Clinical Trials Directory

Trials / Terminated

TerminatedNCT03538886

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Aalborg University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECoronary artery bypass grafting (CABG)Revascularization of LAD lesion by CABG
PROCEDUREPercutaneous coronary intervention (PCI)Revascularization of LAD lesion by PCI

Timeline

Start date
2018-06-01
Primary completion
2019-07-31
Completion
2019-07-31
First posted
2018-05-29
Last updated
2021-04-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03538886. Inclusion in this directory is not an endorsement.