Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study

Abstract

AimsTo investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease.Methods and resultsThe SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39–0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11–0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37–0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27–1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10–4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07–0.97, P = 0.045).ConclusionAt one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted.ClinicalTrials.gov IdentifierNCT02015832

2018 ESC/EACTS Guidelines on myocardial revascularization

“…18 In this trial, 17 The SYNTAX II study (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery), a single-arm, prospective study in patients with multivessel disease incorporating a management strategy including combined iwFR/FFR assessment of stenosis severity in addition to intravascular ultrasound (IVUS)-guided stent implantation and guideline-directed medical therapy, showed encouraging outcomes compared with a historical cohort enrolled in the SYNTAX trial. 34 Randomized trials comparing iwFR-guided revascularization with angiography-guided revascularization or medical therapy are not available. iwFR has not been extensively validated for patients with LMS stenosis.…”

The year in cardiology 2017: coronary interventions

“…1 Characteristics of the SYNTAX II strategy that captures all components of today's 'best of PCI practice' are summarized in Figure 2. Following this approach systematically, the authors demonstrated major adverse cardiac and cerebrovascular events (MACCE) at 1 year to be much improved with respect to a matched historical PCI cohort from the SYNTAX I trial (10.6% vs. 17.4%; P = 0.006).…”

“…Because these results outperform PCI results obtained in the earlier SYNTAX I trial, the hypothesis was generated that a new randomized study of modern best PCI practice in patients with three-vessel disease might show non-inferiority vs. coronary artery bypass grafting (CABG). 1 Glimpsing to the future, the feasibility and technical success of robotically-assisted PCI for complex coronary lesions were investigated in 334 procedures from 315 patients included in the Complex Robotically Assisted Percutaneous Coronary Intervention (CORA-PCI) study. 2 In 108 procedures of robotically-assisted PCI, technical success was 91.7% and clinical success was 99.…”

“…Combined advances in percutaneous coronary intervention performance defining the 'Best of PCI Practice' applied in the SYNTAX-II study, as described by Escaned et al 1 reproduced with permission from the European Heart Journal. …”

Elektroterapia, interwencje, leki… Migawki z Kongresu Europejskiego Towarzystwa Kardiologicznego w Barcelonie, 26–30 sierpnia 2017 roku

“…Jednym z najważniejszych wydarzeń pierwszego dnia kongresu była prezentacja (w ramach sesji "Hot Line-Late--Breaking Science in PCI") wyników badania SYNTAX II [1], dotyczącego porównania wyników rewaskularyzacji wieńcowej metodą chirurgiczną (CABG, coronary artery bypass grafting) i metodami przezskórnymi (PCI, percutaneous coronary intervention) z użyciem współczesnych stentów uwalniających leki (DES, drug-eluting stent). O ile we wcześniejszym badaniu SYNTAX I porównywano wyniki leczenia techniką CABG w chorobie wielonaczyniowej ze standardowym zabiegiem angioplastyki, o tyle w obecnym badaniu uwzględniono ogromny postęp w zakresie oceny istotności hemodynamicznej zmian w łożysku wieńcowym.…”