Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

NCT05931783 | Recruiting

• 1 other identifier: 1135/2023
• Study Type: interventional
• Target: 1,350
• Locations: 3 countries
• Sites: 8

Brief Summary

Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting. The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.

Conditions

Coronary Artery Disease

Keywords

CABG; LITA; graft patency; skeletonized vs. pedicled

Outcome Measures

Primary Outcomes (1)

• Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.

  The primary endpoint will be compared between the two treatment groups using Kaplan-Meier graphs and a center stratified two sample log-rank test. In addition, Cox proportional hazards regression analysis adjusting for clinically relevant confounders will be performed. Hazard ratios and their 95% confidence intervals will be estimated. LITA graft occlusion is defined as the absence of contrast detection in the lumen of the graft indicating a 100% occlusion of LITA graft.

  2 years (+/- 3 months) after surgery

Secondary Outcomes (1)

• composite outcome of all-cause death, myocardial infarction and repeated revascularization

  1 year, 2 years and 5 years after surgery

Study Arms (2)

skeletonized harvesting technique

ACTIVE COMPARATOR

In skeletonized harvesting technique, only the left internal artery itself is harvested.

Procedure: skeletonized harvesting technique

pedicled harvesting technique

ACTIVE COMPARATOR

In pedicled harvesting technique the left internal thoracic artery, it's accompanying veins and parts of the endothoracic fascia is harvested, creating a 1-2 cm broad pedicle.

Procedure: pedicled harvesting technique

Interventions

skeletonized harvesting technique PROCEDURE

In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in skeletonized technique. Thereby, only the artery itself is harvested.

skeletonized harvesting technique

pedicled harvesting technique PROCEDURE

In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in pedicled technique. Thereby, the artery will be harvested together with the accompanying veins, the endothoracic fascia and fatty tissue in order to create an 1-2 cm broad pedicle.

pedicled harvesting technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery).

You may not qualify if:

• Age \> 80 years
• Planned CABG without LITA use
• Preoperative mediastinal radiation therapy
• Emergency operation
• Minimal invasive coronary artery bypass surgery
• Any concomitant cardiac or non-cardiac procedures
• Previous cardiac surgery
• Known contrast agent allergy
• Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
• Chronic kidney disease (GFR \<60ml/min/1.73m²)
• Life expectancy of less than 5 years
• Pregnancy
• Hyperthyroidism
• Iodine allergy
• Y/T graft off the LITA graft

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (8)

Medical University of Graz

Graz, Austria

NOT YET RECRUITING

Medical University of Innsbruck

Innsbruck, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

NOT YET RECRUITING

University of Duisburg-Essen

Essen, Germany

NOT YET RECRUITING

University of Freiburg

Freiburg im Breisgau, Germany

NOT YET RECRUITING

University Hospital Gießen

Giessen, Germany

NOT YET RECRUITING

University of Jena

Jena, Germany

NOT YET RECRUITING

University Hospital Bern

Bern, Switzerland

NOT YET RECRUITING

Related Publications (2)

• Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.

  PMID: 34132753 BACKGROUND

• Gaudino M, Audisio K, Rahouma M, Chadow D, Cancelli G, Soletti GJ, Gray A, Lees B, Gerry S, Benedetto U, Flather M, Taggart DP; ART Investigators. Comparison of Long-term Clinical Outcomes of Skeletonized vs Pedicled Internal Thoracic Artery Harvesting Techniques in the Arterial Revascularization Trial. JAMA Cardiol. 2021 Dec 1;6(12):1380-1386. doi: 10.1001/jamacardio.2021.3866.

  PMID: 34586338 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hannes Abfalterer, Dr. med. univ.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

• Nikolaos Bonaros, Univ. Prof. Dr.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannes Abfalterer, Dr. med. univ.

CONTACT

004351250482988; hannes.abfalterer@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 5, 2023
• Study Start: March 12, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: March 15, 2024

Record last verified: 2023-06

Locations

DE (4); AU (3); CH (1)