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Published on: September 20, 2019
NOBLE trial-is it time to revise the guidelines?
1Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, 700099 India.
Insights
Coronary artery bypass grafting (CABG) is superior to percutaneous coronary angioplasty (PCI) for unprotected left main coronary artery stenosis. CABG reduced major adverse cardiac and cerebrovascular events compared to PCI over 5 years.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiac Surgery
Background:
- Unprotected left main coronary artery (LMCA) stenosis requires revascularization.
- Current guidelines recommend percutaneous coronary angioplasty (PCI) for select patients.
- The Nordic-Baltic-British left main revascularization trial (NOBLE) investigated revascularization strategies.
Purpose of the Study:
- To compare the efficacy and safety of PCI versus coronary artery bypass grafting (CABG) in patients with unprotected LMCA stenosis.
- To evaluate the primary composite endpoint of all-cause mortality, stroke, myocardial infarction, and repeat revascularization at 5 years.
Main Methods:
- Prospective, randomized, multicentre, non-inferiority trial.
- Enrolled patients with unprotected LMCA stenosis.
- Compared PCI with CABG.
Main Results:
- Coronary artery bypass grafting (CABG) demonstrated superior 5-year MACCE rates (28% vs. 19%) compared to percutaneous coronary angioplasty (PCI).
- PCI was associated with significantly higher rates of non-procedural myocardial infarction and repeat revascularization.
- All-cause mortality and stroke rates were similar between the two groups.
Conclusions:
- The NOBLE trial findings challenge current European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines recommending PCI for unprotected LMCA stenosis with SYNTAX score < 23.
- CABG appears to be a superior revascularization strategy for unprotected LMCA stenosis.
- Further research may be warranted to refine treatment guidelines.
Abstract:
The Nordic-Baltic-British left main revascularization trial (NOBLE) is a prospective, randomized, multicentre, non-inferiority trial comparing percutaneous coronary angioplasty (PCI) with coronary artery bypass grafting (CABG) for revascularization of patients with unprotected left main coronary artery (LMCA) stenosis. The primary outcome was a combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization. CABG was found to be superior to PCI with respect to the 5-year MACCE rates (28% vs. 19%) with a hazard ratio (HR) of 1.58 (95% CI 1.24-2.01). All-cause mortality rates were similar, but PCI was associated with increased occurrence of non-procedural myocardial infarction (p = 0.0002) and repeat revascularization (p = 0.0009). There was no difference in the stroke rates (p = 0.11) at 5 years. Currently, European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization assign a class 1A recommendation to PCI in patients with unprotected LMCA stenosis with a SYNTAX score < 23. The findings of the NOBLE trial challenge this premise.
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