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

Coronary Artery Disease Clinical Trial

— NOBLE-LAD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03538886
• Other study ID #: NOBLE-LAD_Protocol version 3
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: April 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Coronary artery bypass grafting (CABG)
Revascularization of LAD lesion by CABG
• Percutaneous coronary intervention (PCI)
Revascularization of LAD lesion by PCI

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University Hospital	Oulu University Hospital, Pauls Stradins Clinical University Hospital, Region Örebro County

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Death of any cause	10 years
Primary	Quality of life	By SF 12 and Seatle Angina Questionaire	1 year
Primary	MACCE	Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)	1 year
Secondary	All-cause death	Death of any cause	1, 2, 3, 5 and 10 years
Secondary	Cardiac death	Death of cardiac disease	1, 2, 3, 5 and 10 years
Secondary	Spontaneous myocardial infarction	Type 1 myocardial infarction	1, 2, 3, 5 and 10 years
Secondary	Procedure related myocardial infarction	Myocardial infarction related to PCI or CABG	1, 2, 3, 5 and 10 years
Secondary	Major stroke, minor stroke and al stroke	Stroke by VARC definition	1, 2, 3, 5 and 10 years
Secondary	Angina	CCS angina class	1, 2, 3, 5 and 10 years
Secondary	Heart failure	NYHA class	1, 2, 3, 5 and 10 years
Secondary	Stent thrombosis	ARC-define stent thrombosis	1, 2, 3, 5 and 10 years