Safety and Efficacy of Drug-Eluting Stents in Women: A Patient-Level Pooled Analysis of Randomised Trials

Jan 24, 2014
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Authors:
Stefanini GG, Baber U, Windecker S, et al.
Citation:
Lancet 2013;382:1879-1888.
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What was the safety and efficacy of drug-eluting stents (DES) in women?

Methods:

The authors performed a pooled patient-level analysis of data from female participants from 26 randomized trials of DES and analysed outcomes according to stent type (bare-metal stents [BMS], early-generation DES, and newer-generation DES). The primary safety endpoint was a composite of death or myocardial infarction. The secondary safety endpoint was definite or probable stent thrombosis. The primary efficacy endpoint was target-lesion revascularization (TLR).

Results:

The 26 trials enrolled 43,904 patients, of whom 11,557 (26.3%) were women. The average age of the women was 67 years. BMS were used in 1,108 (9.6%) women, first-generation DES in 4,171 (36.1%), and second-generation DES in 6,278 (54.3%). At 3 years, estimated cumulative incidence of the composite of death or myocardial infarction occurred in 132 (12.8%) women in the BMS group, 421 (10.9%) in the early-generation DES group, and 496 (9.2%) in the newer-generation DES group (p = 0.001). Definite or probable stent thrombosis occurred in 13 (1.3%), 79 (2.1%), and 66 (1.1%) women in the BMS, early-generation DES, and newer-generation DES groups, respectively (p = 0.01). The use of DES was associated with a significant reduction in the 3-year rates of TLR (18.6% women in the BMS group, 7.8% in the early-generation DES group, and 6.3% in the newer-generation DES group, p < 0.0001).

Conclusions:

The authors concluded that DES use in women is associated with a reduction in TLR and is as safe as BMS.

Perspective:

Women make up about a third of patients undergoing coronary revascularization and have generally been under-represented in clinical trials. Prior small studies suggest that women derive similar benefits from DES compared with men, but most of these studies have been underpowered. This pooled analysis confirms the safety and efficacy of the second-generation DES in women, and these stents should be preferentially used in women undergoing percutaneous coronary intervention.

Keywords: Incidence, Myocardial Infarction, Coronary Restenosis, Thrombosis, Drug-Eluting Stents, Sirolimus, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention


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