Functional Coronary Angiography Guided Revascularization in STEMI
- Conditions
- Myocardial Infarction
- Interventions
- Other: Angiography-derived FFR PCI indication and planningOther: Angiography-guided PCI
- Registration Number
- NCT05818475
- Lead Sponsor
- University Hospital of Ferrara
- Brief Summary
The goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI patients with multivessel disease.
The main questions it aims to answer are:
* is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization.
* is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC) type 3-5.
Participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.
- Detailed Description
Reperfusion of the culprit lesion through primary PCI is the standard of care in ST-segment elevation myocardial infarction (STEMI) patients, regardless of their age. The actual gold standard for the management of non-culprit lesions in STEMI patients with multivessel disease (MVD) is angiography-guided complete revascularization. The Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease after Primary PCI for STEMI (COMPLETE) trial randomized 4 041 patients with STEMI and MVD. The main finding was the highly significant reduction of new MI occurrence in the complete group (7.9% vs 5.4%, hazard ratio (HR) 0.68, 95% CI 0.53-0.87, p=0.002). Revascularization was obtained largely by angiographic evaluation (\>99%).
After COMPLETE, the subsequent step was to ascertain which complete revascularization strategy should be pursued. In particular, physiology-guided revascularization was compared to an angio-guided strategy. The advantages of physiology against angiography are related to: a) lower number of vessels treated, b) lower number of stents implanted; c) avoidance of a second procedure in negative fractional flow reserve (FFR) patients during primary PCI; d) possibility to optimize the procedure from the physiological standpoint after percutaneous coronary intervention (PCI).
In the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI), patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery were randomly assigned to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. FFR-guided revascularization was associated with lower number of stents implanted per patient (1.01±0.99 versus 1.50±0.86). During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively.
The results of the FLOWER-MI trial may suggest that physiology can provide a similar outcome if compared to a conventional angio-guided approach. However, some limitation should be acknowledged: i) rate of events was three-times lower than expected suggesting both a selection bias and the need of a higher number of patients to demonstrate any difference among the two groups; ii) all patients in the FFR-group received a staged procedure to perform physiology assessment diluting one of the major advantages in FFR negative patients, namely the avoidance of a second procedure if physiology is negative; iii) in 16% of patients in the physio-guided group FFR was not performed before PCI, whereas in 82% of patients it was not performed after PCI; iv) even if FFR was associated with lower PCIs, periprocedural MI was three times higher if compared to the angio-group, suggesting its possible underreporting in the angio-group.
After the COMPLETE trial2, the actual standard of care in the management of STEMI patients with MVD is complete revascularization based on angiography. However, this approach may lead to over- or under-estimation of lesions in a relevant portion of patients with negative impact on prognosis. Invasive physiology has been consistently shown to be superior if compared to angio-guided strategy, but it is underutilized in clinical practice mainly due to feasibility issues.
A functional coronary angiography could overcome the applicability issues related to invasive physiology. In addition, it is particularly appealing in the evaluation of non-culprit lesions since:
1. It is possible to acquire projection during primary PCI and perform the analysis off-line
2. In case of negative assessment, the patient can avoid a second procedure to invasively measure physiology
3. It is possible to optimize most of the procedures by the physiological standpoint through the utilization of the virtual-PCI planner tool pre-PCI without the need to repeat physiology after PCI.
4. It has been recently shown that if compared to an angio-guided approach, Angiography-derived FFR was able to reduce the incidence of spontaneous MI by 36% Therefore, a strategy based on functional coronary angiography to indicate and guide PCI could be superior if compared to an angio-guided strategy both from the efficacy (CV death, cerebrovascular accident, MI and ischemia-driven revascularization) and from the safety (BARC 3-5, contrast-associated acute kidney injury) standpoint.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1823
- ST-segment elevation myocardial infarction with indication to invasive management
- Multi-vessel disease defined as at least 1 non-culprit coronary artery lesion at least 2.5 mm in diameter deemed at visual estimation with a diameter stenosis % ranging from 50 to 99% amenable to successful treatment with PCI
- Successful treatment of culprit lesion
- Planned surgical revascularization
- Left main as non-culprit lesion
- Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
- Any factor precluding 1-year follow-up
- Prior Coronary Artery Bypass Graft (CABG) Surgery
- Impossibility to identify a clear culprit lesion
- Presence of a chronic total occlusion (CTO)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography-derived FFR PCI indication and planning Angiography-derived FFR PCI indication and planning Patients will receive PCI of all lesions with at least 50% diameter stenosis and positive angiography-derived FFR value (≤0.80). PCI planning will be based on the pullback curve obtained by angiography-derived FFR to obtain an optimal post-PCI physiology. Angiography-guided PCI Angiography-guided PCI Patients will receive PCI of all lesions with at least 50% diameter stenosis at visual estimation. PCI plan and assessment of PCI results will be based on angiography.
- Primary Outcome Measures
Name Time Method Primary Efficacy Outcome: Patient Oriented Composite Outcome through study completion, an average of 18 months Cumulative occurrence of mortality, cerebrovascular accident, reinfarction, or ischemia-driven revascularization
Primary Safety Outcome: Major Bleeding and Contrast - Associated Acute Kidney Injury through study completion, an average of 18 months Cumulative occurrence of contrast-associated acute kidney injury and bleeding BARC 3-5
- Secondary Outcome Measures
Name Time Method Main Secondary Outcome: Cardiovascular Mortality and Myocardial Infarction through study completion, an average of 18 months Cumulative occurrence of cardiovascular mortality and myocardial infarction
Trial Locations
- Locations (22)
AUSL Bologna Ospedale Maggiore
🇮🇹Bologna, BO, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Ferrara, FE, Italy
Ospedale Annunziata
🇮🇹Cosenza, Italy
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Ospedale Maggiore della Carità Novara
🇮🇹Novara, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
AUSL Romagna Santa Maria delle Croci Ravenna
🇮🇹Ravenna, Italy
Policlinico Casilino
🇮🇹Roma, Italy
NICVD Karachi
🇵🇰Karachi, Pakistan
Ospedale Civile di Baggiovara
🇮🇹Baggiovara, MO, Italy
AUSL Piacenza
🇮🇹Piacenza, PC, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, PR, Italy
Arcispedale Santa Maria Nuova di Reggio Emilia
🇮🇹Reggio Emilia, RE, Italy
AUSL Romagna Ospedale degli Infermi Rimini
🇮🇹Rimini, RN, Italy
Ospedale Santa Maria della Misericordia Rovigo
🇮🇹Rovigo, RO, Italy
Ospedale dell'Angelo Mestre
🇮🇹Mestre, VE, Italy
Ospedale Mater Salutis Legnago
🇮🇹Legnago, VR, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
🇮🇹Verona, VR, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale di Bolzano
🇮🇹Bolzano, Italy
AORN Sant'Anna e San Sebastiano
🇮🇹Caserta, Italy
Azienda Ospedaliero Universitaria Mater Domini
🇮🇹Catanzaro, Italy