Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Timothy Anderson, MD, MAS | Image Credit: University of Pittsburgh

In light of recent recommendations from the American Heart Association (AHA) and the American College of Cardiology (ACC), among other organizations, >50% of all US adults between the ages of 30-79 are recommended for statins to prevent cardiovascular disease, according to recent research.

The 2026 updated recommendations include 5 central changes for primary prevention of 

atherosclerotic cardiovascular disease (ASCVD)

, which may substantially impact statin eligibility. These include an expansion of the population target for ASCVD from 40-75 years to 30-79, the addition of stage 3 or higher 

 and HIV infection as indications for eligibility separate from ASCVD risk, lowering thresholds for ASCVD risk, increasing statin initiation to class IIA, and recommending the PREVENT equations to replace the pooled cohort equations (PCEs) for 10-year ASCVD risk estimation.

“The shift to a longer view of cardiovascular disease risk is a sea change for doctors in counseling patients,” Timothy Anderson, MD, MAS, assistant professor of medicine at Pitt and a lead investigator on the study, said in a statement. “We wanted to better understand the potential population-health effect of the shift.”

Anderson and colleagues analyzed participants from the 2017-2018, 2019-2020, and 2021-2023 cycles of NHANES, including those aged 30-79 who completed the mobile examination center visit while fasting. Adults with self-reported ASCVD or those missing laboratory or physical examination data used in the PREVENT equations were excluded.

The team utilized both the PCEs and PREVENT equations to calculate patients’ 10-year ASCVD risk. The 30-year PREVENT-ASCVD risk was also included for patients 30-59 years. The PCEs included inputs for race, sex, age, 

, systolic blood pressure, antihypertensive medication use, 

, and smoking status. The PREVENT equations used similar inputs, only replacing race with estimated glomerular filtration rate and statin use.

The study ultimately included 4366 participants from NHANES, representative of 154.5 million US adults (95% CI, 141.2-167.8) without known ASCVD. Patients’ mean age was 51 years, and 52% of patients were female. Among the estimated 154.5 million US adults, 17.8% reported currently taking statins, 8.6% met criteria for statin eligibility regardless of ASCVD risk based on LDL-C of ≥190 mg/dL, diabetes, or CKD, 5.5% had LDL-C <70 mg/dL, 2.3% met criteria for statin eligibility through LDL-C ≥190 mg/dL, 5% through diabetes, and 1.3% due to CKD. Anderson and colleagues concluded that roughly 68% (95% CI, 65.9-70%) met guideline criteria for ASCVD risk estimation to guide statin decisions.

Among the estimated 105.1 million adults, 3.2 million were high risk, 11.4 were intermediate risk, 12.9 million were borderline risk, and 77.6 million were low risk. Among the low-risk portion, 5.4 million met eligibility criteria through LDL-C of 170-189 mg/dL, 13.7 million through 30-year risk ≥10%, and the remaining 58.5 million did not meet eligibility criteria. This brought total eligibility to 56.6% (95% CI, 54.2-58.9%) of the cohort, or roughly 87.5 million (95% CI, 80.4-94.5) US adults aged 30-79 years.

“Ultimately, in this grey zone, patients should talk to doctors,” Anderson said. “This is a preference-based decision that should take into account the potential for modest cardiovascular risk reduction alongside the potential for adverse drug events, costs, and patient preferences.”

University of Pittsburgh. More than half of U.S. adults now eligible for statins under new guidelines, Pitt Study finds. 

. July 20, 2026. Accessed July 20, 2026. 

https://www.eurekalert.org/news-releases/1136297

Anderson T, Wilson L, Sussman J. Implications of the 2026 Dyslipidemia Guideline for Primary Prevention Statin Therapy. 

Articles

Updated 2026 dyslipidemia recommendations markedly broaden primary-prevention statin eligibility by expanding the risk-assessment age range to 30–79, adding stage ≥3 CKD and HIV as stand-alone indications, lowering ASCVD risk thresholds, and shifting to PREVENT equations. In NHANES 2017–2023 fasting participants without known ASCVD, PREVENT-based risk stratification suggested 56.6% of US adults aged 30–79 (≈87.5 million) would be eligible. A large low-risk segment still qualified via LDL-C 170–189 mg/dL or elevated 30-year risk, underscoring preference-sensitive decision-making.

After broadening eligibility criteria across several disease states and a wider age range, the new guidelines have made an estimated 87.5 million adults eligible for statins.

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Dyslipidemia

Millions of New Patients Eligible for Statins Under 2026 AHA/ACC Guidelines

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals. 

Each week, we highlight 5 key developments or headlines from healthcare that you need to know — whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the FDA granting full traditional approval to iptacopan (Fabhalta) for adults with primary 

 (IgAN), the FDA approval of enlicitide (Lipfendra) as the first oral PCSK9 inhibitor for 

, phase 2a data from the SIGNAL-AA trial showing bempikibart effective for 

 at 36 weeks, 12-month open-label extension data for treprostinil palmitil inhalation powder (TPIP) in 

 (PAH), and phase 3 topline results for soficitinib in moderate-to-severe 

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of July 12, 2026 — let's jump in!

FDA Grants Full Approval to Iptacopan (Fabhalta) in IgAN

On July 17, 2026, Novartis announced the FDA granted traditional approval to iptacopan (Fabhalta) to slow kidney function decline in adults with primary IgAN at risk of disease progression. The decision converts the therapy's August 2024 accelerated approval into a full approval based on 2-year results from the phase 3 APPLAUSE-IgAN trial, in which iptacopan demonstrated an annualized mean eGFR change of −3.0 mL/min/1.73 m²/yr vs −5.7 mL/min/1.73 m²/yr for placebo — representing a 48% slowing of eGFR decline. Iptacopan is the first and only complement inhibitor approved to significantly slow kidney function decline in adults with primary IgAN. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to risk of serious infections caused by encapsulated bacteria.

FDA Approves Enlicitide (Lipfendra) for LDL-C Lowering in Adults With Hypercholesterolemia

On July 16, 2026, Merck announced the FDA approved enlicitide (Lipfendra) as an adjunct to diet and exercise for the reduction of LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Enlicitide is the first FDA-approved oral PCSK9 inhibitor — a once-daily 20 mg macrocyclic peptide tablet. The approval was supported by two phase 3 CORALreef trials: CORALreef Lipids (n=2,904) showed a placebo-adjusted 56% LDL-C reduction at week 24, and CORALreef HeFH (n=303) showed a 59% reduction. An ongoing cardiovascular outcomes trial, CORALreef Outcomes, is assessing whether enlicitide reduces cardiovascular morbidity and mortality.

SIGNAL-AA: Bempikibart Effective for Alopecia Areata at 36 Weeks

On July 13, 2026, Q32 Bio announced positive 36-week topline results from Part B of the phase 2a SIGNAL-AA trial evaluating bempikibart, an investigational fully human anti-IL-7Rα monoclonal antibody, in 33 adults with severe or very severe alopecia areata. Bempikibart met its primary endpoint, with a 35.3% mean reduction in SALT score and 40.0% of patients achieving SALT-20 at week 36. No treatment-related serious or grade ≥3 adverse events were reported. The trial population included patients with prior JAK inhibitor experience (36.4%), and several patients maintained or improved hair regrowth after stopping treatment. Q32 Bio plans to advance a registration-directed program in the first half of 2027.

Daily Inhaled TPIP Improved PAH Measures at 12 Months in OLE

On July 16, 2026, Insmed announced 12-month data from the open-label extension (OLE) of the phase 2b TPIP PAH program, showing treprostinil palmitil inhalation powder (TPIP) — an investigational once-daily dry powder prostanoid prodrug — produced sustained improvements across all secondary efficacy endpoints in patients with PAH. Both the TPIP-continued group and patients who crossed over from placebo showed approximately 55-meter improvements in 6-minute walk distance and approximately 60% reductions in NT-proBNP from baseline at month 12. Approximately 80% of patients in both groups achieved WHO Functional Class I or II at month 12. The phase 3 PALM-PAH trial is now enrolling, with change in 6-minute walk distance as the primary endpoint.

Soficitinib Meets Primary Endpoint in New Phase 3 Atopic Dermatitis Data

On July 15, 2026, InnoCare Pharma announced positive topline results from a registrational phase 3 trial of soficitinib (ICP-332), an investigational selective oral TYK2 inhibitor, in approximately 579 adults with moderate-to-severe atopic dermatitis. The trial met its primary endpoint with statistical significance and demonstrated clinically meaningful improvements across multiple secondary endpoints. No new safety signals were identified compared with prior clinical experience. Soficitinib is also being evaluated in vitiligo, psoriasis, prurigo nodularis, and chronic spontaneous urticaria, with regulatory filing intentions for AD.

Traditional FDA approval of iptacopan in primary IgA nephropathy was supported by 2-year APPLAUSE-IgAN data showing a 48% slowing of eGFR decline versus placebo, with distribution restricted via REMS due to encapsulated-bacteria infection risk. The FDA also approved enlicitide as the first oral PCSK9 inhibitor, delivering ~56%–59% LDL-C reductions in phase 3 trials, with outcomes data pending. Additional updates include phase 2a efficacy and tolerability signals for bempikibart in alopecia areata, durable 12‑month OLE improvements with once-daily TPIP in PAH, and phase 3 topline success for the TYK2 inhibitor soficitinib in atopic dermatitis.

Stay updated with the latest healthcare breakthroughs, including FDA approvals, phase 3 data, and open-label extension results.

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The HCPFive: Top News for Healthcare Providers from the Week of 07/12

John Sonnenberg, PhD, clinical psychologist, founder of Uptown Research Institute, and faculty at Northwestern University Feinberg School of Medicine.

John Sonnenberg, PhD, clinical psychologist, founder of the Uptown Research Institute, and faculty at Northwestern University Feinberg School of Medicine, sat down with

 to walk through the design of EMERGE, a phase 3 trial evaluating DT120 (lysergide) ODT 100 µg in adults with 

. The conversation took place before phase 3 topline data were announced; those results are now public, and 

EMERGE, a multicenter, randomized, double-blind, placebo-controlled trial, enrolled 149 adults with DSM-5-confirmed MDD across 20 sites and met its primary endpoint, with a placebo-adjusted MADRS reduction of 8.1 points at week 6 (

 <.0001) that was sustained through week 12.¹ The trial also produced a 24% remission rate at week 6, compared with 3% for placebo, and was generally well tolerated, with no serious adverse events or suicidality signals identified.¹

In this Q&A, Sonnenberg details the patient population and inclusion-exclusion criteria, the screening process, what happens during and after a dosing session, and how outcomes were tracked through the 12-week primary endpoint and into the open-label extension—the design choices that ultimately produced the results above.

Addressing Clinician Skepticism About Psychedelic Medicine

 What would you want a clinician who's skeptical of psychedelic medicine to understand about where the science actually stands right now?

 This is being studied as rigorously and as critically as any other psychiatric medication I have ever studied for any indication, whether it's anxiety, depression, bipolar, schizophrenia, [or] PTSD.

The scientists have recognized that there is something special about psychedelics, as opposed to other classes of medications. The pharmaceutical companies I am working with across the board are approaching this as scientists ought to: dispelling the null hypothesis, putting safety signals first, and ensuring that there's a true clinical need being addressed, not just another me-too opportunity.

There's one other thing clinicians might be intrigued by, because I am. Patients who have been exposed to the pharmaceutical-grade LSD we're testing in the Definium studies have shown a pattern where their symptoms have decreased, which isn't unheard of in clinical trials for depression. What I'm seeing that I don't see in other treatments is that patients have a different relationship to the symptoms they have.

The patients may say, "Yeah, I don't sleep well. Yeah, my stomach rumbles. Yeah, I'm just not as bothered by it anymore." So much of psychiatry is focused on this idea that we have to quash the symptoms.

There is this emphasis on trying to regain a stable equilibrium, and I think psychedelics, if they live up to half their promise, will be particularly helpful in letting people feel comfortable with themselves wherever they are on the spectrum from happy to anxious while at the same time allowing them to conquer and quell some of their symptoms. That's fundamentally different from the treatment armament clinicians have at this time.

Can you walk us through the EMERGE trial design? Specifically, what patient population is being enrolled and what the key inclusion and exclusion criteria are?

 The 310 study came down to this: these are depressed adults who don't have other primary psychiatric conditions, and they are not treatment-resistant. They have a [current] depressive episode…which doesn't mean they've had a successful treatment in the past; it just means they've had a failed treatment. Their current episode has to be between 2 weeks and 2 years, which is standard inclusion-exclusion criteria for this type of trial.

The one thing that might differ from other standard phase 3 psychiatric depression trials is [that] some other studies have a lower age cutoff, because there are more safety concerns with some of the other medications out there, interestingly enough. The other difference is that we don't want people who've had significant exposure to psychedelics, because they're going to have bias, and we don't want people going in with assumptions about what the experience should or shouldn't be like. While we didn't exclude [people with past psychedelic exposure], [that population] was capped.

What does the screening process look like for a patient before they're enrolled

 It was very much like another typical psychiatric depression trial. There was about a 30-day screening period, [during which] the patient was evaluated by central raters who worked independently of the site and weren't privy to where the patient was in the site process.

A third party [then] does an independent review to make sure the patient doesn't have a history of treatment resistance or some other hidden psychopathology that would be exclusionary and would muck up the data. Once a patient is identified as appropriate for the study…there's blood work, EKGs, and all the medical parameters done as per FDA [requirements and safety needs].

After about a month of screening, if the patient remains eligible, we do a final [check] to see whether the patient's depression has gone away. If the symptoms are still there and the patient continues to meet criteria, they're then paired with a DSM. This is the dosing session monitor.

What happens on dosing day itself, and what kind of monitoring is built into that visit?

 There's 2 [DSMs]. One is in the room with the patient at all times, and the other is a backup who can observe from somewhere else in a building through closed caption. A baby monitor is actually what we use.

The patient has the dosing session, [then] comes back the next day. Typically, I meet with them at that time to go over any adverse events and do a general assessment of their well-being, and they also meet with the DSM to process the experience.

They're not there to process symptoms; they're there to process the experience, which could be: “Boy, that was the longest 8 hours.” 

How are outcomes measured over the course of the study, and what happens once the primary endpoint window closes?

 [Patients] come back once a week. I meet with them to make sure they're not having residual symptoms, either from the dosing day or from a change in their depression that would require me or a member of my staff to address.

They [also] have weekly assessments done through independent raters, [who administer the MADRS]. That's done through week 12.

The patient then rolls over into an open-label extension, [which] is their choice, and I also have a say if I don't think it's appropriate for them. In the open-label extension, they come in for assessments and also [complete] some assessments through a phone app. If any of those scores reach a certain level, they come in for an additional assessment through the third-party vendor rater…[who] doesn't know where [the patient is] in the study.

Depending on that score, the patient would then be eligible for redosing. One of the things we've been able to do in the phase 3 studies is examine the process of subsequent dosing over the course of a year, which will help us understand how this medication [should] be used in the clinic setting.

Editor’s note: Reported disclosure for Sonnenberg includes Bristol Myers Squibb Company.

Definium Therapeutics. Definium Therapeutics. Published June 22, 2026. Accessed June 23, 2026. 

https://ir.definiumtx.com/news-events/press-releases/detail/232/definium-therapeutics-announces-positive-topline-results-from-phase-3-emerge-study-of-dt120-orally-disintegrating-tablet-odt-in-major-depressive-disorder

Sonnenberg J. Emerge Phase 3: DT120 Shows Rapid, Durable Relief in MDD. HCPLive. June 23, 2026. 

https://www.hcplive.com/view/emerge-phase-3-dt120-rapid-durable-relief-mdd

John Sonnenberg, PhD, outlines EMERGE trial criteria, dosing sessions, and endpoints for DT120 (lysergide) ODT 100 µg in major depressive disorder.

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Sonnenberg Breaks Down EMERGE Phase 3 Trial Design for DT120 in MDD

Medical director, pediatric hematology/oncology, Sarah Cannon Pediatric Transplant and Cellular Therapy Program, TriStar Centennial, and investigator, Sarah Cannon Research Institute

Exa-Cel Approval Expands to Children as Young as 2 With Haydar Frangoul, MD

The US Food and Drug Administration (FDA) has expanded approval of exagamglogene autotemcel (exa-cel; Casgevy) to children ≥ 2 years of age with sickle cell disease (SCD) and recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT), making it the first CRISPR-based gene-editing therapy approved for children this young with either condition.

Announced on July 1, 2026, the supplemental approval lowers the minimum approved age from 12 years and expands access to a one-time gene-editing therapy earlier in the disease course. The decision was supported by efficacy and safety data in children aged 5 to younger than 12 years, with the indication extending to children aged 2 to younger than 5 years based on extrapolation from those findings. The approval was granted 53 days after filing through the FDA Commissioner's National Priority Voucher pilot program.

For Haydar Frangoul, MD, MS, director of the pediatric stem cell transplant program at Sarah Cannon Research Institute and TriStar Centennial Children's Hospital and first author of multiple landmark studies evaluating exa-cel, the expanded indication represents an opportunity to begin discussing curative therapy earlier with patients and families.

"This is a huge milestone in the field, and I hope it won't be the last milestone in the field," Frangoul told 

Earlier Intervention Before Irreversible Complications

Although the pediatric findings closely mirrored results previously reported in adolescents and adults, Frangoul said the expanded indication is most meaningful because it creates the potential to intervene before cumulative disease-related complications become irreversible.

"The striking part is that children did extremely well, which we expect them to because they don't have end organ damage," Frangoul said.

He explained that both SCD and TDT cause progressive complications that accumulate throughout childhood and adulthood.

"Individuals with sickle cell disease... can develop more chronic complications that are irreversible with any type of therapy, including transplant or gene therapy," Frangoul said.

Earlier access to gene-editing therapy, he said, may allow clinicians to intervene before permanent organ damage develops, a concept also reflected in the FDA's rationale for expanding the indication to younger children.

Pediatric Data Extend Earlier Clinical Experience

According to Frangoul, the most important finding from the pediatric studies was not that outcomes differed from older patients, but that they remained remarkably consistent across age groups.

"The biggest takeaway is that the results... mirrored the results that we previously published in those who are 12 to age 35 and adolescents as well as in adults," Frangoul said.

The FDA based the expanded approval on efficacy and safety data in children aged 5 to younger than 12 years.

Among pediatric patients with SCD, all 8 efficacy-evaluable children achieved the primary endpoint of remaining free from protocol-defined severe vaso-occlusive crises for at least 12 consecutive months within the first 24 months following exa-cel infusion. Among pediatric patients with TDT, 8 of 9 efficacy-evaluable children achieved transfusion independence for at least 12 consecutive months, with a median duration of transfusion independence of 20.1 months.

Exa-cel is an autologous CRISPR/Cas9 gene-editing therapy in which a patient's hematopoietic stem cells are edited ex vivo before reinfusion following myeloablative conditioning. By increasing fetal hemoglobin production, the therapy reduces sickling of red blood cells in SCD and can eliminate transfusion dependence in patients with TDT.

Earlier Conversations About Curative Therapy

Beyond the regulatory decision, Frangoul believes the expanded indication should prompt hematologists to begin discussing curative treatment options earlier in the disease course.

Having cared for patients with SCD and TDT for nearly three decades, he said families should understand available treatment options even if gene therapy ultimately is not the right choice.

"I believe that every child and every even adult or adolescent with these diseases need to actually know their options," Frangoul said. "It might not be for everybody, and not everybody might want to do it."

Because most patients receive their routine care from hematologists rather than transplant or gene therapy specialists, he encouraged earlier collaboration between community clinicians and centers offering curative therapies.

"I hope that hematologists... partner with their partners that do the gene therapy and do the curative therapies and discuss these options early in life," Frangoul said.

He noted that introducing these conversations before children become eligible for treatment allows families to better understand future options if disease-related complications emerge over time.

Expanding Access Beyond Bone Marrow Transplantation

Frangoul also emphasized the approval's importance for patients who historically have not had access to curative therapy.

Approximately 80% of patients with SCD or TDT do not have a matched sibling donor and therefore are not candidates for allogeneic bone marrow transplantation, historically the only established curative approach for these disorders.

"This basically opens the door to the majority of the patients to be able to receive this therapy, which is really exciting," Frangoul said.

Treatment with exa-cel requires myeloablative conditioning before reinfusion of gene-edited autologous hematopoietic stem cells. The prescribing information includes warnings for neutrophil engraftment failure, delayed platelet engraftment, hypersensitivity reactions, and the potential for off-target genome editing.

Reflecting on patients he has followed after treatment, Frangoul described seeing children and young adults return to school, pursue careers, and regain opportunities that once seemed out of reach.

"I have some of the patients who went back to college. One graduated law school recently," he said.

Looking back on nearly 30 years caring for patients with SCD and TDT, Frangoul said the pace of progress has exceeded what he imagined earlier in his career.

"We are now in 2026, a place I never dreamt of 20 years ago," Frangoul said. "It is very exciting."

FDA approves first gene therapy for young children with sickle cell disease.

Frangoul H, Locatelli F, Sharma A, et al. Exagamglogene autotemcel for severe sickle cell disease. 

 2024;390(18):1649-1662. doi:10.1056/NEJMoa2309676.

Frangoul H, et al. Exagamglogene autotemcel in children with severe sickle cell disease and transfusion-dependent β-thalassemia. 

Videos

Haydar Frangoul, MD, discusses how the expanded indication may allow earlier conversations about curative therapy and intervention before irreversible complications develop.

Hematology

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

FDA News

FDA Expands Exa-Cel (Casgevy) Approval, Bringing Gene Therapy to Younger Children

Ron Blankstein, MD, is the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

Total Plaque Volume Indicates Patients With 0 CAC May Still Be at Risk

 score of 0, symptomatic patients can remain at significant risk from non-calcified plaque that cannot be detected with standard calcium scoring, according to a recent substudy of the DECIDE registry.

This analysis was presented at the 21st Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT) in San Diego, California, by Ron Blankstein, MD, the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

“Of course, when you look at total plaque volume, we’re now looking at the overall amount of plaque, not just calcified plaque,” Blankstein told 

 in an exclusive interview. “A particular patient may have a small amount of calcified plaque, but when you consider the overall amount, they move to a higher risk category, and that could have implications about treating that patient more aggressively.”

The DECIDE registry, initially conducted by HeartFlow, aimed to collate observational data regarding the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA). The registry itself is a post-market, multi-center, data collection study assessing the change in management of clinically stable patients with plaque detected after coronary computed tomography angiography (CCTA).

Investigators for the DECIDE registry collected data immediately after the CCTA was completed, with analyses conducted 90 days, 180 days, and 365 days post-scan. Patient data were organized into 6 groups, the details of which are as follows:

Group 1: No AI-QCPA – symptomatic patients who were scanned with plaque detected and no prior revascularization

Group 2: Delayed AI-QCPA – previously scanned, symptomatic patients with plaque detected and no prior revascularization. AI-QCPA provided 90 days after CCTA

Group 3: Stress Test Only – symptomatic patients with prior non-invasive stress testing without CCTA and no prior revascularization

Group 4: Prospective AI-QCPA, symptomatic with no prior revascularization – newly scanned symptomatic patients with plaque

Group 5: Prospective AI-QCPA, prior PCI – newly scanned patients with plaque, asymptomatic or symptomatic, with prior PCI in 1 vessel territory

Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization – newly scanned, asymptomatic patients with plaque and no current symptoms or prior revascularization.

The primary endpoint of the registry was change in medical management after AI-QCPA at 90 days versus following CCTA alone. This endpoint was only assessed in group 2 patients. Secondary outcomes included changes in LDL-C, HbA1c, non-HDL-C, HDL-C, and triglyceride levels across all groups, among others.

The present analysis included 11,792 symptomatic patients of the roughly 20,000 enrolled in the DECIDE registry. After analysis and accounting for total plaque volume, investigators found that 50% of all patients with a CAC score of 0 were reclassified into higher-risk categories, as were 30% of those with CAC scores 1-99 or 100-299. Conversely, patients with high calcium but modest total plaque volume were reclassified downwards.

These data reflect existing publications indicating that HeartFlow Plaque Staging substantially changed management in >50% of patients. The current analysis of this dataset effectively provides a model for the intensification of preventive therapy in patients with high total plaque volume despite a CAC score of 0, as well as for deescalating in patients with high CAC but lower total plaque volume.

“Perhaps some patients’ risk is not very high based on a calcium score, and if we had the overall plaque burden, that might reclassify them into a higher risk group, and we may treat them a little differently,” Blankstein said. “I think that’s what this latest study is trying to get at – after all, most of that reclassification occurred in patients who had a mild amount of plaque.”

Editors’ Note: Blankstein reports disclosures with Amgen, Heartflow, Nanox AI, Novartis, Caristo Diagnostics, Siemens, and others.

HeartFlow. New Data at SCCT 2026 Reinforce Heartflow Plaque Analysis as the Standard for AI-Powered Coronary Artery Disease Management. 

https://www.globenewswire.com/fr/news-release/2026/07/09/3324747/0/en/index.html

HeartFlow. AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management (DECIDE). ClinicalTrials.gov Identifier: NCT06376851. Updated October 14, 2025. Accessed July 20, 2026. 

https://clinicaltrials.gov/study/NCT06376851

Ron Blankstein, MD, discusses a secondary analysis of HeartFlow’s DECIDE registry, indicating undetected cardiovascular risk in patients previously labeled safe.

Atherosclerotic Cardiovascular Disease

Total Plaque Volume Indicates Patients With 0 CAC May Still be at Risk

Kimberly Blumenthal, MD, discusses who qualifies for de-labeling and how risk stratification guides testing.

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Most Penicillin Allergy Labels Are Wrong, Blumenthal Says

Richard Lafayette, MD, is a professor of medicine and director of the Glomerular Disease Center at Stanford University Medical Center.

ORIGIN 3 investigator brings atacicept approval to BAFF/APRIL targeting to IgAN 

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The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Atacicept Approval Brings BAFF/APRIL Targeting to IgAN With Richard Lafayette, MD

Abigail Brooks is a strategic content lead overseeing 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Newly published phase 2b RELIEVE UCCD data show strong 14 week results for duvakitug in ulcerative colitis and Crohn disease.

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On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

TL1A Antibody Duvakitug Boosts Clinical Remission in UC, Response in CD

Ashish Rana, MD, is the internal medicine program director and associate chair of academic medicine at Crozer Health, as well as a member of Sermo’s advisory board.

Ashish Rana, MD, discusses Sermo’s recent clinician survey, which highlighted patients’ use of unapproved and compounded GLP-1 medications.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Survey Shows Peptide Misinformation, Misuse Rising in US

Kimberly Blumenthal, MD, MSc, explains how surgical dyes, antibiotic-coated implants, and more can trigger perioperative anaphylaxis without appearing in the chart.

Hidden Operating Room Allergens: Dyes, Implants, Chlorhexidine Overwash

Sanjay Rajagopalan, MD, is the chief academic and scientific officer at University Hospitals Case Medical Center.

Sanjay Rajagopalan, MD, discusses the need for more patient-specific air pollution warnings to optimize accessibility for all individuals.

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