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LDL-C Lowering and CV Outcomes in Diabetics Undergoing Revascularization
Quick Takes
- That an LDL-C <70 mg/dl at 1 year post-PCI for patients with T2DM and stable angina was necessary to demonstrate the benefit of PCI over optimal medical therapy (OMT) strongly supports the guidelines and that “lower is better.”
- How the advances in coronary drug-eluting stents and tools for lesion selection, novel therapy for T2DM such as the SGLT-2 inhibitors and GLP-1 agonists, high-dose icosapent ethyl, and PCSK9 inhibitors will impact the value of OMT vs. PCI and CABG remains to be seen.
Study Questions:
What is the impact of lowering low-density lipoprotein cholesterol (LDL-C) on the incidence of cardiovascular events comparing optimal medical therapy (OMT) plus a coronary revascularization procedure (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) versus OMT alone in patients with stable coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM)?
Methods:
The authors performed a patient-level pooled analysis of three randomized clinical trials conducted in the United States. COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [OMT vs. PCI + OMT]), BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes [OMT vs. PCI + OMT or CABG + OMT]), and FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multi-vessel Disease [PCI + OMT vs. CABG + OMT]). Target LDL-C achievement was based on LDL-C goals for OMT, which in BARI-2D was <100 mg/dl, in COURAGE between 60 and 85 mg/dl, and in FREEDOM <70 mg/dl. Patients enrolled between 1999 and 2010 with T2DM were categorized according to the levels of LDL-C at 1 year following randomization. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE) defined as the composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke.
Results:
A total of 4,050 patients were followed for a median of 3.9 years after the index 1-year assessment. Mean age was 63 years, 27% were female, and 73% were white. Mean baseline LDL-C ranged from 86-113 mg/dl and at 1 year from 56-123 mg/dl. Patients whose 1-year LDL-C remained ≥100 mg/dl experienced higher 4-year cumulative risk of MACCE (17.2% vs. 13.3% vs. 13.1% for LDL-C between 70 and <100 mg/dl and LDL-C <70 mg/dl, respectively; p = 0.016). When compared with OMT alone, patients with PCI experienced a MACCE reduction only if 1-year LDL-C was <70 mg/dl (hazard ratio, 0.61; 95% confidence interval, 0.40-0.91; p = 0.016), whereas CABG was associated with improved outcomes across all 1-year LDL-C strata. In patients with 1-year LDL-C ≥70 mg/dl, patients undergoing CABG had significantly lower MACCE rates as compared with PCI.
Conclusions:
In patients with CHD with T2DM, lower LDL-C at 1 year is associated with improved long-term MACCE outcome in those eligible for either PCI or CABG. When compared with OMT alone, PCI is associated with MACCE reductions only in those who achieved an LDL-C <70 mg/dl.
Perspective:
The study comparing OMT versus OMT + revascularization in T2DM patients with stable angina supports the American College of Cardiology/American Heart Association guidelines suggesting the “lower is better” hypothesis, particularly in PCI. The findings infer that in persons with T2DM who are clinical candidates for either PCI or CABG, the better choice in those with severely elevated LDL-C might be CABG.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Lipid Metabolism, Nonstatins, Chronic Angina
Keywords: Angina, Stable, Cardiac Surgical Procedures, Cholesterol, LDL, Coronary Artery Bypass, Coronary Disease, Diabetes Mellitus, Type 2, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Primary Prevention, Stroke
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