"Comparative Efficacy of PCI with Drug-Eluting Stents vs. CABG in Three-Vessel or Left Main Coronary Artery Disease". The New England Journal of Medicine, 2009. ClinicalTrials.gov number, NCT00114972.
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How does percutaneous coronary intervention (PCI) with drug-eluting stents compare to coronary-artery bypass grafting (CABG) for treating patients with previously untreated three-vessel or left main coronary artery disease?
For patients with three-vessel or left main coronary artery disease, CABG resulted in lower rates of the combined endpoint of major adverse cardiac or cerebrovascular events at one year compared to PCI with drug-eluting stents, and thus should remain the standard treatment for such patients.
Despite PCI with drug-eluting stents being increasingly used to treat complex coronary artery disease, historical data predominantly supports CABG for patients with three-vessel or left main coronary artery disease. The SYNTAX trial compared PCI and CABG in such patients, finding CABG to be associated with lower rates of major adverse cardiac or cerebrovascular events at one year.
According to current guidelines, CABG remains the treatment of choice for patients with severe coronary artery disease, including those with left main coronary artery disease and those with three-vessel disease.
Prospective, multicenter, randomized controlled trial of 1800 patients. Randomization was 1:1 for CABG vs. PCI with Taxus Express paclitaxel-eluting stents. Mean follow-up 12 months.
Patients with previously untreated three-vessel or left main coronary artery disease were eligible. Cases where equivalent anatomical revascularization with either CABG or PCI was feasible were randomized.
Participants underwent CABG or PCI aiming to achieve complete revascularization. Post-procedure pharmacological treatment choices reflected local practices.
The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE) at 12 months. Secondary endpoints included individual components of MACCE, revascularization rates, stent thrombosis, and graft occlusion rates at 12 months.
- The 12-month follow-up may not fully reflect the long-term impact of interventions. - Standard care medication differed between treatment groups. - More patients withdrew from the CABG group after randomization than from the PCI group. - The detection of non-severe myocardial infarction might have been missed due to the study's definition. - Longer-term follow-up is needed to assess sustained effects on cardiac health.
Supported by Boston Scientific.
Information for this trial can be found on ClinicalTrials.gov with the identifier NCT00114972.