Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study

Abstract

Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, 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. 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). Major adverse cardiac and cerebrovascular events’ 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 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. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

Optimal Management of Patients with Severe Coronary Artery Disease following Multidisciplinary Heart Team Approach—Insights from Tertiary Cardiovascular Care Center

“…Very recently, the SYNTAX II strategy of incorporating both clinical and anatomical variables into MHT decisions to guide myocardial revascularization led to better 5-year clinical outcomes in comparison with the SYNTAX trial, which evaluated anatomic factors only [ 21 ]. A total of 454 patients were included and compared with 315 patients from the pre-defined SYNTAX PCI group and 334 patients from the pre-defined SYNTAX CABG cohort.…”

“…At 5 years, MACCE (composite of all-cause death, stroke, any MI, and any revascularization) occurred in 21.5% of SYNTAX II patients, which was significantly lower than the 36.4% MACCE rate in the SYNTAX PCI group (HR: 0.54; 95% CI: 0.41–0.71; p < 0.001). All MACCE components, except stroke, were significantly lower in SYNTAX II PCI patients [ 21 ]. This study proves the relevance of MHT management—taking into account that clinical parameters through decision-shared making resulted in better clinical outcomes for SYNTAX II patients than a matched PCI group from SYNTAX.…”

“…However, though the idea of MHT is generally adopted in medical society, an unsatisfactory consensus on how MHT should cooperate, what desired goals are established, and most importantly, the long-term results of MHT decisions, implementation, and patients’ quality of life are still poorly investigated. Some studies address the association of MHT cooperation and MVD-patients evaluation [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ]. However, among them, there are very few randomized trials supporting this approach since studies describe outcomes of a multidisciplinary approach without a comparator.…”

Ejection Fraction as the Key to Improvement in Ischemic Cardiomyopathy Outcomes

“…In addition, PCI and surgical techniques has advanced significantly over the past 10 years, with operators now able to manage more complex disease including 3-vessel coronary artery disease with similar outcomes to CABG based on appropriate use of SYNTAX 2 scoring. 8 Overall, this real-world study provides 2 take-home messages. First, it supports the use of EF changes as a surrogate outcome measure for clinical studies in addition to hard clinical end points.…”

“…In addition, PCI and surgical techniques has advanced significantly over the past 10 years, with operators now able to manage more complex disease including 3-vessel coronary artery disease with similar outcomes to CABG based on appropriate use of SYNTAX 2 scoring. 8…”