RecruitingNot ApplicableNCT05931783

Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

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

Sponsor

Medical University Innsbruck

Enrollment

1,350 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

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 Criteria17

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
LITA sequential grafting
LITA target vessel other than LAD

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Interventions

PROCEDUREskeletonized 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.

PROCEDUREpedicled 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.