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Randomized Endo-Vein Graft Prospective
NA trial testing Vein Harvesting Procedures in Coronary Artery Bypass Grafting in 1,150 participants. Completed in 30 October 2020.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,150 |
| Start date | 30 September 2013 |
| Primary completion | 30 September 2020 |
| Estimated completion | 30 October 2020 |
| Sites | 16 locations across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Coronary Artery Bypass Grafting. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the active follow-up period.
| Group | Value | 95% CI |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | 80 | |
| Open Vein Harvest (OVH) | 89 |
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively.
| Group | Value | 95% CI |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | 45 | |
| Open Vein Harvest (OVH) | 47 |
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively.
| Group | Value | 95% CI |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | 90 | |
| Open Vein Harvest (OVH) | 90 |
Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the entire follow-up period (active and passive).
| Group | Value | 95% CI |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | 126 | |
| Open Vein Harvest (OVH) | 135 |
Time frame: Participant adverse event data collection stopped at the end of active follow-up. All participants had a minimum of 1 year of SAE reporting with a maximum duration of 4 years 7 months, depending on participants' time of termination from active follow-up. However, all cause mortality was collected through passive follow-up (6.5 years).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Endoscopic Vein Harvest (E… | Open Vein Harvest (OVH) |
|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Chest pain | General disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Postoperative wound infection | Infections and infestations | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Atrial flutter | Cardiac disorders | — | — |
| Localised infection | Infections and infestations | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
Most-reported serious reactions: Cardiac failure congestive, Pneumonia, Atrial fibrillation, Coronary artery disease, Myocardial infarction, Chest pain, Pleural effusion, Cerebrovascular accident.
Data from ClinicalTrials.gov NCT01850082 adverse events section.
Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the United States with over 300,000 cases performed each year. To restore blood flow to the heart, vascular conduits from another part of the body are procured to create a bypass around critically blocked coronary arteries. The left internal thoracic artery is the conduit of choice for CABG due to its superior long-term patency. However, almost all patients referred for CABG require additional grafts to provide complete revascularization. This necessitates the harvest of other vessels, most commonly the saphenous vein which is used almost ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred method over the traditional open harvesting technique (OVH) because it provides a minimally invasive approach. However, more recent investigations indicate potential for reduced long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of EVH on clinical outcomes has never been investigated on a large scale using a definitive, adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing