1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration

Chandrasekhar J 1 , Zeebregts D 2 , Kalkman DN 2 , Sartori S 3 , Roumeliotis A 3 , Aquino MB 3 Show all authors , de Wilde P 2 , de Winter VC 2 , Baber U 3 , Woudstra P 2 , Beijk MA 2 , Hájek P 4 , Atzev B 5 , Hudec M 6 , Ong TK 7 , Mates M 8 , Borisov B 9 , Warda HM 10 , den Heijer P 11 , Wojcik J 12 , Iniguez A 13 , Lee M 14 , Tijssen JG 2 , Koch KT 2 , Dangas GD 3 , Colombo A 15 , Mehran R 16 , de Winter RJ 2 , MASCOT and REMEDEE Investigators

Affiliations 

  • 1 Icahn School of Medicine at Mount Sinai, New York, USA; Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands
  • 2 Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands
  • 3 Icahn School of Medicine at Mount Sinai, New York, USA
  • 4 Motol University Hospital, Prague, Czech Republic
  • 5 University Hospital St. Ekaterina, Sofia, Bulgaria
  • 6 SUSCCH, a.s. Banska Bystrica, Banska Bystrica, Slovakia
  • 7 Sarawak Heart Centre, Sarawak, Malaysia
  • 8 Nemocnice na Homolce - Kardiologie, Prague, Czech Republic
  • 9 MBAL St. Ivan Rilski, Dupnitsa, Bulgaria
  • 10 Alhyatt Cardiovascular Center, Alexandria and Tanta University Hospital, Tanta, Egypt
  • 11 Breda Amphia, Breda, Netherlands
  • 12 Hospital of Invasive Cardiology IKARDIA - Lublin, Nałęczów, Poland
  • 13 Hospital Álvaro Cunqueiro, Vigo, Spain
  • 14 Queen Elizabeth Hospital, Kowloon, Hong Kong
  • 15 San Raffaele Hospital, Milan, Italy
  • 16 Icahn School of Medicine at Mount Sinai, New York, USA. Electronic address: roxana.mehran@mountsinai.org
Cardiovasc Revasc Med, 2020 12;21(12):1542-1547.
PMID: 32507695 DOI: 10.1016/j.carrev.2020.05.002

Abstract

BACKGROUND: Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.

OBJECTIVE: We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.

METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.

RESULTS: The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74-1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93-5.00, p = 0.07.

CONCLUSIONS: One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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