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Alnylam’s Promising HF Treatment | The Dangers of Post-Op AFib
August 3, 2022
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“It is not ‘burnout’ when a broken system is lighting its workers on fire.”

A tweet from Andrew Boozary, MD, founding editor of the Harvard Public Health Review.

 

Cardiology Pharmaceuticals

Alnylam’s Promising Heart Failure Treatment

Alnylam Pharmaceuticals claimed a major success this week, with its RNAi drug Onpattro achieving the primary endpoint in its high-stakes APOLLO-B study for transthyretin amyloid cardiomyopathy. 

The phase 3 clinical trial became one of the year’s most closely watched studies in biotech after BridgeBio Pharma’s competing treatment failed in a late-stage trial last December. Because Alnylam’s trial was similarly designed, investors worried it would face the same fate. 

Alnylam’s Onpattro is FDA approved to treat polyneuropathy caused by the toxic buildup of misfolded transthyretin protein, a condition called ATTR. Alnylam is seeking to expand Onpattro’s use to treat ATTR cardiomyopathy, or ATTR-CM, which is a leading cause of heart failure. 

In the phase 3 study, 360 adults with ATTR-CM were randomized to receive 0.3 mg/kg of Onpattro or placebo intravenously administered every three weeks over 12 months. Here is what researchers found: 

  • Onpattro takers experienced a significant improvement in a six-minute walk test compared to the placebo group (P=0.016), meeting the trial’s primary goal.
  • Patients also reported improved quality of life compared to the placebo group (P=0.04), meeting a secondary goal.
  • However, treatment did not lead to a statistically significant difference in a composite assessment, which tracked all-cause mortality and frequency of CV events, as well as six-minute walk test scores. 

The Takeaway

Alnylam plans to apply for FDA approval of Onpattro in ATTR-CM in late 2022, setting up a potential launch in 2023. If approved, the drug would compete with Pfizer’s blockbuster tafamidis franchise, which raked in $909M last year in the US alone.

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When It’s Good to Find Something Bad

When Cleerly’s own quality director, Terry Schemmel, underwent a CCTA with Cleerly analysis he didn’t have any reason to believe there was anything wrong with his heart. However, Terry’s Cleerly analysis identified a 95% blockage in his left anterior descending artery, allowing him to get the proactive and personalized care he needed. 

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The Wire

Post-Op AFib “Not Benign”: Mayo Clinic research suggests that AFib after noncardiac surgery is “not benign” and just as likely to cause stroke as AFib developed outside the surgical setting. In an analysis of 4,231 patients with AFib over a mean follow-up of 6.3 years, researchers found no difference in stroke risk between those whose AFib appeared after surgery and those with non-operative AFib (adjusted hazard ratio: 1.01). The authors underscore that postoperative AFib “should not be considered a transient, benign phenomenon.” 

South Asian Heart Health: The US House of Representatives passed the South Asian Heart Health Awareness and Research Act which, if signed into law, would authorize $10M toward researching heart disease among South Asian Americans. Cardiology societies have shared their support of the legislation, pointing to WHO statistics that say South Asian Americans are four times more likely to develop heart disease than the country’s general population.

Early TAVR Improvement & Survival: A study published in JAMA found that patients who improve quickly after TAVR have lower long-term all-cause and cardiac mortality rates. Of 659 high- or intermediate- risk patients with baseline LVEF below 50% undergoing transfemoral TAVR, 1 in 3 experienced early LVEF improvement (defined as ≥10 percentage points increase in LVEF at 30 days). At five years, early recoverers experienced lower all-cause death (50% vs. 58%) and cardiac death (29% vs. 38%). 

Cleerly Closes Series C (Again): Even though we called Cleerly’s $192M Series C “colossal” last week, the heart attack prediction startup wasn’t done yet and has now officially closed the funding round after bumping the total raise to $223M. Cleerly plans to use the investment to expand the commercial reach of its AI software that evaluates noninvasive CT angiograms for plaque build-up to enable earlier detection of heart disease and calculate the likelihood of a patient having a heart attack. 

Gut Microbes & Heart Disease: New research found that metabolites produced by gut microbes may be partly responsible for the elevated heart disease risk associated with red meat consumption. Researchers analyzed data from nearly 4,000 participants over the age of 65 (12.5-year median follow-up), finding that every daily serving of meat increased atherosclerotic CVD risk by 22%, with red meat-associated metabolites responsible for one-tenth of the elevated risk.

NE Scientific Earns FDA 510(k): Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, earned FDA 510(k) clearance for reprocessing the Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter. This is the first time the FDA has granted 510(k) approval for reprocessing an atherectomy catheter that treats peripheral arterial disease by emitting UV light to vaporize blockages. 

Genetic Risk Score’s “Minimal Utility”: New research published in Circulation found that genetics are far less predictive of coronary heart disease than lifestyle risk factors such as high blood pressure, high cholesterol, and diabetes. An analysis of 9.8k patients compared the predictive utility of more than 6.6M genetic variants against a traditional 30-year risk factor score, demonstrating that the polygenic risk score did not significantly improve discrimination beyond the lifestyle components.

AstraZeneca Drops CVD Drug: AstraZeneca axed a Moderna-partnered CVD candidate, AZD8601, from its phase 2 pipeline months after reporting positive clinical trial results. The mRNA drug contains the precursor to vascular endothelial growth factor, a protein that supports heart repair and regeneration. Despite positive phase 2a trial results, in which investigators injected the drug into the myocardium of coronary bypass surgery patients, the company’s quarterly update shows that the candidate has been removed from its phase 2 pipeline.

World’s First HIV+ to HIV+ Heart Transplant: Montefiore hospital performed the world’s first successful heart transplant between an HIV+ donor and an HIV+ recipient. The patient, a woman in her 60s, suffered from advanced HF and received the donation in early spring. The procedure took place nearly a decade after the HIV Organ Policy Equity (HOPE) Act allowed people living with the condition to donate their organs to HIV+ recipients. 

The Toll of Methamphetamines: New research indicates that people who use methamphetamine face a much greater risk for CVD, mirroring trends associated with alcohol use and cocaine. Medical records of 20.2M California residents (66k meth users) with no history of CVD revealed that meth users were 53% more likely to develop heart failure and 42% more likely to develop pulmonary hypertension than non-users. Men who used were 73% more likely to have heart attacks than women who used. 

Hospital Margin Loss Streak: Patient volume and expense improvements haven’t been enough to offset the hospital industry’s growing cost of care, as US hospitals’ median operating margin is now officially in the red through the first six months of the year (-0.09%). Kaufman Hall’s latest National Hospital Flash Report showed positive month-over-month trends for both outpatient revenue (up 2.6%) and operating room minutes (up 2.4%), but margins are still “nowhere near pre-pandemic levels” and “will likely end up with historically low margins for the remainder of the year.”

Us2.ai Automates the Fight Against Heart Disease

See how Us2.ai cuts echocardiography’s manual work, subjectivity, and turnaround times to automate the fight against heart disease.

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User Experience and Cardiovascular Imaging Transformation

Check out this Change Healthcare video discussing the importance of user experience in the adoption of structured reporting, and how it can lead to improvements in imaging speed, quality, and cardiologist workflow. 

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