Author + information
- Received June 6, 2019
- Revision received November 10, 2019
- Accepted November 20, 2019
- Published online April 6, 2020.
- Jaya Chandrasekhar, MBBS, MSa,b,∗,
- Marlies M. Kok, MD, PhDc,∗,
- Deborah N. Kalkman, MD, PhDa,b,∗,
- Melissa B. Aquino, MSa,
- Paolo Zocca, MDc,
- Pier Woudstra, MDb,
- Marcel A. Beijk, MD, PhDb,
- Laura S. Kerkmeijer, MDb,
- Samantha Sartori, PhDa,
- Usman Baber, MD, MSa,
- Jan G. Tijssen, PhDb,
- Karel T. Koch, MD, PhDb,
- George D. Dangas, MD, PhDa,
- Antonio Colombo, MDd,
- Stuart Pocock, PhDe,
- Clemens von Birgelen, MD, PhDc,†,
- Roxana Mehran, MDa,†∗ (, )
- Robbert J. de Winter, MD, PhDb,†,
- on behalf of the COMBO Collaborators and BIO-RESORT Investigators
- aIcahn School of Medicine at Mount Sinai Hospital, New York, New York
- bAmsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands
- cThoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- dSan Raffaele Hospital, Milan, Italy
- eLondon School of Hygiene and Tropical Medicine, London, United Kingdom
- ↵∗Address for correspondence:
Prof. Roxana Mehran, Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.
Background The COMBO stainless-steel stent has an anti-CD34+ antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.
Methods For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score–matched analysis.
Results At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score–matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).
Conclusions A propensity score–matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT–Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002)
- anti-CD34+ antibody coating
- COMBO dual-therapy stent
- endothelial progenitor cell capture
- percutaneous coronary intervention
- ultrathin-strut Orsiro stent
↵∗ Drs. Chandrasekhar, Kok, and Kalkman contributed equally to this work.
↵† Drs. von Birgelen, Mehran, and de Winter contributed equally to this work.
The Amsterdam UMC, Academic Medical Center, University of Amsterdam received an unrestricted research grant from OrbusNeich Medical (Hoevelaken, the Netherlands). OrbusNeich Medical (Fort Lauderdale, Florida) was the sponsor of the MASCOT registry. The BIO-RESORT trial was funded by Biotronik, Boston Scientific, and Medtronic. Dr. Dangas has received research support from Abbott Vascular and Boston Scientific; he is a consultant for Biosensors; his spouse is on the advisory board of Abbott Vascular and Boston Scientific; and he has common stock entirely divested in Medtronic. Dr. Mehran has received research grant support to her institution from Eli Lilly/Daiichi-Sankyo, AstraZeneca, The Medicines Company, Bristol-Myers Squibb, and OrbusNeich; and has received consulting fees from Janssen Pharmaceuticals Inc., Medscape, Osprey Medical Inc., and Watermark Research Partners. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 6, 2019.
- Revision received November 10, 2019.
- Accepted November 20, 2019.
- 2020 American College of Cardiology Foundation
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