Key Takeaways:

• The CLEAR SYNERGY trial was a multicenter trial with a 2-by-2 factorial design which randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either a) spironolactone or placebo and b) either colchicine or placebo.
• Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure.
• Safety outcomes, including hyperkalemia and gynecomastia, were more common in the spironolactone group compared to placebo.

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Key Takeaways:

• A single dose of nexiguran ziclumeran (nex-z), a CRISPR-Cas9-based therapy, achieved a 90% reduction in serum transthyretin (TTR) levels at 12 months (95% CI, −93 to −87).
• NT-proBNP levels showed stability with a geometric mean factor change of 1.02 (95% CI, 0.88 to 1.17), while high-sensitivity cardiac troponin T had a mean factor change of 0.95 (95% CI, 0.89 to 1.01).
• Of the 14 patients with serious adverse events, 7 had an event leading to hospitalization associated with cardiac failure (4 patients), arrhythmia (2 patients), or both (1 patient). The observed rate of cardiac events was 0.16 per patient per year (95% CI, 0.08 to 0.36).

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Key Points

• SUMMIT was a multi-national trial that compared cardiovascular outcomes among patients with heart failure with preserved ejection fraction (HFpEF) and obesity that were randomized to tirzepatide (a GLP-1 receptor agonist) or placebo.
• Patients in the tirzepatide arm had a significantly lower risk of a composite of worsening heart failure events and cardiovascular death, driven by a reduction in heart failure events. In addition, they experienced significantly larger gains in health status and physical functioning compared to placebo.

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Key Points

• BPROAD was a randomized control trial in China that assigned nearly 13,000 participants
  with type 2 diabetes (T2DM) and hypertension (HTN) to either a systolic blood pressure
  target of 120mmHg (intensive arm) or 140mmHg (standard arm).
• At 5 years of follow up, the intensive arm had significantly lower rates of major
  cardiovascular events (MACE: a composite of heart attack, stroke, heart failure, and
  cardiovascular death), however symptomatic hypotension and hyperkalemia occurred more frequently in the intensive arm.
• This trial supports targeting a systolic blood pressure of<120 mmHg to prevent MACE
  among patients with T2DM and HTN, with close monitoring for adverse effects.

Nearly 75% of patients with T2DM have high blood pressure. Hypertension is a major risk
factor for cardiovascular disease (CVD), including myocardial infarction, stroke, and heart
failure. While the SPRINT trial demonstrated that intensive blood pressure control improves
cardiovascular risk among those with HTN, patients with T2DM were excluded. 1 The ACCORD
BP trial found no benefit to an intensive blood pressure control strategy among those with
T2DM, however the power of this study was limited, and the interaction between intensive blood pressure control and intensive glycemic control strategies pursued in this study affected the overall results. 2 Therefore, benefit of intensive blood pressure control among those with T2DM remains uncertain.

On November 16, 2024 the results of Blood Pressure Control Target in Diabetes (BPROAD)
Study were presented at AHA Scientific Sessions 2024 with simultaneous publication in the New England Journal of Medicine. The purpose of this study was to determine whether targeting an intensive systolic blood pressure goal of <120 mmHg was more effective than the standard target of <140 mmHg in reducing the risk major cardiovascular adverse events (MACE) –including non-fatal stroke, myocardial infarction, heart failure, and cardiovascular death –among adults with T2DM.

BPROAD randomized 12,821 adults aged 50 or older with T2DM, HTN, and an increased risk of
CVD at 145 study sites across mainland China in 1:1 fashion to the intensive or standard
treatment arm. HTN for this study was defined as an systolic blood pressure of ≥ 140 mmHg on no medications or a systolic blood pressure of ≥130 mmHg on at least one medication. Increased CVD risk was defined as a history of clinical or subclinical cardiovascular disease prior to trial enrollment, at least two cardiovascular risk factors, or CKD. The average age was 64 years, 45% were women, and 23% self-reported a history of CVD. The groups were well balanced in terms of baseline characteristics, including blood pressure, BMI, smoking status, and hemoglobin A1c and lipid levels.

After 1 year of follow up, the mean systolic blood pressure in the intensive arm was 121.6
mmHg compared to 133.2 mmHg in the standard arm. At a median follow up for 4.2 years, rates of MACE were lower in the intensive arm (1.65 per 100 person-years) than in the standard arm (2.09 per 100 person-years), a significant reduction (HR 0.79 [95% CI 0.69-0.90]; p<0.001). The benefit of intensive control was consistent across the pre-specified subgroups. While the incidence of serious adverse events were similar, symptomatic hypotension and hyperkalemia was more frequent in the intensive arm.

Limitations of this study include lack of blinding for participants and study physicians, study
interruptions due to COVID-19 pandemic (the study enrolled from February 2019 through
December 2021), and limited generalizability to other populations.

Guang Ning, M.D., Ph.D., an elected member of the Chinese Academy of Engineering and a
professor at Ruijin Hospital at Shanghai Jiao Tong University School of Medicine in Shanghai,
China, concluded: “We found that for most people with Type 2 diabetes, lowering systolic blood pressure to less than 120 mm Hg reduced the risk of major cardiovascular events. These findings provide strong support for a more intensive systolic blood pressure target in people with Type 2 diabetes for the prevention of major cardiovascular events.”

References
1. The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-
Pressure Control. N Engl J Med. 2015;373(22):2103-2116. doi:10.1056/NEJMoa1511939
2. Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus. N Engl J Med.
2010;362(17):1575-1585. doi:10.1056/NEJMoa1001286

Key Points:

• In patients with atrial fibrillation, it remains unclear if anticoagulation therapy reduces the incidence of neurocognitive impairment
• In this randomized clinical trial, young patients who had atrial fibrillation with low stroke risk were randomized to receiving either rivaroxaban 15mg or placebo.
• Anticoagulation with rivaroxaban 15mg in young patients with atrial fibrillation with low stroke risk did not reduce composite end point of ischemic stroke, TIA, and neurocognitive decline at a median of 3.7 years.

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• The FAVOR III Europe study aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy.
• The findings do not support the use of QFR if FFR is available to guide revascularization decisions in patients with intermediate coronary stenosis.

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• The ECLIPSE trial evaluated orbital atherectomy (OA) vs conventional balloon dilatation (BA) in patients with de novo severely calcified lesions.
• The trial found no difference in target vessel failure (TVF) at one year between the two groups. The minimum stent area at the maximum calcium site was similar, but there was a numerical increase in favor of OA

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• Several randomized trials have shown reductions in MACE with colchicine in the treatment of coronary artery disease.
• The CLEAR SYNERGY (OASIS 9) trial showed that in patients with acute MI undergoing PCI, daily treatment with colchicine did not reduce MACE at 5 years compared with placebo.

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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 

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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 

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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).

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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.

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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.

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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.

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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

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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

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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.

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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

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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

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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

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