Influence of Sex on Long-Term Outcomes After Percutaneous Coronary Intervention With the Paclitaxel-Eluting Coronary Stent: Results of the “TAXUS Woman” Analysis

doi:10.1016/j.jcin.2010.08.020

JACC: Cardiovascular Interventions

Volume 3, Issue 12, December 2010, Pages 1250-1259

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Objectives

We conducted the “TAXUS Woman” analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients.

Background

Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice.

Methods

We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 “real-world” registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent–treated women (n = 395) in the randomized trials.

Results

In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent–treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis.

Conclusions

This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.

Key Words

coronary disease

drug-eluting stent(s)

revascularization

sex

Abbreviations and Acronyms

BMS

bare-metal stent(s)

DES

drug-eluting stent(s)

myocardial infarction

PCI

percutaneous coronary intervention

PES

paclitaxel-eluting stent(s)

RVD

reference vessel diameter

TLR

target lesion revascularization

Cited by (0)

: Supported by Boston Scientific Corporation. Dr. Mikhail has been an advisory board member for Boston Scientific for a new stent platform; and she is on the steering committee of a multicenter trial conducted by Abbott Vascular and is a Speakers' Bureau member for Medtronic. Dr. Cox is a Speakers' Bureau member and has received consulting fees from Boston Scientific. Dr. Ellis is a consultant to Abbott Vascular for a new stent platform and has also received consulting fees from Boston Scientific and Cordis. Dr. Lasala is a Speakers' Bureau member and has received honoraria from Boston Scientific and Cordis/Johnson & Johnson. Dr. Ormiston has received research grants and support from Boston Scientific, Johnson & Johnson, Abbott Vascular, and Elixir Medical as well as honoraria from Boston Scientific and Abbott Vascular and is an advisory board member for Boston Scientific, Abbott Vascular, and Devax. Dr. Stone has received research grants from Boston Scientific and Abbott Vascular. Dr. Turco has received research support and consulting fees from and is a Speakers' Bureau member for Abbott, Boston Scientific, and Medtronic. Dr. Joshi is a full-time employee of Boston Scientific. Dr. Baim was a full-time employee and a stockholder of Boston Scientific. Drs. Gerber and Colombo have reported that they have no relationships to disclose. Dr. Baim is deceased.