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

Cardiovascular complications after revascularization of chronic limb-threatening ischemia (CLTI) are major concerns that guide treatment. Our goal was to assess cardiac and vascular serious adverse events (SAES) with 30 days of revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Criteria for an AE to be serious was one that affected safety in the trial, required or prolonged hospitalization, resulted in significant disability or incapacitation, was life threatening, or resulted in death. There were 850 OPEN and 896 ENDO per-protocol interventions analyzed. There were 40 patients (4.7%) who experienced a cardiac SAE after OPEN and 34 (3.8%) after ENDO (P = .41). Total cardiac SAEs were 54 (0.07 per patient) after OPEN and 40 (0.045 per patient) after ENDO (P = .15). Cardiac SAEs for OPEN were ischemic (52%), heart failure (15.4%), arrythmias (15.4%), heart block (3.8%), and arrest (13.5%) and for ENDO were ischemic (47.5%), heart failure (17.5%), arrythmias (15.0%), heart block (5.0%), and arrest (15.0%). More than one-half were classified as severe for OPEN and ENDO (53.0%). For OPEN, 30% were definitely/probably related and 26% were definitely/probably related for ENDO. There were 56 patients (6.6%) who experienced vascular SAEs after OPEN and 74 (8.3%) after ENDO (8.3%) (P = .2). In total, there were 60 (0.07 per patient) total vascular SAEs after OPEN and 87 (.097 per patient) after ENDO (P = .027). Vascular SAEs for OPEN were distal ischemia/infection (46%), bleeding (17%), occlusive (15%), thromboembolic (14%), cerebrovascular (5%), and other (3%) and for EDNO were distal ischemia/infection (41%), bleeding (13%), occlusive (33%), thromboembolic (9%), cerebrovascular (1%), and other (5%). SAEs were classified as severe for OPEN in 48% and ENDO in 50%. For OPEN. 27% were definitely/probably related and 38% for ENDO. Patients undergoing OPEN and ENDO revascularization experienced similar cardiac and vascular SAEs with more overall SAE in the ENDO patients. The majority were not related to the index intervention, but approximately one-half were severe.