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

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

Journal

Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551

Informations de publication

Date de publication:
12 2020
Historique:
received: 17 03 2020
revised: 27 04 2020
accepted: 04 05 2020
pubmed: 9 6 2020
medline: 13 8 2021
entrez: 9 6 2020
Statut: ppublish

Résumé

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. We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration. 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. 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. One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.

Sections du résumé

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.

Identifiants

pubmed: 32507695
pii: S1553-8389(20)30249-9
doi: 10.1016/j.carrev.2020.05.002
pii:
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1542-1547

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2020 Elsevier Inc. All rights reserved.

Auteurs

Jaya Chandrasekhar (J)

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.

Doreen Zeebregts (D)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Deborah N Kalkman (DN)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Samantha Sartori (S)

Icahn School of Medicine at Mount Sinai, New York, USA.

Anastasios Roumeliotis (A)

Icahn School of Medicine at Mount Sinai, New York, USA.

Melissa B Aquino (MB)

Icahn School of Medicine at Mount Sinai, New York, USA.

Puk de Wilde (P)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Vera C de Winter (VC)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Usman Baber (U)

Icahn School of Medicine at Mount Sinai, New York, USA.

Pier Woudstra (P)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Marcel A Beijk (MA)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Petr Hájek (P)

Motol University Hospital, Prague, Czech Republic.

Borislav Atzev (B)

University Hospital St. Ekaterina, Sofia, Bulgaria.

Martin Hudec (M)

SUSCCH, a.s. Banska Bystrica, Banska Bystrica, Slovakia.

Tiong Kiam Ong (TK)

Sarawak Heart Centre, Sarawak, Malaysia.

Martin Mates (M)

Nemocnice na Homolce - Kardiologie, Prague, Czech Republic.

Borislav Borisov (B)

MBAL St. Ivan Rilski, Dupnitsa, Bulgaria.

Hazem M Warda (HM)

Alhyatt Cardiovascular Center, Alexandria and Tanta University Hospital, Tanta, Egypt.

Peter den Heijer (P)

Breda Amphia, Breda, Netherlands.

Jaroslaw Wojcik (J)

Hospital of Invasive Cardiology IKARDIA - Lublin, Nałęczów, Poland.

Andres Iniguez (A)

Hospital Álvaro Cunqueiro, Vigo, Spain.

Michael Lee (M)

Queen Elizabeth Hospital, Kowloon, Hong Kong.

Jan G Tijssen (JG)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Karel T Koch (KT)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

George D Dangas (GD)

Icahn School of Medicine at Mount Sinai, New York, USA.

Antonio Colombo (A)

San Raffaele Hospital, Milan, Italy.

Roxana Mehran (R)

Icahn School of Medicine at Mount Sinai, New York, USA. Electronic address: roxana.mehran@mountsinai.org.

Robbert J de Winter (RJ)

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

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