BACKGROUND: In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). OBJECTIVES: This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR. METHODS: The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. RESULTS: A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. CONCLUSIONS: At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.

Department of Cardiology Academic Medical Centre University of Amsterdam Amsterdam the Netherlands

Department of Cardiology Asan Medical Center University of Ulsan Seoul South Korea

Department of Cardiology Contilia Heart and Vascular Center Elisabeth Krankenhaus Essen Germany

Department of Cardiology Deutsches Herzzentrum München Technische Universität München Munich Germany

Department of Cardiology Deutsches Herzzentrum München Technische Universität München Munich Germany; Dublin Cardiovascular Research Institute Mater Private Hospital Dublin Ireland; School of Pharmacy and Biomolecular Sciences Royal College of Surgeons in Ireland Dublin Ireland

Department of Cardiology Deutsches Herzzentrum München Technische Universität München Munich Germany; German Centre for Cardiovascular Research Munich Heart Alliance Munich Germany

Department of Cardiology Fu Wai Hospital National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences Beijing China

Department of Cardiology Herz und Kreislaufzentrum Rotenburg an der Fulda Germany

Department of Cardiology Herz und Kreislaufzentrum Rotenburg an der Fulda Germany; Daiichi Sankyo Basking Ridge New Jersey

Department of Cardiology Hospital Clinico San Carlos Madrid Spain

Department of Cardiology Hospital Universitario de La Princesa Madrid Madrid Spain

Department of Cardiology University Hospital Ostrava Ostrava Czech Republic

Department of Cardiology University Hospitals Leuven Leuven Belgium

Mount Sinai Heart The Zena and Michael Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York New York

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