Objectives: 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 (SAE) with 30 days of revascularization in the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. Methods: BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAE, 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. Results: There were 850 OPEN and 896 ENDO per protocol interventions analyzed. There were 40 (4.7%) subjects that experienced a cardiac SAE after OPEN and 34 (3.8%) after ENDO (P=.41). Total cardiac SAE were 54 (.07 per patient) after OPEN and 40 (.045 per patient) after ENDO (P=.15). Cardiac SAE 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%), heart block (5%), and arrest (15%). More than half were classified as severe for OPEN and ENDO (53%). For OPEN 30% were definitely/probably related and 26% were definitely/probably related for ENDO. There were 56 (6.6%) subjects that experienced vascular SAE after OPEN and 74 (8.3%) after ENDO (8.3%) (P=.2). In total there were with 60 (.07 per patient) total vascular SAE after OPEN and 87 (.097 per patient) after ENDO (P=.027). Vascular SAE 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%). SAE were classified as severe for OPEN in 48% and ENDO in 50%. For OPEN 27% were definitely/probably related and 38% for ENDO. Conclusion: Patients undergoing OPEN and ENDO revascularization experienced similar cardiac and vascular SAE with more overall SAE in the ENDO patients. The majority were not related to the index intervention, but about half were severe.
