AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.
Patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography.
Acute myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation myocardial infarction [NSTEMI]).
Age < 18 years old.
Pregnancy.
Severe left ventricle systolic dysfunction (left ventricular ejection fraction ≤30 %).
An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for ICA at participating centers.
Cohort
Prospective
An advanced invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP)
Diagnostic testAID strategy encompasses a hierarchical algorithm intended to investigate both obstructive and non-obstructive causes of myocardial ischaemia. AID strategy starts with an ICA. Angiographically severe-grade stenosis (≥90%) can be safely considered flow-limiting without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis will be evaluated with FFR and/or NHPR in order to determine if they are physiologically significant. Those patients with non-obstructive CAD or normal epicardial coronary arteries should undergo functional coronary tests to investigate the presence of microcirculatory and vasomotor coronary disorders, which would account for non-obstructive causes of ischaemia. Angiography derived physiology will be performed by applying functional coronary angiography to the coronary angiogram using AngioPlus Core software (Pulse Medical Technology, Shanghai, China).
The proportion of patients in whom the origins of obstructive disease and causes of post-PCI angina is identified using the AID strategy combining with ADP.
To establish the obstructive and non-obstructive causes of post-PCI angina and the origins of obstructive disease in an all-comers population of patients referred for invasive angiography using the AID strategy combining with ADP. The origins of obstructive disease can be classified as * Progression of CAD: the presence of a new hemodynamically significant stenosis outside the previous stent(s) which was not detectable by the previous angiogram (Previous PCI µFR\>0.80). * Post-PCI residual disease: the presence of a hemodynamically significant stenosis outside the stent(s) segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80). * Suboptimal stenting: the presence of a hemodynamically significant stenosis within the stented segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80). * In stent restenosis (ISR): the presence of a hemodynamically significant stenosis inside the stented segment which was not detectable by the previous angiogram
The improvement of angina symptom at 6 months
To investigate the benefits of applying the advance invasive diagnosis (AID) strategy in the improvement of angina symptoms at 6 months, evaluated by the Seattle Angina Questionnaire (SAQ). The SAQ score will be reported on a scale of 0-100 with the higher score means less angina symptom (better outcome).
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Fundacion Investigacion Interhospitalaria Cardiovascular
Lead sponsor
Hospital San Carlos, Madrid
Sponsor institution
Instituto de Salud Carlos III
Collaborator
