Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. (NOBLE-LAD)

Aalborg University Hospital

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary artery bypass grafting (CABG); Procedure: Percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03538886

NOBLE-LAD_Protocol version 3

Details and patient eligibility

About

The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion

Full description

It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.

According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.

The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG

The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.

Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.

Substantiated expectations:

• PCI is superior to bypass operation concerning short-term quality of life.
• Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
• Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
• Outcome may be dependent on lesion complexity, diabetes and gender.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Heart Team decision on treatment

1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (>90% by visual assessment or FFR <80% The lesion may be treated by both PCI and surgery

Exclusion criteria

ST-elevation myocardial infarction within 24 hours. Expected survival <1 year, because of high age or severe cardiac or non-cardiac disease.

Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age < 18 years. Study required information and consent suboptimal or impossible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Percutaneous coronary intervention (PCI)

Active Comparator group

Description:

Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion.

Treatment:

Procedure: Percutaneous coronary intervention (PCI)

Coronary artery bypass grafting (CABG)

Experimental group

Description:

Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion.

Treatment:

Procedure: Coronary artery bypass grafting (CABG)