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.

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.

Two years clinical outcomes with the state-of-the-art PCI for the treatment of bifurcation lesions: A sub-analysis of the SYNTAX II study.

Background: Bifurcation PCI is associated with a lower rate of procedural success, especially in multivessel disease patients. We aimed to determine the impact of bifurcation treatment on 2-years clinical outcomes when a state-of-the-art PCI strategy (heart team decision-making using the SYNTAX score II, physiology guided coronary stenosis assessment, thin strut bioresorbable polymer drug-eluting stent, and intravascular ultrasound guidance) is followed.

Methods: Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281).

Aortic Stenosis and Heart Failure: Disease Ascertainment and Statistical Considerations for Clinical Trials.

Aortic stenosis is a progressive disease that develops over decades, and once symptomatic and untreated, is associated with poor survival. Transcatheter aortic valve replacement has evolved significantly in the past decade and has expanded its indication from surgically inoperable and high-risk patients to patients with intermediate risk. Assessment of heart failure-related outcomes include the use of functional assessments, disease-specific quality of life surveys and standardised ascertainment of events, such as hospitalisations.

Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.

The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization.

Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document.

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials.

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.

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.

Detecting Periprocedural Myocardial Infarction in Contemporary Percutaneous Coronary Intervention Trials.

Objectives: This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions.

Quantitative Doppler for Estimation of Paravalvular Leakage after Transcatheter Aortic Valve Implantation.

Background: The echocardiographic grading of paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) severity is challenging. The study aim was to assess the value of quantitative Doppler echocardiography to monitor PVL severity.

Methods: A total of 100 subjects was enrolled in the study, including 65 consecutive patients who had undergone TAVI with a CoreValve prosthesis and without valvular aortic regurgitation, and 35 normal controls.

Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial.

Background: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SES).

Methods: Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36).

Phosphate- or Citrate-Buffered Tirofiban Versus Unfractionated Heparin and its Impact on Thrombocytopenia and Clinical Outcomes in Patients With Acute Coronary Syndrome: A Post Hoc Analysis From the PRISM Trial.

Objectives: The aim of this study was to investigate whether the 2 tirofiban formulations tested in the early and late phases of the PRISM (Platelet Receptor Inhibitor in Ischemic Syndrome Management) trial might differ with respect to risk for thrombocytopenia and clinical outcomes compared with unfractionated heparin (UFH).

Background: Citrate-buffered tirofiban is currently marketed as brand-name drug. However, tirofiban has recently been promoted in some countries as a generic drug with different formulations, such as phosphate-buffered product.

Prediction of atherosclerotic disease progression using LDL transport modelling: a serial computed tomographic coronary angiographic study.

Aim: To investigate the efficacy of low-density lipoprotein (LDL) transport simulation in reconstructed arteries derived from computed tomography coronary angiography (CTCA) to predict coronary segments that are prone to progress.

Methods And Results: Thirty-two patients admitted with an acute coronary event who underwent 64-slice CTCA after percutaneous coronary intervention and at 3-year follow-up were included in the analysis. The CTCA data were used to reconstruct the coronary anatomy of the untreated vessels at baseline and follow-up, and LDL transport simulation was performed in the baseline models.

First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.

Background: Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.

Methods And Results: The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.

DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial.

Aims: Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load.

Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II).

Objectives: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment.

Background: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR.

Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial.

Background: The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the "site" SYNTAX SS (sSS) remain unknown.

Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials.

Objective: To investigate the long-term prognostic implications of coronary calcification in patients undergoing percutaneous coronary intervention for obstructive coronary artery disease.

Methods: Patient-level data from 6296 patients enrolled in seven clinical drug-eluting stents trials were analysed to identify in angiographic images the presence of severe coronary calcification by an independent academic research organisation (Cardialysis, Rotterdam, The Netherlands). Clinical outcomes at 3-years follow-up including all-cause mortality, death-myocardial infarction (MI), and the composite end-point of all-cause death-MI-any revascularisation were compared between patients with and without severe calcification.

Prognostic implications of severe coronary calcification in patients undergoing coronary artery bypass surgery: an analysis of the SYNTAX study.

Objectives: To investigate the prognostic implications of the presence of severe lesion calcification in patients undergoing coronary artery bypass graft (CABG) operation.

Background: There is robust evidence that lesion calcification is a predictor of worse prognosis in patients undergoing percutaneous coronary intervention; however, there is limited data about the prognostic implication of lesion calcium in patients treated with CABG.

Methods: We retrospectively analyzed data from 1,545 patients who underwent CABG and were recruited in the SYNTAX study and CABG registry.

Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention.

Aims: To compare clinical outcomes after percutaneous coronary intervention (PCI) between patients with acute coronary syndromes (ACS) and those with stable ischaemic heart disease (SIHD) stratified by anatomic disease complexity (SYNTAX score).

Methods And Results: Patient-level data from three all-comers PCI trials were pooled. Patients (n=4,204) were stratified by clinical presentation (i.

Short-term and long-term clinical impact of stent thrombosis and graft occlusion in the SYNTAX trial at 5 years: Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery trial.

Objectives: The aim of this study was to report the short-term and long-term clinical impact of stent thrombosis (ST) and graft occlusion (GO) in the final 5-year outcomes of the SYNTAX (SYNergy Between PCI With TAXUS and Cardiac Surgery) trial.

Background: The clinical effect of newer-generation drug-eluting stents and operative factors in complex coronary artery disease is uncertain.

Methods: The incidence of 5-year ST and GO, and their association with clinical outcomes, were analyzed in the randomized percutaneous coronary intervention and coronary artery bypass graft cohorts.

Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: a substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial.

Aims: The aim of the present investigation was to determine the long-term prognostic association of post-procedural cardiac enzyme elevation within the randomised Synergy between Percutaneous Coronary Intervention (PCI) with TAXUS and Cardiac Surgery (SYNTAX) Trial.

Methods: 1800 patients with unprotected left main or de novo three-vessel coronary artery disease were randomised to undergo coronary artery bypass graft (CABG) surgery or PCI. Per protocol patients underwent post-procedural blood sampling with creatine kinase (CK), and the cardiac specific MB iso-enzyme (CK-MB) only if the preceding CK ratio was ≥ 2 × the upper limit of normal (ULN).