Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial
We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \[15O\]H2O cardiac PET/CT in patients with symptomatic chronic coronary syndrome.
• Age \> 18 years
• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
• Known ischemic heart disease defined as one of the following
‣ Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting
⁃ Previous coronary computed tomography angiography or invasive coronary angiography documenting atherosclerosis.
• Undergoing clinically indicated \[15O\]H2O cardiac PET/CT due to chest discomfort or dyspnea as angina equivalent
• Additional inclusion criteria for randomized trial:
• Initial \[15O\]H2O cardiac PET/CT with abnormal perfusion defined as all of the following
‣ Hyperemic myocardial blood flow (hMBF) ≤2.3 mL/min/g in at least two adjacent myocardial segments
⁃ Relative hMBF ≤ 65% in at least two adjacent segments as compared with the mean hMBF of the two adjacent segments with the highest mean hMBF
⁃ Tissue perfusion defect extent ≥ 5% based on indices of relative hypoperfusion
• Clinical indication for invasive coronary angiography decided at a multidisciplinary conference between consultants in nuclear medicine and cardiology