Characterization of Cardiovascular Serious Adverse Events after Bypass or Endovascular Revascularization for Limb Threatening Ischemia in the BEST-CLI Trial

Jeffrey J Siracuse; Matthew T Menard; Kenneth Rosenfield; Michael S Conte; Richard Powell; Naomi Hamburg; Gheorghe Doros; Michael B Strong; Alik Farber

doi:10.1016/j.jvs.2024.04.025

Characterization of Cardiovascular Serious Adverse Events after Bypass or Endovascular Revascularization for Limb Threatening Ischemia in the BEST-CLI Trial

J Vasc Surg. 2024 Apr 14:S0741-5214(24)00987-X. doi: 10.1016/j.jvs.2024.04.025. Online ahead of print.

Authors

Jeffrey J Siracuse¹, Matthew T Menard², Kenneth Rosenfield³, Michael S Conte⁴, Richard Powell⁵, Naomi Hamburg⁶, Gheorghe Doros⁷, Michael B Strong², Alik Farber⁸

Affiliations

¹ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA. Electronic address: Jeffrey.Siracuse@bmc.org.
² Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
³ Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard medical School, Boston, MA.
⁴ Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
⁵ Division of Vascular and Endovascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
⁶ Division of Cardiovascular Medicine, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA.
⁷ Boston University, School of Public Health, Boston, MA.
⁸ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA.

PMID: 38626847
DOI: 10.1016/j.jvs.2024.04.025

Abstract

Objectives: Cardiovascular complications after revascularization to treat chronic limb threatening ischemia (CLTI) are a major concern that guides treatment. Our goal was to assess periprocedural cardiac and vascular serious adverse events (SAE) in the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion.

Results: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P=.35). Overall there were 53 Cardiac SAEs (.06 per patient) after OPEN and 40 (.045 per patient) after ENDO interventions. Cardiac SAE in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), and arrest (15%), and heart block (5%). Approximately half of SAE were classified as severe for both OPEN and ENDO. SAE's were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P=.2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P=.19). In total, there were 59 (.07 per patient) and 87 (.097 per patient) vascular SAE after OPEN and ENDO procedures. Vascular SAE in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAE were classified as severe for OPEN in 45.8% and ENDO in 46%. SAE's were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P=.35), respectively.

Conclusion: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAE. The majority were not related to the index intervention, but approximately half were severe.