Women who present with coronary artery disease have different characteristics, undergo different treatment, and have a different prognosis than men. The increasing use of coronary stenting has improved the outcome of percutaneous coronary intervention (PCI). However, little is known about the outcomes for men versus women after PCI, especially for those presenting with a diagnosis of acute coronary syndrome. Thus, we compared the baseline features, management, and long-term outlook of men versus women undergoing PCI. All consecutive patients who had undergone PCI with stents at our center from July 1, 2002 to June 30, 2004 were identified retrospectively. The primary end point was the long-term rate of major adverse cardiac events (i.e., death, infarction, and repeat revascularization). The secondary end points were the individual components of the major adverse cardiac events and stent thrombosis. A total of 833 patients were included, 210 women (25.2%) and 623 men (75.8%). The women were significantly older (70.9 vs 63 years, p <0.001) and more often had diabetes mellitus (36.2% vs 21.0%, p <0.001) and hypertension (82.3% vs 73.7%, p = 0.006). The number of drug-eluting stents and the length were significantly lower in the female patients. The incidence of major adverse cardiac events after a median follow-up of 60 months was similar for both women and men (38.8% vs 46.4%, p = 0.075), with a trend toward greater mortality rate for women (21.2% vs 15.4%, p = 0.090). All other end points occurred with similar frequencies. Only in the subgroup of ST-segment elevation myocardial infarction were the rates of death significantly greater for the women than for the men (20.0% vs 8.1%; p = 0.029). In conclusion, very long-term follow-up of women undergoing PCI with coronary artery stenting resulted in similar rates of cardiac event compared to those of men, but greater care should be given to women presenting with ST-segment elevation myocardial infarction. Also, despite their greater baseline risk profile, women were significantly less likely to have received effective treatment, the use of including drug-eluting stents.
The aim of the present study was to compare the clinical outcomes of percutaneous coronary intervention (PCI) in male and female patients in the short and very long term according to their admission diagnosis.
The present retrospective study included all consecutive patients who had undergone percutaneous transluminal coronary angioplasty at our center from July 2002 to December 2004. These patients were divided into 2 cohorts according to their gender. All patients had provided written informed consent for the procedure, and ethical approval was waived, given the retrospective, observational design.
All patients had been pretreated with aspirin 100 mg/day and clopidogrel 75 mg/day or ticlopidine 250 mg twice daily for ≥3 days before the procedure. Loading doses of 300 to 600 mg of clopidogrel and 250 to 500 mg of aspirin were given to patients who had not been pretreated. At the start of the procedure, unfractionated heparin was administered at a dose of 70 to 100 UI/kg to achieve an activated clotting time of ≥250 seconds. The use of glycoprotein IIb/IIIa was left to the discretion of the operators. Coronary vasodilators (nitroglycerin) were routinely used both before and after the procedure. Coronary angioplasty and stent implantation were performed according to the current practice and technical guidelines.
The primary end point was the rate of major adverse cardiac events (MACE), defined as a nonhierarchical composite of all causes of death, nonfatal acute myocardial infarction, and target vessel revascularization. The secondary end points were the rates of the single components of MACE (i.e., death, acute myocardial infarction, percutaneous or surgical revascularization on the procedure target vessels or additional procedures such as nontarget vessel revascularization, stent thrombosis, and stroke). Moreover, we evaluated death, myocardial infarction, stroke, and stent thrombosis according to the admission diagnosis, stratified as stable angina or stable ischemia, unstable angina, or non–ST-segment elevation myocardial infarction (non-STEMI) and STEMI.
Myocardial infarction was defined as Q-wave or non–Q-wave myocardial infarction with elevation of total creatine kinase-MB 2 times greater than the upper limit of normal. Target vessel revascularization was defined as any intervention, surgical or percutaneous, to treat a luminal stenosis occurring in the same coronary vessel treated at the index procedure. Stent thrombosis was adjudicated according to the Academic Research Consortium definitions as definite, probable or possible. Stroke was defined as any ischemic neurologic event extended >24 hours with irreversible neurologic injury or permanent disability.
To assess all procedural and in-hospital outcomes, we consulted our institutional electronic database and individual patient charts. We recorded the long-term outcomes of those with ≥3 years of follow-up, determined by telephone interviews, ambulatory visits, or formal query of the primary care physician.
The continuous variables are expressed as the mean ± SD and were compared using analysis of variance. The categorical variables are presented as the counts and percentage and were compared using the chi-square test, with the results reported as the hazard ratios and 95% confidence intervals. Statistical significance was set at the 2-tailed 0.05 level. A multivariate-adjusted Cox proportional hazard analysis was performed that included all variables with a statistically significant difference (p <0.05) on univariate analysis Computations were performed using the Statistical Package for Social Sciences, version 11.0 (SPSS, Chicago, Illinois).
A total of 833 patients were selected, 210 women and 623 men. The clinical, angiographic, and procedural characteristics are summarized in Tables 1 and 2 . Although the women were older and had greater rates of the most important cardiovascular risk factors, such as diabetes mellitus and hypertension, the men had more frequently reported a previous surgical or percutaneous revascularization. Also, the admission diagnosis showed significant differences, with greater rates of unstable coronary disease in the women, with the men more often referred to the hemodynamic laboratory for silent ischemia and stable angina.
|Variable||Women (n = 210)||Men (n = 623)||p Value|
|Mean age (years)||70 ± 9||63 ± 8||<0.0001|
|Type 2 diabetes mellitus||36.2%||21.0%||0.001|
|Type 1 diabetes mellitus||6.0%||2.6%||0.030|
|Previous myocardial infarction||21.8%||22.3%||0.894|
|Left ventricular ejection fraction ≤35%||10.9%||8.3%||0.355|
|Peripheral artery disease||9.5%||10.5%||0.704|
|Silent myocardial ischemia||5.6%||8.7%||0.005|
|Stable coronary artery disease||4.5%||12.6%||0.03|
|Unstable coronary artery disease||43.4%||32.1%||<0.001|
|Non–ST-segment elevation myocardial infarction||15.7%||16.7%||0.972|
|ST-segment elevation myocardial infarction||27.8%||28.8%||0.8778|
|Primary percutaneous coronary intervention||19.7%||20.3%||0.843|
|Variable||Women (n = 210)||Men (n = 623)||p Value|
|Chronic total occlusion||19.8%||22.3%||0.460|
|Unprotected left main coronary artery||8.4%||7.4%||0.630|
|Vessels <2.75 mm||19.9%||19.2%||0.972|
|American College of Cardiology/American Heart Association type C lesion||10.4%||15.2%||0.110|
|Total number of diseased vessels||1.94 ± 0.813||2.02 ± 0.813||0.789|
|Total number of treated vessels||1.70 ± 0.755||1.70 ± 0.737||0.530|
|Total number of target lesions||2.27 ± 1.383||2.42 ± 1.377||0.372|
|Total number of stents||2.30 ± 1.628||2.39 ± 1.476||0.678|
|Total length of stent (mm)||32.48 ± 24.07||34.54 ± 23.60||0.788|
|Total number of bare metal stents||1.95 ± 1.747||1.82 ± 1.51||0.242|
|Total bare metal stent length (mm)||27.17 ± 24.66||24.64 ± 21.89||0.268|
|Total number of drug-eluting stents||0.35 ± 0.948||0.58 ± 1.143||<0.001|
|Total drug-eluting stent length (mm)||8.90 ± 14.531||13.87 ± 23.090||0.002|
|Use of both bare metal stents and drug-eluting stents||8.1%||12.3%||0.092|
|Use of paclitaxel-eluting stents only||2.4%||5.3%||0.082|
|Use of sirolimus-eluting stents only||7.6%||11.0%||0.162|
|Intra-aortic balloon pump||2.0%||1.1%||0.323|
|Intravenous glycoprotein IIb/IIIa inhibitors||15.2%||23.7%||0.010|
|Dual antiplatelet therapy at discharge||90.5%||90.3%||0.960|
|Length of dual antiplatelet therapy (months)||1.81 ± 1.54||1.78 ± 1.64||0.837|
During coronary angiography and angioplasty, chronic total occlusion and small vessels were more frequently found in the men, and the number and length of the drug-eluting stents were inferior in the women. Moreover, the women were less likely to receive intravenous glycoprotein IIb/IIIa inhibitors.
The long-term outcomes are reported in Table 3 . The rates of both MACE and the single components of MACE and the other secondary outcomes did not differ between the 2 groups. As reported in Table 4 , the outcomes of patients stratified by their admission diagnosis were not significantly different, apart from those presenting with a diagnosis of STEMI. The rate of death for those presenting with STEMI was significantly greater for the women, and this difference persisted after adjustment for confounders.