Real-World Treatment of In-Stent Restenosis: The Return of the Balloon

Since the inception of balloon angioplasty in the late 1970s to treat coronary artery stenoses in patients with atherosclerotic diseases, the tendency of the stenosis to recur (ie, restenosis) has been the Achilles heel of the technology. In the era of "plain old balloon angioplasty" procedures, the restenosis process was partly caused by acute arterial recoil after angioplasty. Therefore, the advent of metallic stents to prevent this acute recoil resulted in a reduction of restenosis, although angiographic and clinical restenosis rates were still high. 1 Serruys P.W. de Jaegere P. Kiemeneij F. et al. Benestent Study GroupA comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994; 331: 489-495 Crossref PubMed Scopus (4445) Google Scholar Bare-metal stents (BMS) are themselves often associated with restenosis, which in that case is largely the result of neointimal hyperplasia due to the proliferation of vascular smooth muscle cells and the deposition of extracellular matrix components. Restenosis within stents (in-stent restenosis [ISR]) is a difficult problem to tackle, because simple reballooning of the lesion with balloon angioplasty is associated with high rates of failure and target lesion revascularisation (TLR). 2 Alfonso F. Coughlan J.J. Giacoppo D. Kastrati A. Byrne R.A. Management of in-stent restenosis. EuroIntervention. 2022; 18: e103-e123 Crossref PubMed Scopus (34) Google Scholar Therefore, neointimal hyperplasia within BMS was often addressed initially with the use of more complex procedures, such as brachytherapy. The development of drug-eluting stents (DES), combining metal stent scaffolding with drugs inhibiting cellular proliferation and neointimal hyperplasia, led to significant reduction in the rates of angiographic and clinical restenosis. Moreover, DES showed superiority over both balloon angioplasty 3 Alfonso F. Perez-Vizcayno M.J. Hernandez R. et al. A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006; 47: 2152-2160 Crossref PubMed Scopus (159) Google Scholar and brachytherapy 4 Holmes D.R. Jr Teirstein P. Satler L. et al. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006; 295: 1264-1273 Crossref PubMed Scopus (253) Google Scholar for ISR, therefore becoming the criterion standard for ISR treatment. Although DES have significantly reduced the rates of ISR and TLR, interventional cardiologists nowadays embark in procedures that are increasingly complex, including diffuse disease, calcifications, small vessels, bifurcations, and chronic total occlusions. Consequently, even with new-generation DES, the rate of ISR at 1 year can still be as high as 20%, depending on patient characteristics and lesion complexity. 5 Condello F. Spaccarotella C. Sorrentino S. et al. Stent thrombosis and restenosis with contemporary drug-eluting stents: predictors and current evidence. J Clin Med. 2023; 12: 1238 Crossref PubMed Scopus (16) Google Scholar Moreover, the fact that a given patient can present with repeated ISR episodes, leading to multiple layers of stent struts within the artery, could make the treatment of ISR with another DES less appealing. In this context, the emergence of drug-eluting balloons (DEBs) offers a promising alternative to DES, as the antiproliferative drug is delivered via the balloon with no need for a permanent metal scaffold. Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical ExperienceCanadian Journal of CardiologyPreviewThe use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. Full-Text PDF