JAMA executive editor Gregory Curfman, MD on the journal’s decision whether to publish a study on a traditional Chinese medicine’s ability to improve heart attack outcomes.

Pharmaceuticals

Chinese Medicine Tongxinluo Improves STEMI Outcomes, Sparks Debates

Could the next major heart attack treatment come from a traditional Chinese medicine? A new JAMA study suggests that might be more realistic than many of us think, after showing that the Chinese medicine Tongxinluo significantly improves outcomes among patients with acute ST-segment elevation myocardial infarction (STEMI). 

• Tongxinluo has been cleared in China to treat angina and stroke since 1996, and has shown to have cardioprotective effects in over a dozen previous clinical studies
• It also has a list of ingredients that’s sure to raise Western eyebrows (plants, cockroach, scorpion, cicada, centipede, leech)

CTS-AMI trial researchers randomized 3,777 patients from 124 hospitals in China to take either Tongxinluo or a placebo within 24 hours of STEMI, and then receive guideline-directed treatments (antiplatelet therapy and coronary reperfusion) for one year.

As you might have guessed, the results were far stronger in the Tongxinluo group.

• MACCE at 30 days (3.4% vs. 5.2%)
• Cardiac death at 30 days (3.0% vs 4.2%)
• Myocardial reinfarction at 30 days (0% vs 0.5%)
• MACCE at 1 year (5.3% vs 8.3%)
• Cardiac death 1 year (4.5% vs. 6.1%)
• All cause death at 1 year (5.1% vs. 6.6%)

The Tongxinluo group did have more adverse drug reactions than placebo-takers (2.1% vs 1.1%), largely due to GI issues like stomach discomfort and nausea.

The Tongxinluo group’s 36% lower MACCE rate is quite remarkable, avoiding one major adverse event for every 55 patients who took it, which is even below alirocumab’s “number needed to treat” of 62.

However, the CTS-AMI study generated far more pushback than we typically see when a drug shows these types of improvements in a double-blind RCT.

• An accompanying JAMA editorial expressed doubts about whether these results could be repeated outside of China given genetic, diet, and health differences, while emphasizing that Tongxinluo’s mechanisms are unknown. 

• An Editor’s Note discussed the challenges JAMA faced when deciding whether to even publish this study, given that none of Tongxinluo’s ingredients are known to benefit STEMI patients.

• Other online comments suggested that the Chinese government pressures researchers to show positive results in traditional Chinese medicine studies. 

The loudest proponent of the CTS-AMI trial ended up being John Mandrola, MD, who suggested that this might be “selective skepticism” given the trial’s solid design and outcomes, and considering that we don’t understand the mechanisms behind a number of major Western cardiovascular pharmaceuticals without similar concerns.

The Takeaway

Tongxinluo has been approved to treat angina and stroke patients in China for over 26 years, and based on the results of the CTS-AMI trial it might also reduce post-STEMI events by a very significant 36%. 

However, responses to this study suggest that Western clinicians and scientists will need a lot more evidence that Tongxinluo (and its individual ingredients) actually improve MI outcomes before they’re ready to accept it. It is made out of centipedes after all…

Overcoming Cardiovascular Data Challenges

Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.

Relying on Echo AI for Heart Failure Management

The ESC has updated its heart failure guidelines, for the first time including a guideline-directed medical therapy for heart failure with preserved ejection fraction (HFpEF). See how cardiologists are trusting echo AI to find these cases earlier in this video from Us2.ai.

The Wire

• Lilly Acquires Beam’s CV Rights: Lilly agreed to acquire Beam Therapeutics’ opt-in rights to co-develop and co-commercialize Verve Therapeutics’ cardiovascular disease base editing programs, including programs targeting PCSK9, ANGPTL3, and an undisclosed cardiovascular target. The acquisition will give Beam $200M upfront, plus a $50M equity investment, and could add another $350M in milestone payments. The deal strengthens Lilly and Verve’s gene editing alliance, after teaming up on Verve’s Lp(a) therapy in June.

• MitraClip G4’s Strong Results: Abbott’s MitraClip G4 TEER system shined in the 1,164-patient EXPAND G4 registry study, where it reduced MR severity to mild or less in 92.6% of patients and none/trace in 44.2%, while achieving low one-year death and HF hospitalization rates (12.5% & 17.7%). The results were hailed as “outstanding” in a corresponding JACC editorial, which praised it as an achievement for the MitraClip G4 and the valve teams using it.

• Unnecessary Stents: More than one-in-five stents placed in Medicare patients between 2019 and 2021 were unnecessary, amounting to 229k excess procedures and $2.44B in wasteful costs. That’s the takeaway from a Lown Institute analysis of 1,733 facilities that also found wide variations across different hospitals. For example, 52.58% of all stents were deemed unnecessary at Northwest Texas Hospital, while just 1.58% were unnecessary at Kaiser Permanente San Francisco Medical Center.

• Fleicainide Improves CPVT: A large international registry data study shows the sodium-channel blocker fleicainide can help lower the number of arrhythmic events in patients severely affected by catecholaminergic polymorphic ventricular tachycardia. In the study of 247 patients who switched from beta blockers alone to beta blockers with fleicainide, the annual rate of arrhythmic events (sudden cardiac death, sudden cardiac arrest, appropriate implantable cardioverter defibrillator shock, and arrhythmic syncope) dropped from 5.6% to 4%. 

• TAVR+LAOO Cuts Blood Thinner Use: The WATCH TAVR study showed that performing TAVR and LAAO at the same time could reduce blood thinner use in patients with severe aortic stenosis and Afib. In 349 patients, those who underwent simultaneous TAVR and LAAO had similar outcomes (death, stroke, major bleeding) at two years as those who underwent TAVR and took blood thinners as needed. Additionally, significantly fewer TAVR/LAAO patients were on blood thinners at two years (13.9% vs 66.7%).

• AHA Joins ABCVM: Just over a month after most of the major cardiovascular societies announced plans to create the American Board of Cardiovascular Medicine (ABCVM), The American Heart Association joined the consortium with its “full support.” The ABCVM was launched to replace the American Board of Internal Medicine’s incredibly unpopular Maintenance of Certification program, revealing plans to offer a recertification process that’s less burdensome, lower cost, and more relevant to cardiologists’ roles.

• Climate Change and CV Deaths: Extreme heat drove 1,651 excess cardiovascular deaths per year in the US between 2008 and 2019, and that rate could increase significantly by 2036-2065 due to climate change. An AHA study detailed two scenarios, including a “middle-of-the-road” scenario with a 162% increase to 4,320 annual heat-related cardiovascular deaths, and a more extreme scenario where heat-related CV deaths jump 233% to 5,491 per year. Heat-related CV deaths would have the greatest impact on the elderly and Black adults.

• Biden’s AI Plan: President Biden’s just-issued executive order directs “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems,” while setting up the HHS as the lead policy enforcer within healthcare. The order establishes a range of AI guardrails relevant to all industries, balancing them with new grants related to areas like immune-response treatments and burnout. Although the initial response has been generally positive, critics are holding out to see whether meaningful actions will back up those words.

• Amulet, Watchman Showdown: Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman had statistically similar outcomes post-LAA closure in the head-to-head SWISS-APERO study. Among 221 patients who had LAA closure and underwent follow up CCTAs at 13 months, Amulet and Watchman had similar leak rates (53.6% vs. 48.8%), composite CV death, stroke, systemic embolism rates (9.5% vs. 10.2%), as well as rates of cerebrovascular events (2.7% vs. 3.7%) and bleeding (40.8% vs. 31.4%).

• Cardiac Monitoring Headphones: Your headphones might someday be able to double as cardiac monitors. Google researchers presented what they are calling Audioplethysmography (APG), a new cardiac monitoring modality that allows consumer-grade noise canceling headphones to send and receive low intensity ultrasound signals and measure changes in heart rate. When used with 153 participants, the APG headphones accurately measured heart rate and heart rate variability (3.21% & 2.70% median error rates) across variations in skin tone and ear canal size. 

• Opsens’ TAVR Guidewire Safe, Effective: Data published in the JACC and presented at TCT 2023 bode well for Opsens’ SavvyWire, a pressure-sensor and pacing TAVR guidewire. In the SAFE-TAVI multicenter trial of 121 patients, the efficacy endpoint (effective LV rapid pacing runs with the guidewire and a significant systemic pressure drop) was achieved in 98.3% of patients. The guidewire was also safe, with no major procedural complications in 99.2% of patients, including no procedure-related deaths, no strokes, and no ventricular perforations.

Cleerly Brings the Confidence to Compete

Pro triathlete Timothy O’Donnell recently spoke on the Rich Roll Podcast about surviving a heart attack mid-race and how getting a Cleerly analysis gave him confidence to compete again. Once he confirmed his heart was ready, he returned to racing and went on to win an Ironman at the age of 42.

Scaling Your Cardiovascular CT Service With CT-FFR

Ready to enhance your cardiovascular CT services with automated CT-FFR integration? Tune-in to Keya Medical and Precision Image Analysis’s SCCT webinar and learn from industry experts how to solve the challenges of scaling CT-FFR services and overcome the complexity of CT-FFR implementation.

The Resource Wire

• Do you know how many patients with high CVD risks are in your chest CT archive? See how the Stanford Health Care System used Bunkerhill Health’s Incidental CAC algorithm to screen its previous non-gated chest CTs, identify patients with coronary calcium, and get them on statins.

• Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!

• What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains.

• The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.