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Multicenter Study
. 2020 Dec;21(12):1542-1547.
doi: 10.1016/j.carrev.2020.05.002. Epub 2020 May 7.

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

Jaya Chandrasekhar  1 , Doreen Zeebregts  2 , Deborah N Kalkman  2 , Samantha Sartori  3 , Anastasios Roumeliotis  3 , Melissa B Aquino  3 , Puk de Wilde  2 , Vera C de Winter  2 , Usman Baber  3 , Pier Woudstra  2 , Marcel A Beijk  2 , Petr Hájek  4 , Borislav Atzev  5 , Martin Hudec  6 , Tiong Kiam Ong  7 , Martin Mates  8 , Borislav Borisov  9 , Hazem M Warda  10 , Peter den Heijer  11 , Jaroslaw Wojcik  12 , Andres Iniguez  13 , Michael Lee  14 , Jan G Tijssen  2 , Karel T Koch  2 , George D Dangas  3 , Antonio Colombo  15 , Roxana Mehran  16 , Robbert J de Winter  2 ; MASCOT and REMEDEE Investigators
Affiliations
Multicenter Study

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

Jaya Chandrasekhar et al. Cardiovasc Revasc Med. 2020 Dec.

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.

Keywords: Anti-CD34; Dual therapy stent; Endothelial progenitor cell capture; Percutaneous coronary intervention; Small vessel coronary disease.

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