Related Experiment Video
Updated: Aug 7, 2026
Assessing Therapeutic Angiogenesis in a Murine Model of Hindlimb Ischemia
Published on: June 8, 2019
Characterization of cardiovascular serious adverse events after bypass or endovascular revascularization for
Jeffrey J Siracuse1, Matthew T Menard2, Kenneth Rosenfield3
1Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Boston, MA.
Insights
Surgical and endovascular revascularization for chronic limb-threatening ischemia (CLTI) showed similar rates of serious adverse events (SAEs). Most SAEs were not procedure-related, but about half were severe.
Area of Science:
- Vascular Surgery
- Cardiology
- Interventional Radiology
Background:
- Cardiovascular complications are a significant concern following revascularization for chronic limb-threatening ischemia (CLTI).
- Understanding periprocedural risks is crucial for guiding treatment decisions in CLTI patients.
Purpose of the Study:
- To compare periprocedural cardiac and vascular serious adverse events (SAEs) between surgical (OPEN) and endovascular (ENDO) revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
Main Methods:
- A prospective randomized trial (BEST-CLI) comparing OPEN and ENDO revascularization for CLTI.
- Analysis of 30-day cardiac and vascular SAEs, defined by severity and impact on patient safety.
- Interventions were assessed in a per-protocol manner.
Main Results:
- No significant difference in cardiac SAEs between OPEN (4.7%) and ENDO (3.8%) groups (P=.35).
- Vascular SAEs were also similar: 6.8% in OPEN vs. 9.6% in ENDO (P=.19).
- Approximately half of all SAEs were classified as severe, with most not definitively linked to the index procedure.
Conclusions:
- Both OPEN and ENDO revascularization strategies for CLTI result in comparable rates of cardiac and vascular SAEs.
- The severity of SAEs was substantial, with roughly half deemed severe, regardless of treatment approach.
- A majority of SAEs were not directly attributable to the revascularization procedure itself.
Objective:
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 (SAEs) in the Best Endovascular vs 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 (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs 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%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs 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 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs 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%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively.
Conclusions:
Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe.
More Related Videos
05:26Postconditioning with Lactate-enriched Blood for Cardioprotection in ST-segment Elevation Myocardial Infarction
Published on: May 28, 2019
07:25Predicting Amputation using Local Circulating Mononuclear Progenitor Cells in Angioplasty-treated Patients with Critical Limb Ischemia
Published on: September 22, 2020
Related Concept Videos
01:17Ischemic Heart Disease: Overview
Atherosclerosis, the primary malefactor, orchestrates this dangerous condition. It manifests as the accumulation of fatty deposits, akin to insidious plaques, within arterial walls. As time elapses, these plaques metamorphose, hardening and narrowing...
01:18Cardiovascular Drugs: Classification based on Therapeutic Indications
01:30Coronary Artery Disease III: Clinical Manifestations
01:19Acute Coronary Syndrome II: Pathophysiology and Clinical Manifestations
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:21Peripheral Arterial Disease II: Clinical Manifestations and Diagnostic Evaluation