Clinical impact of diabetes mellitus on 2-year clinical outcomes following PCI with second-generation drug-eluting stents; Landmark analysis findings from patient registry: Pooled analysis of the Korean multicenter drug-eluting stent registry.

BACKGROUND

Patients with diabetes mellitus are at an increased risk for adverse clinical events following percutaneous coronary interventions (PCI). However, the clinical impact of diabetes mellitus (DM) on second-generation drug-eluting stent (DES) implantation is not well-known. The aim of the current analysis was to examine the clinical impact of DM on clinical outcomes and the time sequence of associated risks in patients treated with second-generation DES.

METHODS

Using patient-level data from two stent-specific, all-comer, prospective DES registries, we evaluated 1,913 patients who underwent PCI with second-generation DES between Feb 2009 and Dec 2013. The primary outcomes assessed were two-year major cardiac adverse events (MACE), composite endpoints of death from any cause, myocardial infarction (MI), and any repeat revascularization. We classified 0-1 year as the early period and 1-2 years as the late period. Landmark analyses were performed according to diabetes mellitus status.

RESULTS

There were 1,913 patients with 2,614 lesions included in the pooled dataset. The median duration of clinical follow-up in the overall population was 2.0 years (interquartile range 1.9-2.1). Patients with DM had more cardiovascular risk factors than patients without DM. In multivariate analyses, the presence of DM and renal failure were strong predictors of MACE and target-vessel revascularization (TVR). After inverse probability of treatment weighting (IPTW) analyses, patients with DM had significantly increased rates of 2-year MACE (HR 2.07, 95% CI; 1.50-2.86; P <0.001). In landmark analyses, patients with DM had significantly higher rates of MACE in the early period (0-1 year) (HR 3.04, 95% CI; 1.97-4.68; P < 0.001) after IPTW adjustment, but these findings or trends were not observed in the late period (1-2 year) (HR 1.24, 95% CI; 0.74-2.07; P = 0.41).

CONCLUSIONS

In the second-generation DES era, the clinical impact of DM significantly increased the 2-year event rate of MACE, mainly caused by clinical events in the early period (0-1 year). Careful observation of patients with DM is advised in the early period following PCI with second-generation DES.