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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