Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk

Author:

Erriquez Andrea1,Campo Gianluca1,Guiducci Vincenzo2,Escaned Javier3,Moreno Raul4,Casella Gianni5,Menozzi Mila6,Cerrato Enrico7,Sacchetta Giorgio8,Menozzi Alberto9,Santos Ignacio Amat10,Ibañes Enrique Gutiérrez11,Scarsini Roberto12,Vadalà Giuseppe13,Andò Giuseppe14,Díez-Gil José Luis15,d’Amore Sergio Musto2,Capecchi Alessandro5,Colaiori Iginio16,Gallo Francesco17,Pavasini Rita1,Marrone Andrea1,Pompei Graziella1,Lanzilotti Valerio5,Dudek Dariusz18,Barbato Emanuele19,Tebaldi Matteo20,Biscaglia Simone1

Affiliation:

1. Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy

2. Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy

3. Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain

4. Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares, Madrid, Spain, Instituto de Investigación Hospital La Paz, University Hospital La Paz, Madrid, Spain

5. Cardiology Unit, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy

6. Cardiovascular Department, Infermi Hospital, Rimini, Italy

7. Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Infermi Hospital ASLTO3, Rivoli, Turin, Italy

8. Cardiology Unit, Umberto I Hospital, ASP Siracusa, Siracusa, Italy

9. S. C. Cardiologia, Ospedale Sant’Andrea, ASL5 Liguria, La Spezia, Italy

10. Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain

11. Centro de Investigation Biomedica end Red en Enfermedades Cardiovasculares, Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain

12. Azienda Ospedaliero Universitaria Integrata di Verona, Verona, Italy

13. Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy

14. Azienda Ospedaliero Universitaria Policlinico Gaetano Martino, Messina, Italy

15. Centro de Investigation Biomedica en Red en Enfermedades Cardiovasculares, Cardiology Department, H. Universitario y Politécnico La Fe, Valencia, Spain

16. Cardiology Unit, Ospedale Santa Maria Goretti, Via Lucia Scaravelli, Latina, Italy

17. Interventional Cardiology, Department of Cardio-Thoracic and Vascular Sciences, Ospedale dell’Angelo, Via Paccagnella, Venice, Italy

18. Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland

19. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Roma, Italy

20. Interventional Cardiology Unit, Presidio Ospedaliero San Salvatore di Pesaro, Pesaro, Italy

Abstract

ImportancePatients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI).ObjectiveTo investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease.Design, Setting, and ParticipantsThis was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document.InterventionsPatients were randomized to either physiology-guided complete revascularization or culprit-only strategy.Main Outcomes and MeasuresThe primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5.ResultsAmong 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points.Conclusions and RelevanceHBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI.Trial RegistrationClinicalTrials.gov Identifier: NCT03772743

Publisher

American Medical Association (AMA)

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