PRADA: Cardioprotective Agents May Not Be Required During Breast Cancer Tx

Adjuvant breast cancer therapy, while beneficial in prolonging survival, has been shown to have harmful effects on the heart, prompting some providers to prescribe neurohormonal blocking agents to attenuate the myocardial damage. The original PRADA trial showed that candesartan and metoprolol helped prevent a decline in LVEF in patients on adjuvant therapy. To date, however, smaller studies have not shown a similar benefit to neurohormonal blockade. In a late breaking clinical trial session on May 16 at the 2021 American College of Cardiology Scientific Sessions meeting, Dr. Siri Lagethon Heck of Akershush University Hospital in Oslo, Norway, presented the long-term follow up results of the PRADA trial. Continue reading

TWILIGHT: Analysis Shows Sex Disparities in PCI Outcomes Still Exist

Women fared worse than men in terms of increased bleeding risk, but comparable to men for ischemic event rates, results of a subgroup analysis of the TWILIGHT study presented May 15 at the 70th annual meeting of the American College of Cardiology (ACC) found. However, benefits of early aspirin withdrawal and continued use of ticagrelor in this high-risk PCI population was found to be comparable between sexes. Continue reading

Rivaroxaban shown to lower future vascular events after peripheral revascularization: results from VOYAGER-PAD

Rivaroxaban should be considered as adjunctive therapy to aspirin alone in patients undergoing peripheral limb revascularization, authors of the VOYAGER-PAD trial concluded today. In the Late Breaking Clinical Trials session earlier today at the 2021 American College of Cardiology Scientific Sessions, Dr. Rupert Bauersachs of Darmstadt, Germany, presented the anticipated results of the trial, which attempted to answer whether post-intervention rivaroxaban could prevent future limb ischemia and need for repeat revascularization.

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Dapagliflozin in the Treatment of COVID-19: Insights from the DARE-19 Trial

SGLT-2 inhibitors have demonstrated efficacy in various cardiometabolic conditions, including heart failure, coronary artery disease, chronic kidney disease, and diabetes. Given its favorable profile in various disease states, and the lack of effective therapies for patients hospitalized with COVID-19, it was hypothesized that dapagliflozin could provide organ protection in patients with cardiometabolic risk factors and COVID-19. During today’s Late Breaking Clinical Trials Session at the American College of Cardiology 2021 Scientific Sessions meeting, Dr. Mikhail Kosiborod of Saint Luke’s Mid Americas Hospital system presenting the findings of DARE-19, Dapagliflozin in Respiratory Failure in patients with COVID-19.

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Tricuspid Valve Replacement with the Transcatheter Evoque Valve is Safe and Effective at 30 days

Transcatheter tricuspid valve replacement has become a feasible alternative to surgery in patients deemed to be at high risk of adverse events, and in the past decade, various devices have been designed to meet this clinical need. In his Focused Clinical Research session on the opening day of the American College of Cardiology 2021 Scientific Sessions, Dr. Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian/ Columbia University Medical Center presented the 30-day results from the implantation of the EVOQUE valve, as part of the TRISCEND study. Continue reading

Real-World Data Supports Continued use of Transcatheter Left Atrial Appendage Occlusion

The WATCHMAN left atrial appendage occluder device has been widely accepted as an alternative to oral anticoagulation for stroke prevention in patients with underlying atrial fibrillation. However, the indications for WATCHMAN implantation laid forth by the Centers for Medicare & Medicaid Services in the United States differ from the original trials supporting its use. Real-world practice, therefore, highlights significant differences in the characteristics of patients receiving the therapy from those originally studied.  In a Focused Clinical Research Session at the 2021 American College of Cardiology meeting, Dr. Matthew Price, Director of the Cardiac Cath Lab at Scripps Green Hospital and Assistant Professor at the Scripps Translational Science Institute, La Jolla, California, presented the results of his study from the NCDR LAAO Registry (NCT02699957), assessing one- year real-world outcomes for patients undergoing WATCHMAN implantation.

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Apixaban Associated with Fewer Subclinical Valve Thrombosis Events: Results from the ATLANTIS 4D-CT Substudy

Subclinical valve thrombosis after transcatheter aortic valve intervention (TAVI) has emerged as a challenge to the standardization of antithrombotic therapy after valve implantation. Results of the randomized ATLANTIS trial, presented also today, May 15, as a Late Breaking Clinical Trial at ACC 2021, showed no superiority of apixaban over standard of care after transcatheter aortic valve intervention, irrespective of the baseline need for anticoagulants. In his Focused Clinical Research Session, Gilles Montalescot, MD, PhD, Professor of Cardiology at the Pitié-Salpêtrière Hospital, Paris, presented the 4D-CT substudy results to assess the incidence and implications of CT-proven valve thrombosis. Continue reading

Apixaban not Superior to Standard of Care after TAVR in ATLANTIS

The administration of apixaban monotherapy after transcatheter aortic valve replacement is not superior to the standard of the care antithrombotic treatment, results of the randomized, phase IIIb, prospective, open label, ATLANTIS trial, Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis (NCT02664649), show. These findings hold true regardless of a patient’s baseline requirement for anticoagulation. Continue reading

Prospective ARNI Versus Ace Inhibitor Trial to Determine Superiority In Reducing Heart Failure Events After Myocardial Infarction (PARADISE-MI)

KEY POINTS

  • Sacubitril/valsartan did not provide a lower rate of cardiovascular death, heart failure hospitalization, or outpatient development of heart failure when compared to active treatment with ramipril in patients after high-risk myocardial infarction.
  • When examining total adjudicated events and investigator reported primary endpoints, there was a trend toward clinical benefit in patients randomized to sacubitril/valsartan.

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Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) trial

KEY POINTS:

  • There was no significant difference in primary composite endpoint of all-cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke in patients with coronary artery disease taking 81 mg versus 325 mg of aspirin every day.
  • There was no significant difference in the safety endpoint of hospitalization for major bleeding with blood product transfusion in patients with coronary artery disease taking 81 mg versus 325 mg of aspirin every day.
  • Conducting pragmatic study in a real world, patient-centric approach will likely continue to emerge as an appealing, cost effective trial design in the field of cardiology.

Cardiovascular disease is costly and a major cause of death worldwide. Aspirin has been the mainstay of treatment in secondary prevention of coronary artery disease for over thirty years. More recently, several analyses have suggested varying doses aspirin (81 mg vs 325 mg) as well as the use of other, newer antiplatelet agents for the treatment of coronary artery disease. Continue reading

EXPLORER-HCM Trial: Mavacamten Associated With Significant Improvement in Patients’ Health Status in Patients With Symptomatic LV Outflow Tract Obstruction

EXPLORER-HCM presented at the American College of Cardiology 2021 meeting by John A. Spertus, MD, MPH, and simultaneously published in The Lancet, demonstrated that the use of mavacamten, a first-in-class cardiac myosin inhibitor, was associated with a highly significant improvement in patients’ health status. 1 out of 5 patients treated with mavacamten tended to experience a significant improvement in health status. Continue reading

Left Atrial Appendage Occlusion during Cardiac Surgery shown to Decrease Risk of Stroke

Patients with atrial fibrillation undergoing cardiac surgery should have concomitant atrial appendage occlusion, according to a new study presented at the American College of Cardiology 2021 Scientific Sessions.

“We have shown that left atrial appendage occlusion is not only a viable option but should be standard of care for patients with atrial fibrillation undergoing cardiac surgery,” says Dr. Richard Whitlock, primary investigator of the LAAOS III trial, a cardiovascular surgeon and professor of surgery at McMaster University. The results of LAAOS III were concurrently published in the New England Journal of Medicine . Continue reading

In a Recent Large Cohort Renin–Angiotensin–Aldosterone System Inhibitors Were Not Associated with Increased Risk of COVID-19 and Severe Illness

Medications acting on the renin-angiotensin-aldosterone system (RAAS), such as ACE inhibitors and angiotensin receptor blockers, did not increase the likelihood of a positive test for Covid-19 or the severity of the Covid-19. A cohort study of more than 12,500 patients conducted in a large health network in New York City, led by Dr. Reynolds, revealed. The findings of the study were recently published in the New England Journal of Medicine. Continue reading

A Population-Based Study Showed No Association Between COVID-19-Induced In-Hospital Death and Angiotensin-Converting–Enzyme Inhibitors and Angiotensin-Receptor Blockers Use

A recent study by Dr. Mehra, published in the New England Journal of Medicine, disapproved of the previously concerning idea regarding the potential harmful effect of angiotensin-converting–enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) in the clinical context of Coronavirus disease 2019 (Covid-19). This study also demonstrated that Covid-19 may disproportionately affect individuals with cardiovascular disorders.
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ORION-10 and ORION-11: Pooled Analysis of Two Phase 3 Trials Showed Sustained LDL Cholesterol Reduction with Inclisiran in Patients with ASCVD or ASCVD Risk Equivalent

The results of a pooled analysis of the ORION-10 and ORION-11 trials were recently presented at the American College of Cardiology 2020 Conference. The combined results published in the New England Journal of Medicine, demonstrated that inclisiran, a drug that inhibits hepatic synthesis of proprotein convertase subtilisin–kexin type 9, reduced low-density lipoprotein (LDL) cholesterol by 50% over 510 days.

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Study Shows Patient Self Reports Overestimated And Pharmacy Fills Underestimated Medication Persistence Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill A Secondary Analysis of the Cluster Randomized ARTEMIS Trial

In an original investigation done by Dr. Alexander C. Fanaroff et al and recently published in JAMA Cardiology, it was found that there was discordance in medication persistence as measured by patient-reported and the pharmacy fill data. The patient self-reports overestimated and pharmacy fill data underestimated medication persistence. Those who had non-persistence by both measures had the highest rate of major adverse cardiovascular events (MACE). The authors also noted the need for giving preference to interventions that will promote medication-taking behavior. Continue reading

Study Shows Myocardial Perfusion Mapping Using Artificial Intelligence Quantification of Cardiovascular Magnetic Resonance Imaging Provides Prognostic Information in Patients With Suspected Coronary Artery Disease Above Traditional Cardiovascular Risk Factors

A recent study by Dr. Knott, published in Circulation, have shown the prognostic value of measuring myocardial blood flow (MBF) using artificial intelligence quantification of cardiovascular magnetic resonance (CMR) perfusion mapping in cardiovascular outcomes. According to this study, both MBF and myocardial perfusion reserve (MPR) were associated with death and major adverse cardiovascular events (MACE) independently of other clinical risk markers. Using this technique, quantitative analysis of myocardial perfusion for clinical use is now available. Continue reading

Cohort Study Showed a Large Number of Patients Receiving Anticancer Therapy Demonstrate Myocardial Injury or Left Ventricular Dysfunction, With Only Few Showing Severe Cardiotoxicity

A recent study by Dr. Lopez-Sendon, published in European Heart Journal, showed that cardiotoxicity in the form of left ventricular dysfunction or myocardial injury affects a large portion of patients receiving high-risk anticancer therapy with only severe form strongly associated with all-cause mortality.

Cardiotoxicity has been known as one of the major side effects of anti-cancer therapy that may present with left ventricular dysfunction and heart failure. Given that the early recognition and treatment of these side effects have been associated with a higher recovery rate, a united diagnostic and management guideline seems necessary.

The CARDIOTOX (CARDIOvascular TOXicity induced by cancer-related therapies) registry has been established to determine the prevalence of cardiotoxicity markers as well as their association with guideline-based heart failure criteria and treatment in patients receiving chemotherapeutic agents. To achieve this purpose, a total of 865 patients receiving anticancer regimens associated with moderate to high cardiotoxicity were selected and followed for a median of 24 months. Clinical data, blood samples, and echocardiographic features were collected before the initiation of anticancer therapy and then at 3 weeks, 3 months, 6 months, 1 year, 1.5 years, and 2 years afterward. Patients with past or current history of heart failure or reduced left ventricular ejection fraction (< 40%) and those with a history of previous cancer therapy including chemotherapy and radiation therapy were excluded from the study. Cardiotoxicity was defined as any new deterioration from the baseline of myocardial/ventricular function during follow-up periods. Cardiotoxicity was also sub-classified into four stages depending on the worst myocardial dysfunction/injury observed in the follow-up period. Myocardial dysfunction/injury stages include the following: normal, normal biomarkers (high-sensitivity troponin T and N-terminal natriuretic pro-peptide), and left ventricular (LV) function; mild, abnormal biomarkers, and/or LV dysfunction (LVD) maintaining an LV ejection fraction (LVEF) ≥ 50%; moderate, LVD with LVEF 40–49%; and severe, LVD with LVEF ≤ 40% or symptomatic heart failure.

The study indicated a high incidence (37.5%) of ventricular dysfunction among the patients, of whom only 3.1% were classified as having severe dysfunction and the majority have been classified as mild (31.6%). All-cause mortality was also observed to be higher among those with severe cardiotoxicity than other groups. According to the author, the relatively low prevalence of severe cardiotoxicity in the study population was due to the exclusion of patients with a previous history of cardiac dysfunction and the improvement in the follow-up of the cancer patients in the context of cardio-oncology service. Severe cardiotoxicity has also been associated with a 10-fold increase in total mortality compared to a less severe form of cardiotoxicity. A classification of cardiotoxicity using current heart failure guidelines is also proposed by the authors for future studies. This study acknowledged the critical role of comprehensive monitoring and follow-up for the development of cardiovascular symptoms and left ventricular dysfunction in patients receiving chemotherapeutic agents with potential cardiotoxicity.

Limitations that are worthy of mentioning include the inclusion of patients with some degree of abnormality in biomarkers and echocardiographic findings at baseline. Secondly, the prevalence of myocardial damage may be underestimated due to a number of missing visits or incomplete data collection during the follow-up period. Future research is warranted to approve the relationship of different stages of cardiotoxicity with clinical outcomes.

SOLVE-TAVI Trial: No Difference in 30-Day Outcomes Between Balloon-Expandable and Self-Expandable Aortic Valves in High Risk Patients With Symptomatic Aortic Stenosis

A trial led by Dr. Holger Thiele showed that there was no difference in outcomes by 30 days when comparing the use of self-expandable and balloon-expandable valves in transcatheter aortic valve implantation (TAVI). The findings of this study published in the European Heart Journal suggest that both can be safely used in the majority of the population.

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Study Shows Hepatitis C Status Not Associated With Adverse Events in Adult Heart Transplant Patients by 1 Year

A recent study by Dr. Kilic, published in the American Heart Association Journal, showed similar adverse outcomes in the 1-year survival, rejection rates, and complications of patients who received a heart transplant using hepatitis C-positive (HCV+) donors whereas those using hepatitis C-negative donors.

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