Daniele Giacoppo1, Fernando Alfonso2, Bo Xu3, Bimmer E P M Claessen4, Tom Adriaenssens5, Christoph Jensen6, María J Pérez-Vizcayno7, Do-Yoon Kang8, Ralf Degenhardt9, Leos Pleva10, Jan Baan11, Javier Cuesta2, Duk-Woo Park8, Pavel Kukla10, Pilar Jiménez-Quevedo7, Martin Unverdorben12, Runlin Gao3, Christoph K Naber6, Seung-Jung Park8, José P S Henriques11, Adnan Kastrati13, Robert A Byrne14. 1. Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: giacoppo@dhm.mhn.de. 2. Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain. 3. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. 4. Mount Sinai Heart, The Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 5. Department of Cardiology, University Hospitals Leuven, Leuven, Belgium. 6. Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany. 7. Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. 8. Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea. 9. Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany. 10. Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic. 11. Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands. 12. Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany; Daiichi-Sankyo, Basking Ridge, New Jersey. 13. Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, Munich Heart Alliance, Munich, Germany. 14. 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.
Abstract
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.
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.
Authors: Mehdi Madanchi; Giacomo Maria Cioffi; Adrian Attinger-Toller; Mathias Wolfrum; Federico Moccetti; Thomas Seiler; Luca Vercelli; Philipp Burkart; Stefan Toggweiler; Richard Kobza; Matthias Bossard; Florim Cuculi Journal: Open Heart Date: 2021-09