Results from a cohort study published in Cardiology show that elderly women have a higher risk for complications and in-hospital mortality immediately after treatment with either drug-eluting stents (DES) or bare metal stents (BMS) than elderly men.
In the USA, nearly one-third of all percutaneous coronary intervention (PCI) procedures are conducted in women. The Food and Drug Administration has recently issued a draft guidance recommending women be included in representative numbers in trials of implantable medical devices such as stents, and that gender-specific outcomes should be analyzed.
Monique Anderson (Duke University Medical Center, Durham, North Carolina, USA) and colleagues reviewed the medical records of nearly 427,000 patients aged at least 65 years from the National Cardiovascular Data Registry. These patients had undergone PCI stenting procedures with either DES or BMS in community practices over a 5-year period.
The investigators found that women experienced higher rates of all-cause in-hospital mortality than men (2.2 vs 1.6%) and were more likely to have a periprocedural myocardial infarction (MI), vascular complications, and bleeding. Women also had greater adjusted rates of renal failure, incident coronary heart failure, and cardiogenic shock.
However, at 30 months following the stent procedure, women had a lower risk for death than men (hazard ratio of 0.92), although they had similar adjusted rates of MI, revascularization, and bleeding. More deaths occurred in patients treated with BMS than with DES, irrespective of gender.
Results from this study confirm those from other trials. While it has been supposed that worse outcomes for women may be due to the greater burden of comorbidities, smaller body size, and/or less aggressive pharmacologic therapy, in this study the elevated risk remained despite adjustment for these and other variables.
The investigators note that one of the study's limitations was that it was conducted in the elderly, and results therefore are not pertinent to patients aged under 65 years. They also caution not to overemphasize the potential benefit of DES versus BMS, as "it is recognized that stent selection is biased towards a patient's clinical profile and risk, as well as socioeconomic factors."
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