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Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis

D. Giacoppo, F. Alfonso, B. Xu, BEPM. Claessen, T. Adriaenssens, C. Jensen, MJ. Pérez-Vizcayno, DY. Kang, R. Degenhardt, L. Pleva, J. Baan, J. Cuesta, DW. Park, P. Kukla, P. Jiménez-Quevedo, M. Unverdorben, R. Gao, CK. Naber, SJ. Park, JPS....

. 2020 ; 75 (21) : 2664-2678. [pub] 20200602

Jazyk angličtina Země Spojené státy americké

Typ dokumentu srovnávací studie, časopisecké články, metaanalýza, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21012502

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.

Citace poskytuje Crossref.org

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$a Giacoppo, Daniele $u Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: giacoppo@dhm.mhn.de
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$a 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.
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$a Alfonso, Fernando $u Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain
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$a Xu, Bo $u Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
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$a Claessen, Bimmer E P M $u Mount Sinai Heart, The Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
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$a Adriaenssens, Tom $u Department of Cardiology, University Hospitals Leuven, Leuven, Belgium
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$a Jensen, Christoph $u Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany
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$a Pérez-Vizcayno, María J $u Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain
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$a Kang, Do-Yoon $u Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea
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$a Degenhardt, Ralf $u Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany
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$a Pleva, Leos $u Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic
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$a Baan, Jan $u Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands
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$a Cuesta, Javier $u Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain
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$a Park, Duk-Woo $u Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea
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$a Kukla, Pavel $u Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic
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$a Jiménez-Quevedo, Pilar $u Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain
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$a Unverdorben, Martin $u Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany; Daiichi-Sankyo, Basking Ridge, New Jersey
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$a Gao, Runlin $u Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
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$a Naber, Christoph K $u Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany
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$a Park, Seung-Jung $u Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea
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$a Henriques, José P S $u Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands
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$a Kastrati, Adnan $u Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, Munich Heart Alliance, Munich, Germany
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$a Byrne, Robert A $u 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
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