Clinical trial NCT03538886: Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.
Official title: The Nordic-Baltic Heart Team Initiative for Improved Long-term Coronary Artery Revascularization Outcome in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. NOBLE LAD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary revascularization
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Region Örebro County
name: Pauls Stradins Clinical University Hospital
First posted: 2018-05-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 10 years
measure: Quality of life
timeFrame: 1 year
measure: MACCE
timeFrame: 1 year
Secondary outcomes:
measure: All-cause death
timeFrame: 1, 2, 3, 5 and 10 years
measure: Cardiac death
timeFrame: 1, 2, 3, 5 and 10 years
measure: Spontaneous myocardial infarction
timeFrame: 1, 2, 3, 5 and 10 years
measure: Procedure related myocardial infarction
timeFrame: 1, 2, 3, 5 and 10 years
measure: Major stroke, minor stroke and al stroke
timeFrame: 1, 2, 3, 5 and 10 years
measure: Angina
timeFrame: 1, 2, 3, 5 and 10 years
measure: Heart failure
timeFrame: 1, 2, 3, 5 and 10 years
measure: Stent thrombosis
timeFrame: 1, 2, 3, 5 and 10 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Department of Cardiology, Aalborg University Hospital
name: Leif Thuesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic Surgery, Aalborg University Hospital
name: Jan Jesper Andreasen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, aaalborg University Hospital
name: Peter Sogaard, Prof
role: STUDY_CHAIR
References: