Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry

Colombo, Antonio; Chandrasekhar, Jaya; Aquino, Melissa; Ong, Tiong Kiam; Sartori, Samantha; Baber, Usman; Lee, Michael; Íñiguez, Andrés; Hájek, Petr; Borisov, Borislav; Atzev, Borislav; Heijer, Peter den; Coufal, Zdeněk; Hudec, Martin; Mates, Martin; Snyder, Clayton; Moalem, Kamilia; Morrell, Deborah; Elmore, Francesca; Rowland, Stephen; Mehran, Roxana; investigators, Mascot

doi:10.1016/j.ijcard.2019.01.053

Cited by 19 publications

(13 citation statements)

References 32 publications

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“…The study design and primary results of the MASCOT registry have been described elsewhere [7] . In brief, this was a prospective international post-marketing registry of all comers undergoing attempted PCI with the COMBO stent as part of routine clinical care.…”

Section: Methodsmentioning

confidence: 99%

“…In addition, this stent combines a circumferential pro-healing antibody layer which attracts circulating endothelial progenitor cells (EPCs) that mature in to healthy endothelial cells for faster coverage and more homogeneous endothelialization [5] , [6] . The global MASCOT registry recently demonstrated a low rate of 1-year target lesion failure (TLF) and definite ST after COMBO stent PCI [7] . Given the stent’s unique properties for healthy strut coverage, and the possibility of short DAPT duration, the efficacy and safety of the COMBO stent in all-comer patients at increased bleeding risk are of interest.…”

Section: Introductionmentioning

confidence: 99%

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1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Chandrasekhar

Baber

Sartori

et al. 2020

IJC Heart & Vasculature

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Background The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. Objective We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. Methods MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. Conclusions Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Chandrasekhar

Baber

Sartori

et al. 2020

IJC Heart & Vasculature

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“…Meanwhile, bioresorbable vascular scaffolds (BVSs) can decrease the propensity for thrombosis, since BVSs allow implants to degrade over time and leave an intact vessel (Stone, 2016). Furthermore, bio-engineered stents (BESs) adopt biocompatible materials, cell capture technology, or autologous venous tissue for better therapeutic effects (Stone et al, 2002;Hara et al, 2006;Colombo et al, 2019). In addition to material innovation, novel stent designs also employ coatings to improve the surface properties and clinical behaviors (Yang (Lundberg et al, 2015;Palmerini et al, 2015) Sirolimus/zotarolimus Interfere cell cycle by inhibiting the mammalian target of rapamycin Promote re-endothelialization Long-term safety concerns, late stent thrombosis (Joner et al, 2006;Park et al, 2010) Biomolecules NO and NO-producing materials…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Nitric Oxide-Producing Cardiovascular Stent Coatings for Prevention of Thrombosis and Restenosis

Rao

Bei

Yang

et al. 2020

Front. Bioeng. Biotechnol.

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Cardiovascular stenting is an effective method for treating cardiovascular diseases (CVDs), yet thrombosis and restenosis are the two major clinical complications that often lead to device failure. Nitric oxide (NO) has been proposed as a promising small molecule in improving the clinical performance of cardiovascular stents thanks to its anti-thrombosis and anti-restenosis ability, but its short half-life limits the full use of NO. To produce NO at lesion site with sufficient amount, NO-producing coatings (including NO-releasing and NO-generating coatings) are fashioned. Its releasing strategy is achieved by introducing exogenous NO storage materials like NO donors, while the generating strategy utilizes the in vivo substances such as S-nitrosothiols (RSNOs) to generate NO flux. NO-producing stents are particularly promising in future clinical use due to their ability to store NO resources or to generate large NO flux in a controlled and efficient manner. In this review, we first introduce NO-releasing and-generating coatings for prevention of thrombosis and restenosis. We then discuss the advantages and drawbacks on releasing and generating aspects, where possible further developments are suggested.

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“…Whether this finding has the potential to influence sex differences in stent‐related outcomes after COMBO PCI is unknown. The COMBO collaboration is a pooled patient‐level dataset of 3,614 all‐comer patients treated with the COMBO stent globally in the MASCOT and REMEDEE registries 8–10 . In this prespecified subgroup analysis, we assessed for sex differences in 1‐year clinical outcomes.…”

Section: Introductionmentioning

confidence: 99%

Sex differences in 1‐year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration

Chandrasekhar

Kerkmeijer

Kalkman

et al. 2020

Cathet Cardio Intervent

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Background The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. Methods and results We examined for sex differences in 1‐year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient‐level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1‐year target lesion failure (TLF), composite of cardiac death, target vessel‐myocardial infarction (TV‐MI), or clinically driven target lesion revascularization (CD‐TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1‐year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59–1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV‐MI (1.5% vs. 1.1%, p = .32), or CD‐TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06–1.11, p = .069). Conclusions Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1‐year TLF and other ischemic outcomes compared to men.

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Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry

Cited by 19 publications

References 32 publications

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Nitric Oxide-Producing Cardiovascular Stent Coatings for Prevention of Thrombosis and Restenosis

Sex differences in 1‐year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration

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