Diabetes mellitus and 10-year outcomes after percutaneous coronary intervention with drug eluting stents: insights from the DECADE cooperation
M Immobile Molaro, F Simonetti, T Lenz, L Ortega Paz, L Raber, L Okkels Jensen, M Maeng, S Brugaletta, K L Laugwitz, D Heg, M Sabate, S Windecker, K K W Olesen, A Kastrati, S CasseseAbstract
Background
Diabetes is a significant predictor of adverse cardiovascular events following percutaneous coronary intervention (PCI). However, comprehensive data on very long-term outcomes in the era of drug-eluting stents (DES) is still limited.
Purpose
To assess the impact of diabetes on clinical outcomes after PCI with DES over a 10-year period, using individual patient-level data from randomised controlled trials (RCTs).
Methods
We pooled individual patient data from five RCTs with a 10-year follow-up. Patients were divided into two groups according to their diabetic status at baseline. The primary endpoint was all-cause mortality. The secondary endpoints were cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), target lesion revascularisation (TLR), target vessel revascularisation (TVR) and non-target vessel revascularisation (nTVR).
Results
Of the 9,699 patients, 2,298 (31%) had diabetes mellitus at baseline. Over a period of up to 10 years, diabetic patients were found to be at a higher risk than nondiabetic patients regarding all-cause death (41.3% vs. 26.4%; HRadj:1.67 [95% CI, 1.59–1.77]); cardiovascular death, (23.5% vs. 12.9%; HRadj: 1.74 [1.61–1.87]); MI (HRadj: 1.29 [0.92 - 1.80]); definite ST (HRadj: 1.44 [1.11 – 2.14]); TLR (HRadj: 1.35 [1.21 – 1.51]); TVR (HRadj: 1.28 [1.14 – 1.43]) and nTVR (HRadj:1.23 [1.09 – 1.40]). Statistically significant interactions were found for most outcomes between diabetes and age (a stronger impact of diabetes in patients under 75 years old), sex (a stronger impact of diabetes in women), clinical presentation (a stronger impact of diabetes in patients with acute coronary syndromes) and type of DES (a stronger impact of diabetes in patients receiving second-generation DES).
Conclusions
Having diabetes independently increases the risk of adverse events after DES implantation. Interestingly, however, the impact of diabetes varies depending on patient characteristics and the type of PCI performed.Ten-Year Cumulative Incidence