Title page -- Copyright page -- Contents -- List of Contributors -- Preface -- List of Abbreviations -- CHAPTER 1: Introduction to randomized clinical trials in cardiovascular disease -- What is a randomized clinical trial? -- Concept of randomization -- Clinical trial phases -- Preclinical studies -- Phase 1 clinical trials -- Phase 2 clinical trials -- Phase 3 clinical trials -- Phase 4 clinical trials -- Study objective -- Study populations -- Efficacy variables -- Surrogate variables -- Control groups -- Placebo-controlled trials -- Active-control trials -- Study design (bias) -- Methods of randomization -- Minimization -- Random and systematic error -- Study design issues to overcome systematic bias -- Blinding -- Study design (samples) -- Comparisons -- Trials to show superiority -- Trials to show equivalence or non-inferiority -- Trials to show a dose-response relationship -- Study protocol -- Trial monitoring -- Data monitoring -- Data analysis sets -- Intention-to-treat analysis and data set -- Per protocol analysis and on-treatment analysis data sets -- Subgroup analysis data sets -- Unit of analysis -- Missing data -- Sensitivity analysis -- Analysis methods -- Demographic and other baseline characteristics -- Measurements of treatment compliance -- Analysis of efficacy -- Distribution of data -- Statistical analysis of clinical trials (elementary concepts) -- Adjustments for covariates -- Time to event ("survival") analysis -- Sample size and power -- Safety evaluation -- Subsets and more -- Types of significance -- Statistical significance -- Practical or "clinical" significance -- How have trials contributed to medical care? -- Clinical trials for treatment of high blood pressure (see also Chapter 12) -- Clinical trials of atherosclerosis, lipid lowering, and statins (see also Chapter 12).

Clinical trials of acute myocardial infarction, coronary thrombosis, aspirin, and fibrinolysis (see also Chapter 4) -- Conducting reliable trials: issues of size and simplicity -- Costs, cost-effectiveness, and health economics -- Practical issues: managing a trial, funding, and regulation -- What does the future hold? -- References -- CHAPTER 2: Publishing results of clinical trials and reviewing papers for publication -- General considerations -- Authorship -- Title -- Manuscript structure -- Abstract -- Introduction -- Methods -- Results, tables, and figures -- Discussion -- Database searches -- References -- Reviewing a submitted article for a journal -- Integrity of the data and novelty of the results -- Generalizability -- Appropriateness of the study design -- Scientific value of hypothesis and validity study results -- Adequateness of methods -- Ethical issues, plagiarism, and publication fraud -- Language style, formatting, and presentation of data -- Adequateness of citation -- Recommendation to accept or decline the manuscript -- References -- CHAPTER 3: Management of chronic coronary artery disease -- Introduction -- Definition and classification -- Pathophysiology -- Medical management of myocardial ischemia -- Lifestyle changes -- Antiplatelet agents -- ACE inhibitors -- Statins -- Inhibition of cholesterol absorption -- Beta-blockers -- Calcium channel blockers -- Nitrates -- Newer agents -- Non-pharmacological antianginal approaches -- Role of myocardial revascularization -- Comparing percutaneous coronary intervention with medical therapy -- Comparisons of CABG with medical therapy -- Comparisons of PCI with CABG surgery for multivessel coronary artery disease -- Prognosis with optimal management -- CHARISMA trial -- Putting CHARISMA into therapeutic perspective -- COURAGE trial.

Intensity of optimal medical therapy and importance of achieving treatment targets -- Angina relief and improved quality of life -- Reducing myocardial ischemia -- Has clinical practice changed post COURAGE? -- Conclusions -- References -- CHAPTER 4: Acute coronary syndromes (ST elevation and non-ST elevation) -- Definition and pathophysiology -- Epidemiology and healthcare costs -- Diagnosis -- Examination -- Investigation -- Electrocardiography -- Cardiac markers -- Role of imaging techniques -- Management -- General measures -- Antithrombotic therapies -- Other treatments -- Reperfusion therapy -- Appraisal of selected clinical trials that have changed the management of acute coronary syndromes -- CURE trial -- TRITON-TIMI-38 trial -- PLATO trial -- CURRENT-OASIS 7 trial -- Conclusions -- References -- CHAPTER 5: Heart failure -- Epidemiology -- Pathophysiology -- Clinical presentation: registry data -- Standard management strategies -- Pharmacological therapies -- Device therapies -- Surgical therapies -- Exercise training -- Current challenges of heart failure: acute heart failure syndromes -- Pharmacological fluid management -- Vasodilators -- Inotropes -- Conclusion -- References -- CHAPTER 6: Atrial fibrillation -- Introduction -- Epidemiology -- Clinical classification -- Management -- New-onset atrial fibrillation -- Cardioversion -- Rate control -- Paroxysmal atrial fibrillation -- Persistent atrial fibrillation -- Permanent atrial fibrillation -- Non-pharmacological treatments -- Thromboembolism prevention -- Warfarin versus placebo -- Aspirin versus placebo -- Warfarin versus antiplatelet therapy -- Combined warfarin and antiplatelet therapy -- Combined aspirin and clopidogrel therapy versus placebo -- Antithrombotic treatment with direct thrombin inhibitors -- Triple antithrombotic therapy -- Stroke risk stratification -- Bleeding risk.

Conclusion -- References -- CHAPTER 7: Electrophysiology and pacing -- Arrhythmias -- Sinus rhythm -- Mechanisms -- Pacing and pacing technologies -- Implantation procedure -- Indications and differential pacing modes -- Electrophysiological assessment -- Conventional mapping techniques -- Baseline electrophysiological study -- Myocardial mapping for arrhythmias -- Ablation procedures -- "Simple" electrophysiological substrates -- "Complex" electrophysiological substrates -- Mapping and ablation of focal tachycardias (atrial or ventricular) -- Mapping and ablation for macrore-entrant tachycardias (atrial or ventricular) -- Implantable defibrillators -- Technical basics -- Lead integrity -- Specific functions: tachyarrhythmia detection and therapy -- Cardiac resynchronization -- Lead implantation -- Pacing modes -- Indications -- Review of key clinical trials -- Defibrillators -- Cardiac resynchronization -- Review of key trials evaluating atrial fibrillation ablation versus medical therapy -- Conclusion -- Disclaimer -- References -- CHAPTER 8: Percutaneous coronary intervention -- Introduction -- Balloon PTCA -- PTCA versus medical therapy (Table ) -- Current indications for PTCA alone -- Bare metal stents -- Bare metal stents versus PTCA (Table ) -- Drug-eluting stents -- Sirolimus-eluting stents -- Paclitaxel-eluting stents -- SES versus PES -- Everolimus-eluting stents -- Zotarolimus-eluting stents -- EES versus ZES -- Biodegradable stents -- Local antiproliferative treatment for in-stent restenosis -- Directional coronary atherectomy -- Cutting balloon angioplasty -- Rotational atherectomy -- Excimer laser angioplasty -- Mechanical thrombectomy -- For primary PCI (Table ) -- For SVG interventions -- Special issues -- Femoral versus radial access -- Left main PCI -- Revascularization of chronic totally occluded lesions -- Conclusions.

References -- CHAPTER 9: Randomized controlled trials in cardiac surgery: is there any alternative? -- Controversies and uncertainties in cardiac surgery -- Need for a hierarchical system to stratify the evidence -- What are the most common difficulties encountered in performing RCTs in cardiac surgery? -- Randomization and blinding -- Methodological issues -- Recruitment process -- Funding -- Need for a variety of endpoints and patient-reported based outcomes -- Need to improve reporting of RCTs in cardiac surgery -- A palliative treatment for the problem: the need for progress in statistical methodology of non-randomized designs -- Matching -- Multivariable logistic regression analysis and adjustment -- Use of multilevel and hierarchical modeling -- Use of Bayesian methods and statistical simulation techniques -- Use of balancing scores -- Recent clinical trials in cardiac surgery: where are we? -- The STICH trial -- Surgery versus stent trials -- Transcatheter versus surgical aortic valve replacement -- Conclusions -- References -- CHAPTER 10: Adult congenital heart disease -- Introduction -- Atrial septal defects -- Anatomy -- Clinical implications -- Treatment -- Patent foramen ovale -- Embryology -- Clinical implications -- Management -- Tetralogy of Fallot -- Sudden cardiac death -- Pulmonary valve replacement -- Eisenmenger syndrome -- Pregnancy in patients with adult congenital heart disease -- Aortic stenosis -- Pulmonic stenosis -- Pulmonary regurgitation -- Aortopathies -- References -- CHAPTER 11: Cardiac imaging -- Introduction -- Myocardial perfusion imaging with SPECT or PET -- SPECT MPI -- PET MPI and PET-FDG imaging -- Non-perfusion parameters on myocardial perfusion imaging -- Diagnostic value of myocardial perfusion imaging -- Role of nuclear cardiology in clinical decision-making: evidence-based approach -- Whom should we scan?.

Summary.