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Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT
Per Mølstad1, Jan Erik Nordrehaug2, Terje Steigen3
1Department of Cardiology, LHL Clinics Gardermoen, Jessheim, Norway, moelsta@online.no.
Insights
Known diabetes significantly increases mortality risk, while new diabetes is linked to higher noncardiac mortality. Both diabetic and nondiabetic patients respond similarly to drug-eluting stents versus bare-metal stents.
Area of Science:
- Cardiology
- Endocrinology
- Clinical Trials
Background:
- The NORSTENT trial randomized 9,013 patients to drug-eluting stents (DES) or bare-metal stents (BMS).
- A subgroup of 5,512 patients had glucose or HbA1c levels measured at the time of the procedure.
- This study analyzed mortality and treatment response in diabetic versus nondiabetic subgroups.
Purpose of the Study:
- To evaluate the impact of diabetes on mortality after percutaneous coronary intervention.
- To assess treatment heterogeneity between drug-eluting stents and bare-metal stents in diabetic and nondiabetic patients.
Main Methods:
- Analysis of a cohort from the NORSTENT trial, including patients with known diabetes, new diabetes, and no diabetes.
- 5-year follow-up to assess all-cause, cardiac, and noncardiac mortality.
- Statistical adjustment for baseline variables and analysis of treatment effect heterogeneity.
Main Results:
- Patients with known diabetes had significantly increased all-cause, cardiac, and noncardiac mortality.
- Patients with new diabetes showed marginally increased all-cause and significantly increased noncardiac mortality, but no increase in cardiac mortality.
- Noncardiac mortality became the dominant cause of death after the first 1-2 years post-intervention, with varying timelines between groups.
Conclusions:
- Known diabetes is associated with increased cardiac and noncardiac mortality.
- New diabetes is primarily linked to increased noncardiac mortality over a 5-year follow-up.
- Diabetic and nondiabetic patients demonstrated similar responses to both BMS and DES treatments, indicating no treatment heterogeneity.
Background:
NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention with drug-eluting stents (DES) or bare-metal stents (BMS) with a 5-year follow-up. Among the patients, 5,512 had measured either fasting glucose level or percent glycated hemoglobin (HbA1c) at the index procedure. That cohort constitutes the present study population analyzing mortality and evaluating treatment heterogeneity of randomized stent in diabetic versus nondiabetic subgroups.
Results:
The cohort consisted of 4,174 (75.7%) patients without diabetes, 716 (13.0%) with known diabetes, and 622 (11.3%) with no diabetes in history but elevated fasting glucose level >7.0 mmol/L or HbA1c >6.5% and therefore defined as new diabetes. Patients with known diabetes had a significantly increased all-cause (hazard ratio [HR] 1.99, 95% CI 1.51-2.62, p < 0.001), cardiac (subhazard ratio [SHR] 2.47, 95% CI 1.55-3.93, p < 0.001), and noncardiac (SHR 1.74, 95% CI 1.23-2.44, p = 0.002) mortality after adjustment for baseline variables. In the follow-up of 5 years, patients with new diabetes, however, had a marginally increased all-cause (HR 1.40, 95% CI 1.01-1.93, p = 0.043) and significantly increased noncardiac mortality (SHR 1.52, 95% CI 1.06-2.20, p = 0.025), but no increase in cardiac mortality (SHR 1.06, 95% CI 0.53-2.12, p = 0.86) after the same adjustment. The majority of the mortality was cardiac in the first 1-2 years after intervention; thereafter, noncardiac mortality dominated. However, the time period for when noncardiac mortality became the dominating cause varied considerably and significantly between the groups. There was no heterogeneity in mortality in response to randomized stent between diabetics and nondiabetics.
Conclusion:
Known diabetes has increased cardiac and noncardiac mortality in contrast to new diabetes which is only associated with increased noncardiac mortality during the 5-year follow-up. Diabetic and nondiabetic patients have the same response to the treatment with BMS or DES.
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