Impact of Diabetes on 10-Year Outcomes of Patients With Multivessel Coronary Artery Disease in the Medicine, Angioplasty, or Surgery Study II (MASS II) Trial

Eduardo Gomes Lima, MD; Whady Hueb, MD, PhD; Rosa Maria Rahmi Garcia,MD, PhD; Alexandre Costa Pereira,MD, PhD; Paulo Rogério Soares, MD, PhD; Desiderio Favarato, MD, PhD; Cibele Larrosa Garzillo, MD, PhD; Ricardo D'Oliveira Vieira, MD; Paulo Cury Rezende, MD; Myrthes Takiuti, RN, PhD; Priscyla Girardi, RN, PhD; Alexandre Ciappina Hueb, MD, PhD; José A. F. Ramires, MD, PhD; Roberto Kalil Filho,MD, PhD

Disclosures

Am Heart J. 2013;166(2):250-257. 

In This Article

Results

Baseline Characteristics

From the total population of 611 patients, 232 were diabetic subjects (88 in MT, 64 in PCI, and 80 in CABG groups), and 379 patients were non-diabetic subjects (115 in MT, 141 in PCI, and 123 in CABG groups).

Baseline characteristics are shown in Table I. They were similar among patients randomized to medical treatment, angioplasty, or surgery within the diabetic and non-diabetic subgroups, except by a higher prevalence of hypertension among diabetic subjects compared with non-diabetic subjects (P = .004). There was a lower prevalence of smokers among diabetic patients in the PCI group but with no statistical significance (P = .08). No statistically significant difference occurred in relation to age, sex, previous myocardial infarction, and body mass index. Regarding laboratory tests, triglycerides and fasting plasma glucose levels were higher in diabetic subjects compared with non-diabetic subjects, as expected (P < .001 for both comparisons). However, non-diabetic groups had higher levels of low-density lipoprotein (LDL) cholesterol than diabetic groups had (P = .01). No difference existed between groups in relation to total and high-density lipoprotein (HDL) cholesterol or left ventricular ejection fraction (LVEF). We observed no differences among groups with respect to the presence of 3-vessel disease (P = .72) and involvement of the left anterior descending artery. No difference was seen regarding the percentage of patients treated with stents (P = .81) and the number of treated vessels (P = .36) in the PCI group comparing diabetic versus non-diabetic patients. In addition, in the CABG group, the percentage of patients that received a left internal mammary artery (LIMA) and/or right internal mammary artery[16] (P = .71) and the number of vessels treated (P = .47) were not different in diabetic versus non-diabetic groups. However, the difference is significant between the number of stents per patient versus grafts per patients in PCI and CABG groups, respectively (P < .001 for diabetic and non-diabetic patients).

Medication Usage and Laboratory Findings in Follow-up

Medication usage at last follow-up visit is shown in Table II. Patients received the same prescription except among diabetic subjects (P = .005) use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) was greater, and nitrates were used more often among non-diabetic patients (P = .006). Specifically in patients with diabetes, we observed a less frequent use of ACE inhibitors or ARB among patients in the CABG group (P = .035). In addition, nitrates were used less by patients in the non-diabetic PCI group (P = .001). There were no differences among insulin or oral anti-diabetic drug use among diabetic treatment groups.

Cholesterol levels and glycemic control at last follow-up visit are shown in Table III. Fasting glucose and hemoglobin A1c levels among diabetic subjects were higher compared to non-diabetic group levels. In addition, diabetic patients had lower levels of total and LDL cholesterol compared to non-diabetic patients. Among diabetic subjects, the PCI group had higher levels of HDL cholesterol.

Clinical Outcomes

The average follow-up was 11.4 years for patients still alive (range from 9 to 15 years). All patients received medical regimens according to a predefined approach. No patient was lost to follow-up in any of the 3 regimen groups.

In this follow-up, 75 deaths occurred in diabetic group and 88 in non-diabetic group with 10-year rates of 32.3% and 23.2% respectively (P = .024) (Figure 1). Regarding cardiac mortality, 45 deaths due to cardiac causes occurred in diabetics and 48 in non-diabetics with 10-year cardiac mortality rates of 19.4% and 12.7%, respectively (P = .031) (Figure 2).

Figure 1.

Survival free of overall death in 10-year follow-up of 611 patients from the MASS II-trial according to diabetes status. DM indicates diabetes mellitus.

Figure 2.

Survival free of cardiac death in 10-year follow-up of 611 patients from the MASS II-trial according to diabetes status. DM indicates diabetes mellitus.

Considering only diabetic patients and stratifying this population by treatment option, we found that 20 patients died in PCI group, 22 in CABG group, and 33 in MT group. Mortality rates were 31.3% for PCI, 27.5% for CABG and 37.5% for MT (P = .180 for PCI vs CABG; P = .350 for PCI vs MT; and P = .015 for CABG vs MT) (Figure 3 and Table IV). In relation to cardiac mortality, 12 cardiac deaths occurred in PCI group, 10 in CABG group and 23 in MT group, with cardiac mortality rates of 18.8%, 12.5% and 26.1% respectively (P = .119 for PCI vs CABG; P = .413 for PCI vs MT; and P = .005 for CABG vs MT) (Figure 4 and Table IV).

Figure 3.

Survival free of overall death in 10-year follow-up of 232 diabetic patients from the MASS II-trial according to treatment.

Figure 4.

Survival free of cardiac death in 10-year follow-up of 232 diabetic patients from the MASS II-trial according to treatment.

In diabetic subjects, an additional intervention in follow-up was necessary in 27.2% of patients in the MT group, 20.3% in the PCI (P = .35 for PCI vs MT) and 5% in the CABG group (P < .001 for CABG vs MT and P = .002 for CABG vs PCI).

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