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1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration
Jaya Chandrasekhar1, Doreen Zeebregts2, Deborah N Kalkman2
1Icahn 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.
Insights
This study found that the COMBO sirolimus-eluting stent showed similar 1-year outcomes for percutaneous coronary intervention (PCI) in both small (<3 mm) and large (≥3 mm) vessels. These findings suggest stent diameter may not impact clinical outcomes in this patient population.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Small vessel diameter increases the risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI).
- The COMBO stent, a sirolimus-eluting biodegradable-polymer stent, features an anti-CD34 antibody layer designed to promote uniform endothelialization, potentially benefiting small vessel treatments.
Purpose of the Study:
- To investigate 1-year clinical outcomes following PCI based on the maximum implanted stent diameter within the COMBO collaboration.
- To compare the efficacy and safety of COMBO stents in small (<3 mm) versus large (≥3 mm) coronary vessels.
Main Methods:
- A pooled patient-level analysis of 3614 patients from the MASCOT and REMEDEE registries undergoing PCI with COMBO stents.
- Comparison of outcomes between patients receiving stents <3 mm (n=792) and ≥3 mm (n=2798).
- Primary endpoint: 1-year target lesion failure (TLF); Secondary endpoints: cardiac death, target vessel-myocardial infarction (TV-MI), TLR, and stent thrombosis (ST). Cox regression analysis was used for adjusted outcomes.
Main Results:
- Patients receiving small stents (<3 mm) had higher rates of female sex, lower BMI, and more diabetes, but similar acute coronary syndrome prevalence compared to large stent recipients.
- One-year TLF rates were comparable between small and large stent groups (4.4% vs. 3.8%, HR 1.12).
- No significant differences were observed in cardiac death, TV-MI, TLR, or stent thrombosis rates between the two groups.
Conclusions:
- One-year ischemic outcomes following COMBO stent percutaneous coronary intervention (PCI) were similar regardless of stent diameter in this international, all-comers cohort.
- The findings suggest that COMBO stent performance is consistent across different vessel sizes.
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.
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