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The National Blood Shortage: An Unprecedented Challenge

New findings from a prespecified secondary analysis of the TWILIGHT study highlight sex-based disparities in bleeding risk, and similarities in ischemic events and aspirin benefit, among patients of percutaneous coronary intervention (PCI) who were treated with ticagrelor and aspirin.

American College of Cardiology (ACC) 2021 Scientific Sessions

 this weekend, showed women—who comprised just 23.9% of the 7119-participant TWILIGHT population—reported greater bleeding risks than men primarily due to baseline differences in the 2019-published trial.

However, ischemic events including composite death, myocardial infarction or stroke were similar across both sexes with high-risk PCI.

Additionally, early aspirin withdrawal plus continued ticagrelor treatment over 12 months was associated with similarly lowered bleeding risks in men and women.

, study authors Birgit Vogel, MD, and Roxana Mehran, MD, both of the Icahn School of Medicine at Mount Sinai, discussed the sex-based treatment and risk implications derived from the outcomes.

“For the ischemic outcome, we found one significant interaction between treatment strategy and sex—and that was that in women, the mortality was significantly decreased with the ticagrelor monotherapy strategy compared to the continued (dual-acting platelet therapy), but this was not the case in men,” Vogel said.

Vogel explained that the observed similar relative risk reduction for bleeding, when considered with the overall higher risk of bleeding among women with high-risk PCI, would constitute a greater response to the observed therapy for bleeding risk reduction in women.

Contributing to the point of the secondary analysis’ significance in PCI treatment understanding, Mehran highlighted the continued underrepresentation of women patients in cardiovascular research—despite the burden of such diseases on the sex.

“I think that the TWILIGHT sex analysis underlines the importance of making sure that we absolutely perform sex-based analyses on large, prospective clinical trials that examine pharmacologic revascularization or device strategies in patients,” she said. “Overall, we’re underpowered to evaluate the effectiveness in women.”

The study, “Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention,” was published online in 

Videos

Investigators discuss observed outcomes in females with high-risk PCI treatment, and their continued underrepresentation in pharmacologic studies.

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Surgery

TWILIGHT Analysis Highlights Sex Disparities in PCI Treatment, Outcomes

New findings show that etripamil nasal spray was effective in relieving symptoms related to 

paroxysmal supraventricular tachycardia (PSVT)

. Furthermore, the calcium channel blocker was associated with reduced emergency room visits.

This data, reported from the NODE-301 trial, was presented at the 

American College of Cardiology (ACC) Annual Scientific Session

A team, led by Bruce Stambler, MD, of Piedmont Heart Institute, sought to investigate whether self-administered etripamil was superior to placebo in terminating PSVT events in an outpatient setting. At this year's conference, they presented key secondary endpoints, which included relief of PSVT-related symptoms, emergency room intervention or rescue medical therapy, and treatment satisfaction.

At the study outset, 156 individuals were randomized 2:1 to receive either etripamil (n = 107) or placebo (n = 49) during PSVT. All patients experienced a vagal-maneuver refractory, symptomatic episode of sustained PSVT and were medically unsupervised during self-administration.

Stambler and colleagues evaluated the percentage of patients who required an emergency room intervention or other such intervention to terminate their PSVT at 5 hours post-administration.

Symptom relief and nasal spray satisfaction were evaluated using the Treatment Satisfaction Questionnaire for Medication (TSQM-9), with higher scores indicating higher satisfaction.

“Etripamil was more effective than placebo at relieving symptoms associated with PSVT including rapid pulse (

Furthermore, they indicated that etripamil was associated with a 51% reduction in the need for the emergency room compared with placebo (

 = .051). Even more, there was a 47% prolongation in the time to next emergency room visit following etripamil use versus placebo.

Of all patients who used etripamil, 12% needed emergency room therapy to terminate PSVT after 116 mins compared with 25% of placebo users after 79 minutes. Further, 2 more patients—1 in each treatment arm—required oral rescue medical therapy.

Patients who used etripamil indicated higher scores of treatment effectiveness (54) than patients who used placebo (35; 

 = .001). A similar pattern was noted for global effectiveness—57 versus 43 (

And finally, both treatments were considered highly convenient (etripamil, 74 vs placebo, 76).

, Stambler noted etripamil had failed meet its primary endpoint of time to conversion of PSVT to sinus rhythm compared to placebo over 5 hours—

 which were reported last year. However, a post-hoc analysis showed etripamil was superior to placebo in converting PSVT over the first 45 minutes post-administration.

Stambler emphasized the overall convenience of the medication, noting the importance in such patients.

“The ability to have something on hand to potentially be able to improve symptoms, terminate their arrhythmia puts the control in the patient,” he said. “Because [PSVT} is a rhythm disturbance that can create huge anxiety — and importantly, patients don’t know when or if this arrhythmia will develop.”

The study, “Etripamil Nasal Spray Relieves Symptoms and Reduces Emergency Room Interventions In Patients With Paroxysmal Supraventricular Tachycardia (PSVT): Analysis Of Clinical Outcomes In The Node-301 Trial,” was presented at ACC 2021.

Articles

A smaller proportion of patients who used etripamil required an emergency department intervention 5 hours post-administration—compared to placebo users. 


Etripamil Nasal Spray Well-Tolerated, Improves PSVT-Related Symptoms

Mavacamten, a first-in-class cardiac myosin inhibitor, was associated with substantial improvements in the health status of patients with 

obstructive hypertrophic myocardiopathy (oHCM)

, according to findings presented at the 

HCM is characterized by unexplained left ventricular hypertrophy. Investigative drug mavacamten is a targeted inhibitor that decreases contractile function as well as improves VO

. Nevertheless, little has been understood about the drug’s effect on patient symptoms, function, and quality of life.

In the pivotal phase 3 EXPLORER-HCM trial, patients (n = 251) with left ventricular outflow tract (LVOT) ≥50 mmHg and New York Heart Association (NYHA) class II-III symptoms were enrolled. They were then randomized 1:1 to either mavacamten or placebo for 30 weeks.

Health status was evaluated according to the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) at weeks 6, 12, 18, 30, and 38. The disease-specific questionnaire consisted of 23 items and quantified symptoms, physical function, social function, and quality of life, with higher scores (0-100) representing fewer symptoms, better function, and better quality of life, respectively.

The investigative team then analyzed change from baseline in KCCQ score using mixed model repeated measures and responder analyses. 

The findings for this analysis were presented at the conference by John Spertus, MD, of Univeristy of Missouri-Kansas City.

Of the 123 patients in the mavacamten cohort, 92 complete the KCCQ; of the 128 patients in the placebo cohort, 88 completed the questionnaire. The mean age of the KCCQ population was 58 years, and the majority (61%) was male, white (92%), and NYHA class II at baseline (73%).

Spertus and colleagues thus observed early and sustained improvements in KCCQ in the mavacamten group through week 30 compared to the placebo group (mean difference, +9.1; 95% CI, 5.5-12.8). They noted in particular that the mean difference in score was among the largest for any medication. However, these improvements were not sustained through week 38 (post-treatment).

Furthermore, the investigators reported that, at week 30, a greater proportion (36%) of patients who received mavacamten achieved a very large clinically meaningful improvement in KCCQ — defined as ≥20-points—when compared with the placebo group (15%).

In fact, a higher proportion of placebo patients experienced no change (32%) or a deterioration (23%) in their health status compared with mavacamten patients (20% and 32%, respectively).

, Spertus indicated that more work needs to be done to fully understand the mechanisms behind these observed improvements in patients.

“As we learn what’s causing these quality of life benefits, there may be other diseases that may also benefit from the drug,” he noted. As an example, he pointed to the potential for the drug in patients with heart failure and a reduced ejection fraction.

Even then, studies assessing patients not necessarily with hemodynamically significant oHCM—as well as longer-term trials—are warranted.

The study, “Health Status Benefits of Mavacamten in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results from the EXPLORER-HCM Randomized Clinical Trial,” was presented at ACC 2021.

Improvements in patient symptoms, function, and quality of life were not sustained once treatment was discontinued.


Mavacamten May Improve Health Status in Patients with Obstructive HCM

Combination therapy sacubitril/valsartan (Entresto) was not associated with significantly reduced risk of heart failure nor cardiovascular death versus angiotensin converting enzyme (ACE) inhibitor ramipril among patients treated after a myocardial infarction, according to new findings from the PARADISE-MI trial.

The Novartis-funded research, presented at the 

American College of Cardiology (ACC) 2021 Annual Scientific Sessions

 this weekend, provides the first large-scale assessment of the neprilysin inhibitor and angiotensin receptor blocker (ARB) therapy combination in reducing heart failure-associated hospitalizations and death among patients at greater risk of such events due to a heart attack.

Sacubitril/valsartan has been previously approved by the US Food and Drug Administration (FDA) for the reduced risk of cardiovascular death or heart failure hospitalization in adult patients with chronic heart failure and reduced ejection fraction (HFrEF), as well as 

 with systemic left ventricular systolic dysfunction in patients aged 1 year and older.

Study lead author Marc Pfeffer, MD, professor of Medicine at Harvard Medical School and cardiologist at Brigham and Women’s Hospital, presented findings from the Prospective ARNI Versus ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events after Myocardial Infarction (PARADISE-MI) on May 15.

Pfeffer and colleagues enrolled 5669 patients from 41 countries who had survived a myocardial infarction less than 1 week prior to enrollment.

Patients were observed to have high risk of heart failure development based on a litany of risk factors; a majority of patients were taking antiplatelet, antihypertensive, and cholesterol-lowering therapy prior to randomization.

Investigators randomized patients 1:1 to sacubitril/valsaratan and ramipril for a median follow-up period of 23 months. The team sought a primary endpoint of composite cardiovascular death, hospitalization due to heart failure, or development of symptomatic heart failure. They set a threshold of 15% reduced risk of such events for patients administered sacubitril/valsartan, to signify significant improvement against ramipril.

Key secondary endpoints included cardiovascular death, heart failure hospitalization, non-fatal heart attack or non-fatal stroke, and all-cause death.

Pfeffer and colleagues observed a 10% lowered risk of the composite primary endpoint in patients treated with sacubitril/valsartan versus those administered ramipril—short of the 15% mark for significant improvement.

However, they did observe a 21% reduction in total heart failure burden including recurrent events in the patients administered sacubitril/valsartan, and achievement of improved risk reduction in all key secondary endpoints.

Adverse event frequency was similar across the 2 treatment groups, and included angioedema, abnormal potassium levels, renal impairment, and liver abnormalities. Hypotension was more frequent among sacubitril/valsartan-treated patients.

In a statement accompanying the findings, Pfeffer called the PARADISE-MI results consistent to the proposal of sacubitril/valsaratan as an incrementally improved treatment for heart failure reduction over ramipril.

“The results are encouraging, especially when considering recurrent heart failure events and not just the first heart failure events, but the study is not definitive,” he wrote. “We did notice several aspects of heart failure development that were lessened with sacubitril/valsartan but to investigate these observations would require further evaluations.”

Though the trial “may not change guidelines,” Pfeffer stated it should provide physicians greater ease in prescribing the therapy to patients with heart failure.

Though the combination heart failure therapy did provide overall benefit versus ramipril in post-heart attack patients, the rate of events reduced was not considered significant.

Heart Failure

Hospital Medicine

Sacubitril/Valsartan Misses Significant HF Event Reduction Mark in PARADISE-MI

 Schuyler Jones, MD, and Manesh Patel, MD


15,076 patients with atherosclerotic cardiovascular disease

 81 mg versus 325 mg daily aspirin for reduced risk of death, or hospitalization from myocardial infarction or stroke

 Reduced risk of hospitalization for major bleeding

 No significant difference in outcomes between doses over median 26.2 months

 Dose-switching to 81 mg was significant among patients assigned to 325 mg aspirin (42%)

 “More than anything, the process of the trial is important: can we do a pragmatic study on a limited budget in the United States in a relatively short period?”

Introducing Heart Trials, the newest specialty podcast series from 

. Heart Trials is a breakdown of the studies that define modern 

In this first episode, in alignment with new late-breaking research from the 

American College of Cardiology (ACC) 2021 Virtual Sessions

, study author W. Schuyler Jones, MD, and his colleague Manesh Patel, MD, join to discuss the ADAPTABLE study, presented Saturday morning at the meeting and published online at 

Jones is an associate professor of Medicine and Population Health Sciences at the Duke University School of Medicine.

Patel is professor of Medicine and chief of the Division of Clinical Pharmacology and Division of Cardiology at the Duke University School of Medicine.

In contributing to the current debate of optimal daily aspirin dosage for the reduced risk of major cardiovascular events in at-risk patients, Jones and colleagues presented pragmatic findings featuring 15,000-plus participants suggesting that there is little difference in outcomes and safety associated with 81 mg and 325 mg aspirin.

What they did find, however, was a significant rate of participants switching from 325 mg doses assigned at baseline, to the standard practice 81 mg dose.

After running through a brief history of aspirin use in the US and highlighting the key outcomes of ADAPTABLE, Jones and Patel join to provide background into the research, share their opinions on the trials’ clinical impact, and gauge how future research may be shaped by these outcomes.

Listen to Heart Trials on your favorite podcast platforms, including 

Podcasts

The first episode of the Heart Trials podcast series focuses on new ACC 2021 research into aspirin dosages for reduced cardiovascular event risk.

Stroke

ADAPTABLE, with Schuyler Jones, MD, and Manesh Patel, MD

Data suggests that the non-vitamin K antagonist blood thinner may be used as default treatment among post-operative patients in need of oral anticoagulation. 

Apixaban Use Post-TAVR is Not Superior to Standard of Care

Data show sublingual sufentanil tablets did not affect pain scores, but did benefit patient satisfaction outcomes.

Pain

Opioid-induced Constipation

Acute Pain

Chronic Pain

Sublingual Sufentanil Tablet Linked to Reduction in Opioid Requirement Rates 

The single 1000 mg dose treats iron deficiency anemia in adult patients. 

Nephrology

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FDA Approves Single Dose Ferric Carboxymaltose Injection Treatment

Vaccinated individuals no longer need to wear masks indoors in accordance with CDC guidance.

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William Schaffner, MD: Lifting the Mask Mandate

Data show a nearly 30% reduction in individuals filling naloxone prescriptions at the start of COVID-19 pandemic, with no significant recovery observed. 

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FIX activity was similar in participants without and with pre-existing neutralizing antibodies.

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The low-dose cohort of RP-A501 conferred cardiac LAMP2B transgene expression. 

RP-A501 Gene Therapy Treatment Well-Tolerated in Male Patients with Danon Disease 

Patients who received 2 mg or 4 mg of baricitinib maintained vIGA-AD scores through 68 weeks of treatment. 

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Baricitinib Shows Long-Term Efficacy for Atopic Dermatitis

Sickle cell patients in rural areas may actually benefit from telemedicine practices and access to satellite clinics. 

Latest Clinical News

TWILIGHT Analysis Highlights Sex Disparities in PCI Treatment, Outcomes

Etripamil Nasal Spray Well-Tolerated, Improves PSVT-Related Symptoms

Mavacamten May Improve Health Status in Patients with Obstructive HCM

Sacubitril/Valsartan Misses Significant HF Event Reduction Mark in PARADISE-MI

ADAPTABLE, with Schuyler Jones, MD, and Manesh Patel, MD