The novel MagicTouch sirolimus-coated balloon shows an “encouraging” safety and efficacy profile in a broad spectrum of coronary artery disease (CAD) patients, according to new data from the EASTBOURNE investigator-driven registry. The study, published online Monday and in the July 24 issue of JACC: Cardiovascular Interventions, notes that drug-coated balloons (DCBs) are increasingly used in several types of lesions and patient settings, with sirolimus having been recently added as an alternative to the well-studied paclitaxel. Indeed, the study authors, led by Bernardo Cortese, MD, from Fondazione Ricerca e Innovazione Cardiovascolare, Milan, noted that DCBs represent one of the most promising innovations in interventional cardiology, “and may represent a valid alternative to drug-eluting stents.” “More recently, newer anti-restenotic and antiproliferative drugs, including sirolimus, have been developed and tested, aimed at reducing the mid- and long-term events invariably associated with drug-eluting stents (DES) failure,” said the authors. “After some interesting preliminary results in pilot studies or small registries, the performance of a novel sirolimus-coated balloon (SCB) in a broad spectrum of CAD patients has been tested in a properly sized and all-comer prospective study.” Study details Cortese and colleagues noted that the S EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. The primary endpoint was target lesion revascularization (TLR) at 12 months, while secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR); all adverse events were censored and adjudicated by an independent clinical events committee, they added. All patients were followed up clinically, with planned visits at 6 and 12 months from the index procedure. The team reported that a total population of 2,123 patients with an average age of 66.6 years (with 2,440 lesions) were enrolled at 38 study centers in Europe and Asia. “The experience of the centers in DCB PCI was variable, with DCB use ranging between 8% to 54% of the interventions performed each year by the operators,” said the authors, adding that multivessel CAD was present in 59.3% of the patients, a previous MI in 42.9%, and a previous PCI in 66.3%; while ACS was the clinical indication for PCI in 46.6% of patients. “De novo lesions, mostly in small coronary vessels, were treated in 1,173 patients (56%), and ISR in 910 (44%): the clinical characteristics of these 2 patient populations were significantly different,” said Cortese and colleagues, adding that bailout stenting occurred in 7.7% of patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients, reported the team, adding that the all-cause death rate was 2.5%, cardiac death 1.5%, MI 2.4%, and BARC (Bleeding Academic Research Consortium) type 3 or 5 bleeding 0.7%. Overall MACE occurred in 9.9% of the patients (4.9% in the de novo group, and 14.9% in ISR; P < 0.001), reported the team. Analysis showed that the primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% confidence interval [CI]: 1.13-3.19), they said, adding that after multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (odds ratio [OR]: 5.5; 95% CI: 3.382-8.881). “It is now mandatory to confirm these findings with adequately powered studies comparing the performance of sirolimus-coated balloons with current era drug-eluting stents in a randomized fashion,” said the authors. Back to the future? Writing in an accompanying editorial, Manel Sabaté, MD, PhD, from the Cardiovascular Institute, Hospital Clinic, Barcelona, Spain, noted that DCBs have emerged to overcome the need of permanent metal caging – by allowing further vessel enlargement and potential return of the physiological vasomotion. “The concept of ‘leaving nothing behind’ is very appealing for the treatment of de novo coronary lesions specifically in contexts such as diffuse coronary artery disease, treatment of side branches or high bleeding risk patients,” wrote the editorialist. He noted that DCB devices are not intended to be used to prepare the lesion; rather, they are to be applied after proper and uncomplicated vessel preparation. “Here, we can apply an aphorism from George Santayana: Those who cannot remember the past are condemned to repeat it,” said Sabaté, noting that abrupt vessel closure after plain old balloon angioplasty “was the main challenge in the early days, which was controlled by the implantation of a stent.” “If going back to the essentials is the way to progress to the future, we should refine the protocol for vessel preparation and define criteria for when to safely deliver a DCB or when to implant a stent as bailout,” suggested the expert commentator. “We are entering a fascinating new era in which old concepts will be reassessed and refined to the benefit of patients with coronary artery disease requiring revascularization,” he concluded. “Understanding the past will surely help create the future of this technique.” Sources: Cortese B, Testa L, Heang TM, et al. Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry. JACC Cardiovasc Interv 2023;16:1794-1803. Sabaté M. Drug-Coated Balloon for De Novo Lesions: Back to the Past or Back to the Future? JACC Cardiovasc Interv 2023;16:1804-1806. Image Credit: Pitchy – stock.adobe.com