Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population

Abstract

BackgroundThe place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS).ObjectiveCompare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS.MethodsA retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank.ResultsThe cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06).ConclusionIn a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

Comparative outcomes of MACE after Drug eluting balloon Vs. Drug Eluting Stent in treatment of in-stent restenosis (ISR) patients presented with acute coronary syndrome.

“…Regardless of the increasing use of newer generation DES, DES-ISR still manifests in 5-10% of patients following DES deployment 11,12 , and it has now become a prevalent therapeutic problem 13,14 . Additionally, DES-ISR therapy is linked to poorer long-term results when compared to BMS ISR; recent data indicate that 10 to 20% of these individuals will go on to get recurrent ISR after many stentings 15,16 . DEB angioplasty is a novel therapeutic approach for BMS-ISR and DES-ISR; studies have shown that it is 51.43 linked with better results when compared to other traditional treatment techniques 16,17 .…”

A Multilayer Functionalized Drug-Eluting Balloon for Treatment of Coronary Artery Disease

“…Due to the short drug treatment time, it is required for fast detachment from the balloon and higher efficient drug delivery to the tissue. Paclitaxel, the 1st-generation drug to treat vascular diseases, can inhibit the proliferation of SMCs with short time treatment [ 39 , 40 ]. However, treatment with alternative drugs has been introduced due to various problems, including the delayed reendothelialization and vascular healing after paclitaxel administrations with randomized inhibition of both endothelial cells (ECs) [ 41 , 42 ].…”