Italy: In a landmark randomized clinical trial, researchers have delved into a crucial aspect of cardiac care: the optimal approach to revascularization in older patients experiencing myocardial infarction (MI) and possessing a high risk of bleeding. The study, published in JAMA Cardiology, sheds light on a debate that has long perplexed cardiologists and aims to provide clarity for practitioners and patients alike.

The prespecified analysis of the FIRE randomized clinical trial (RCT), including 1445 patients, revealed that high bleeding risk (HBR) status was common in older patients with MI, and is correlated with a significant rise in ischemic and bleeding complications risk. Physiology-guided complete revascularization effectively improves outcomes and reduces complication rate, regardless of HBR status.
Based on the findings, the researchers suggest that HBR status alone should not deter applying physiology-guided complete revascularization in older patients with MI and multivessel disease.
Myocardial infarction, commonly known as a heart attack, is a life-threatening condition characterized by a blood flow blockage to the heart muscle. Revascularization, blood flow restoration to the affected area, is a cornerstone of treatment. However, the optimal extent of revascularization has been a subject of ongoing debate, particularly in older patients with additional risk factors such as a high propensity for bleeding.
Patients with high bleeding risk have a poor prognosis, and whether they may benefit from complete revascularization after myocardial infarction is not known. Considering this, Andrea Erriquez, Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy, and colleagues aimed to investigate the benefit of physiology-guided complete revascularization versus a culprit-only strategy in patients with HBR, MI, and multivessel disease.
FIRE was an investigator-initiated, open-label, multicenter trial. Researchers enrolled patients aged 75 years or older with MI and multivessel disease at 34 European centers from 2019 to 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories per the Academic Research Consortium HBR document.
Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy.
The primary outcome comprised a composite of death, stroke, MI, or revascularization at one year. Secondary outcomes included a composite of MI or cardiovascular death and Bleeding Academic Research Consortium (BARC) types 3 to 5.
The following were the key findings of the study:
Among 1445 patients (mean age, 81 years; 63% male), 71% met HBR criteria.
Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01), cardiovascular death or MI (HR, 1.89), and BARC types 3 to 5 (HR, 3.28).
There was a significant reduction in the primary endpoint with physiology-guided complete revascularization than the culprit-only strategy in patients with HBR (HR, 0.73).
There was no indication of interaction between revascularization strategy and HBR status for primary and secondary endpoints.
The findings suggest that HBR status was common in older patients with MI and was linked with a higher risk of ischemic and bleeding complications, including death. Physiology-guided complete revascularization emerged as an effective method to reduce ischemic complications, including myocardial infarction and cardiovascular death, and should be considered in treating patients with HBR.
In conclusion, the randomized clinical trial comparing complete versus culprit-only revascularization in older patients with myocardial infarction and high bleeding risk represents a significant advancement in the field of cardiology. These findings are poised to inform guidelines and shape clinical practice, ultimately improving the quality of care for individuals navigating the complexities of cardiovascular disease.
Reference:
Erriquez A, Campo G, Guiducci V, et al. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial. JAMA Cardiol. Published online May 08, 2024.
doi:10.1001/jamacardio.2024.0804