ABI
: ankle–brachial index
ACCORD
: Action to Control Cardiovascular Risk in Diabetes
ADVANCE
: Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation
AGREE
: Appraisal of Guidelines Research and Evaluation
AHA
: American Heart Association
apoA1
: apolipoprotein A1
apoB
: apolipoprotein B
CABG
: coronary artery bypass graft surgery
CARDS
: Collaborative AtoRvastatin Diabetes Study
CCNAP
: Council on Cardiovascular Nursing and Allied Professions
CHARISMA
: Clopidogrel for High Athero-thrombotic Risk and Ischemic Stabilisation, Management, and Avoidance
CHD
: coronary heart disease
CKD
: chronic kidney disease
COMMIT
: Clopidogrel and Metoprolol in Myocardial Infarction Trial
CRP
: C-reactive protein
CURE
: Clopidogrel in Unstable Angina to Prevent Recurrent Events
CVD
: cardiovascular disease
DALYs
: disability-adjusted life years
DBP
: diastolic blood pressure
DCCT
: Diabetes Control and Complications Trial
ED
: erectile dysfunction
eGFR
: estimated glomerular filtration rate
EHN
: European Heart Network
EPIC
: European Prospective Investigation into Cancer and Nutrition
EUROASPIRE
: European Action on Secondary and Primary Prevention through Intervention to Reduce Events
GFR
: glomerular filtration rate
GOSPEL
: Global Secondary Prevention Strategies to Limit Event Recurrence After MI
GRADE
: Grading of Recommendations Assessment, Development and Evaluation
HbA1c
: glycated haemoglobin
HDL
: high-density lipoprotein
HF-ACTION
: Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing
HOT
: Hypertension Optimal Treatment Study
HPS
: Heart Protection Study
HR
: hazard ratio
hsCRP
: high-sensitivity C-reactive protein
HYVET
: Hypertension in the Very Elderly Trial
ICD
: International Classification of Diseases
IMT
: intima-media thickness
INVEST
: International Verapamil SR/Trandolapril
JTF
: Joint Task Force
LDL
: low-density lipoprotein
Lp(a)
: lipoprotein(a)
LpPLA2
: lipoprotein-associated phospholipase 2
LVH
: left ventricular hypertrophy
MATCH
: Management of Atherothrombosis with Clopidogrel in High-risk Patients with Recent Transient Ischaemic Attack or Ischaemic Stroke
MDRD
: Modification of Diet in Renal Disease
MET
: metabolic equivalent
MONICA
: Multinational MONItoring of trends and determinants in CArdiovascular disease
NICE
: National Institute of Health and Clinical Excellence
NRT
: nicotine replacement therapy
NSTEMI
: non-ST elevation myocardial infarction
ONTARGET
: Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial
OSA
: obstructive sleep apnoea
PAD
: peripheral artery disease
PCI
: percutaneous coronary intervention
PROactive
: Prospective Pioglitazone Clinical Trial in Macrovascular Events
PWV
: pulse wave velocity
QOF
: Quality and Outcomes Framework
RCT
: randomized clinical trial
RR
: relative risk
SBP
: systolic blood pressure
SCORE
: Systematic Coronary Risk Evaluation Project
SEARCH
: Study of the Effectiveness of Additional Reductions in Cholesterol and
SHEP
: Systolic Hypertension in the Elderly Program
STEMI
: ST-elevation myocardial infarction
SU.FOL.OM3
: SUpplementation with FOlate, vitamin B6 and B12 and/or OMega-3 fatty acids
Syst-Eur
: Systolic Hypertension in Europe
TNT
: Treating to New Targets
UKPDS
: United Kingdom Prospective Diabetes Study
VADT
: Veterans Affairs Diabetes Trial
VALUE
: Valsartan Antihypertensive Long-term Use
VITATOPS
: VITAmins TO Prevent Stroke
VLDL
: very low-density lipoprotein
WHO
: World Health Organization

### 1.1 Introduction

Atherosclerotic cardiovascular disease (CVD) is a chronic disorder developing insidiously throughout life and usually progressing to an advanced stage by the time symptoms occur. It remains the major cause of premature death in Europe, even though CVD mortality has …

/pdf/european-guidelines-on-cardiovascular-disease-prevention-in-4z4nw4311i.pdf

European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (Version 2012)

Jeffrey L. Anderson, MD, FACC, FAHA, Chair 

Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect 

Nancy M. Albert, PhD, RN, FAHA

Biykem Bozkurt, MD, PhD, FACC, FAHA

Ralph G. Brindis, MD, MPH, MACC

Mark A. Creager, MD, FACC, FAHA[#][1]

Lesley H. Curtis, PhD, FAHA

David DeMets, PhD[#][1]

Robert A

/pdf/2014-aha-acc-hrs-guideline-for-the-management-of-patients-1v8ficsqox.pdf

2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society

Preamble 2072

1. Introduction 2074

2. Clinical Characteristics and Evaluation of AF 2076

3. Thromboembolic Risk and Treatment 2077

4. Rate Control: Recommendations 2079

5. Rhythm Control: Recommendations 2080

6. Specific Patient Groups and AF: Recommendations 2086

7. Evidence Gaps and Future Research Directions 2089

References 2090

Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2095

Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant) 2097

Appendix 3. Initial Clinical Evaluation in Patients With AF 2104

The medical profession should play a central role in evaluating the evidence related to drugs, devices, and procedures for the detection, management, and prevention of disease. When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve the quality of care, optimize patient outcomes, and favorably affect costs by focusing resources on the most effective strategies. An organized …

/pdf/2014-aha-acc-hrs-guideline-for-the-management-of-patients-4kflhgi5zh.pdf

2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary

2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society

Writing Group Members* Craig T. January, MD, PhD, FACC (Chair), L. Samuel Wann, MD, MACC, FAHA (Vice Chair), Hugh Calkins, MD, FACC, FAHA, FHRS,* Lin Y. Chen, MD, MS, FACC, FAHA, FHRS, Joaquin E. Cigarroa, MD, FACC, Joseph C. Cleveland Jr., MD, FACC,*,x Patrick T. Ellinor, MD, PhD,* Michael D. Ezekowitz, MBChB, DPhil, FACC, FAHA,*,k Michael E. Field, MD, FACC, FAHA, FHRS,k Karen L. Furie, MD, MPH, FAHA,k Paul A. Heidenreich, MD, FACC, FAHA,{ Katherine T. Murray, MD, FACC, FAHA, FHRS,k Julie B. Shea, MS, RNCS, FHRS,*,k Cynthia M. Tracy, MD, FAHA,k Clyde W. Yancy, MD, MACC, FAHAk

2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons

Background Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes Methods We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic The primary end point was the time to a first major event (stroke, major bleeding episode, or death) Results The patients were followed for 20 to 475 years, for a total of 8730 patient-years of follow-up The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing 

https://www.nejm.org/doi/pdf/10.1056/NEJMoa1002617

Effect of Home Testing of International Normalized Ratio on Clinical Events

SUMMARY A class of flexible and asymptotically efficient group sequential designs is developed herein for one-sided and two-sided tests of the parameter of an exponential family. Efficiency is measured in terms of the expected sample size and power function, under prespecified constraints on the maximum sample size and Type I error probability. It is shown how these designs achieve asymptotic efficiency by adapting to the information about the unknown parameter during the course of the experiment. Moreover, they are very flexible and can circumvent the difficulties due to 'information time' versus 'calendar time' that arise in more complex settings such as time-sequential clinical trials comparing the failure times of two treatments.

Power, sample size and adaptation considerations in the design of group sequential clinical trials

Introduction.- Nonlinear Regression, Experimental Design, and Phase I Clinical Trials.- Sequential Testing Theory and Stochastic Optimization over Time.- Group Sequential Design of Phase II and III Trials.- Sequential Methods for Vaccine Safety Evaluation and Surveillance in Public Health.- Time-Sequential Design of Clinical Trials with Failure-Time Endpoints.- Confidence Intervals and p-Values.- Adaptive Design of Confirmatory Trials.- References.

Sequential Experimentation in Clinical Trials: Design and Analysis

Features 7 Interdisciplinary approach that Statistics researchers and advanced students will use, in addition to Statisticians working in medical fields 7 Includes recent work that provides a new class of adaptive designs which are both flexible and efficient a new development for adaptive design literature 7 Uses a unique approach to: early phase I and II trials, both information and time-sequential phase III trials, the analysis following a clinical trial, the interactions between each of the stages

Sequential Experimentation in Clinical Trials

The evaluation of vaccine safety involves pre-clinical animal studies, pre-licensure randomized clinical trials, and post-licensure safety studies. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the vaccine exceeds a prescribed bound on the adverse event rate. After a review of the recent developments in this area, we propose a new class of sequential generalized likelihood ratio tests for evaluating adverse event rates in two-armed pre-licensure clinical trials and single-armed post-licensure studies. The proposed approach is illustrated using data from the Rotavirus Efficacy and Safety Trial. Simulation studies of the performance of the proposed approach and other methods are also given.

/pdf/sequential-generalized-likelihood-ratio-tests-for-vaccine-1gd6ins2uy.pdf

Mei-Chiung Shih

Papers

Effect of Home Testing of International Normalized Ratio on Clinical Events

Power, sample size and adaptation considerations in the design of group sequential clinical trials

Sequential Experimentation in Clinical Trials: Design and Analysis

Sequential Experimentation in Clinical Trials

Sequential generalized likelihood ratio tests for vaccine safety evaluation.