Findings Published From Diabetic Subset Analysis in the ULISSE Registry of Terumo’s Ultimate Biodegradable Stent
January 6, 2020—One-year clinical outcomes from the ULISSE registry were published by Alessandro Benedict, MD, et al in Catheterization and Cardiovascular Interventions.
The Italian all-comers registry evaluated the real‐world performance of the Ultimate biodegradable polymer sirolimus‐eluting stent (BP‐SES; Terumo Interventional Systems) in a multicenter independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients with diabetes mellitus (DM). This study is the first all‐comers evaluation of BP‐SES in DM patients, noted the investigators.
The subgroup analysis of the ULISSE registry was composed of 1,660 consecutive patients with 2,422 lesions who were treated with BP‐SES. These patients were divided into two groups: DM (485 patients, 728 lesions) and non‐DM (1,175 patients, 1,694 lesions).
As summarized in Catheterization and Cardiovascular Interventions, the primary endpoint of the analysis was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR) at 1‐year. The secondary endpoint was TLR at 1‐year.
The investigators reported the following at 1‐year follow‐up:
- TLF occurred in 5% overall patients and was significantly higher in DM patients (8% vs 3.7%; P = .001), because of more cardiac deaths (3.4% vs 1.1%; P = .002)
- TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared with non‐DM patients (4.4% vs 2.8%; P = .114)
- The incidence of stent thrombosis was low and similar between groups (0.4% vs 0.9%; P = .526)
- Patients with insulin‐treated DM showed higher rate of TLF as compared with patients without insulin‐treated DM (13% vs 6.5%; P = .041), but a similar rate of TLR (6 vs. 4%; P = .405)
- After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP‐SES implantation
The investigators stated that these findings show that DM patients, mostly those with insulin-treated DM, still represent a vulnerable population and experience a significantly higher rate of TLF. Overall BP‐SES efficacy is considerable, although a not statistically significant higher rate of TLR is still present in DM compared with non‐DM patients, concluded the investigators in Catheterization & Cardiovascular Interventions.