Comparison of 7-Year, Real World Clinical Outcomes Between Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients with Drug-Eluting Stent In-stent Restenosis

There are no data comparing the real-world, long-term clinical outcomes of drug-eluting balloon (DEB) angioplasty and drug-eluting stent (DES) implantation in DES-in-stent restenosis (ISR) lesions. We aimed to compare the real-world, long-term data between DEB and DES in DES-ISR lesions. We analyzed consecutive DES-ISR lesions (225 lesions from 205 patients; male: 66.3%; mean age: 62.4 years) treated with DEB or DES. The primary endpoint was target lesion revascularization (TLR) and the primary safety endpoint was the lesion-oriented composite outcome (LOCO). LOCO is composed of cardiac death, myocardial infarction, or target lesion thrombosis during follow-up. During the 7-year follow-up period, TLR did not differ significantly between DEB (n=108) and DES (n=117) (hazard ratio, 1.07; 95% CI 0.59–1.93, P=0.83). LOCO was significantly lower in the DEB group than in the DES group (hazard ratio, 0.40; 95% CI 0.16–0.98, P=0.04), which was mainly driven by less myocardial infarction (HR 0.24, 95% CI, 0.06–0.94, P=0.04) and absence of target lesion thrombosis in the DEB group (vs. DES group 6%, P=0.02). Additionally, cardiac death was similar between DEB and DES groups (HR 0.56, 95% CI 0.18–1.75, P=0.32).DEB angioplasty showed favorable safety with similar efficacy to that of DES implantation in DES-ISR lesionsduring the long-term follow-up period.