Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery (HARVITA)

Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: skeletonized harvesting technique; Procedure: pedicled harvesting technique

• Study Type: Interventional
• Enrollment (Estimated): 1350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes Abfalterer, Dr. med. univ.; Phone Number: 004351250482988; Email: hannes.abfalterer@i-med.ac.at

Study Locations

• Austria
  • Graz, Austria
    • Not yet recruiting
    • Medical University of Graz
    • Contact: Daniel Zimpfer, Univ. Prof. Dr.
  • Innsbruck, Austria
    • Recruiting
    • Medical University of Innsbruck
    • Contact: Hannes Abfalterer, Dr. med. univ.
  • Vienna, Austria
    • Not yet recruiting
    • Medical University of Vienna
    • Contact: Sigrid Sandner, Assoz. Prof. Priv. Doz. Dr.
• Germany
  • Essen, Germany
    • Not yet recruiting
    • University of Duisburg-Essen
    • Contact: Matthias Thielmann, Univ. Prof. Dr.
  • Freiburg, Germany
    • Not yet recruiting
    • University of Freiburg
    • Contact: Martin Czerny, Univ. Prof. Dr.
  • Gießen, Germany
    • Not yet recruiting
    • University Hospital Giessen
    • Contact: Andreas Böning, Univ. Prof. Dr.
  • Jena, Germany
    • Not yet recruiting
    • University of Jena
    • Contact: Torsten Doenst, Univ. Prof. Dr.
• Switzerland
  • Bern, Switzerland
    • Not yet recruiting
    • University Hospital Bern
    • Contact: Matthias Siepe, Univ. Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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).

Exclusion criteria:

• 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

Intraoperative exclusion criteria:

• Y/T graft off the LITA graft
• LITA sequential grafting
• LITA target vessel other than LAD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: skeletonized harvesting technique; In skeletonized harvesting technique, only the left internal artery itself is harvested.	Procedure: skeletonized harvesting technique; 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.
Active Comparator: pedicled harvesting technique; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite outcome of all-cause death, myocardial infarction and repeated revascularization	The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing.	1 year, 2 years and 5 years after surgery

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Hannes Abfalterer, Dr. med. univ., Medical University Innsbruck; Principal Investigator: Nikolaos Bonaros, Univ. Prof. Dr., Medical University Innsbruck

Publications and helpful links

General Publications

• 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. Erratum In: JAMA Cardiol. 2021 Aug 18;:null.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: CABG; graft patency; LITA; skeletonized vs. pedicled
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 1135/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No