Persistent or recurrent angina after successful percutaneous coronary intervention (PCI) remains a common clinical problem, affecting approximately 20-30% of patients despite complete epicardial coronary revascularization. Coronary microvascular dysfunction (CMD) has been proposed as a potential mechanism underlying persistent symptoms and abnormal functional testing after PCI, but it is still unclear whether CMD develops as a consequence of the PCI procedure or represents a pre-existing condition associated with coronary artery disease.
The NICE-CAD-PCI study is a prospective, single-center study designed to investigate coronary microvascular function in patients with stable single-vessel coronary artery disease treated with PCI. Specifically, the study will compare coronary microvascular function in the left anterior descending coronary artery (LAD) territory between patients undergoing PCI of the LAD and patients undergoing PCI of a different coronary artery (right coronary artery or left circumflex artery). This approach aims to clarify whether impaired coronary microvascular function is limited to the treated vascular territory, suggesting a PCI-related effect, or is also present in non-treated territories, supporting the hypothesis of a pre-existing generalized microvascular abnormality.
Within four weeks after PCI, all participants will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE) to assess coronary blood flow velocity in the LAD during hyperventilation, cold pressor, and dipyridamole stress tests. Coronary flow reserve and coronary flow responses to the different physiological stimuli will be evaluated as markers of coronary vascular function.
Participants will be followed for six months after PCI to assess the occurrence of clinically driven target lesion revascularization and major adverse cardiovascular events. The study will also explore whether abnormalities detected by non-invasive coronary functional testing are associated with restenosis or adverse clinical outcomes.
The findings of this study may improve the understanding of the mechanisms responsible for persistent symptoms after PCI and contribute to the identification of patients with coronary microvascular dysfunction who may benefit from tailored diagnostic and therapeutic strategies.
Invasive coronary angiography and PCI performed within the previous 4 weeks from enrollment;
Obstructive single-vessel CAD (>75% coronary diameter reduction or fractional flow reserve <0.80) treated with PCI.
Presentation as an acute coronary syndrome (i.e. unstable angina or myocardial infarction) or a typical history of variant angina (frequent angina pain at rest with ST-segment elevation at the ECG, caused by recurrent coronary spasm);
Previous history of specific heart disease, e.g., ischemic (previous percutaneous or surgical myocardial revascularization, myocardial infarction), valvular, congenital heart disease or cardiomyopathy;
Multivessel coronary artery disease;
Serious medical conditions, including renal failure (eGFR <30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
Parallel
Coronary flow reserve assessed by Echocardiography
Diagnostic testAll patients and controls will undergo the following tests during transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, with time intervals of 15 minutes from each other: a) hyperventilation test: the patient is asked to breathe at a rate of 30 respirations per minute, for 5 minutes; b) cold pressor test: the patient puts his/her right hand in ice water for 2 minutes; c) dipyridamole test: intravenous dipyridamole is administered at a dose of 0.84 mg/kg over 6 minutes; Peak diastolic velocity (PDV) of blood flow in the left anterior descending coronary artery will be measured before and at the end of each test by pulsed-wave Doppler, using a GE E95 echocardiographic machine. The ratio between peak flow velocity of coronary blood flow at peak of each test and the relative basal peak flow velocity of coronary blood flow is taken as the response of coronary blood flow velocity to each test.
Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups
Coronary flow reserve (CFR) will be measured by transthoracic Doppler echocardiography (TTDE) in the left anterior descending coronary artery during dipyridamole administration. CFR will be calculated as the ratio between peak hyperemic and baseline diastolic coronary blood flow velocity. Mean CFR values will be compared between patients undergoing PCI of the LAD (LAD group) and patients undergoing PCI of a non-LAD coronary artery (non-LAD group). CFR is a dimensionless ratio.
Incidence of major adverse cardiovascular events (MACE) according to the presence of functional coronary abnormalities
The incidence of major adverse cardiovascular events (MACE) at 6-month follow-up will be assessed according to the presence or absence of functional coronary abnormalities detected by transthoracic Doppler echocardiography (TTDE) during coronary functional testing. MACE will be defined as a composite of cardiovascular death, myocardial infarction, and target vessel revascularization (percutaneous or surgical). The outcome will be reported as the number and percentage of patients experiencing at least one MACE during follow-up.
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