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1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
Jaya Chandrasekhar1,2, Usman Baber1, Samantha Sartori1
1Icahn School of Medicine at Mount Sinai Hospital, New York, United States.
Insights
Patients with higher bleeding risk using the PARIS score experienced more target lesion failure and major bleeding events after COMBO stent implantation. This highlights the importance of bleeding risk assessment in cardiovascular interventions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The COMBO stent is a novel biodegradable-polymer sirolimus-eluting stent designed for enhanced endothelialization through endothelial progenitor cell capture technology.
- Assessing the safety and efficacy of new stent technologies in relation to patient-specific risk factors is crucial for clinical practice.
Purpose of the Study:
- To evaluate the clinical outcomes of COMBO stent implantation in patients stratified by bleeding risk using the PARIS bleeding score.
- To determine if bleeding risk influences key adverse cardiac and cerebrovascular events (KACE) and bleeding events post-stenting.
Main Methods:
- The MASCOT international registry included all-comers undergoing COMBO stent implantation.
- Patients were categorized into low bleeding-risk (LBR; PARIS score ≤3) and intermediate-to-high bleeding-risk (IHBR; PARIS score >3) groups.
- The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). Bleeding was assessed using Bleeding Academic Research Consortium (BARC) criteria.
Main Results:
- The study comprised 1270 LBR and 1009 IHBR patients.
- IHBR patients exhibited a significantly higher incidence of 1-year TLF (4.1% vs. 2.6%, p=0.047), primarily driven by cardiac death (1.7% vs. 0.7%, p=0.029).
- Major BARC 3 or 5 bleeding events (2.3% vs. 0.9%, p=0.0094) and dual antiplatelet therapy (DAPT) cessation (29.3% vs. 22.8%, p<0.01) were also significantly higher in the IHBR group.
Conclusions:
- Intermediate-to-high bleeding risk, as defined by the PARIS score, is associated with increased 1-year TLF and major bleeding events following COMBO stent implantation.
- These findings underscore the importance of pre-procedural bleeding risk assessment for optimizing DAPT duration and patient management.
- No significant difference in stent thrombosis rates was observed between the LBR and IHBR groups.
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.
