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SYNTAX II: Contemporary PCI strategy for high-risk patients confers positive outcomes
A contemporary PCI strategy for patients with three-vessel disease was associated with better clinical results than a previous strategy, according to findings published in the European Heart Journal.
Researchers conducted the SYNTAX II all-comers, open-label, single-arm study of 708 patients with de novo three-vessel disease without left main artery involvement.
The goal was to evaluate the SYNTAX II strategy, which was as follows: decision-making by a heart team using the SYNTAX Score II encompassing anatomical and clinical factors; making revascularization decisions guided by coronary physiology; implanting stents with IVUS guidance; employing contemporary chronic total occlusion revascularization techniques when necessary; and prescribing guideline-directed medical therapy.
The SYNTAX II cohort was compared with a predefined PCI cohort from the SYNTAX I trial, selected on the basis of equipoise of 4-year mortality between CABG and PCI. The primary outcome was MACCE, defined as all-cause death, cerebrovascular events, any MI and any revascularization at 1 year.
Of the 708 patients screened by a heart team, 454 were adjudicated as appropriate to undergo PCI, Javier Escaned, MD, PhD, FESC, from Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, and colleagues reported.
At 1 year, the SYNTAX II strategy was superior to the SYNTAX I cohort for the primary outcome (10.6% vs. 17.4%; HR = 0.58; 95% CI, 0.39-0.85), driven by lower rates of MI (HR = 0.27; 95% CI, 0.11-0.7) and revascularization (HR = 0.57; 95% CI, 0.37-0.9), according to the researchers.
There were no differences between the groups at 1 year in all-cause death (HR = 0.69; 95% CI, 0.27-1.73) and stroke (HR = 0.69; 95% CI, 0.1-4.89).
Definite stent thrombosis at 1 year was lower in the SYNTAX II group (HR = 0.26; 95% CI, 0.07-0.97), Escaned and colleagues wrote.
“Together with the optimized implant technique, the thin-strut bioresorbable polymer [drug-eluting stent] used in the present study (Synergy, Boston Scientific) is probably responsible for the observed reduction in stent thrombosis, MI and revascularization,” the researchers wrote.
The findings were also presented at the European Society of Cardiology Congress. – by Erik Swain
Disclosure: The study was sponsored by the European Cardiovascular Research Institute with unrestricted research grants from Boston Scientific and Volcano. Escaned reports he is a consultant for Boston Scientific and Philips/Volcano. Please see the full study for a list of the other authors’ relevant financial disclosures.
Perspective
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One-year results of the SYNTAX II trial suggested that contemporary optimal PCI practices improve outcomes compared with a prespecified historical PCI cohort from the SYNTAX I trial. In this unusual, open-label, nonrandomized design, 454 patients with three-vessel CAD deemed appropriate for PCI were revascularized according to a protocol that required heart team assessment, coronary physiologic assessment, post-procedural IVUS imaging, use of modern thin-strut drug-eluting stents (Synergy), chronic total occlusion techniques, and optimal medical therapy. In this cohort, 75% of lesions underwent physiologic assessment with instantaneous wave-free ratio and fractional flow reserve, resulting in 31% of the lesions being deferred from revascularization.
At 1 year, the SYNTAX II strategy was superior to the equipoise-derived SYNTAX I PCI cohort (MACCE: SYNTAX II, 10.6%; SYNTAX I, 17.4%; HR = 0.58; 95% CI, 0.39-0.85). This difference was driven by a significant reduction in the incidence of MI (HR = 0.27; 95% CI, 0.11-0.7) and revascularization (HR = 0.57; 95% CI, 0.37-0.9). In an exploratory analysis, the SYNTAX II cohort had equivalent outcomes to a SYNTAX I CABG cohort (HR = 0.91; 95% CI, 0.59-1.41).
As the SYNTAX II trial was nonrandomized with only a historical control, the results are only hypothesis-generating, but give interventionalists tantalizing evidence that recent advances in percutaneous revascularization can make PCI equivalent to CABG in a larger group of patients. After SYNTAX II, the next logical step would be to prove the results with (yet) another randomized trial of PCI vs. CABG, but is now the time? Given recent advances in coronary physiology, imaging, stent design, and CTO techniques, and the likelihood that further progress would be limited, I think the answer is yes.