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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.
Escaned, J, Collet, C, Ryan, N, De Maria, GL, Walsh, S, Sabate, M, Davies, J, Lesiak, M, Moreno, R, Cruz-Gonzalez, I, et al
European heart journal. 2017;(42):3124-3134
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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.
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Independent and Combined Effects of Serum Albumin and C-Reactive Protein on Long-Term Outcomes of Patients Undergoing Percutaneous Coronary Intervention.
Wada, H, Dohi, T, Miyauchi, K, Doi, S, Naito, R, Konishi, H, Tsuboi, S, Ogita, M, Kasai, T, Okazaki, S, et al
Circulation journal : official journal of the Japanese Circulation Society. 2017;(9):1293-1300
Abstract
BACKGROUND Both inflammation and malnutrition have been reported to be closely linked to atherosclerosis, especially in patients with chronic kidney disease (CKD). The combined effects of serum albumin and C-reactive protein (CRP) on clinical outcomes after percutaneous coronary intervention (PCI) were investigated.Methods and Results:A total of 2,164 all-comer patients with coronary artery disease who underwent their first PCI and had data available for preprocedural serum albumin and hs-CRP levels between 2000 and 2011 were studied. Patients were assigned to 4 groups according to their median serum albumin and CRP levels (4.1 g/dL and 0.10 mg/dL, respectively). The incidence of major adverse cardiac events (MACE), including all-cause death and non-fatal myocardial infarction (MI), was evaluated. During a median follow-up period of 7.5 years, 331 cases of MACE (15.3%), including 270 deaths and 61 non-fatal MIs, occurred. Kaplan-Meier curves showed that the rates of MACE differed significantly among the groups (log-rank P<0.0001), even stratified by with or without CKD (both log-rank P<0.0001). After adjustment for established cardiovascular risk factors, low serum albumin with high CRP levels was associated with adverse cardiac events (hazard ratio 2.55, 95% confidence interval 1.72-3,88, P<0.0001, high albumin/low CRP group as reference). CONCLUSIONS The presence of both low serum albumin and high CRP levels conferred a synergistic adverse effect on the risk for long-term MACE in patients undergoing PCI.
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Trial design and rationale of TY-51924 as a novel Na+/H+ exchanger inhibitor in patients with ST-elevation acute myocardial infarction undergoing percutaneous coronary intervention.
Ishihara, M, Asakura, M, Kimura, K, Nakao, K, Hamada, C, Hirayama, A
Journal of cardiology. 2014;(1):82-7
Abstract
BACKGROUND Reperfusion therapy limits infarct size and improves survival in patients with ST-elevation myocardial infarction (STEMI). However, reperfusion itself may, in some cases, deteriorate myocardial damage, causing the so-called ischemia-reperfusion injury. Activation of the Na(+)/H(+) exchanger (NHE) at the time of reperfusion plays an important role in ischemia-reperfusion injury. We designed a Phase IIa proof of concept clinical trial to evaluate the potential of TY-51924, an NHE inhibitor, as adjunctive therapy to primary percutaneous coronary intervention (pPCI) for patients with STEMI. METHODS This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and the safety of TY-51924 in patients with first anterior STEMI who are undergoing pPCI. Immediately before pPCI, a bolus intravenous injection followed by infusion of TY-51924 (up to 30 mg/kg) or placebo was administered. Primary endpoints were myocardial salvage index (MSI) determined by (201)Tl/(123)I-beta-methyl-p-iodophenyl pentadecanoic acid (BMIPP) dual-isotope single photon emission computed tomography (SPECT) performed 3-5 days after pPCI, and safety up to 7 days. Secondary endpoints were the degree of myocardial injury based on cardiac enzyme release and QRS score by electrocardiogram (ECG), cardiac functions determined by SPECT or magnetic resonance imaging (MRI), and safety up to 3 months following pPCI. Furthermore, MRI studies were also performed where possible 3-7 days and 3 months after pPCI. DISCUSSION The appropriateness of assessing safety and efficacy of TY-51924 as adjunctive therapy to pPCI for patients with STEMI will be discussed in this study plan.