Month: November 2023
TEAMMATE Trial: Everolimus with Low-Dose Tacrolimus to Prevent Rejection in Children after Cardiac Transplantation
Key Points
- This was the first randomized trial to evaluate the safety and efficacy of everolimus and low-dose tacrolimus in pediatric heart transplant recipients.
- The open-label trial demonstrated that this combination is safe compared to standard dose tacrolimus and mycophenolate mofetil but was not associated with a lower burden of coronary allograft vasculopathy, rejection, and chronic kidney disease.
- TEAMMATE was limited by lower event rates than expected and challenges related to protocol adherence due to the COVID19 pandemic.
Percutaneous Coronary Intervention Improved Symptoms in Stable Angina: ORBITA-2 trial
Key points:
- PCI is often performed for chronic stable angina, but current evidence is unclear to what extent the benefit is physiologic vs placebo
- This trial compared PCI with placebo-procedure in stable angina patients not on antianginal therapy with primary outcome of angina symptom assessment
- PCI was significantly associated with decreased angina symptoms measured by an angina symptom score compared to placebo
Lowering blood pressure significantly reduced dementia risk in people with hypertension in rural China
Key Points:
- Intensive blood pressure (BP) lowering intervention was tested on hypertensive patients in rural China.
- In this four year blood pressure intervention program in rural China, the intervention, led by non-physician community health-care providers, significantly reduced systolic blood pressure and the risk of all-cause dementia.
- Serious adverse events were less frequent in the intervention group, indicating the safety of the approach.
MINT Trial – In Patients with MI and Anemia, Liberal Blood Transfusion not Significantly Different to Restrictive Strategy in Reducing Death or MI
Key Points
- Anemia is common among individuals with acute myocardial infarction, however, transfusion thresholds and targets remain uncertain.
- The MINT trial randomized 3,506 patients with acute myocardial and anemia (hemoglobin concentration < 10 g/dL) to a restrictive transfusion strategy (transfusion permitted if hemoglobin was less than 8 g/dL or in the event of anginal symptoms despite medications) or a liberal strategy (transfusion when hemoglobin was less than 10 g/dL).
- At 30-days the primary endpoint of all-cause death or recurrent myocardial infarction was not statistically different between the two strategies.
DAPA-MI: Dapagliflozin improves clinical and cardiometabolic outcomes in post-AMI patients with impaired LV function versus placebo
Key Points
- This trial of patients with acute myocardial infarction (AMI) and impaired left ventricular (LV) systolic function found that dapagliflozin significantly improved clinical and cardiometabolic outcomes compared with placebo.
- There was no significant difference in clinical events rates, which were low in both groups.
- The innovative registry-based clinical trial design helped facilitate efficient patient recruitment and outcomes ascertainment.
SELECT TRIAL: Semaglutide reduces cardiovascular events among overweight or obese patients with cardiovascular disease in the absence of diabetes
Key Points:
- Semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, has previously been shown to reduce body weight among overweight or obese individuals. However, data on whether the medication reduces cardiovascular events among overweight or obese individuals with established cardiovascular disease in the absence of diabetes are lacking.
- The SELECT trial enrolled 17,604 overweight or obese patients (BMI ≥ 27 kg/m2) with established cardiovascular disease who do not have diabetes and randomized them to once weekly subcutaneous semaglutide 2.4 mg or placebo.
- Over approximately 3 years of follow-up, treatment with semaglutide resulted in a 20% relative reduction in the composite primary endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.