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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Coronary artery bypass grafting (CABG) | Revascularization of LAD lesion by CABG |
| PROCEDURE | Percutaneous 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.