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Five-Year Outcomes After Revascularization in the SYNTAX II Study
Quick Takes
- The results of 5-year follow-up of the SYNTAX II study show that, compared with patients treated with PCI within the SYNTAX I trial, use of the SYNTAX II strategy was associated with a significantly lower rate of MACCE.
- Furthermore, rates of MACCE at 5 years for patients treated with PCI in SYNTAX II were comparable to rates of MACCE in patients treated surgically in the SYNTAX I CABG cohort.
- The results provide equipoise for a randomized clinical trial for appropriately selected patients with multivessel CAD comparing outcomes after revascularization with either CABG or PCI using a contemporary heart team approach.
Study Questions:
What are the 5-year clinical outcomes of patients in the SYNTAX II study, and the impact of integration of new developments in percutaneous coronary intervention (PCI) on patient outcomes?
Methods:
The investigators report 5-year outcomes of the SYNTAX II trial, a multicenter, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. This report compares rates at the 5-year follow-up time point with no formal testing. A p value of <0.05 was considered significant.
Results:
At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, p < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, p < 0.001) and myocardial infarction (MI) (2.7% vs. 10.4%, p < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, p < 0.001) and spontaneous MI (2.3% vs. 6.9%, p = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, p = 0.013), reflecting a lower rate of cardiac death (2.8% vs. 8.4%, p < 0.001). MACCE outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, p = 0.35).
Conclusions:
The authors concluded that use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial.
Perspective:
The results of 5-year follow-up of the SYNTAX II study show that, compared with patients treated with PCI within the SYNTAX I trial, the use of the SYNTAX II strategy was associated with a significantly lower rate of MACCE, comprising a lower rate of repeat revascularization, spontaneous MI, and cardiac death. Furthermore, rates of MACCE at 5 years for patients treated with PCI in SYNTAX II were comparable to rates of MACCE in patients treated surgically in the SYNTAX I CABG cohort. A major limitation is that this was a nonrandomized study comparing a contemporary strategy with an historical control group (SYNTAX I). The results, however, provide equipoise for a randomized clinical trial for appropriately selected patients with multivessel coronary artery disease (CAD) comparing outcomes after revascularization with either CABG or PCI using a contemporary heart team approach.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Coronary Artery Disease
Keywords: Cardiac Surgical Procedures, Coronary Artery Bypass, Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Secondary Prevention, Treatment Outcome
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