Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial
Aung Myat1,2, David Hildick-Smith1, Adam J de Belder1
1Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
Insights
The EXCEL trial found similar outcomes for percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for left main disease, regardless of location. However, North American patients undergoing PCI had higher rates of repeat revascularization.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- The EXCEL trial previously demonstrated comparable five-year outcomes for PCI and CABG in treating obstructive left main coronary artery disease (LMCAD).
- This analysis investigates geographical variations in these outcomes.
Purpose of the Study:
- To assess if the outcomes of PCI versus CABG for LMCAD in the EXCEL trial differ based on the region of patient enrollment (European Union vs. North America).
Main Methods:
- A prespecified subgroup analysis of the EXCEL trial was conducted, stratifying patients by their geographical enrollment center (EU vs. NA).
- Comparison of primary and secondary composite endpoints between PCI and CABG groups within each geographical subgroup.
Main Results:
- While the primary composite endpoint (death, MI, stroke) at 30 days and 5 years showed consistency between PCI and CABG across EU and NA centers, significant geographical differences emerged for secondary outcomes.
- North American participants treated with PCI experienced substantially higher rates of late ischemia-driven revascularization (IDR) compared to European participants.
- This led to a significant difference in the five-year secondary composite outcome (death, MI, stroke, or IDR) between the regions (p=0.02).
Conclusions:
- The effectiveness of PCI relative to CABG for the primary composite outcome in LMCAD is consistent across European and North American centers.
- Higher rates of ischemia-driven revascularization after PCI in North American centers warrant consideration in treatment decisions for patients with LMCAD.
Background:
The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD).
Aims:
We sought to determine whether these outcomes remained consistent regardless of geography of enrolment.
Methods:
We performed a prespecified subgroup analysis based on regional enrolment.
Results:
Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02).
Conclusions:
In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.
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