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

Medical University Innsbruck

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: pedicled harvesting technique; Procedure: skeletonized harvesting technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05931783

1135/2023

Details and patient eligibility

About

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.

Enrollment: 1,350 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,350 participants in 2 patient groups

skeletonized harvesting technique

Active Comparator group

Description:

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

Treatment:

Procedure: skeletonized harvesting technique

pedicled harvesting technique

Active Comparator group

Description:

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.

Treatment:

Procedure: pedicled harvesting technique