1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the
Jaya Chandrasekhar1, Deborah N Kalkman2, Melissa B Aquino3
1Icahn School of Medicine at Mount Sinai Hospital, New York, United States of America; Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Insights
Outcomes after COMBO stent percutaneous coronary intervention (PCI) were similar for Asians and Europeans, with no significant differences in 1-year target lesion failure (TLF). However, Asians had higher cardiac death rates and lower target lesion revascularization (TLR) rates, though adjusted differences were not significant.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The COMBO stent is a novel drug-eluting stent featuring sirolimus elution from a biodegradable polymer and an anti-CD34+ antibody coating to promote early endothelialization.
- Understanding geographical variations in stent performance is crucial for optimizing patient care in percutaneous coronary intervention (PCI).
Purpose of the Study:
- To investigate potential geographical differences in clinical outcomes following PCI with the COMBO stent, specifically comparing Asian and European patient populations.
- To evaluate the safety and efficacy of the COMBO stent across diverse demographic and clinical subgroups.
Main Methods:
- A pooled patient-level analysis of the MASCOT and REMEDEE registries was conducted, including all-comers undergoing attempted COMBO stent PCI.
- The primary endpoint was the 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR).
- Demographic, clinical, and procedural data were analyzed to identify differences between Asian and European cohorts.
Main Results:
- The study included 604 Asians (17.9%) and 2775 Europeans (82.1%), with Asians being younger and having a higher prevalence of diabetes but fewer comorbidities.
- One-year TLF rates were similar between Asians (4.0%) and Europeans (4.1%) (p=0.93).
- Asians exhibited higher rates of cardiac death (2.8% vs. 1.3%, p=0.007) and lower rates of TLR (1.0% vs. 2.5%, p=0.025) compared to Europeans, while TV-MI and stent thrombosis rates were similar.
Conclusions:
- Despite geographical variations in specific adverse events like cardiac death and TLR, the overall 1-year target lesion failure (TLF) after COMBO stent PCI was comparable between Asian and European populations.
- Adjusted analyses indicated that observed differences in cardiac death and TLR did not reach statistical significance, suggesting similar long-term efficacy regardless of geography.
- The COMBO stent demonstrates consistent performance across diverse populations, though further research may explore underlying reasons for regional event variations.
Background:
The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization.
Objective:
We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans.
Methods:
The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR).
Results:
This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant.
Conclusions:
In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. CLINICALTRIAL.
Gov Identifier-Numbers:
NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).
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