Daily Briefing for November 9, 2026

Show Notes

Stopping statins after 70 meets noninferiority but adds 1 event per 40 patients

The voices on this episode are generated, and so is the script, from the day's post at Physician in the Loop. Every fact in the post links to its source.

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Adults 70 and older who stopped primary-prevention statins had more heart attacks, strokes and deaths, but within a preset noninferiority margin, a 1,880-patient trial reported Nov. 7 in the New England Journal of Medicine.

The STREAM trial enrolled people 70 and older with at least two chronic conditions and no known atherosclerotic disease, and the investigators estimated one additional major cardiovascular event or death over two years for every 40 people who stopped, according to HCPLive. Study author Dr. Rita Redberg called for shared decision-making rather than a blanket recommendation to stop, the report said.

Also at the American Heart Association's Scientific Sessions, Cleerly reported that its AI analysis of coronary CT beat stress-test-guided care at 180 days in a randomized trial whose results have not been peer reviewed. The Food and Drug Administration asked for feedback on robotic devices that act on their own or are run from a distance, and a 1,706-patient trial in Colombia and Jamaica found single-pill combination therapy with team-based care cut systolic pressure 10.1 mm Hg more than usual care.

In this episode

• Stopping statins in adults 70 and older without heart disease met noninferiority in a 1,880-patient trial, though events rose to 12.7% from 9.2%
• AI plaque analysis on coronary CT beat stress-test-guided care at 180 days in a 530-patient trial, the company reports
• FDA asks how to weigh the benefits and risks of robots that operate on their own or are run from afar
• Single-pill combinations delivered through team-based care cut systolic pressure 10.1 mm Hg more than usual care in a 1,706-patient trial
• FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer after platinum and immunotherapy, with a 42% response rate

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Voice 1: This is Physician in the Loop, the daily briefing on AI in medicine. It's Monday, November 9th, 2026.

Voice 1: A trial of 1,880 adults 70 and older found that stopping statins met its noninferiority goal, but major cardiovascular events still rose, from about 9% among people who kept taking the drug to about 13% among those who stopped. The investigators estimate one additional heart attack, stroke or death for every 40 people who quit, over roughly two years.

Voice 2: Noninferior but worse sounds like a contradiction. How does that work statistically?

Voice 1: The trial set a margin ahead of time. Event-free survival over two years came out to about 96 weeks after stopping versus about 98 weeks with continuing, a gap of about 2 weeks. The prespecified margin was about 5 weeks, so the difference still fell inside it.

Voice 2: What happened to their cholesterol once they stopped?

Voice 1: LDL at 12 months landed around 176 in a subsample that stopped, versus about 99 for those who stayed on therapy. Quality of life, pain, falls and sarcopenia risk didn’t differ much between the groups. There was no placebo arm.

Voice 2: So the numbers moved, just not enough to tip the trial’s own bar. What did the study’s safety board do with that?

Voice 1: After the trial ended, the board advised everyone in the discontinuation group to talk with their physician about restarting. Study author Dr. Rita Redberg argued for shared decision-making here rather than a blanket recommendation to stop, published in the New England Journal of Medicine.

Voice 2: A different kind of heart test got attention at the same meeting.

Voice 1: Cleerly says its AI analysis of coronary CT scans beat stress-test-guided care at 180 days, in a 530-patient trial with a win ratio of 2. These are the company’s own figures, presented in Chicago, and they haven’t been peer reviewed.

Voice 2: What was actually driving that win ratio?

Voice 1: Mostly greater certainty about whether chest pain was coming from coronary disease at all. Lipid-lowering therapy jumped from 31% to 75% of patients in the AI arm, versus 32% to 47% with usual stress testing.

Voice 2: Did it change who ended up in the cath lab for nothing?

Voice 1: Among patients sent for invasive angiography, 38% in the AI arm had no revascularization, against 60% in the usual-care arm. Full results are expected early next year.

Voice 2: A company's own numbers from a late-breaking slide are worth remembering until that full data lands.

Voice 1: A different approach to blood pressure worked in Colombia and Jamaica.

Voice 2: A cluster trial across 40 primary care clinics there cut systolic pressure about 10 mm Hg more than usual care. The intervention paired locally purchased single-pill combinations with physician and nurse training, health coaching, home monitoring and audit and feedback.

Voice 1: Who were these patients to start with?

Voice 2: Mean age was about 61, and 98% were already taking blood pressure drugs at baseline. Systolic pressure fell about 19 mm Hg with the intervention over 18 months, versus about 9 mm Hg with usual care.

Voice 1: Did more of them actually hit a safe target?

Voice 2: About 70% reached below 130 over 80, against 29% with usual care. Serious adverse events, meaning death or hospitalization, ran about 8% with the intervention and 10% with usual care.

Voice 1: 1,706 patients, nearly all already medicated, still getting meaningfully better control just from how the care was organized.

Voice 2: The FDA had a cancer approval worth a mention too.

Voice 1: Subcutaneous amivantamab got accelerated approval for head and neck cancer that progressed after platinum chemotherapy and immunotherapy. In a 102-patient trial, the response rate was 42%.

Voice 2: How does that stack up against what's already out there?

Voice 1: The FDA says currently approved therapies for this group respond about 20% of the time or less. Of the patients who responded, 56% kept that response for six months or more.

Voice 2: Any strings attached to the approval?

Voice 1: It excludes HPV-associated oropharyngeal cancer, the label warns of hypersensitivity reactions, lung disease, skin and eye toxicity and risk to a fetus, and confirmatory studies are required.

Voice 2: Before we go, something to watch.

Voice 1: The FDA wants feedback by January 5th on a discussion paper covering robotic devices that act with some autonomy or are run remotely, everything from surgical systems to imaging equipment.

Voice 2: Is this an actual proposed rule, or just a conversation starter?

Voice 1: Just a conversation starter. The agency says it's neither draft nor final guidance and proposes no policy change yet. The topics go to an agency workshop December 2nd and 3rd.

Voice 2: There's a separate clock running too, isn't there?

Voice 1: Comments on Palmetto and Noridian's proposals to stop covering AI brain MRI quantification software are due November 14th. Both contractors found the software not reasonable and necessary.

Voice 2: Two different reviewers landing on the same conclusion about the same kind of software is the detail that'll matter most if the coverage actually goes away.

Voice 1: Sources and corrections are at physicianintheloop.org, where you can sign up for the free email briefing. This briefing was read by AI voices.