Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome

The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.

ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.

Inclusion Criteria:

• Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
• Patients with chronic coronary syndromes
• Signed written informed consent

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled)
• Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
• Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
• Inability or unwillingness to undergo CT scan or coronary angiography
• Patients on hemodialysis or with severe hepatic or renal insufficiency
• Left main coronary artery stenosis ≥ 50%
• Target vessel total occlusion
• Pregnancy or intention to become pregnant during the course of the trial
• Patients with a life expectancy less than 2 years