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Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Three-Vessel Disease and Left Main Coronary Disease: 5-Year Follow-Up of the Randomised, Clinical SYNTAX Trial
Study Questions:
What are the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease?
Methods:
The randomized, clinical SYNTAX trial with nested registries took place in 85 centers in the United States and Europe. A cardiac surgeon and interventional cardiologist at each center assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. The investigators analyzed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis.
Results:
A total of 1,800 patients were randomly assigned to CABG (n = 897) or PCI (n = 903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs. 11). After 5-year follow-up, Kaplan-Meier estimates of MACCE were 26.9% in the CABG group and 37.3% in the PCI group (p < 0.0001). Estimates of myocardial infarction (3.8% in the CABG group vs. 9.7% in the PCI group; p < 0.0001) and repeat revascularization (13.7% vs. 25.9%; p < 0.0001) were significantly increased with PCI versus CABG. All-cause death (11.4% in the CABG group vs. 13.9% in the PCI group; p = 0.10) and stroke (3.7% vs. 2.4%; p = 0.09) were not significantly different between groups. A total of 28.6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32.1% of patients in the PCI group (p = 0.43), and 31.0% in the CABG group with left main coronary disease had MACCE versus 36.9% in the PCI group (p = 0.12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25.8% of the CABG group vs. 36.0% of the PCI group; p = 0.008; high score, 26.8% vs. 44.0%; p < 0.0001).
Conclusions:
The authors concluded that CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores).
Perspective:
Results of this final 5-year analysis of the SYNTAX trial suggest that CABG remains the standard of care for patients with complex coronary lesions, driven by favorable rates of MACCE, cardiac death, myocardial infarction, and repeat revascularization in the CABG group compared with the PCI group. However, in patients with less complex disease (i.e., left main coronary disease with low or intermediate SYNTAX scores, or three-vessel disease with low SYNTAX scores), PCI appears to be a reasonable alternative treatment to CABG. The optimum revascularization strategy for an individual patient should depend on a careful consideration of the risks and benefits of each procedure in conjunction with the baseline risk profile and patient preferences, and should ideally be made by a multidisciplinary team involving the patient’s cardiologist, an interventionalist, and a cardiac surgeon.
Keywords: Paclitaxel, Cause of Death, Myocardial Infarction, Stroke, Kaplan-Meier Estimate, Coronary Disease, Coronary Artery Bypass, Cardiac Surgical Procedures, Pregnancy, United States, Stents, Percutaneous Coronary Intervention
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