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NCT Number: NCT05931783

Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 1 year, 2 years and 5 years after surgery

    The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannes Abfalterer, Dr. med. univ.

CONTACT

[email protected]

004351250482988

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: HARVITA

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Jul 5, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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