Meta-analysis: Best Outcomes Seen with Newer-Generation DES in Women
AMSTERDAM, The Netherlands—Drug-eluting stents (DES), specifically second-generation devices, are as safe as and more effective than bare-metal stents (BMS) in women, according to a pooled analysis of randomized trials presented on September 2, 2013, at the European Society of Cardiology Congress and simultaneously published in the Lancet.
Roxana Mehran, MD, of Mount Sinai Medical Center (New York, NY), and colleagues culled data on 43,904 patients—of whom 11,557 (26.3%) were women—implanted with either BMS or DES in 26 randomized trials from 2002 to 2013.
New DES Show Clear Advantage
After a mean follow-up period of 2.9 years, women had similar rates of death (5.7% vs. 5.9%), MI (5.5% vs. 4.5%), definite/probable stent thrombosis (1.6% vs. 1.6%), and TLR (8.0% vs. 8.3%) compared with the overall population.
A comparison across the eras of BMS, early DES, and new DES in women only found that the newer-generation devices came out ahead for death or MI (primary safety endpoint), definite/probable stent thrombosis (secondary safety endpoint), and TLR (primary efficacy endpoint; table 1).
Table 1. Clinical Outcomes at 3 Years Among Women
BMS |
Early DES |
New DES |
P Value (Overall) |
P Value (Early vs. New DES) |
|
Death or MI |
12.8% |
10.9% |
9.2% |
0.001 |
0.01 |
Definite/Probable Stent Thrombosis |
1.3% |
2.1% |
1.1% |
0.01 |
0.002 |
TLR |
18.6% |
7.8% |
6.3% |
< 0.001 |
0.005 |
MACE (Death, MI, TLR) |
27.7% |
16.5% |
14.1% |
< 0.0001 |
0.002 |
Multivariable analysis also found a clear advantage for newer-generation DES over early-generation DES in the risk of adverse events compared with BMS at 3 years (table 2).
Table 2. Adverse Events at 3 Years vs. BMS: Adjusted HR (95% CI)
Early DES |
New DES |
P Value |
|
Death or MI |
0.94 (0.69-1.27) |
0.70 (0.51-0.97) |
0.002 |
Definite/Probable Stent Thrombosis |
0.95 (0.41-2.17) |
0.55 (0.24-1.26) |
0.02 |
TLR |
0.46 (0.33-0.65) |
0.44 (0.31-0.64) |
0.68 |
The results held true in subgroup analyses with the exception of BMS being favored against newer-generation DES in diabetic patients in terms of MI rates.
No Comparison Needed
“Women comprise of only one-fourth of the patients recruited for randomized trials of drug-eluting stents,” Dr. Mehran reported. “The use of DES is safe and effective in the long run, and new-generation DES are associated with an improved safety profile. This kind of patient analysis of prior trials does allow for analysis of safety and efficacy in underrepresented populations, and we’re hoping this can be done in other populations as well.”
Discussant Stuart J. Pocock, PhD, of the London School of Hygiene and Tropical Medicine (London, United Kingdom), called the findings of the study “unique and robust.” However, he questioned the existence of a “driving force” among the numerous DES used, suggesting that, as seen in prior studies, everolimus alone could be responsible for the positive results, particularly stent thrombosis.
Dr. Pocock also questioned if “the conclusions we draw [are] equally applicable in men and women,” and why the researchers did not conduct a head-to-head comparison.
“We did not mean to compare women to men,” Dr. Mehran responded. “We know we’re very different from men in many, many ways, especially in the anatomy and comorbidities at the time of PCI. This comparison that has been done multiple times. . . . Men vs. women was not the purpose of this analysis. We really wanted to understand safety and efficacy of the evolution of PCI in women over this decade of interventional trials that women have been underrepresented in.”
Study Details
Early-generation DES included Cypher (Cordis/Johnson & Johnson) and Taxus (Boston Scientific), while newer-generation DES were Xience/Promus (Abbott, Boston Scientific), Endeavor (Medtronic), Resolute (Medtronic), Biomatrix/Nobori (Biosensors, Terumo), and Yukon PC (Translumina). As trials shifted to newer-generation DES, patients tended to be older and had more comorbidities and prior disease.
Note: Dr. Mehran is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Source:
Stefanini GG, Baber U, Windecker S, et al. Safety and efficacy of drug-eluting stents in women: A patient-level pooled analysis of randomized trials. Lancet. 2013;Epub ahead of print.
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Read Full BioDisclosures
- Dr. Mehran reports receiving research grant support from Bristol-Myers Squibb/Sanofi-Aventis, Lilly/Daiichi Sankyo, and The Medicines Company and consulting fees from Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, Janssen Pharmaceuticals, Maya Medical, Merck, Regado Biosciences, and Sanofi-Aventis; and serves on the advisory boards of Covidien, Janssen Pharmaceuticals, and Sanofi-Aventis.
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