KEY POINTS:

• Significant bleeding is a common complication of cardiac surgery. Frozen plasma is the standard therapy but prothrombin complex concentrate offers an alternative treatment option.
• In the Factor Replacement in Surgery study (FARES II) patients experiencing significant bleeding during cardiac surgery who received PCC were 44% less likely to require additional intervention to control bleeding, compared to frozen plasma.

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KEY POINTS:

• SGLT2 inhibitors reduce admission for heart failure exacerbations.
• Clinical trials for SGLT2 inhibitors have historically excluded patients with aortic stenosis, a group with high rates of heart failure.
• In this prospective, randomized, open-label trial, elderly patients started on dapagliflozin shortly after TAVI had lower rates of all cause death or heart failure exacerbations at both 3 months and at 1 year compared to standard care.

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Key Points

• After DES placement, guidelines recommend considering shorter DAPT duration (e.g. 1-3 months) for those with high bleeding risk (HBR) and longer DAPT duration (e.g., 3-12 months) for those with low-bleeding risk (LBR). However, there is no randomized evidence comparing DAPT duration by bleeding risk category. 
• HOST-BR is the first study to stratify patients by bleeding risk and then randomize them to different DAPT durations. 
• Approximately ~1600 HBR patients were randomized to either 1 or 3 months of DAPT, and ~3300 LBR patients were randomized to either 3 or 12 months of DAPT after DES placement. The co-primary, hierarchical endpoints were net adverse clinical events (NACE; a composite of all-cause death, MI, stent thrombosis, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCE), and bleeding at 12 months. 
• Among HBR patients, a DAPT duration of 1 month was inferior to 3 months for both NACE and MAACE, without a significant improvement in bleeding. Among LBR patients, a DAPT duration of 3 months reduced bleeding compared with 12 months of DAPT, without increasing NACE or MAACE. 
• Therefore, 3 months of DAPT appeared to be the optimal duration for both low- and high- bleeding risk populations after PCI with DES. Limitations include generalizability beyond South Korea, as clopidogrel is preferentially used over ticagrelor in this population. 

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Key Points

• Injectable semaglutide, a GLP-1 receptor agonist, reduces CV events in patients with T2DM, however whether the oral form of semaglutide confers the same CV risk reduction is uncertain.
• The SOUL trial randomized 9650 participants age ≥50 with T2DM and established CAD, cerebrovascular disease, symptomatic PAD, or CKD to oral semaglutide or placebo. The primary outcome was 3-point MACE (CV death, nonfatal MI, and nonfatal stroke).
• Oral semaglutide was associated with a significant 14% relative reduction in MACE compared to placebo (HR 0.86 [95% CI: 0.77 – 0.96]), primarily driven by reduction in non-fatal MI. At 3 years, the absolute risk reduction with semaglutide was 2.0 percentage points, for number needed to treat of 50 persons. Serous adverse events were higher in the placebo group, but GI events were more common with semaglutide.
• Oral semaglutide is the first and only oral GLP-1 receptor agonist with proven CV benefits, demonstrating a risk reduction comparable to injectable GLP-1 agents, with no new safety signals identified.
   

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Key Points:

• A major limitation of antithrombotic therapy is the risk of bleeding if a patient requires urgent surgical or invasive procedures as well as the risk of spontaneous hemorrhage.
• Bentracimab is a first in class recombinant human immunoglobulin monoclonal antibody fragment that binds to ticagrelor and its active metabolite, rapidly neutralizing their antiplatelet effects.
• In this multi-center, phase 3 prospective, open-label, single-arm trial, bentracimab was shown to rapidly and effectively reverse ticagrelor in patients requiring urgent surgery or experiencing major bleeding, with high rates of hemostasis and favorable safety outcomes.

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Key Points:

• Patients with peripheral artery disease (PAD) in combination with type 2 diabetes (T2D) suffer from significant functional limitations and limited treatments.
• GLP-RA medications have demonstrated benefits that may target the pathobiology of PAD.
• In STRIDE, semaglutide was compared with placebo in patients with T2D and early symptomatic PAD.
• Semaglutide was associated with a significant improvement in maximum walking distance, pain free walking distance, quality of life, ankle brachial index, and disease progression.

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Key Points:

• Venous thromboembolism (VTE) is a leading cause of mortality in cancer patients
• Extended anticoagulation is recommended for cancer patients with VTE, but balancing efficacy and bleeding risk remains a challenge.
• The API-CAT trial demonstrated that extended reduced-dose apixaban (2.5 mg twice daily) was non-inferior to full-dose apixaban (5 mg twice daily) in preventing VTE recurrence while significantly lowering bleeding risk.

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Key Points: 

• In the WARRIOR trial, ~ 2500 women with signs and symptoms of ischemia without obstructive coronary disease (INOCA) were randomized to receive intensive medical therapy for coronary artery disease vs. continued usual care

• At five years, there was no significant difference in the rate of first occurrence of a major adverse cardiac event between the intensive medical therapy and control arms

• Important limitations of the trial include under-enrollment due to the COVID-19 pandemic and higher than anticipated rates of contamination of therapies due to the pragmatic trial design

According to a 2017 report from the Cardiovascular Disease in Women Committee of the American College of Cardiology, at least 3-4 million men and women in the United States have ischemia without obstructive coronary disease (INOCA), a syndrome that is defined by the presence of signs and symptoms of cardiac ischemia with no significant epicardial coronary disease (≥ 50% stenosis). Women are significantly more likely to have INOCA than men, and although there are no specific guidelines on the appropriate management of INOCA, there is growing evidence that INOCA is associated with higher rates of major adverse cardiac events (MACE). 

The Women’s IschemiA TRial to Reduce Events In Non-ObstRuctive CAD was a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) conducted in 4,422 symptomatic women with INOCA (NCT03417388) across approximately 70 United States sites. The hypothesis was that IMT will reduce the primary outcome of the first occurrence of MACE by 20% vs. UC at ∼2.5 year followup. Secondary outcomes included quality of life, time to return to “duty”/work, healthcare utilization, angina, cardiovascular death and individual primary outcome components over 3 years follow-up. The study utilized web-based data capture, e-consents, single IRB and centralized pharmacy distribution of strategy medications directly to patients’ homes to reduce site and patient burden. A biorepository was used to collect blood samples to assess potential mechanisms.

In the WARRIOR study, 2476 women from 71 centers across the United States who were found to have INOCA based on coronary angiography (n=1353) or coronary computed tomography angiography (n=1123) were randomized to receive intensive medical therapy versus ongoing usual care and followed every six months for the development of MACE including death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic attack or hospitalization for heart failure or angina. In the intensive medical therapy arm, patients received low-dose aspirin, statin and an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). The average age of the population was 64 years old and ~ 89% of women were white. The sample included high representation of some risk factors for coronary disease including ~64% with hypertension, ~ 53% with obesity and ~37% with a history of tobacco use but only ~21% of patients had diabetes. 

At five years, there was no difference in the composite primary outcome of MACE between the two arms with an event rate of ~16% in both arms and a hazard ratio of 1.13 (95% CI: 0.94-1.37, p=0.20). There was no notable heterogeneity in the treatment effect for the primary outcome when evaluating subgroups of individual risk factors for coronary disease or subgroups of medication types. 

One of the most important limitations of the study is the high rate of contamination between the two treatment arms; approximately half the patients enrolled in the usual care arm were ultimately started on many of the medications included in the intensive medical therapy arm. In addition, 70% of patients were already taking statins at baseline and half were already on an ACE/ARB, further limiting the ability to detect a treatment effect between the two arms. Another notable limitation is that because the trial enrolled during the COVID-19 pandemic, there was significant under-enrollment leading to inability to achieve the target enrollment of 4,476 patients. Finally, because the population was primarily non-Hispanic white and post-menopausal, the results may not be generalizable to the broader population with INOCA. In conclusion, although the WARRIOR study did not show a benefit to intensive medication therapy compared to usual care, the findings of the study are not fully definitive or generalizable to the broader population. Future studies are needed to further understand the increased risk of MACE associated with INOCA and the best strategies to mitigate it. 

Key Points:

• Left ventricular thrombus (LVT) is a serious complication following heart attacks, particularly STEMIs, and can lead to systemic embolism or stroke.
• Warfarin has traditionally been the recommended therapy for treating LVT in patients post-STEMI.
• The RIVAWAR trial demonstrated that rivaroxaban was comparable to warfarin in achieving clot resolution at three months, providing a safer, more convenient alternative without the need for regular blood tests.

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Key Points:

• REALIZE-K trial was a double-blind, placebo-controlled, randomized withdrawal study investigating SZC’s ability to maintain normokalemia (NK) and optimize spironolactone therapy (≥25 mg daily) in HFrEF patients with or at risk of HK.
• In participants with HFrEF and hyperkalemia, SZC led to large improvements in the percentage of participants with normokalemia while on optimal spironolactone dose, and reduced risk of hyperkalaemia and down-titration/discontinuation of spironolactone.
• Although underpowered for clinical outcomes, more participants had HF events with SZC than placebo, which should be factored into the clinical decision making.

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Key Points:

• AI-ECHO RCT is the first randomized trial to evaluate AI-based automated analysis within a real-world clinical echocardiography workflow.
• The study demonstrated:
  • Improved Workflow Efficiency: AI-assisted workflows increased the number of daily examinations per sonographer and reduced examination time.
  • Enhanced Data Analysis: The number of parameters analyzed per study tripled on AI-assisted days, showcasing comprehensive capabilities.
  • High Diagnostic Accuracy: Strong concordance between AI-generated data and expert-reviewed results, with parameters like LVEF showing robust correlation.
  • Superior Image Quality: Higher rates of “excellent” ratings for images on AI-assisted days.

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Key Points:

• BROOKLYN was a phase III trial that assessed the safety and effectiveness of obicetrapib as an adjunct to maximally tolerated lipid-modifying therapies, in patients with heterozygous familial hypercholesterolemia (HeFH).
• Obicetrapib reduced LDL-C levels by 36.3% at day 84, reaching 41.5% at day 365.
• Obicetrapib also demonstrated a 54.3% reduction in lipoprotein(a) levels, addressing a key cardiovascular risk factor.
• Adverse events were comparable between groups, with no significant differences in serious adverse events or cardiovascular deaths.
• Obicetrapib also improved non-HDL cholesterol and apolipoprotein B levels, enhancing lipid management.

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Key Points:

• Sustained Efficacy: Continued improvements in cardiac biomarkers, functional capacity, and symptom relief over extended treatment periods.
• Safety Profile: Consistent safety findings with no new concerns emerging during long term use.
• Reduced Hospitalizations: Fewer heart failure hospitalizations, highlighting its clinical impact.
• Mechanism of Action: Stabilizes transthyretin to prevent amyloid fibril formation, mitigating myocardial damage.

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Key Takeaways:

1. Black patients with peripheral artery disease (PAD) had significantly higher major amputation rates than White patients across all U.S. states (3.0% vs. 0.9%, p<0.001), with disparities varying widely by state and correlating strongly with the Social Vulnerability Index (rho 0.46, p<0.001).
2. Geographic and community-level factors, including socioeconomic vulnerabilities, play a critical role in driving racial disparities in PAD treatment, emphasizing the need for equitable healthcare access and interventions targeting high-risk communities.

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Key Points:

• The presence of mitral annular calcification (MAC) in prior studies of transcatheter aortic valve replacement (TAVR) has been associated with poor outcomes, but these studies used semiqualitative assessment, whereas quantitative assessment has generally not been analyzed
• The CT-derived MAC score is a quantitative assessment that can used in patients undergoing TAVR, but its clinical significance has not been assessed
• In this study, MAC scores of moderate or severe were associated with increased mortality risk, and involvement of the anterolateral trigone (one component of the score) was independently associated with adverse outcomes
• The CT-derived MAC score may be a useful quantitative assessment of risk in severe AS patients requiring TAVR

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Key Points:

• Cardiac rehabilitation (CR) is a guideline-directed multifaceted intervention that is shown to improve cardiovascular morbidity and mortality, but enrollment is low, especially among underrepresented groups, owing due to multiple patient-level and health-system-level factors
• The mTECH-Rehab trial tested implementation of an equity-focused digital health intervention to determine improvement in functional capacity among study participants
• This study evaluated the functional capacity of participants after 12 weeks using the 6-minute walk test (6MWT) as well as various secondary outcomes important in cardiovascular disease (CVD) prevention
• Though the study’s methodology has been presented previously, preliminary results are forthcoming as the study is ongoing

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Key Takeaways:

• Zerlasiran, a short interfering RNA (siRNA) targeting lipoprotein(a) (Lp(a)), was well tolerated and led to significant reductions in Lp(a) serum concentrations in both healthy participants and patients with stable atherosclerotic cardiovascular disease (ASCVD).
• A single dose of 600 mg of zerlasiran resulted in a maximal median reduction of Lp(a) by 99%, with 90% and 89% reductions sustained at 201 days for the 300 mg and 450 mg doses, respectively.
• The study found no serious adverse events, with mild to moderate injection site reactions being the most common side effect. Elevations in C-reactive protein were transient and resolved by day 7.

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Key Takeaways:

• The AMULET IDE trial compared the AMPLATZER Amulet occluder with the Watchman 2.5 device in patients with nonvalvular atrial fibrillation (NVAF) at high risk of thromboembolism.
• Patients with the Amulet occluder were significantly more likely to be free from oral anticoagulation (OAC) at 5 years compared with the Watchman device (94.0% vs. 90.9%, p = 0.009) and clinical outcomes, including rates of ischemic stroke or systemic embolism (7.4% vs. 7.1%, p = 0.851) and major bleeding (20.1% vs. 20.0%, p = 0.882), were similar between the devices.
• Strokes in the Amulet occluder group were less often fatal or disabling compared to the Watchman group (22 vs. 39 events, p = 0.030).

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Key Takeaways:

1. In this international registry, 266 patients with dual pathology, aortic stenosis and cardiac amyloidosis were identified and matched.  A control cohort of lone AS receiving aortic valve replacement was used for outcome comparison.
2. ATTR-specific medication, predominantly tafamidis, significantly improved survival in patients with dual aortic stenosis (AS) and transthyretin-associated cardiac amyloidosis (ATTR-CA) (adjusted HR 0.42; 95% CI 0.24–0.72), emphasizing its role in managing this complex pathology.
3. Aortic valve replacement (AVR), particularly in severe AS, provided substantial survival benefits (HR 0.42; 95% CI 0.25–0.72), with the combination of AVR and ATTR-specific therapy yielding outcomes comparable to lone AS patients undergoing AVR.

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Key Points:

• Patients with peripheral artery disease (PAD) at an increased risk of both major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
• Bempedoic acid is thought to reduce MACEs in primary and secondary prevention patients, but it is unknown whether the same can be said for MALEs
• The CLEAR Outcomes trial randomized patients to either bempedoic acid versus placebo to determine rates of MALEs, and some rates of MACEs, among at risk patients and patients diagnosed with PAD
• The study showed significant reduction in MALEs for all patients and patients with diagnosed PAD, as well as reduction in composite MACEs and MALEs, suggesting a possible role for bempedoic acid in PAD treatment and prevention

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