2.1

Study population

Patients with Type 2 diabetes mellitus undergoing percutaneous coronary intervention (PCI) from January 2003 to January 2006 were included in the study. Patients were excluded if they received both BMS and DES. Patients were not excluded from the study for any other reason.

2.2

Study procedures

The study population consisted of patients in whom intracoronary stents were successfully placed after PCI at our institution. Before undergoing catheterization, 100 mg of aspirin, and 200 mg of ticlopidine or clopidogrel with a loading dose of 300 mg followed by 75 mg daily were started orally, and all patients received a 5000-U bolus of heparin intravenously in the absence of contraindications. Coronary angiography was performed. The stents were selected at operator’s discretion. In patients treated with BMS and pioglitazone, pioglitazone (30 mg once a day), a novel insulin-sensitizing agent, was started at 2 weeks after the procedure.

2.3

Study end points and definitions

Study end points were time to cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis, and all-cause mortality.

We defined diabetes mellitus according to the World Health Organization definition from 1998 . Diabetes mellitus was defined as fasting plasma glucose not less than 126 mg/dl (7.0 mmol per liter) or 2 h blood glucose not less than 200 mg/dl (11.1 mmol/l).

We defined acute myocardial infarction (AMI) according to criteria jointly recommended by the European Society of Cardiology and the American College of Cardiology . Patients were diagnosed as having an AMI if they had two values of serum troponin T greater than 0.1 ng/ml or creatine kinase-MB greater than 7 ng/ml together with either typical symptoms (chest pain >15 min; pulmonary oedema in the absence of valvular heart disease; cardiogenic shock; arrhythmia such as ventricular fibrillation or ventricular tachycardia), new Q-waves in at least two of the 12 standard electrocardiographic leads, or electrocardiogram changes indicating acute ischemia (ST elevation, ST depression, or T-wave inversion).

We defined stent thrombosis according to the Academic Research Consortium . Definite stent thrombosis was defined as angiographic confirmation of stent thrombosis and ≥1 of the signs present within 48 h of new onset of ischemic symptoms at rest, new ischemic electrocardiographic change suggestive of acute ischemia, or typical increase and decrease in cardiac biomarkers. Probable stent thrombosis was defined as any unexplained death within the first 30 days after intracoronary stenting. Possible stent thrombosis was defined as any unexplained death from 30 days after intracoronary stenting until the end of the follow-up period. In addition, stent thrombosis was characterized as acute (0–24 h), subacute (≥1 to <30 days), late (≥30 days to <1 year), and very late (≥1 year to <15 months).

2.4

Statistical analysis

Results are expressed as the mean value±S.D. or as proportions (%). The Student’s t test was used for parametric data when normal distribution and equal dispersion were recognized. The Mann–Whitney U and the Wilcoxon signed rank tests were used when the variance was unequal. Differences in the categorical data were analyzed by chi-square analysis, and the Fisher’s Exact test was used when appropriate. Time-to-event variables are presented as Kaplan-Meier curves, and the overall incidence was tested using the log-rank test. Cox’s proportional hazards regression was used to compute hazard ratios as estimates of relative risks (RRs) for each end point. Differences were considered to be statistically significant when the P values were less than .05.

2.1

Study population

Patients with Type 2 diabetes mellitus undergoing percutaneous coronary intervention (PCI) from January 2003 to January 2006 were included in the study. Patients were excluded if they received both BMS and DES. Patients were not excluded from the study for any other reason.

2.2

Study procedures

The study population consisted of patients in whom intracoronary stents were successfully placed after PCI at our institution. Before undergoing catheterization, 100 mg of aspirin, and 200 mg of ticlopidine or clopidogrel with a loading dose of 300 mg followed by 75 mg daily were started orally, and all patients received a 5000-U bolus of heparin intravenously in the absence of contraindications. Coronary angiography was performed. The stents were selected at operator’s discretion. In patients treated with BMS and pioglitazone, pioglitazone (30 mg once a day), a novel insulin-sensitizing agent, was started at 2 weeks after the procedure.

2.3

Study end points and definitions

Study end points were time to cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis, and all-cause mortality.

We defined diabetes mellitus according to the World Health Organization definition from 1998 . Diabetes mellitus was defined as fasting plasma glucose not less than 126 mg/dl (7.0 mmol per liter) or 2 h blood glucose not less than 200 mg/dl (11.1 mmol/l).

We defined acute myocardial infarction (AMI) according to criteria jointly recommended by the European Society of Cardiology and the American College of Cardiology . Patients were diagnosed as having an AMI if they had two values of serum troponin T greater than 0.1 ng/ml or creatine kinase-MB greater than 7 ng/ml together with either typical symptoms (chest pain >15 min; pulmonary oedema in the absence of valvular heart disease; cardiogenic shock; arrhythmia such as ventricular fibrillation or ventricular tachycardia), new Q-waves in at least two of the 12 standard electrocardiographic leads, or electrocardiogram changes indicating acute ischemia (ST elevation, ST depression, or T-wave inversion).

We defined stent thrombosis according to the Academic Research Consortium . Definite stent thrombosis was defined as angiographic confirmation of stent thrombosis and ≥1 of the signs present within 48 h of new onset of ischemic symptoms at rest, new ischemic electrocardiographic change suggestive of acute ischemia, or typical increase and decrease in cardiac biomarkers. Probable stent thrombosis was defined as any unexplained death within the first 30 days after intracoronary stenting. Possible stent thrombosis was defined as any unexplained death from 30 days after intracoronary stenting until the end of the follow-up period. In addition, stent thrombosis was characterized as acute (0–24 h), subacute (≥1 to <30 days), late (≥30 days to <1 year), and very late (≥1 year to <15 months).

2.4

Statistical analysis

Results are expressed as the mean value±S.D. or as proportions (%). The Student’s t test was used for parametric data when normal distribution and equal dispersion were recognized. The Mann–Whitney U and the Wilcoxon signed rank tests were used when the variance was unequal. Differences in the categorical data were analyzed by chi-square analysis, and the Fisher’s Exact test was used when appropriate. Time-to-event variables are presented as Kaplan-Meier curves, and the overall incidence was tested using the log-rank test. Cox’s proportional hazards regression was used to compute hazard ratios as estimates of relative risks (RRs) for each end point. Differences were considered to be statistically significant when the P values were less than .05.

3.1

Characteristics of the patients

Clinical characteristics of patients are shown in Table 1 . Sixty-three percent of patients were men, and the mean age was 66.1 years; 6.5 percent of patients were insulin-dependent. The two groups were well matched for all baseline characteristics. There were no significant differences in the various treatments in the 2 groups. At admission, fasting plasma glucose was 9.0±4.0 mmol/l, and HbA1c was 7.2±2.0 (%) in the DES group. fasting plasma glucose was 9.1±3.7 mmol/l and HbA1c was 7.5±2.1 (%) in the pioglitazone group. There were no significant differences between two groups.

3.2

Procedural characteristics

Angiographic and procedural data are summarized in Table 2 . The lesions in the two groups were treated similarly with the use of conventional techniques. Angiographic and procedural data were comparable between two groups except final balloon pressure, which was higher in the DES group than in the BMS with pioglitazone group. The target vessel was the left anterior descending coronary artery in 35.2% of the patients, the right coronary artery in 18.0%, and left circumflex artery in 46.8%. The treated lesion types according to the American College of Cardiology–American Heart Association classification were similar in the 2 groups. The number of narrowed coronary arteries is one in 41.0% of patients, two in 35.3%, and three in 23.7%.

Table 2

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