Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry

Abstract

Background The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. Aims To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). Methods We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2–5 bleedings. Results Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91–2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95–3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92–1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09–4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. Conclusions In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

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

“…To mitigate these risks, meticulous attention is paid to the selection of stent types, antiplatelet therapy, and procedural techniques. Drug-eluting stents (DES) are preferred over bare-metal stents (BMS) due to their superior efficacy in reducing restenosis rates [ 6 , 7 , 8 ]. Moreover, the duration of dual antiplatelet therapy (DAPT) may be extended in DM patients to minimize the risk of stent thrombosis, or more potent antiplatelet drugs might be used, such as ticagrelor [ 9 ].…”

“…Furthermore, managing DM patients undergoing PCI involves a multidisciplinary approach, with close collaboration between cardiologists, endocrinologists, and other healthcare providers [ 10 ]. Optimal glycemic control, along with aggressive management of other cardiovascular risk factors such as hypertension and dyslipidemia, plays a crucial role in improving outcomes post-PCI [ 6 , 11 ]. Additionally, careful patient selection, thorough pre-procedural evaluation, and personalized treatment plans are essential for optimizing PCI outcomes and reducing the risk of complications in DM patients with CAD [ 12 ].…”