Study Pinpoints Influence of CAD Presentation, DES Type in Female Patients
Although women with STEMI tend to have higher mortality after PCI than those with stable or unstable angina, the introduction of newer DES has improved outcomes overall for women across the CAD spectrum, according to a study published online June 24, 2015, ahead of print in the American Journal of Cardiology.
Researchers led by Roxana Mehran, MD of Mount Sinai Hospital (New York, NY), pooled patient-level data on female patients (n = 10,449) with stable angina, unstable angina/NSTEMI, or STEMI from 26 RCTs of DES conducted between 2002 and 2013.
Outcomes Worst With STEMI
At 3 years, there were stepwise increases in the cumulative rates of death; death or MI; and the composite of death, MI, or stent thrombosis in patients whose disease presentations ranged from stable angina to unstable angina/NSTEMI to STEMI (table 1).
Landmark analysis showed that the higher risks of death and of death, MI or stent thrombosis for STEMI patients were only apparent in the first year after treatment (P < 0.01), whereas there were no differences among the presentations between years 1 and 3.
After multivariable adjustment, STEMI remained an independent predictor of increased risk of 3-year mortality (HR 3.45; 95% CI 1.99-5.98), but no differences were observed between the groups of women who presented with stable angina or unstable angina/NSTEMI (HR 0.99; 95% CI 0.73-1.34). Importantly, women with STEMI had lower risk of MI at 3 years compared with the other 2 groups (HR 0.41; 95% CI 0.18- 0.91).
Compared with early-generation DES, newer-generation devices were associated with lower rates of MACE (death, MI, TLR, or definite or probable stent thrombosis; HR 0.58; 95% CI 0.34-0.98), definite or probable stent thrombosis (HR 0.15; 95% CI 0.03-0.82), and cardiac death (HR 0.24; 95% CI 0.07-0.83).
Notably, the “magnitude of the benefit associated with the use of new-generation DES was uniform across clinical presentation, without evidence of interaction,” the investigators add.
Unique Patterns Seen for Women
“To the best of our knowledge, this is the first and largest analysis evaluating the safety and efficacy of DES in women according to their clinical presentation,” Dr. Mehran and colleagues write.
Cindy Grines, MD, of Detroit Medical Center (Detroit, MI), told TCTMD that this study is valuable because it involves “a huge cohort of well-studied women.”
Dr. Grines expressed surprise at the finding that “women with stable angina have similar mortality to those with unstable angina or NSTEMI. One would think that unstable lesions would predict worse outcomes.”
The association between STEMI and mortality may be more pronounced in women, the authors explain, due to female patients having a “greater extent of myocardial necrosis and ventricular compromise with subsequent higher risk of negative myocardial remodeling and [heart failure–related death]” and “the high risk of bleeding among women undergoing primary PCI.”
Importantly, they say, the current study—unlike earlier RCTs that mainly enrolled men—found that the harm associated with STEMI was restricted to the first year after treatment. No differences were seen between years 1 and 3.
According to Dr. Grines, recent iterations of DES may be particularly beneficial in female patients, who have arteries that are smaller and more tortuous than those of men along with more diffuse disease. “We think of women as being higher risk for PCI, but with newer generation DES that are more thin, flexible, and deliverable, with superior drugs and coatings, women do very well with percutaneous revascularization,” she said.
“Perhaps PCI should be the default treatment for women with CAD,” Dr. Grines concluded. “Unfortunately, trials comparing patients (both men and women) to either medical therapy or surgery did not use the current, vastly improved DES. Therefore, guidelines that recommend medical or surgical therapy in certain patient subgroups may not be valid.”
Note: Dr. Mehran and several coauthors are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Giustino G, Baber U, Stefanini GG, et al. Impact of clinical presentation (stable angina pectoris versus unstable angina pectoris or non-ST-elevation myocardial infarction versus ST-elevation myocardial infarction) on long-term outcomes in women undergoing percutaneous coronary intervention with drug-eluting stents. Am J Cardiol. 2015;Epub ahead of print.
- Meta-analysis: Best Outcomes Seen With Newer-Generation DES in Women
- Registry Confirms Long-term Survival Higher in Women After Stenting
- Meta-analysis Confirms Advantage of New-Generation DES in STEMI
Nicole Lou is the 2015 Recipient of the Jason Kahn Fellowship in Medical Journalism
- Dr. Mehran reports receiving institutional research grant support and consulting fees from as well as holding advisory board positions with multiple pharmaceutical and device companies.
- Dr. Grines reports serving on the advisory board for Abbott Vascular.