Diabetes mellitus and 10-year clinical outcomes after percutaneous coronary intervention with drug-eluting stents: insights from the DECADE cooperation

Abstract Background Diabetes mellitus (DM) is a well-established risk factor for adverse cardiovascular outcomes after percutaneous coronary intervention (PCI). However, research assessing the magnitude and the timing of clinical events over the long term in patients with DM undergoing PCI with a drug-eluting stent (DES) is limited. Methods The data of patients treated with DES in five randomized controlled trials with available 10-year follow-up were pooled. Patients were grouped according their DM diagnosis at baseline. The primary endpoint was all-cause death. The secondary endpoints were cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), target lesion revascularization (TLR), target vessel revascularization (TVR) and non-target vessel revascularization (nTVR). All-cause death was estimated using the Kaplan–Meier method, whereas cumulative incidence functions accounting for the competing risk of death were calculated for secondary endpoints. Associations were evaluated using both cause-specific Cox regression, yielding cause-specific hazard ratios (HRs), and Fine-Gray regression, yielding subdistribution hazard ratios (sHRs). Multivariable analyses with adjustment for relevant variables and subgroup analyses were performed. Results Among 9,699 patients, 2,298 had DM at baseline. Compared with patients without DM, patients with DM had a higher risk of all-cause death (adjusted hazard ratio [HR adj ] 1.68 [95% confidence interval 1.59–1.78]) and cardiovascular death (HR adj 1.74 [1.63–1.87]) up to 10 years. The risks of definite ST (HR adj 1.55 [1.18–2.04]), TLR (HR adj 1.35 [1.21–1.51]), TVR (HR adj 1.28 [1.14–1.43]), and nTVR (HR adj 1.23 [1.09–1.40]) were significantly increased in patients with DM. Landmark analyses showed endpoint-specific temporal patterns: the excess MI risk was predominantly observed within the first month, whereas the excess definite ST risk was detected between 30 days and 1 year. Notably, the association between DM at baseline and clinical outcomes varied across subgroups defined by age, sex, clinical presentation, and DES-generation (all P interaction <0.001). Insulin-treated patients represent the higher risk phenotype. Conclusions DM was associated with distinct temporal patterns of adverse outcomes after PCI with DES, with an early associations with MI and definite ST, as well as an increased risk of death and repeat revascularisation in the longer term. These findings further emphasize the need for intensified secondary prevention and provide a long-term benchmark against which novel management strategies should be evaluated in patients with DM undergoing PCI.