Percutaneous Coronary Interventions with Sirolimus-Eluting Alex Plus Stents in Patients with or without Diabetes: 4-Year Results

TL;DR

A study evaluated a new heart stent in diabetic and non-diabetic patients over four years, finding it effective and safe for diabetics.

Contribution

The study provides 4-year real-world data on a sirolimus-eluting stent's performance in diabetic patients.

Findings

Diabetic patients had higher rates of MACE, cardiac death, and MI compared to non-diabetic patients.

The Alex Plus stent showed efficiency and safety in diabetic patients undergoing heart procedures.

TLR rates did not differ significantly between diabetic and non-diabetic patients.

Abstract

We characterized the performance, as well as the safety, of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), implanted in patients with type 2 diabetes (DM) with a 4-year follow-up. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12, 24, 36, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 97 DM and 135 non-DM patients. The mean age of the DM patients was 69.5 ± 10.1 years and females accounted for 30% of the patients. DM patients had higher rates of arterial hypertension (97% vs. 88%, p = 0.016), dyslipidemia (86% vs. 70%, p = 0.005), prior MI (61% vs. 40%, p = 0.002), prior PCI (65% vs. 50%, p = 0.020), and prior CABG (14% vs. 5.9%, p = 0.029). We recorded statistically significant differences for MACE (HR 1.85, 95% CI 1.01–3.41, p = 0.046), cardiac death (HR 4.46, 95% CI 1.44–13.8, p = 0.010), and MI (HR 3.17, 95% CI 1.10–9.12, p = 0.033), but not for TLR, between DM and non-DM patients in terms of the analyzed endpoints at 4 years. Our study showed that Alex Plus was efficient and safe in a contemporary cohort of real-world DM patients undergoing percutaneous revascularization.

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