Month: September 2024
ApoA-I Infusions and Burden of Ischemic Events after Acute Myocardial Infarction
KEY POINTS:
- In this prespecified exploratory analysis of the AEGIS-II trial, the authors compare rates of recurrent myocardial infarction, stroke, and cardiovascular death up to 365 days among individuals who present with acute myocardial infarction and receive an infusion of ApoAI versus placebo
- Patients who had multiple events during the 365 day follow-up period were more likely to be older and have more cardiovascular comorbidities
- In this study, individuals who received ApoAI infusions had lower rates of major adverse cardiac events at 180 days with sustained benefit at 365 days compared to those who received placebo
Apolipoprotein A-I infusions Lowers Risk of Recurrent CV Events in Patients With Baseline LDL-C ≥100 mg/dL
KEY POINTS:
- In this exploratory analysis of the AEGIS-II randomized control trial, the authors compare the rates of stroke, myocardial infarction and death at 90 days between patients with hyperlipidemia who receive ApoA-I infusions (CSL112) versus placebo after presentation with acute myocardial infarction
- In patients with hyperlipidemia and LDL cholesterol ≥ 100 mg/dL who present with acute myocardial infarction, the infusion of ApoA-I may result in lower rates of major adverse cardiovascular events
Improved Accuracy of HF Diagnosis with HFDetect-AI
Key Points:
- HFDetect-AI significantly improves the accuracy of diagnosing heart failure by predicting left ventricular dysfunction using standard echocardiographic measurements.
- The system was validated with a dataset comprising over a million echocardiographic studies, showing a remarkable reduction in one-year mortality for patients with predicted heart failure phenotypes.
- HFDetect-AI offers potential for earlier intervention and personalized treatment strategies in cardiology, aligning with modern approaches using tools like intravascular ultrasound (IVUS).
Pre-Hospital Pulse-Dose Glucocorticoid Did not Reduce Infarct Size in STEMI: PULSE-MI
Key Points:
- The PULSE-MI trial assessed the effects of pre-hospital pulse-dose glucocorticoid on final infarct size in STEMI patients, revealing no significant reduction compared to placebo.
- Despite the lack of impact on final infarct size, glucocorticoid administration improved acute LVEF, reduced acute infarct size, and decreased the presence of microvascular obstruction.
- The trial confirmed the safety of pre-hospital glucocorticoid use, with no significant differences in adverse events between the treatment and placebo groups.
ECLS-SHOCK: At One Year, ECMO Does Not Reduce Mortality in Acute MI-Related Cardiogenic Shock
Key Points:
- The 30-day ECLS SHOCK study demonstrated no benefit to up-front ECLS in the reduction of 30-day mortality in acute, infarct-related cardiogenic shock.
- At one year, there were similarly no differences in the primary endpoint of all-cause mortality between ECLS and control. Additionally, there were no differences in the secondary outcomes of CV mortality, readmissions, and repeat revascularization.
- Patients receiving ECLS had significantly higher moderate or extreme pain at one year relative to those in the control arm, with no differences in other quality of life measures.
REC-CAGEFREE I: Drug Coated Balloon Fails To Achieve Non-Inferiority vs DES For De Novo Coronary Lesions
Key Points
- Drug-eluting stents are the standard of care for percutaneous coronary intervention of de novo coronary lesions but nevertheless have a risk of stent thrombosis and in-stent restenosis. Drug coated balloons may offer an alternative treatment strategy.
- REC-CAGEFREE I was an open label, randomized non-inferiority trial comparing drug-coated balloon angioplasty with drug eluting stent among 2272 patients with acute and chronic coronary syndromes and de novo coronary lesions.
- Over 24 months of follow-up, the composite endpoint of cardiac death, target lesion myocardial infarction, and clinically and physiologically indicated target vessel revascularization occurred in 6.4% of patients in the drug-coated balloon angioplasty arm and 3.4% in the drug-eluting stent arm failing to meet the criterion for non-inferiority.
Plozasiran Lowered Triglyceride Levels and Pancreatitis in Persistent Chylomicronemia: PALISADE
Key Points:
- Familial chylomicronemia syndrome (FCS) is a clinically or genetically defined syndrome of extremely high plasma triglycerides due to failure of clearance of chylomicrons
- A novel siRNA therapeutic, plozasiran, is hypothesized to treat FCS by targeting the main regulator implicated in FCS, APOC3, which precipitates persistent chylomicronemia by inhibiting lipolysis and decreasing hepatic clearance of triglyceride-rich lipoproteins (TRLs)
- The investigators randomized groups to low-dose or high-dose plozasiran vs placebo to investigate primary outcome of median percent change in triglycerides at 10 months, as well as notable secondary outcomes, including overall reduction in triglycerides and APOC3 as well as reduced risk of pancreatitis
- Plozasiran, compared to placebo, met all clinical endpoints, including significant reductions in triglycerides, APOC3, and reduced risk of pancreatitis, with a favorable safety profile
Bailout GP IIb/IIIa inhibition in AMI with angiographic MVO failed to reduce the primary endpoint infarct size but decreased CMR-derived MVO: The REVERSE-FLOW trial
Key Points:
- Though primary PCI for coronary obstruction is first-line therapy in acute myocardial infarction (AMI), many patients experience impaired myocardial perfusion despite vessel patency (no-reflow phenomenon), worsening morbidity and mortality post-AMI
- Current guidelines recommend using GP IIb/IIIa inhibitors to manage no-reflow phenomenon; however, this is based on expert consensus alone, as there are no randomized clinical trials assessing the efficacy and safety of this approach
- The REVERSE-FLOW study compared use of GP IIb/IIIa inhibitors for no-reflow phenomenon in ACS patients by comparing infarct size and microvascular obstruction (MVO) on CMR as well as assessing safety of this therapy regarding bleeding risk
- The study did not find significant difference between infarct size with GP IIb/IIIa treatment but did find decreased presence and extent of MVO on CMR; however, this study also found increased bleeding risk with GP IIb/IIIb therapy, though this was limited to non-life-threatening bleeding
AZALEA-TIMI 71 Sub-study: Periprocedural Bleeding Risk Very Low and Similar With Long-acting Factor XI Inhibitor Abelacimab vs Rivaroxaban
Key Points:
- Factor XI inhibitors have the potential to reduce thromboembolic events while minimizing major bleeding risks.
- Invasive procedures are frequent among patients with atrial fibrillation (AF), and the overall risk of major bleeding in this population is relatively low.
- In patients with AF mostly undergoing low risk invasive procedures, the rates of major bleeding or clinically relevant non-major bleeding were similar between those receiving abelacimab and those on rivaroxaban.
De-escalation to Ticagrelor Monotherapy Beneficial in Ischemic Events and Bleeding vs 12 months of DAPT: a Systematic Review and Individual Patient-Level Meta-analysis
KEY POINTS:
- Ticagrelor monotherapy was found to be non-inferior to 12 months of dual-antiplatelet therapy (DAPT) regarding major cardiovascular and cerebrovascular events (MACCE) in patients with acute coronary syndrome (ACS)
- A superiority analysis revealed lower bleeding rates in a per-protocol analysis with ticagrelor monotherapy versus DAPT in ACS patients
Microvascular Resistance Reserve as a Potential Predictor of Angina in Moderate Coronary Stenoses.
Key Points:
- The Microvascular Resistance Reserve (MRR), a novel measurement, assess the vasodilator reserve capacity of the coronary microvasculature while eliminating resistance of epicardial stenoses
- This novel index has both diagnostic and prognostic implications in chronic coronary syndrome, but it is unknown whether the MRR can guide symptomatic benefit from revascularization.
- The study investigators found that MRR with associated with freedom from angina and lower MRR was associated with more freedom from angina post-revascularization, as well as associations with health status and coronary perfusion
- These results suggest that the MRR may have a diagnostic and prognostic role in patients with acute chest pain on chronic coronary syndrome with coronary lesions of unclear significance to help guide revascularization decisions
Functional Improvement of non-infarcT relaTed coronary artery stenosis by Extensive LDL-C Reduction with a PCSK9 Antibody (FITTER)
Key Points:
- Adverse cardiovascular events can still occur from atherosclerotic events in non-culprit coronary arteries
- Evidence suggests lipid lowering therapy can significantly reduce the burden of disease in these segments, but analyses are lacking that investigate these effects on high-risk, high plaque burden segments of coronary arteries
- The FITTER study investigated PCSK-9 inhibitor therapy vs placebo on the background of high-intensity to treat high-risk non-culprit lesions identified in the setting of ACS in patients with multivessel coronary artery disease
- Though LDL was more reduced in the PCSK-9 inhibitor group, there were no significant differences between groups in either physiologic or imaging-based anatomic primary outcomes or secondary outcomes, perhaps in part due to study size, treatment effect, and/or short study length
A Low-Dose Triple Single-Pill Combination Effective at Lowering Blood Pressure
Key Points:
- A single pill containing low doses of three different medicines induced significant and rapid reductions in blood pressure (BP) vs. dual therapy or placebo, with around 70% of patients with hypertension achieving BP control.
- The triple single-pill combination had good tolerability with no increase in treatment withdrawals.
- A low-dose triple single-pill combination could help to reverse current therapeutic inertia and transform hypertension management.
OCCUPI: Optical Coherence Tomography (OCT) Outperforms Conventional Angiography in Guiding Revascularization for Complex Coronary Lesions
Key Points:
- In all-comer populations, coronary imaging guidance shows superior outcomes compared to conventional angiography in percutaneous coronary interventions (PCI).
- The OCCUPI trial demonstrated that OCT-guided PCI significantly improved clinical outcomes over conventional angiography-guided PCI in patients with complex coronary lesions.
EARTH STEMI: Complete Revascularization Reduces Ischemic Events up to 4 years Among Older Patients with STEMI with Multivessel Disease
Key Points:
- Approximately 50% of patients with STEMI have multivessel disease but data regarding the benefit of complete versus culprit only revascularization are limited among older adults.
- The EARTH STEMI meta-analysis, pooled individual patient level data from 7 randomized clinical trials, to examine the benefit of complete versus culprit only revascularization among 1,733 older patients (75 years or older) with STEMI and multivessel disease.
- Over 4 years of follow-up, complete revascularization resulted in a reduction in the primary composite endpoint of death, MI, or ischemia-driven revascularization as compared with culprit only revascularization. However, in the setting of a numeric increase in non-cardiovascular deaths and lower available follow-up data, the reduction in the primary endpoint was nullified beyond 4 years.
SENIOR-RITA: In Elderly Patients With NSTEMI, An Invasive Strategy Improved Clinical Outcomes Compared To Optimal Medical Therapy Alone
Key Points:
- Many older patients with NSTEMI do not receive coronary angiography during their index admission due to a high concern for complications and uncertainty regarding its benefits.
- SENIOR-RITA randomized type 1 NSTEMI patients aged 75 or older to a conservative strategy of optimal medical therapy alone or an invasive strategy of optimal medical therapy plus angiography, with revascularization if indicated.
- There was no difference in the primary composite endpoint of cardiovascular death or MI at a median of 4.1 years between the two strategies, but there was a significant reduction in non-fatal MI and subsequent revascularization procedures in the invasive arm, with a low procedural complication rate of <1%.
- The relative safety and potential benefit of an invasive strategy observed in SENIOR-RITA—the largest trial to date in this population—can help inform shared decision making for elderly patients with NSTEMI.
Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)
KEY POINTS:
- Fasting before cardiac catheterization is a common practice, however, the evidence supporting its benefit is limited
- The SCOFF trial demonstrated that during routine cardiac catheterization with conscious sedation, safety events, including aspiration, did not occur more frequently in the non-fasting group
FINEARTS-HF – Finerenone Improves outcomes in in HF with mildly reduced and preserved ejection fraction
KEY POINTS:
- There is a scarcity of treatments for HFpEF and HFmrEF with a high burden of disease worldwide
- In this randomized, double-blind, placebo-controlled trial, finerenone, a non-steroidal MRA, significantly reduced the risk of hospitalization or urgent outpatient visits in patients with HFpEF and HFmrEF compared to placebo in addition to standard of care treatment.
GUARD–AF: Wearable ECG Patch Increased the Yield of AF Diagnosis
Key Points:
- A 14-day heart rhythm monitoring with a wearable patch in primary care increased the diagnostic yield for atrial fibrillation by 52% compared to usual care.
- Despite treatment with oral anticoagulants, rates of stroke and hospitalizations were similar between screened patients and those receiving usual care.
OCEANIC AF – Asundexian is inferior to apixaban for stroke prevention in patients with atrial fibrillation
Key Points:
- Factor XIa inhibition may reduce stroke risk while causing bleeding.
- In this phase III trial, asundexian, a factor XIa inhibitor, was associated with a higher incidence of stroke or systemic embolism than apixaban but had fewer bleeding events.