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

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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention (PCI); Procedure: Coronary artery bypass grafting (CABG)

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous coronary intervention (PCI); Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion.	Procedure: Percutaneous coronary intervention (PCI); Revascularization of LAD lesion by PCI
Experimental: Coronary artery bypass grafting (CABG); Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion.	Procedure: Coronary artery bypass grafting (CABG); Revascularization of LAD lesion by CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death of any cause	10 years
Quality of life	By SF 12 and Seatle Angina Questionaire	1 year
MACCE	Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Death of any cause	1, 2, 3, 5 and 10 years
Cardiac death	Death of cardiac disease	1, 2, 3, 5 and 10 years
Spontaneous myocardial infarction	Type 1 myocardial infarction	1, 2, 3, 5 and 10 years
Procedure related myocardial infarction	Myocardial infarction related to PCI or CABG	1, 2, 3, 5 and 10 years
Major stroke, minor stroke and al stroke	Stroke by VARC definition	1, 2, 3, 5 and 10 years
Angina	CCS angina class	1, 2, 3, 5 and 10 years
Heart failure	NYHA class	1, 2, 3, 5 and 10 years
Stent thrombosis	ARC-define stent thrombosis	1, 2, 3, 5 and 10 years

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Oulu University Hospital; Pauls Stradins Clinical University Hospital; Region Örebro County
• Investigators: Principal Investigator: Leif Thuesen, MD, Department of Cardiology, Aalborg University Hospital; Principal Investigator: Jan Jesper Andreasen, Prof, Department of Cardiothoracic Surgery, Aalborg University Hospital; Study Chair: Peter Sogaard, Prof, Department of Cardiology, aaalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Coronary revascularization
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: NOBLE-LAD_Protocol version 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After publication of the trial, data will be made available for metaanalyses on request, and after accept by the steering committee.
• IPD Sharing Time Frame: Study protocol and statistical analysis plan available by now.
• IPD Sharing Access Criteria: At clinicaltrial.gov
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No