Secondary endpoint objectives
angina, Seattle angina, dislocations, infections, angina pectoris
MAJOR ADVERSE CARDIAC EVENTS, SECONDARY, INFECTIONS
An overview of the secondary objectives is given in Table Secondary objectives.
Changes in absolute quantification of myocardial blood flow using myocardial perfusion PET scan including myocardial blood flow & myocardial flow reserve regionally and globally.
Patient related outcome measures:
Patient condition using 6‐minute walking test;Frequency of angina pectoris using the SAQ;Severity of angina pectoris using the Numeric Rating Scale;Grading of angina pectoris using the Canadian Cardiovascular Society class;Quality of life using the RAND 36‐item Health Survey;Frequency of short‐acting nitrate use using the SAQ.
Major Adverse Cardiac Events:
Number of hospital admissions due to acute coronary syndrome;Revascularization (CABG and/or PCI);Number of presentations at the emergency room due to angina pectoris;Cardiovascular mortality.
Safety endpoints;
Number of device infections (lead and/or battery);Number of device dislocations (lead and/or battery);Number of lead fractures/breakages;Number of lead failures;Number of battery end of life.Abbreviations: CABG, coronary artery bypass grafting; PCI, percutaneous coronary intervention; PET, positron emission tomography; SAQ, Seattle angina questionnaire.