Debra L. Beck, MSc, and Eugene Braunwald, MD
In SYNTAX I, coronary artery bypass grafting (CABG) was found to be superior to percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) in patients with 3-vessel disease. Given the many innovations in PCI since the trial was conducted, the SYNTAX II study evaluated the impact of these advances all integrated into a single revascularization strategy on outcomes of patients with de novo 3-vessel disease. Banning et al presented 5-year outcomes from SYNTAX II.
The multicentre, single-arm, open-label SYNTAX II trial employed decision-making utilizing the SYNTAX score II, use of coronary physiology assessment, thin-strut biodegradable polymer DES, intravascular ultrasound, enhanced treatment of chronic total occlusions, and optimized medical therapy.
Patients (n=454) demonstrated clinical equipoise for treatment with either CABG or PCI predicted by the SYNTAX score II and were compared with predefined historical control patients from the SYNTAX I trial for whom there was expected calculated equipoise for PCI and CABG.
At 5 years, there was a lower rate of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause death, stoke, MI, revascularization) in SYNTAX II as compared to the SYNTAX I PCI cohort (21.5% vs. 36.4%, p<0.001), primarily driven by lower rates of revascularization (13.8% vs. 23.8%, p<0.001), and myocardial infarction (2.7% vs. 10.4%, p<0.001).
All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, p=0.013), driven by fewer cardiac deaths (2.8% vs. 8.4%, p<0.001).
When MACCE rates from SYNTAX II were compared to the predefined historic CABG arm from SYNTAX I, no significant difference was seen (21.5% vs. 24.6%, p=0.35).
The investigators concluded that the PCI strategy used in SYNTAX II led to improved and durable clinical results as compared to PCI as performed in SYNTAX I in patients with de novo 3-vessel disease. In a predefined exploratory analysis, the MACCE outcomes were also similar between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.
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