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

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Highlights

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    The COMBO collaboration included 22% patients with stents <3 mm and 78% with stents ≥3 mm.

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    Small stent patients included more women with higher prevalence of diabetes.

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    One-year TLF occurred in 4.4% small vs. 3.8% large stent groups, HR 1.12 (0.74–1.72), p = 0.58.

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    There were no differences in the rates of cardiac death, TV-MI or TLR by stent size.

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    Definite ST occurred in 0.8% small vs. 0.4% large stent groups, HR 2.50 (0.88–7.14), p = 0.08.

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.

Introduction

Percutaneous coronary intervention (PCI) with new generation drug eluting stents (DES) has remarkably improved clinical outcomes compared to use of bare metal stents, particularly for lower risk of target lesion failure (TLF) [1]. However, patients with small vessel coronary disease remain at higher risk than their counterparts [[2], [3], [4]]. The primary driver of worse stent related outcomes with small vessel disease is greater restenosis or stent thrombosis (ST) resulting in higher target lesion revascularization rates (TLR) [[2], [3], [4]]. With the availability of improved DES iterations, examining the effectiveness of these novel technologies in small vessel disease is relevant to understanding the need for alternative approaches such as drug eluting balloon angioplasty [5] for optimal treatment of this relatively high-risk cohort. The COMBO stent is a newer generation sirolimus-eluting biodegradable-polymer DES which has the additional unique technology for luminal endothelial progenitor cell (EPC) capture, which promotes active healing with faster and more homogeneous endothelialization than durable polymer DES [6]. The COMBO collaboration is a pooled patient-level dataset of 3614 all-comer patients treated with the COMBO stent globally in the MASCOT and REMEDEE registries [[7], [8], [9]]. In this manuscript we examined for differences in 1-year clinical outcomes following COMBO PCI in patients receiving small stents with maximum stent diameter < 3 mm or large stents with maximum diameter ≥ 3 mm.

Section snippets

Study device

The COMBO stent is a 100 μm stainless steel stent that elutes sirolimus from a biodegradable polymer. The stent is coated with sirolimus (5 μg/mm) which is eluted over 30 days, whereas the polymer is completely resorbed over 3 months. In addition, the stent has a pro-healing circumferential layer coated with anti-CD34 antibodies that bind with circulating EPCs for faster endothelialization with reduced vascular inflammation [10,11]. The COMBO stent is available in 2.5, 2.75, 3.0, 3.5 and 4.0 mm

Results

The COMBO collaboration included 792 (22.0%) patients undergoing PCI with small stents <3 mm and 2798 (78%) undergoing PCI with large stents ≥3 mm. Table 1 shows the baseline characteristics and Table 2 shows the procedural characteristics. There were no age differences between the groups (63.69 ± 10.73 vs. 63.48 ± 11.36 years, p = 0.64), however patients with small stents included more women (28.4% vs. 22.6%, p = 0.0007) with smaller body mass index (27.58 ± 4.58 vs. 28.17 ± 4.76 kg/m2, p

Discussion

The key findings of this analysis on associations between coronary stent size and outcomes after COMBO PCI are as follows: 1. Patients with small stents <3.0 mm included significantly more women with lower body mass index and higher prevalence of diabetes. There were no differences in the prevalence of prior coronary artery disease or prior PCI, and over 50% of small and large stent patients underwent PCI for ACS. Despite this clopidogrel rather than potent P2Y12 inhibitors was preferentially

Conclusions

In the COMBO collaboration, 1-year risk of TLF was similar in patients receiving small or large COMBO stents with low risk of definite ST and TLR. Longer-term follow up is warranted to confirm preserved safety and efficacy in patients undergoing small vessel PCI with this novel stent.

Funding

The Academic Medical Center received an unrestricted research grant from OrbusNeich Medical BV (Hoevelaken, The Netherlands). OrbusNeich Medical (Ft. Lauderdale, Florida, USA) is the sponsor of the MASCOT registry.

CRediT authorship contribution statement

Jaya Chandrasekhar: Conceptualization, Methodology, Writing - original draft, Visualization. Doreen Zeebregts: Conceptualization, Methodology, Writing - original draft, Visualization. Deborah N. Kalkman: Conceptualization, Methodology, Formal analysis, Writing - review & editing. Samantha Sartori: Data curation, Formal analysis, Writing - review & editing. Anastasios Roumeliotis: Conceptualization, Writing - review & editing. Melissa B. Aquino: Data curation, Formal analysis, Writing - review &

Acknowledgements

We thank all the research participants and site researchers for their contributions.

References (28)

  • K.H. Bonaa et al.

    Drug-eluting or bare-metal stents for coronary artery disease

    N Engl J Med

    (2016)
  • A. Plitt et al.

    Impact of stent diameter on outcomes following percutaneous coronary intervention with second-generation drug-eluting stents: results from a large single-center registry

    Catheter Cardiovasc Interv

    (2020)
  • T. Nestelberger et al.

    Drug-coated balloons for small coronary vessel interventions: a literature review

    Interv Cardiol

    (2019 Nov)
  • S. Saito et al.

    Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich’s Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome

    Eur Heart J

    (2018)

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