Patients with diabetes have worse angiographic and clinical outcomes after percutaneous coronary intervention (PCI) compared with patients without diabetes, even with the use of contemporary stents, according to study results published in JACC: Cardiovascular Interventions.
The BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis (N = 1919) trial was a comparative analysis of ridaforolimus-eluting stents and zotarolimus-eluting stents among a study population undergoing PCI. In a prespecified analysis, study researchers investigated the effect of medically-treated diabetes on outcomes following revascularization with contemporary drug-eluting stents in PCI. Target lesion failure at 12 months was the primary study outcome, defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization. Clinical safety and efficacy were secondary outcomes. The study population was composed of participants with medically-treated diabetes (n = 559) and without medically-treated diabetes (n = 1360).
The clinical characteristics at baseline showed individuals with diabetes had higher body mass index, prior revascularization, and were more prone to hyperlipidemia and hypertension. Compared with patients without diabetes, study outcomes indicated that target lesion failure was higher in patients with diabetes at the 1-year (7.8% vs 4.2%; P =.002) and 2-year (11.3% vs 5.8%; P <.0001) follow-up; major adverse cardiac events and target vessel failure were also higher. No differences in death or MI incidence were observed between groups. Demarcation of the diabetes group into patients treated with insulin (32.4%) and patients treated with a noninsulin diabetes medication (67.6%) showed that the insulin-treated group had higher frequencies of target lesion failure, major adverse cardiac events, stent thrombosis, and target vessel revascularization at 1 year. There was a noticeable trend in the insulin-treated cohort experiencing more MI events and mortality. At 2 years, there were significant differences noted in target lesion failure rates between noninsulin-treated (9.8%) and individuals without diabetes (5.8%; P =.007).
Angiographic follow-up showed that among individuals with diabetes, in-stent binary restenosis (≥50% of lumen diameter) rates were 3 times greater than restenosis rates for individuals without diabetes (15.2% vs 4.7%; P =.01). The researchers noted no differences in the performance of ridaforolimus-eluting stents vs zotarolimus-eluting stents regardless of diabetes status. They also noted that diabetes, prior coronary artery bypass grafting, complex lesions, and age were independent predictors of target lesion failure at 1 year.
Study limitations included the lack of power in the diabetes subcohort analysis and routine angiographic follow-up for most of the study population. In addition, the comparative analysis between ridaforolimus-eluting stents and zotarolimus-eluting stents limited generalizability to other new-generation stents.
The researchers concluded that “modern [drug-eluting stents] still fail more frequently among patients with versus without [diabetes] and among insulin-treated versus noninsulin-treated [patients with diabetes]… The study highlights the need for drug-eluting stents with even more potent anti-restenosis efficacy to be used among [patients with diabetes].”
Multiple authors declared affiliations with the pharmaceutical industry. Please refer to original reference for a full list of authors’ disclosures.
Konigstein M, Ben-Yehuda O, Smits PC, et al. Outcomes among diabetic patients undergoing percutaneous coronary intervention with contemporary drug-eluting stents: analysis from the BIONICS randomized trial. J Am Coll Cardiol Intv. 2018;11(24):2467-2476.