Methods

The Korean TRI registry was used for this retrospective observational study. A total of 4,890 patients from 12 centers were enrolled in this study from January to December of 2009. This study was based on 1,827 patients who underwent PCI by way of TRI. We excluded the patients who had access site crossover and implantation of intra-aortic balloon pump. Because the baseline characteristics between male and female patients were not matched, propensity score analysis was performed using a logistic regression model for male and female genders to adjust for differences in baseline characteristics. The variables used in propensity score matching included age, hypertension, diabetes mellitus, acute coronary syndrome (ACS), and chronic kidney disease (CKD). Male and female patients were matched one to one on the basis of the estimated propensity score of each patient. After all the propensity score matches were performed, a total of 1,194 patients (597 in each group) were studied ( Figure 1 ). Detailed data on demographics, medical history, coronary anatomy, procedural process, procedural events, pharmacotherapy, and 1-year outcome from the index procedure were collected using a standardized reporting form. This study received approval from each institutional review board.

Flowchart of this study. IABP = intra-aortic balloon pump.

We assessed clinical outcomes and safety outcomes at 1 year after the index procedure, which were determined before the registry was started. Clinical outcomes were major adverse cardiac events (MACE) composed of all-cause mortality, myocardial infarction (MI), target vessel revascularization, and stroke. All-cause mortality consisted of cardiac and noncardiac deaths. MI was defined as a creatine kinase myocardial band value of ≥3 times the upper normal limit. Target vessel revascularization was defined as any repeated PCI or bypass surgery of any segment of the target vessel. Stroke was defined as a clinical neurologic deficit from a hemorrhagic or ischemic neurologic insult.

The safety outcome was based on the rate of major bleeding. Major bleeding was defined according to the radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL) trial as one of the following: bleeding requiring transfusion of ≥2 units of packed cells or bleeding that was fatal. Fatal bleeding included the following: (1) intracranial bleeding, (2) one that brought about a reduction in the hemoglobin level of ≥5 g/dl or led to substantial hypotension requiring the use of intravenous inotropic agents, (3) one that required surgical intervention, or (4) one that required transfusion of ≥4 units of packed cells. Vascular access-related bleeding was defined as one that was related to surgical or procedural interventions, such as access artery dissection, perforation, arteriovenous fistula, pseudoaneurysm, or local hematoma requiring transfusion.

Continuous variables are expressed as mean ± SD and were compared using the independent t test. Categorical variables are expressed as number and percentage and were compared using the Fisher’s exact test or chi-square test. For descriptive analysis, we compared baseline and procedural characteristics and clinical and safety outcomes between the male and female groups. Stepwise logistic regression analysis was performed to assess the relation between female gender and outcomes. For major bleeding, the following variables were tested as independent predictors with bidirectional entry and p <0.2 for initial entry and removal: age ≥75 years, gender, hypertension, diabetes, dyslipidemia, smoking, ACS, previous MI, CKD, use of glycoprotein IIb/IIIa inhibitor, left ventricular ejection fraction, and arterial sheath size. All reported p values are 2-sided, and p values of <0.05 were considered statistically significant. SPSS software, version 18.0 (SPSS Inc, Chicago, Illinois), was used for all statistical analyses.

Results

There were no significant differences between the male and female groups in baseline demographics and co-morbid variables except smoking and previous MI ( Table 1 ). Procedural characteristics were similar between the 2 groups, but the male group had more chronic total occlusion lesion than the female group (7% vs 4%, p = 0.025; Table 2 ).

There was no significant difference in MACE at 1 year between the 2 groups (6.2% vs 4.7%, p = 0.308; Table 3 ). On multivariate analysis, independent predictors of MACE were age ≥75 years (odds ratio [OR] 2.387, 95% confidence interval [CI] 1.416 to 4.025, p = 0.001), presence of CKD (OR 2.255, 95% CI 0.970 to 7.413, p = 0.054), and major bleeding (OR 4.934, 95% CI 1.753 to 13.884, p = 0.002; Table 4 ).

Table 3

Outcomes at 1 year

Variable	Male (n = 597)	Female (n = 597)	p Value
Clinical outcomes
Major adverse cardiac events	37 (6.2%)	28 (4.7%)	0.308
All-cause mortality	13 (2.2%)	17 (2.8%)	0.580
Cardiac death	9 (1.5%)	13 (2.2%)	0.520
Myocardial infarction	3 (0.5%)	1 (0.2%)	0.374
Target vessel revascularization	22 (3.7%)	11 (1.8%)	0.076
Stroke	1 (0.2%)	2 (0.3%)	0.625
Safety outcome
Major bleeding	2 (0.3%)	18 (3.2%)	<0.001
Combination of safety and efficacy	39 (6.5%)	40 (6.7%)	0.908

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