.3% (2490 patients)Men comprised 72.3% (2490 patients) Stents received: Taxus 1238, 1252 bare metalStents received: Taxus 1238, 1252 bare metal

Follow-up is complete to 3 years for TAXUS II Follow-up is complete to 3 years for TAXUS II and IV, 2 years for TAXUS VI and 1 year for and IV, 2 years for TAXUS VI and 1 year for TAXUS VTAXUS V

Baseline Patient CharacteristicsBaseline Patient Characteristics

Overall Taxus Control (BMS)

Variable Women Men P-value Women* Men* P-value Women* Men* P-value

Patients (n=955) (n=2490) (n=480) (n=1238) (n=475) (n=1252)

Age (years) 65.4 ± 10.9 61.0 ± 10.4 <0.0001 65.3 ± 10.6 61.1 ± 10.5 <0.0001 65.5 ± 10.5 60.9 ± 10.3 <0.0001

Body Surface Area 1.80 ± 0.19 2.05 ± 0.20 <0.0001 1.80 ± 0.18 2.05 ± 0.20 <0.0001 1.79 ± 0.19 2.04 ± 0.20 <0.0001

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% <0.0001 78.8% 65.8% <0.0001 77.3% 64.5% <0.0001

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% <0.0001 32.1% 19.8% <0.0001 28.6% 22.3% 0.0067

*P-value=non-significant for all comparisons between the Taxus and Control groups in women and men (data not shown)

Baseline Lesion and Procedural Baseline Lesion and Procedural CharacteristicsCharacteristics

*P-value=non-significant for all comparisons between the Taxus and Control groups in women and men (data not shown)

Overall Taxus Control (BMS)

Variable Women Men P-value Women* Men* P-value Women* Men* P-value

Patients (n=955) (n=2490) (n=480) (n=1238) (n=475) (n=1252)

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 <0.0001 2.63 ± 0.46 2.78 ± 0.52 <0.0001 2.63 ± 0.47 2.77 ± 0.52 <0.0001

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

Clinical Outcomes at 30 Clinical Outcomes at 30 daysdays

Taxus 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 (n=480) (n=1238) (n=475) (n=1252)

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

Clinical Outcomes at 1 yearClinical Outcomes at 1 yearTaxus 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 (n=480) (n=1238) (n=475) (n=1252)

MACE 15.6% 13.2% 24.0% 21.7% 0.2139 0.3320 0.0015 <0.0001

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 <0.0001 <0.0001

TVR 11.7% 9.7% 20.0% 18.3% 0.2489 0.4477 0.0005 <0.0001

ConclusionsConclusions

The Taxus stent is as effective at reducing The Taxus stent is as effective at reducing repeat revascularization in women as menrepeat revascularization in women as men

The Taxus stent is safe in women The Taxus stent is safe in women Long-term clinical outcomes in women Long-term clinical outcomes in women

and men treated in these contemporary and men treated in these contemporary PCI studies are equivalent despite the PCI studies are equivalent despite the adverse risk profile of women at baselineadverse risk profile of women at baseline

Women treated with the Taxus stent have Women treated with the Taxus stent have a lower rate of late stent thrombosis than a lower rate of late stent thrombosis than menmen

taxus woman

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