Key result
Known diabetes is linked to ~99% higher all-cause mortality, with no difference between stent types.
Why the study?
Mortality differences and treatment heterogeneity between known diabetes, new diabetes, and non-diabetic patients with coronary disease undergoing PCI were not fully characterized.
Does known or newly diagnosed diabetes increase mortality in patients with coronary disease undergoing percutaneous coronary intervention?
RCT (n=5,512)
Drug-eluting stents (DES) or bare-metal stents (BMS)
Does known or newly diagnosed diabetes increase mortality in patients with coronary disease undergoing percutaneous coronary intervention?
Hazard Ratio: 1.99 (95% CI 1.51–2.62)
p-value: p=<0.001
Known diabetes is associated with increased cardiac and noncardiac mortality after PCI, whereas newly diagnosed diabetes at the time of PCI is primarily associated with increased noncardiac mortality over 5 years.
Subgroup findings on diabetes, mortality, and stent type are hypothesis-generating; leaves open differential effects in broader populations.
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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Mølstad et al. (2021) conducted an RCT in Coronary disease (n=5,512). Known diabetes vs. Without diabetes was evaluated on All-cause mortality (HR 1.99, 95% CI 1.51-2.62, p=<0.001). Known diabetes was associated with significantly increased all-cause mortality compared to no diabetes (HR 1.99; 95% CI 1.51-2.62; p<0.001), with no mortality difference between DES and BMS.
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