News
ABYSS – Beta Blocker Interruption in Post-Myocardial Infarction Patients
Key Points:
- In the ABYSS trial, 3700 patients who had a left ventricular ejection fraction ≥ 40% and were > 6 months post myocardial infarction were randomized to receive beta blocker continuation vs. beta blocker interruption
- The authors found higher rates of the primary endpoint, the composite of death, MI, stroke and cardiovascular hospitalization, among patients who had interruption of their beta blocker, especially if those individuals had a history of hypertension
- Beta blocker interruption had no impact on quality of life and not surprisingly, resulted in higher blood pressures and heart rates
Vitrusiran Reduces Risk of Death and CV Events in Patients with ATTR-CM
Key Points:
- ATTR amyloid cardiomyopathy, resulting from accumulation of TTR amyloid protein in the heart, leads to progressive heart failure, complicated by arrhythmias, with a significant increase in worsened quality of life, hospitalization, and death
- This study tested the efficacy and safety of vutrisiran, a novel subcutaneously (SQ) administered RNAi therapeutic, dosed quarterly, to treat ATTR amyloid cardiomyopathy
- Vutrisiran demonstrated statistically significant improvement over standard therapy (tafamadis, SGLT2i inhibitors, and diuretics) on both primary and secondary outcomes, including mortality, disease progression, and quality of life
- The authors argue these results support vutrisiran as a reasonable new standard-of-care for ATTR amyloid cardiomyopathy patients, either as first-line for new diagnosis, or alternative vs add-on therapy in treated patients with progressive disease
IVUS-Guided DES Reduced MACE at 1 year Compared to Angiography-Guided PCI: IVUS-ACS Trial
Key Points:
- The IVUS-ACS trial assessed whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome.
- The study showed that IVUS-guided implantation of contemporary DES resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularization compared with angiography guidance alone.
IVUS -DBC: IVUS-guided drug-coated balloon angioplasty improves primary patency
Key Points:
- One-year success rates of angioplasty in peripheral artery disease (PAD) patients were significantly higher when guided by intravascular ultrasound (IVUS) alongside angiography.
- IVUS, offering precise vessel measurements and visualization, demonstrated its effectiveness in achieving longer-lasting benefits from the procedure.
- At 12 months, primary patency was achieved in 83.8% of patients who received IVUS and 70.1% of those receiving angiography alone, with IVUS group showing significant superiority.
A technology assisted Web App allowed >90% of consumers to correctly self-select for statin use and achieve clinically important LDL-C reduction
Key Points:
- Nonprescription statin access may help statin-eligible patients receive appropriate treatment.
- This prospective, actual-use study employed a Web App for participants to self-qualify for guideline-appropriate moderate intensity statin initiation use, and found that this technology had high accuracy in making clinician-concordant statin determinations and led to a significant reduction in participant LDL.
PROACT: Enalapril Does Not Mitigate Anthracycline Toxicity in Breast Cancer and NHL
Key Points:
- Anthracycline toxicity is an important cause of cardiomyopathy; it is unclear whether prophylactic treatment with ACE inhibitors could mitigate this risk.
- In PROACT, enalapril was compared to standard of care in individuals undergoing anthracycline treatment for breast cancer or NHL. The primary endpoint was myocardial injury (defined as cTnT≥14 ng/L).
- Enalapril did not result in a significant reduction in anthracycline toxicity as measured by myocardial injury, LVEF, or GLS a month after chemotherapy completion.
Topical TXA Does Not Reduce Peri-Operative Seizures but Increases Risk of Transfusion in Cardiac Surgery Compared to Intravenous TXA
Key Points:
- IV TXA is used to prevent peri-operative bleeding in cardiac surgery, but it carries a risk of seizure. It is hypothesized that topical TXA may reduce this risk of seizure.
- In DEPOSITION, topical and IV TXA were compared in individuals undergoing cardiac surgery. The primary endpoint was seizure. Authors also investigated differences in RBC transfusions between arms.
- Topical TXA did not result in a significant difference in peri-operative seizures, but it did increase RBC transfusion requirement relative to IV TXA.
IMPROVE-HCM: Cardiac Mitotrope -Ninerafaxstat- Improves Functional Capacity in Symptomatic Non-Obstructive HCM
Key Points:
- Despite the high symptomatic burden, very few effective treatments exits for symptomatic, non-obstructive HCM.
- In IMPROVE-HCM, a novel cardiac mitotrope (ninerafaxstat) was compared to placebo in non-obstructive HCM. The primary efficacy endpoint was change in KCCQ score from baseline. Safety and tolerability were also assessed.
- In the primary intention-to-treat analysis, ninerafaxstat did not improve symptoms; however, when restricting the population to patients with baseline limitation by KCCQ (or NYHA III), treatment resulted in a significant improvement in HF symptoms. Ninerafaxstat also improved exercise capacity on CPET in the total sample.
A Restrictive Benzodiazepine Strategy During Cardiac Surgery Does Not Reduce Post-Operative Delirium
Key Points:
- Benzodiazepine use contributes to delirium before and after cardiac surgery, but intra-operative benzodiazepine use has not been well-studied.
- In B-Free, a restrictive intraoperative benzodiazepine strategy was compared with a liberal benzodiazepine strategy in the reduction of post-operative delirium.
- In the primary intention-to-treat analysis, the restrictive benzodiazepine strategy did not result in a significant reduction in post-operative delirium. However, this endpoint was significantly reduced in the restrictive arm using either an on-policy analysis approach or after excluding patients receiving pre-operative benzodiazepines.
TRAVERSE: Transseptal approach to LV ablation results in fewer cerebral emboli compared to retrograde aortic approach
Key Points:
- Among patients who undergo endocardial ablation for left ventricular arrythmias, it is uncertain whether the number of imaging-detected cerebral emboli differs based on the anatomical approach.
- In this randomized trial, participants who were assigned to a transseptal approach had significantly lower rates of imaging-detected cerebral emboli compared to those assigned to a retrograde aortic approach.
FFR-Guided Complete Revascularization in STEMI did not reduce MACE vs Culprit-lesion only PCI: The FULL REVASC Trial
Key Points
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- Researchers compared outcomes in patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization.
- There was no significant difference in the composite primary outcome of death, myocardial infarction or unplanned revascularization, between patients randomized to culprit lesion only PCI versus FFR-guided complete revascularization
PREVENT: PCI of non-flow-limiting vulnerable plaques reduced MACE compared to medical therapy alone
Key Points:
- Vulnerable plaques can lead to acute coronary syndromes, but it is unknown whether performing PCI on these lesions improves outcomes.
- In this RCT, patients with at least one non-flow limiting vulnerable plaque who received PCI plus OMT had significantly lower rates of target-vessel failure compared to OMT alone at a median follow up of 4.4 years.
EMBO-ABL: Cryoballoon non-inferior to radiofrequency catheter ablation for AF for silent cerebral events
Key Points:
- Among AF patients undergoing catheter ablation, cryoballoon was non-inferior compared to radiofrequency for the primary endpoint of silent cerebral embolic events detected on MRI.
RELIEVE HF: Inter-Atrial Shunting Does Not Reduce Symptoms or Improve Prognosis in HF
Key Points:
- Inter-atrial shunting (IAS) may provide a useful opportunity to dynamically regulate left atrial pressure in heart failure.
- In the RELIEVE-HF study, IAS was compared with placebo in patients with at least a 6-month history of HF, across all LVEF categories and HF etiologies. The primary endpoint was a hierarchical composite of all-cause death, transplant or LVAD placement, all HF hospitalizations, and change in KCCQ score from baseline to 12 months; the primary safety endpoint was a composite of major adverse cardiac or neurologic events over 30 days.
- IAS was well-tolerated with zero adverse safety events, but it did not result in a significant reduction in the primary endpoint. However, in exploratory pre-specified stratified analyses by LVEF, IAS appeared to cause harm in patients with HFpEF and confer benefit in HFrEF.
SHASTA 2: Novel RNAi Therapeutic Plozasiran Results in Sustained Reduction In Triglycerides in Severe Hypertriglyceridemia
Key Points:
- Severe hypertriglyceridemia portends high risk of both CVD and acute pancreatitis, but there are limited effective treatment options.
- A novel RNA interference (RNAi) therapeutic plozasiran can reduce APOC3, a mediator of triglyceride elevation.
- In the Phase 2B trial SHASTA-2, two doses of plozasiran were compared with placebo in long-term (24 and 48 week) reduction of triglycerides and other cholesterol pathway mediators.
- All doses of plozasiran was well-tolerated and resulted in sustained reduction in triglycerides, APOC3, and remnant cholesterol with increased HDL-C by 24 weeks, with a still-significant but attenuated effect at 48 weeks.
DanGer Shock: Impella Reduces All-Cause Mortality in STEMI Cardiogenic Shock
Key Points:
- Cardiogenic shock (CS) mortality remains high despite increased utilization of mechanical circulatory support. Specifically, no randomized data has supported the use of Impella CP in CS.
- In DanGer Shock, routine use of Impella CP was compared with standard of care in selected individuals with cardiogenic shock after STEMI.
- Impella CP use was associated with a 13% reduction in 6-month all-cause-mortality but increased rates of both ischemic and hemorrhagic adverse events.
AT-001, a potent aldose reductase inhibitor, did not improve exercise capacity in diabetic cardiomyopathy with impaired exercise capacity
Key Points:
- The ARISE-HF trial evaluates the use of AT-001, a potent aldose reductase inhibitor, to reduce the risk of diabetic cardiomyopathy among patients with Type II diabetes.
- The trial did not find a significant difference in its primary outcome, change in a patient’s peak VO2 consumption, or secondary outcomes, including risk of progression to overt heart failure, between patients who received the higher dose of AT-001 (1500 mg) compared to placebo.
- In a pre-specified secondary analysis of patients who were not receiving either a GLP1 agonist or an SGLT2 inhibitor, there was a statistically significant difference in VO2 consumption after 15 months between patients receiving AT-001 1500 mg and those receiving placebo.
TAVR non-inferior to SAVR in Low to Intermediate Risk Patients With Severe Aortic Stenosis: DEDICATE-DZHK6 Trial
Key Points
- In the DEDICATE-DZHK6 trial, patients with a history of severe aortic stenosis who were ≥ 65 years old and low to intermediate risk for surgery were randomized to receive TAVR versus SAVR.
- TAVR was noninferior to SAVR with respect to death from any cause or stroke at 1 year.
- Patients who received a TAVR had improved secondary outcomes including lower rates of disabling stroke, cardiovascular death, bleeding and new-onset atrial fibrillation compared to those who received a SAVR
ORBITA COSMIC: Coronary sinus reducer did not improve transmural myocardial perfusion but angina symptoms
Key Points
– Coronary sinus reduction (CSR) is a potential therapeutic device for patients with refractory angina
– In this first-of-its-kind randomized, placebo-controlled, double-blind trial, participants underwent CSR implantation or a placebo procedure, with pre- and post-trial CMR and daily angina reporting
-Participants who received a CSR reported fewer episodes of angina, but CMR did not demonstrate improved blood flow
TARGET BP I: Alcohol-mediated renal artery denervation reduced SBP in treatment-resistant hypertension at 3 months compared to sham control
Key Points:
- Achieving hypertension control has remained an elusive goal in the US and globally, and procedural treatments like renal denervation have gained traction as a means to successfully overcome non-adherence to traditional lifestyle and medical treatment for hypertension.
- The TARGET BP I investigated a novel percutaneous device, capable of injecting a small amount of alcohol into the renal artery perivascular space, to achieve a circumferential and confluent (yet self-limited) arc of ablation of the sympathetic nervous system.
- Between 2019 and 2023, 301 patients with hypertension despite treatment with 2-5 medications were randomized 1:1 to renal denervation or sham control. At 3 months of follow-up, there was a modest but statistically significant reduction in 24-hour ambulatory systolic blood pressure (-10.0 ± 14.2 mm Hg versus -6.8 ± 12.1 mm Hg, i.e. a delta of -3.2 mm Hg with 95%CI -6.3 to 0.0, P=0.049), but no reduction in office systolic blood pressure, nor office or ambulatory diastolic blood pressure. This was in the context of an alarmingly high rate of medication non-adherence in both arms (50-60%).
- While encouraging, these results require confirmation via longer follow-up beyond 3 months, in order to understand whether alcohol-mediated renal denervation will demonstrate persistent reduction in blood pressure and perhaps show a larger advantage of the sham control arm, which may be expected to further worsen in hypertension control over time.