C. Michael Gibson MD

“The Last Shift” Oil on clay covered wood board by C. Michael Gibson 2020. Welcome home to all of our courageous #CoronaHeroes who made the ultimate sacrifice 🙏💙 #cmgsees #COVID19

Dr. Ashkan Shoamanesh and Dr. C. Michael Gibson discuss findings presented at the recent ESOC meeting about what the latest data reveals about asundexian and ischemic stroke prevention. We examine the characteristics and severity of ischemic strokes occurring during the study, the consistency of treatment benefit over time, and the rates, outcomes, and predictors of intracranial hemorrhage (ICH) and hemorrhagic stroke. The analyses found that the benefit with asundexian persisted over time, strokes in patients receiving asundexian were less likely to be severe or treated with endovascular thrombectomy, while rates and severity of ICH and hemorrhagic stroke were similar between asundexian and placebo. Dr. Ashkan Shoamanesh discusses latest data reveals about asundexian and ischemic stroke prevention Watch video here: clinicaltrialresults.org/wp-… S/b Bayer

When in doubt, randomize #cmgsays AI models Non-randomized observational data Mendelian randomization data All these failed to predict that outcomes of a large Phase 3 randomized trial I am a fan of AI tools, but they are no substitute for a randomized trial

Recently, #Asundexian was approved by the FDA for the treatment of patients with a recent #stroke. Dr. Mike Sharma and I review the data that supported the approval.

I am proud to have served our nation’s veterans as Cath Lab Director and Chief of Cardiology at the West Roxbury VA. Caring for them was a privilege ! Our veterans are among the very best of us. Freedom isn’t free, and they have sacrificed so much to protect the freedoms we cherish. This Veterans Day, please join me in thanking them for their service and honoring all they have given.

My thoughts as a patient with an elevated Lp(a) after the results of Horizons came out (check with your own healthcare provider, this is not medical advice, just perspective as a patient): The trial was a success as it answered a major question. The result was neutral, not negative. I don't like it when people use the word negative to describe well done trials. I am personally optimistic that driving my LDL down as low as possible (it is 19 mg/dl) will be protective of my risk of cardiac events. On the other hand, I still worry about the risk of aortic stenosis and we need more data on that. I'm less anxious than I was, and that is good!

True or False: If you create something with #AI (an app, a product), there is no moat (product differentiation that protects you) as it can be infinitely replicated.

Heart failure with preserved ejection fraction (HFpEF) is common, carries a significant clinical burden, and is often underrecognized. How does its prevalence and impact compare with HFrEF, and why is early diagnosis so critical? Dr. Dmitry Abramov and I discuss the importance of recognizing HFpEF, understanding its associated outcomes, and navigating a practical diagnostic pathway to help identify patients sooner. Watch video here: clinicaltrialresults.org/wp-… S/b Bayer

The Lp(a) inhibitor #pelacarsen was not associated with a reduction in adverse cardiovascular events when evaluated by treatment exposure, baseline lipid levels, or achieved lipoprotein(a) level in a more in depth analysis. Full results here eviden.cc/4eQEutM

Ionis Pharmaceuticals market capitalization plummeted by 1 billion dollars after low prescribing of their #triglyceride-lowering drug #Tryngolza Ionis announced that it expects the drug, Tryngolza, to bring in $50 million in sales by the end of this year, compared to their previous forecast of $100 to $110 million. Third quarter sales came in at $9 million, well below Wall Street consensus expectations of $21 million during the quarter. statnews.com/2026/11/09/ioni…

MAJOR The U.S. Food and Drug Administration today approved Sunharbo (#asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke (a #stroke caused by a clot that did not originate in the heart) or a high-risk transient ischemic attack (TIA), often called a “mini-stroke.” “Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke,” said Hylton V. Joffe, M.D., MMSc, Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention.” The effectiveness of Sunharbo was demonstrated in the OCEANIC-STROKE study, a multicenter, randomized, double-blind, placebo-controlled phase 3 study that enrolled 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke (NIH Stroke Scale ≤15) or high-risk TIA and were randomly assigned to Sunharbo or placebo within 72 hours of symptom onset. Both groups also received antiplatelet therapy. Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared to placebo over a median treatment of 14.2 months. The overall rate of major bleeding was similar between the Sunharbo and placebo groups but was increased with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more commonly with Sunharbo compared to placebo. The most frequently reported adverse reaction (occurring in 3% or greater of Sunharbo-treated patients) was diarrhea. Concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers (such as carbamazepine) is not recommended because these medicines may decrease Sunharbo’s effectiveness. Sunharbo is not recommended in patients with moderate or severe hepatic impairment. Sunharbo should be withheld at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke. Sunharbo is not approved for stroke prevention in patients with atrial fibrillation. The FDA granted Sunharbo Fast Track and Priority Review designations. The approval was granted to Bayer HealthCare Pharmaceuticals Inc., Whippany, N.J. fda.gov/news-events/press-an…

The U.S. Food and Drug Administration is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (#NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss. Data from an analysis of 126 randomized, controlled clinical trials across multiple GLP-1 RAs showed an occurrence of 6.4 NAION cases per 100,000 person-years (PY) in patients treated with GLP-1 RAs compared to 3.8 NAION cases per 100,000 PY for patients treated with a placebo or a non-GLP-1 RA glucose-lowering medication. Based on published literature, the incidence of NAION in the general population is 2.3 to 10.2 cases per 100,000 persons per year in adults older than age 50. Patients with a history of NAION are at increased risk of recurrence. Instruct patients to immediately report sudden onset of acute, painless, decreased vision; visual field deficits; or other visual disturbances in one eye. If NAION is suspected, promptly refer the patient to an ophthalmologist for evaluation. Consider discontinuing the GLP-1 RA in patients who develop NAION, unless the benefits of treatment clearly outweigh the risk. fda.gov/drugs/drug-safety-co…

Among patients with stable #CoronaryDisease and moderate or severe ischemia, an initial invasive strategy with guideline-directed medical therapy plus coronary angiography and revascularization did not improve long-term all-cause mortality vs an initial conservative strategy with guideline-directed medical therapy alone. These findings support shared decision-making by indicating no significant survival difference between the 2 initial management approaches over approximately a decade. ja.ma/3UsUBaa

Among veterans with stable #CoronaryArteryDisease in extended follow-up of the COURAGE randomized trial, an initial strategy of #PercutaneousCoronaryIntervention plus optimal medical therapy did not reduce long-term risk of death or myocardial infarction vs optimal medical therapy alone. These findings do not support a routine strategy of elective upfront percutaneous coronary intervention to reduce long-term ischemic outcomes in this population. ja.ma/3UDRrAs

RECOVER-AUTONOMIC trial: Coordinated nonpharmacologic care involving weekly telehealth sessions, wearable activity trackers, and under-desk exercise bicycles did not significantly alter OHQ/OIQ composite score compared to usual care at 3 months in adults with Long COVID POTS, indicating that a simple instruction sheet may suffice for symptom management goals. Download slides here: clinicaltrialresults.org/wp-…

Dr. Marat Fudim and Dr. C. Michael Gibson discuss the RECOVER-AUTONOMIC trial: Coordinated nonpharmacologic care, including weekly telehealth sessions and home monitoring equipment, showed no significant improvement in orthostatic intolerance compared with usual care at 3 months in adults with Long COVID POTS. Watch video here: clinicaltrialresults.org/wp-…

New trial of gene editing therapy: A one-time intravenous infusion of CTX310, a CRISPR-Cas9 gene editing therapy targeting hepatic ANGPTL3, produced substantial reductions in ANGPTL3 and serum triglycerides at 30 days in participants with severe hypertriglyceridemia, providing evidence of durable target knockdown and lipid-lowering efficacy. Download slides here: clinicaltrialresults.org/wp-…

Dr. Ashish Saraju and Dr. C. Michael Gibson discuss the phase 1b study of severe hypertriglyceridemia: A single dose of CTX310, an investigational CRISPR-Cas9 therapy targeting ANGPTL3, achieved a mean triglyceride reduction of 63% from baseline at 30 days in patients with severe hypertriglyceridemia, diabetes, and ASCVD, demonstrating preliminary clinical efficacy and a favorable safety profile. Watch video here: clinicaltrialresults.org/wp-…

On the final day of #ScientificSessions26, don't miss these #BaimInstitute faculty. 🫀 @EricSecemskyMD @ambarish4786 @JavedButler1 #ClinicalResearch #Cardiology

On the final day of #ScientificSessions26, don't miss these #BaimInstitute faculty. 🫀 @DJ_Lakkireddy @ambarish4786 @LincoffMichael @PamTaubMD #ClinicalResearch #Cardiology