The COronary and MICrocirculatory measurements in patients with Aortic valve Stenosis (COMIC-AS) study: Rationale and design
Objective: Although coronary artery disease (CAD) is frequent in patients with aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging. Myocardial hypertrophic remodelling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and non-hyperemic pressure ratios (NHPRs). The aim is to investigate these effects on current CAD indices by comparing intra-coronary hemodynamics prior to, immediately after and six months after aortic valve replacement (AVR), when it is expected that microvascular function has improved. Furthermore, we will compare FFR and Resting Full Cycle Ratio (RFR) with myocardial perfusion SPECT as indicators of myocardial ischemia in patients with AS and CAD. Study design: One hundred patients with AS and CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intra-coronary hemodynamic assessment at baseline, immediately after and six months after AVR. The primary endpoint is the change in FFR. Secondary endpoints include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR.Conclusion: The present study will evaluate intra-coronary physiology before, immediately after and six months after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR and microvascular function may help guide the need for revascularization in these patients.