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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: Aims:To 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 results:The 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). Conclusion:At 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 Identifier:NCT02015832.

SUBMITTER: Escaned J

PROVIDER: S-EPMC5837643 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:AimsThe 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 resultsSYNTAX 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).ConclusionsUse 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.

Project description:ImportanceMany studies have compared outcomes for incomplete revascularization (IR) among patients undergoing percutaneous coronary interventions (PCI), but little is known about whether outcomes are related to the nature of the IR.ObjectiveTo determine whether some coronary vessel characteristics are associated with worse outcomes in patients with PCI with IR.Design, setting, and participantsNew York's PCI registry was used to examine mortality (median follow-up, 3.4 years) as a function of the number of vessels that were incompletely revascularized, the stenosis in those vessels, and whether the proximal left anterior descending artery was incompletely revascularized after controlling for other factors associated with mortality for patients with and without ST-elevation myocardial infarction (STEMI). This was a multicenter study (all nonfederal PCI hospitals in New York State) that included 41 639 New York residents with multivessel coronary artery disease undergoing PCI in New York State between January 1, 2010, and December 31, 2012.ExposuresPercutaneous coronary interventions, with complete and incomplete revascularization.Main outcomes and measuresMedium-term mortality.ResultsFor patients with STEMI, the mean age was 62.8 years; 26.2% were women, 11.9% were Hispanic, and 81.5% were white. For other patients, the mean age was 66.6 years, 29.1% were women, 11.3% were Hispanic, and 79.1% were white. Incomplete revascularization was very common (78% among patients with STEMI and 71% among other patients). Patients with IR in a vessel with at least 90% stenosis were at higher risk than other patients with IR. This was not significant among patients with STEMI (17.18% vs 12.86%; adjusted hazard ratio [AHR], 1.16; 95% CI, 0.99-1.37) and significant among patients without STEMI (17.71% vs 12.96%; AHR, 1.15; 95% CI, 1.07-1.24). Similarly, patients with IR in 2 or more vessels had higher mortality than patients with completely revascularization and higher mortality than other patients with IR among patients with STEMI (20.37% vs 14.39%; AHR, 1.35; 95% CI, 1.15-1.59) and among patients without STEMI (20.10% vs 12.86%; AHR, 1.17; 95% CI, 1.09-1.59). Patients with proximal left anterior descending artery vessel IR had higher mortality than other patients with IR (20.09% vs 14.67%; AHR, 1.31; 95% CI, 1.04-1.64 for patients with STEMI and 20.78% vs 15.62%; AHR, 1.11; 95% CI, 1.01-1.23 for patients without STEMI). More than 20% of all PCI patients had IR of 2 or more vessels and more than 30% had IR with more than 90% stenosis.Conclusions and relevancePatients with IR are at higher risk of mortality if they have IR with at least 90% stenosis, IR in 2 or more vessels, or proximal left anterior descending IR.

Project description:BackgroundImprecise interpretation of coronary angiograms was reported and resulted in inappropriate revascularization. Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a comprehensive system to evaluate the complexity of the overall lesions. We hypothesized that a real-time SYNTAX score feedback from image analysts may rectify the mis-estimation and improve revascularization appropriateness in patients with stable coronary artery disease (CAD).MethodsIn this single-center, historical control study, patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited. During the control period, SYNTAX scores were calculated by treating cardiologists. During the intervention period, SYNTAX scores were calculated by image analysts immediately after coronary angiography and were provided to cardiologists in real-time to aid decision-making. The primary outcome was revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization.ResultsA total of 3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n = 1525) or the intervention group (03/2017-09/2017, n = 1720). For SYNTAX score tertiles, 17.9% patients were overestimated and 4.3% were underestimated by cardiologists in the control group. After adjustment, inappropriate revascularization significantly decreased in the intervention group compared with the control group (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.73-0.95; P = 0.007). Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group. There was no significant difference in 1-year adverse cardiac events between the control group and the intervention group.ConclusionsReal-time SYNTAX score feedback significantly reduced inappropriate coronary revascularization in stable patients with CAD.Clinical trial registrationNos. NCT03068858 and NCT02880605; https://www.clinicaltrials.gov.

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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.

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