Key Points:

• This trial randomized 6,000 patients with high bleeding risk or acute coronary syndrome undergoing planned PCI to a strategy of 3.75mg of prasugrel or DAPT with aspirin 81-100 mg and prasugrel 3.75mg, following a prasugrel load in both arms.
• At 1 month, prasugrel alone failed to demonstrate superiority for the co-primary endpoint of major bleeding. However, the aspirin-free strategy was non-inferior to DAPT for the co-primary endpoint of cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke).
• DAPT remains the standard strategy post-PCI even in the current era with the newest generation of drug-eluting stents.

  Continue reading →

Key Points

• The FIRE trial aimed to address the lack of evidence regarding complete revascularization in older MI patients and examined the superiority of complete revascularization based on coronary physiology.
• The trial enrolled 1,445 patients with a median age of 80, and the primary outcome (death, MI, stroke, or ischemia-driven coronary revascularization) occurred in fewer patients in the physiology-guided complete revascularization group compared to the culprit-only group.
• Physiology-guided complete revascularization reduces ischemic events compared with culprit-only revascularization in myocardial infarction patients aged 75 years or older with multivessel disease.

Continue reading →

Key Points:

• Iron-deficiency is common in heart failure (HF) and associated with increased mortality and hospitalization.
• Previous trials of intravenous (IV) iron in the form of ferric carboxymaltose (FCM) in iron-deficient HF patients have shown improvements in symptoms and quality of life, but effects on clinical events have been unclear.
• This meta-analysis pooled data from three randomized controlled trials (RCTs) – CONFIRM-HF, AFFIRM-HF, and HEART-FID – to assess both a composite endpoint of total CV hospitalizations and death, as well as a composite endpoint of total HF hospitalizations and CV death through 52 weeks.
• In iron-deficient patients with HF with reduced ejection fraction (HFrEF) or HF with mildly reduced ejection fraction (HFmrEF), IV FCM is associated with reduced risk of composite outcome of total cardiovascular (CV) hospitalization and death through 52 weeks compared with placebo.

Continue reading →

Key Points:

• The use of ECLS has increased substantially over the past decade despite stagnant, high mortality in cardiogenic shock.
• This multicenter randomized trial compared ECLS with control in patients with acute MI-related cardiogenic shock. The primary endpoint was 30-day all-cause mortality.
• There were no differences in the primary endpoint of all-cause mortality between ECLS and placebo; however, ECLS resulted in higher rates of moderate-to-severe bleeding and peripheral ischemia requiring intervention.

Continue reading →

Key Points:

• Qiliqiangxin is a traditional Chinese herbal medicine extract which has been approved since 2004 for the treatment of HF in China.
• This multicenter, double-blind, placebo-controlled trial compared qiliqiangxin with placebo amongst patients with HFrEF (EF<40%). The primary endpoint was a composite of CV death and HF hospitalizations.
• Over a median follow-up of 18 months, qiliqiangxin use resulted in a reduction in the composite primary endpoint.

Continue reading →

Key Points:

• More than 80% of patients with HFpEF are overweight or obese, but there has not yet been a study examining the use of weight-loss agents in body weight reduction or HF symptomatology in HFpEF.
• In the Step-HFpEF study, subcutaneous once-weekly semaglutide was compared with placebo in patients with HFpEF and obesity. The two primary endpoints were change of KCCQ-CCS and body weight from baseline after 52 weeks of treatment.
• Semaglutide use resulted in a significant reduction in both heart failure symptomatology and body weight at 52 weeks.

Continue reading →

Key Points

• This trial randomizing patients aged 55 or older to colchicine or placebo following non-cardiac thoracic surgery found no difference in the co-primary endpoints of atrial fibrillation or myocardial injury, but post-hoc analyses indicated benefit in composite outcomes without a signal for increased harm.
• Colchicine increased risk of diarrhea, but patients reported that these symptoms were mostly temporary and benign.
• Further research is needed to explore the encouraging and consistent trend of fewer cardiovascular events with colchicine after non-cardiac surgery.

Continue reading →

Key Points

• This trial randomized elderly patients without a known diagnosis of atrial fibrillation with device-detected atrial high-rate episodes (AHREs) and a median CHA2DS2VASC of 4 to edoxaban or placebo.
• The study was stopped early due to safety concerns and trend towards futility for efficacy after enrollment of all planned patients.
• Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not result in lower incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo. Rather, it was associated with a higher incidence of a composite of death or major bleeding.
• The results indicate that patients with AHREs on their implanted device should not be prescribed anticoagulation unless atrial fibrillation is diagnosed on surface ECG. However, the stroke rates in the control arm were lower than expected.

Continue reading →

Key Points:

• Among patients undergoing PCI using third-generation DES with ultrathin struts and advanced polymer technology, 3- to 6-month DAPT was noninferior to 12-month DAPT for net adverse clinical events (NACE; defined as the composite of cardiac death, TVMI, CD-TLR, stent thrombosis, or major bleeding) at one year (3.7% vs. 4.1%; HR, 0.93; 95% CI, 0.60 to 1.45; p=0.75).
• The rates of target lesion failure (TLR; defined as the composite of cardiac death, TVMI, or CD-TLR) were comparable (2.4% vs. 2.5%; HR, 0.98; 95% CI, 0.56 to 1.71; p=0.94).
• No significant difference in major bleeding (BARC type 3 or 5) was observed (1.5% vs. 1.9%; HR, 0.82; 95% CI, 0.41 to 1.61; p=0.56).
• NACE, TLR, or major bleeding was not affected by the mode of presentation (stable ischemic heart disease or acute coronary syndrome).

Continue reading →

Key Points:

• In spite of the increase popularity of low-carbohydrate high-fat diet due to purported benefit in a variety of conditions, there is limited data on the effect of LCHF diet on overall lipid profile and risk of ASCVD
• Compared to the standard diet, regular consumption of a self-reported low-carbohydrate, high-fat diet was associated with elevated levels of total cholesterol (6.08 vs. 5.85 mmol/L; p=0.002), LDL cholesterol (3.80 vs. 3.64 mmol/L; p=0.004), and apolipoprotein B (1.09 vs. 1.04 g/L; p<0.001).
• At 11 years, LCHF diet was associated with a two-fold risk of incident major adverse cardiac event (MACE; defined as the composite of angina, myocardial infarction, coronary artery disease, ischemic stroke, peripheral arterial disease, or coronary/carotid revascularization) compared to standard diet (9.8% vs. 4.3%; p<0.001).
• Other covariates linked to a greater MACE risk included diabetes (HR=3.37), current smoking (HR=2.44), and hypertension (HR=1.89).

Continue reading →

Key Points:

• Both inflammatory risk and hyperlipidemia and crucial risk factors for MACE in patients at high risk of CVD.
• In a large collaborative study of patients combining data from the PROMINENT (N = 9,988), REDUCE-IT (N = 8,179) and STRENGTH (N = 13,078) trials, the effect of residual inflammatory risk (as measured by hsCRP) and LDL-C levels on MACE were assessed.
• Residual inflammatory risk as assessed by hsCRP was a stronger determinant of risk for future cardiovascular events and death than residual cholesterol risk as assessed by LDL-C.

Continue reading →

Key Points:

• There have been conflicting data on the role and recommended dosage of anticoagulation in non-critically-ill patients with COVID-19.
• In the open-label FREEDOM COVID study, therapeutic anticoagulation was compared with prophylactic doses of enoxaparin in patients hospitalized for COVID-19. The primary endpoint was a 30-day composite of all-cause mortality, requirement For ICU level-of-care, systemic thromboembolism, or ischemic stroke.
• Therapeutic anticoagulation did not result in any significant differences in the composite endpoint, but it did result in lower 30-day mortality and endotracheal intubation compared with prophylaxis.

Continue reading →

Key Points:

• Sotatercept is a novel activin signaling inhibitor which was designed to target pulmonary vascular remodeling in PAH.
• In the STELLAR study, sotatercept was tested against placebo on a background of baseline PAH therapy in adults with WHO II/III PAH. The primary endpoint was change in 6MWD at 16 weeks.
• Sotatercept resulted in an improvement in 6MWD, PVR, NT-proBNP, and a composite of time to clinical worsening and all-cause mortality at 16 weeks compared to placebo.

Continue reading →

Key Points:

• SGLT2i therapy reduces HF hospitalizations and CV mortality in HFpEF, but the mechanism is not yet clear.
• In this single-center, double-blinded RCT, patients with HFpEF were randomized to dapagliflozin or placebo and underwent exercise and resting hemodynamics at baseline and at 24 weeks.
• Dapagliflozin resulted in reduced resting and exercise PCWP, weight, and plasma volume relative to placebo.

Continue reading →

Key Points:

• The μCor monitor is a novel device that uses radiofrequency signals to assess the wearer’s thoracic fluid index, which can indicate HF complications.
• The BMAD trial enrolled 522 patients with HF within 10 days of hospitalization and fitted them with the μCor monitor, which was worn continuously for 90 days.
• Results showed that patients whose clinicians monitored their thoracic fluid index using the μCor device had a 38% relative risk reduction compared to those in the control arm.

Continue reading →

Key Points 

-Lowering LDL-C is known to reduce the risk of ASCVD

-In patients at very high risk for ASCVD or in those with intolerance to statins, PCSK-9 inhibitors are recommended, however, current PCSK-9 inhibitors are administered subcutaneously, limiting their use

-The findings of this Phase 2 trial suggest that MK-0616, an oral PCSK-9 inhibitor significantly reduced LDL-C at 8 weeks by as much as 60.3% compared to placebo

Continue reading →

Key Points

-HCM is the most common cause of sudden cardiac death in athletes

-In patient diagnosed with HCM, long-established guidelines have advocated against vigorous exercise with the assumption this decreases the risk of sudden death

-The findings of the LIVE-HCM trial, suggest that vigorous exercise is not associated with an increased risk of death, cardiac resuscitation, ICD shock, or cardiogenic syncope

Continue reading →

Key Points

– Prompt identification of patients suffering from ACS requires measurements of the blood level of the cardiac troponin biomarker, which is traditionally dependent on laboratory turn-around times.

– A novel wrist-worn, point-of-care test for estimating high-sensitivity cardiac troponin-I (hs-cTnI) based on transdermal infra-red spectrophotometric sensors, and coupled with a machine-learning algorithm, was trained and externally validated on a cohort of 238 patients presenting with ACS across 5 hospitals in India.
– The externally validated model demonstrated an excellent performance with AUC of 0.92 (95% CI, 0.80-0.98; sensitivity, 0.94; specificity, 0.64), and also predicted obstructive coronary disease and regional wall motion abnormalities. As such, this innovative wearable technology may have important implications in real-world settings for diagnosing patients presenting with ACS inside and outside of a hospital.

Continue reading →

Key Points

-Patients with diagnosed sudden cardiac death (SCD)-predisposing genetic heart diseases (GHDs) have traditionally been restricted from participating in competitive sporting activities.

-This retrospective study was the first to assess the risk of potentially life-threatening arrhythmias among NCAA D1 and professional athletes with a mean age of 22±5 years at the time of return to play.

– Over an average follow-up period of seven years, only three (3) athletes (4%) experienced a non-lethal cardiac episode related to their genetic heart disease, with fainting being the most common event. One of these athletes received an appropriate ICD shock. No athletes died during the study follow-up period.

Individuals diagnosed with sudden cardiac death (SCD)-predisposing genetic heart diseases (GHDs) have traditionally been restricted from participating in competitive sporting activities. There has been a paucity of data available to help clinicians make informed shared-decisions with patients and families. However, the concerns for adverse outcomes after return to play (RTP) include a range of scenarios which include, but are not limited to: cardiogenic fainting or seizures, implantable cardio-defibrillator (ICD) shocks, sudden cardiac arrest or sudden cardiac death. One of the largest, most contemporary studies to address this uncertainty, was a 20-year retrospective Mayo Clinic study on shared decision making (SDM)-mediated return-to-play (RTP). Although this study provided promising evidence of extremely low, non-lethal event rates, it was unfortunately, representative of a very young (<22 year of age) athletic cohort in non-elite level (Division I University or Professional) sporting activities.

In a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology today, Katherine A. Martinez (an undergraduate student at Loyola University, Baltimore, MD) and her team presented their study: “Return-to-play For Elite Level Athletes With Sudden Cardiac Death Predisposing Genetic Heart Diseases”, which is the first to assess s the risk of potentially life-threatening arrhythmias among National Collegiate Athletic Association (NCAA) Division I and professional athletes with heart conditions that can increase the risk of sudden cardiac death.

This was a multi-center, retrospective analysis of 76 elite athletes playing at the Division I or professional level treated for GHD at Mayo Clinic, Morristown Medical Center, Massachusetts General Hospital, and Atrium Health Sports Cardiology Center. About half of the elite athletes with GHD who were cleared for RTP (40 patients, 53%) had hypertrophic cardiomyopathy (HCM), and one-quarter (20 patients, 26%) had Long QT Syndrome (LQTS).  Slightly more than half of the athletes (40/76, 52%) had no symptoms prior to their diagnosis and were flagged after an abnormal cardiac evaluation, usually during pre-season screening. Approximately a quarter of athletes were diagnosed after experiencing symptoms suggestive of GHD. The remainder were diagnosed due to family history or an unrelated event. About 28% were female, with a mean age at return to play of 22±5 years. The breakdown of elite level participation was 49 (64%) NCAA D1 level and 27 (36%) at the professional level. Approximately one-third of athletes had an ICD.

The athletes included in the analysis played a range of sports, including basketball, hockey, track and field, triathlon and soccer, representing a variety of racial and ethnic backgrounds. Most athletes three-quarters (55/76, 72%) had been initially disqualified from sports based on their diagnosis but ultimately opted for unrestricted return to play after comprehensive clinical evaluation and implementation of SDM.

Over an average follow-up period of seven years, only three athletes (4%) experienced a non-lethal cardiac episode related to their genetic heart disease, with fainting being the most common event. One of these three patients received an appropriate ICD shock. No athletes died during the study follow-up period.

The results of this study by Katherine A. Martinez and team, provides hope for many patients with GHDs who wish to participate in sporting activities, particularly at the elite level. This study particularly highlights the importance of shared decision-making approaches to clinician-patient interactions as well as the need for multidisciplinary specialist involvement (genetic cardiologists and sports cardiologists among others) in the care of this patient population. This brings focus to the growing importance of an individualized approach to clinical recommendations. The devastating instances of high-profile tragedies naturally influences organizational, clinician and public perceptions of the health risks posed by GHDs in the sporting arena. However, this contemporary analysis stresses the importance of using scientific evidence in informed decision making. Prospective, multi-center data will be prudent to help bolster policy and guideline statements. The authors acknowledged that essential criteria for a comprehensive RTP protocol, must include: patient commitment to adherence to prescribed treatments and follow-up, access to an AED and open communication with relevant stakeholders overseeing elite sporting activities.

In closing, regarding the clinical implications of the study, Katherine Martinez stated: “our study provides scientific evidence, that for athletes competing at an elite level with an ICD, the outcomes are good.”

Continue reading →

Key Points:

• Macitentan and Tadalfil are frequently used in combination for PAH, which opens up the possibility of a fixed-dose combination pill.
• In the DUE study, macitentan/tadalafil FDC therapy was compared against macitentan and tadalafil monotherapy. The primary outcome was PVR reduction at 16 weeks.
• M/T FDC resulted in a significant reduction in PVR at 16 weeks compared to either macitentan or tadalfil monotherapy. There was a non-significant trend towards reduction in 6MWD at 16 weeks.

Continue reading →