A multi-part panel discussion centered around management of lipid disorders in 2021 led by Practical Cardiology Advisory Board members.

Inside Cardiology: Lipid Management in 2021

StatinWISE is to my knowledge the third “N-of-1” study to examine statin-associated muscle symptoms (SAMS).

“N-of-1” studies use an individual subject as his/her own control and treat these subjects with multiple periods of treatment or placebo. The first statin n-of-1 randomized 8 patients with possible SAMS to 3 x 3-week, randomized, double-blind trials of treatment with their offending statin or placebo separated by 3-week washout phases.

 All patients had developed myalgia within 3 weeks of starting their statin, justifying the brief treatment periods. The second trial randomized 60 patients to 1-month trials of atorvastatin 20, placebo, or no pill for a year.

 All patients had previously developed SAMS within 2 weeks of starting statin therapy. Compared to no pill at all, symptom intensity was 15.4 during placebo pill treatment and 16.3 during statin treatment. This trial demonstrated that taking a pill, even a placebo, caused more symptoms than no pill at all and that treatment with the statin or placebo pill were similar.StatinWISE (Statin Web-based Investigations of Side Effects) is the third trial and randomized 200 participants to 6 x 2-month treatments with atorvastatin 20 mg or placebo.

Withdrawal secondary to intolerable muscle symptoms occurred in 9% of the statin and 7% of the placebo subjects, a non-significant difference, but only 151 of the randomized subjects completed at least one pair of statin/placebo trials. All 3 trials failed to confirm SAMS during statin therapy.

We imagine science as Lady Justice equally balancing the scales, but most studies find what they are designed to find. These n-of-1 trials were designed to show that most SAMS complaints are not related to the statins. These trials are useful because they encourage clinicians and patients to use these life-saving drugs. But these trials’ results should not be used to deny the existence of SAMS. That’s because these patients complained of SAMS, but obviously did not have SAMS. In genetics, you cannot get the genotype right without a consistent phenotype. The same is true with SAMS. How can you prove an intervention works for SAMS if you are not sure you are studying SAMS?

We have advocated verifying the presence of SAMS in SAMS studies. In our NIH-funded study of Co-Enzyme Q10 in treating SAMS, we randomized 120 of my patients, whom I thought had SAMS, to 2-month preliminary trials of simvastatin 20 or placebo separated by a 4-week washout

. Statin first subjects got placebo second and vice versa. Remarkably only 35.8% of the subjects got pain only on the statin, 17.5% got pain on both treatments, 29.2% only on placebo, and 17.5% had no pain. Only the subjects with verified SAMS were entered into the CoQ10 Trial, which by the way, did not work. The GAUSS-3 Trial used our design to determine if 491 patients had verifiable SAMS before assigning subjects to injections with the PCSK-9 inhibitor, evolocumab, or placebo

. GAUSS-3 found results similar to our:42.6% had verified myalgia, 9.8% had pain on both, 26.5% had pain on placebo, and 17.3% had no pain. What is striking in GAUSS-3 is that 42.6% had pain on atorvastatin only vs. 26.5% on placebo, a highly significant difference. Our CoQ10 study and GAUSS-3 were designed to evaluate specific therapies for SAMS. Both studies showed that many SAMS complaints are not SAMS, and GAUSS-3 confirmed that muscle symptoms are much more likely on a statin than on placebo.

So, these n-of-1 studies are useful in encouraging statin use, but they have to get the phenotype right before they can conclude that SAMS does not exist or are not real for some patients.

1. Herrett E, Williamson E, Beaumont D, et al. Study protocol for statin web-based investigation of side effects (StatinWISE): A series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care. 

. 2017;7(12):e016604-2017-016604. doi: 10.1136/bmjopen-2017-016604 [doi].

2. Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. 

. 2014;160(5):301-310. doi: 10.7326/M13-1921 [doi].

3. Wood FA, Howard JP, Finegold JA, et al. N-of-1 trial of a statin, placebo, or no treatment to assess side effects. 

. 2020;383(22):2182-2184. doi: 10.1056/NEJMc2031173 [doi].

4. Taylor BA, Lorson L, White CM, Thompson PD. A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy. 

. 2015;238(2):329-335. doi: 10.1016/j.atherosclerosis.2014.12.016 [doi].

5. Nissen SE, Stroes E, Dent-Acosta RE, et al. Efficacy and tolerability of evolocumab vs ezetimibe in patients with muscle-related statin intolerance: The GAUSS-3 randomized clinical trial. 

Articles

Dr. Paul Thompson reflects on the results of recent N-of-1 studies examining the effects of statin therapy on muscle pain and offers his perspective on the conclusions drawn by these trials. 

Do N-of-1 Studies Prove Statin Muscle Complaints are Bogus?

This article was originally published on 



The American Heart Association and the American Stroke Association Stroke Council Leadership have released guidance related to signs, symptoms, and best treatment options for rare blood clots and low platelets related to the COVID-19 vaccine.

“COVID-19 infection is a significant risk factor for CVST. A preliminary analysis of U.S. data during the COVID-19 pandemic, available online, preprint on April 15, 2021, found that the risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” said Karen L. Furie, lead author of the special report and chair of the department of neurology at The Warren Alpert Medical School of Brown University, 

. “The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low. We urge all adults to receive any of the approved COVID-19 vaccines.”

For the report, investigators analyzed data from 59 healthcare organizations, which included 81 million patients. Of those, nearly 514,000 had a confirmed case of COVID-19 and 20 of those were diagnosed with CVST.

Subsequently, investigators compared this to those who received a Pfizer or Moderna COVID-19 vaccine and found no cases of thrombocytopenia. When assessing data on the Janssen vaccine, investigators identified 15 reported cases, among the nearly 7 million doses administered, of TTS following vaccination among patients in the US.

“We are confident the benefits of vaccination far exceed the very small, rare risks.” The authors wrote. “The risks of vaccination are also far smaller than the risks of COVID-19 and its potentially fatal consequences.”

The report recommends that if individuals who received a vaccination develop symptoms including severe headache, abdominal pain, leg pain or shortness of breath within 3 weeks, they should quickly contact their health care professional.

Also discussed within the report was a list of details regarding treatment for suspected CVST, TTS, or VITT, including, among others:

All patients with suspected CVST due to a COVID-19 vaccine should be treated with non-heparin anticoagulants such as argatroban, bivalirudin, danaparoid, fondaparinux, or a direct oral anticoagulant (DOAC). No heparin products in any dose should be given.

Magnetic Resonance Imaging with a venogram (MRI/MRV) or computed tomography with venogram (CT/CTV) is recommended to accurately detect and diagnose CVST.

Blood tests should include a CBC (Complete Blood Count) plus:

platelet count - to determine the number of platelets per liter of blood;

a peripheral smear - examination under a microscope to count the number of various types of blood cells and if they appear normal.

“We are learning the various intricacies of COVID-19 live, in real-time with the patients we see in our hospitals every day. CVST is extremely rare, however, further research and investigation are necessary as the pandemic continues,” Furie said. “We will need data and robust research on the people who did not develop blood clots after the vaccine, too, so that we can fully understand the molecular and cellular mechanisms underlying CVST related to COVID-19 infection or after vaccination.”

Diagnosis and Management of Cerebral Venous Sinus Thrombosis with Vaccine-Induced Thrombotic Thrombocytopenia

The American Heart Association and American Stroke Association have released a special report related to the treatment of blood clots or low platelet counts related to the COVID-19 vaccine, which has garnered mass amounts of attention despite being a rare complication. 

AHA/ASA Release Guidance for Treatment of COVID-19 Vaccine-Related Clotting, Low Platelet Counts

Research presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions is providing clinicians with further insight into the effectiveness of Medtronic Harmony transcatheter pulmonary valve (TPV) system in patients with congenital heart disease (CHD) and severe pulmonary regurgitation.

Approved by the US Food and Drug Administration in March 2021

, results presented at SCAI 2021 detail the 1-year outcomes from the pivotal trial and 30-day outcomes from the continued access study examining Harmony TPV

“This is a brand-new class of cardiac devices designated to help a very specific patient population where no less-invasive, percutaneous treatment options were available until now,” said Thomas Jones, MD, principal investigator of the trial and director of Cardiac Catheterization Laboratories at Seattle Children’s Hospital,

. “Unlike any other TPV, this novel technology is designed to expand into the enlarged RVOT in these patients while simultaneously deploying a suitable bioprosthetic pulmonary valve. The Harmony TPV system has the potential to fundamentally alter the lifetime management of CHD patients from here on out.”

The first non-surgical heart valve approved in any country to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the Harmony TPV system stands poised to fill an unmet in need patients with CHD. With the FDA basing their approval partially on 6-month data from the Harmony TPV Clinical Study, which was designed as a prospective, non-randomized, multicenter study, the 1-year outcomes data was among the most anticipated information to be released at 

Conducted in 12 centers in the US, Canada, and Japan, the pivotal trial enrolled 31 patients, 21 to TPV22 and 10 to TPV25, and the continued access study enrolled 37 patients, 1 to TPV22 and 36 to TPV25. Investigators noted 1 implant in the continued access study was unsuccessful. The mean follow-up times were 21.7±10.1 and 2.3±2.1 months for patients in the pivotal trial and continued access study, respectively.

All pivotal trial patients survived to 1-year follow-up.

All pivotal trial patients were free from pulmonary regurgitation at 1-year.

Greater than 90% of patients had none/trace pulmonary regurgitation at all follow-up visits.

Zero explants or instances of endocarditis, major stent fractures, or thrombosis.

Two patients in the continued access study required reintervention or reoperation.

One required balloon angioplasty of the distal device

Five patients had stable, non-sustained ventricular tachycardia after implant that resolved and did not appear to be clinically important. 

The Harmony Transcatheter Pulmonary Valve: 1-Year Outcomes from the Pivotal Trial and 30-Day Outcomes from the Continued Access Study,

Results of 1-year follow-up from the Harmony TPV Clinical trial provide insight into the safety and efficacy of the recently approved Harmony TPV system in patients with congenital heart disease and severe pulmonary regurgitation. 

Follow-up Results for Harmony TPV System Demonstrate Efficacy at 1-Year 

Dapagliflozin (Farxiga) has received a historic approval from the US Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD), according to a 

Almost a year to the date after receiving approval for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes, dapagliflozin now becomes the first SGLT2 inhibitor to receive approval for treatment of CKD.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, MS, deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Few agents have captured the attention of the masses in recent years in the same manner as dapagliflozin. With the SGLT2 inhibitor class blazing trails in heart failure and chronic kidney disease, many expected it was only a matter of time until today’s approval became reality based on data from multiple clinical trials.

In their own statement, AstraZeneca referred to the approval as "the most significant advancement in the treatment of chronic kidney disease in more than 20 years". 

"We’ve shown impressive efficacy for 

 in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US," added Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, in the 

Based on the results of the DAPA-CKD trial, which was 

, the latest approval for dapagliflozin is for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. In the phase 3 trial, 4304 patients were randomized in a 1:1 ratio to either dapagliflozin or placebo.

Designed with a primary composite endpoint that included a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death, results of the study indicated dapagliflozin was associated with a 39% reduction in the study’s primary endpoint. Trial investigators noted this reduction was seen in patients with and without diabetes, with reductions of 36% in patients with diabetes and 50% in patients without.

For more on the cardiorenal protection observed within the DAPA-CKD trial, check out this video with John McMurray, MD, from AHA 2020. 


The US FDA announced dapagliflozin (Farxiga) received approval for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression in a statement on April 30. 

Dapagliflozin (Farxiga) Receives Historic FDA Approval for Chronic Kidney Disease

While it appears medicine is starting to see light at the end of the tunnel for the COVID-19 pandemic, clinicians and researchers are just beginning to uncover the multitude of lessons that can be taken from the pandemic.

One of the most perplexing lessons to come from the pandemic could relate to heart attack presentations in emergency departments. While early data suggested fear of COVID-19 may have been keeping patients from seeking necessary attention, some have begun to theorize clinicians may have been overdiagnosing these events.

Society for Cardiovascular Angiography and Interventions (SCAI) 2021 

Scientific Sessions is diving deeper into the issue and providing insight from a hospital center based in New York City.

“We were surprised to observe a significant reduction in the number of patients referred for coronary management of MI; this suggests that many patients may have stayed at home despite their symptoms of a heart attack,” said Nina Talmor, MD, lead investigator and internal medicine resident at NYU Langone Health, 

. “Our findings point to the need for improved public health messaging for future health crises, so that people do not remain at home out of fear, rather than seeking necessary and potentially lifesaving care. We hope our study will bring awareness to the need for timely cardiac care both in and out of a pandemic.”

To learn more about the reductions in patients presenting with acute myocardial infarction, Talmor and a team of colleagues designed the current study as a single-center, retrospective analysis of data from NYU Langone Health. Using the month of April in 2019 and 2020 as the time periods of inters, investigators performed an electronic medical record review to identify all STEMI and NSTEMI patients referred for invasive coronary angiography.

During April 2019, 59 patients presented with acute myocardial infarction, including 47 with NSTEMI and 12 with STEMI. During April 2020, 13 patients presented with acute myocardial infarction, including 7 with NSTEMI and 5 with STEMI. Overall, this represents a reduction of 78%. Investigators noted 2 of the 13 patients presenting with acute myocardial infarction in April 2020 tested positive for COVID-19.

Despite the decrease in acute myocardial infarction, investigators noted there were no significant differences in baseline demographics, comorbidities, or medication use between the study groups. investigators pointed out patients in 2020 had a longer median delay from symptom onset to hospital presentation (70.7 vs 34.2 hours; 

Further analysis indicated multivessel coronary disease was more prevalent during 2019 than 2020 (73% vs 31%; 

=.01). When assessing for potential differences in troponin levels, investigators found initial troponin levels were similar with a mean of 5.98 ng/mL and 3.02 ng/mL in 2019 and 2020, respectively. In contrast, investigators found peak troponin feels were significantly higher among patients presenting during the pandemic compared to those presenting in 2019 (2019: 19.49 ng/mL; 2020: 83.92 ng/mL).

Additionally, investigators noted there were no significant differences in patient outcomes between the study groups. Specifically, the median length of stay was 3 days in 2019 and 4 days in 2020 and in-hospital death occurred in 6.8% of patients in 2019 and 7.7% in 2020.

Where Did All the Acute Myocardial Infarctions Go? Fewer Presentations During the Initial Wave of the COVID-19 Pandemic

An analysis of data from NYU Langone provides perspective into the rapid decline of emergency department presentations for acute myocardial infarction that occurred during the peak of the COVID-19 pandemic. 

Presentations for Acute MIs Dropped Drastically During Peak of COVID-19 Pandemic

An analysis of 60 studies examining pediatric type 2 diabetes is detailing the risk of hypertension and albuminuria among this patients population—suggesting one or both comorbidities was present among nearly 1-in-5 patients. 

The study, which was conducted by investigators at McMaster University, suggests both comorbidities were common among patients with pediatric diabetes and noted there was a disproportionate burden among Pacific Islander and Indigenous youth.

“These data are relevant for health care professionals and policymakers, as clinical services treating pediatric patients with type 2 diabetes need to be resourced to track kidney screening and treatments to improve outcomes,” wrote investigators.

With cardiorenal comorbidities posing a major threat to the overall health and quality of life for patients with diabetes later in life, M. Constantine Samaan, MD, MSc, of the Department of Pediatrics at McMaster University, and a team of colleagues sought to assess the prevalence of hypertension and albuminuria in patients with pediatric type 2 diabetes. To do so, investigators designed the current study as a systematic review and meta-analysis of data from the MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, gray literature, and references from the inception of each database through February 20, 2020.

For the purpose of analysis, investigators limited their search to observational studies with at least 10 participants reporting the prevalence of hypertension and/or albuminuria in pediatric patients with type 2 diabetes. Three different teams made up of 2 independent reviewers each screen a total of 7614 articles and determined 60 met the study’s inclusion criteria.

The primary outcome of interest for investigators was the pooled prevalence rates for hypertension and albuminuria. Investigators also assessed pooled prevalence rates by sex and racial/ethnic group as secondary outcomes. Investigators noted their meta-analysis was conducted using a random-effects model and followed the MOOSE guidelines.

Within the 60 studies identified by investigators, mean diabetes duration ranged from inclusion at diagnosis to 15.0 years after diagnosis and mean age at diagnosis ranged from 6.5 to 21.0 years. Among the 60 studies included, 46 reported prevalence of hypertension and 39 studies reported the prevalence of albuminuria.

Upon analysis, results suggested hypertension was present among 25.33% (95% CI, 19.57-31.53) of patients. When assessing factors associated with hypertension, investigators found male participants were at a greater risk than their female counterparts (OR, 1.42; 95% CI, 1.10-1.83) and patients classified as Pacific Islander and Indigenous youth when compared to their other racial/ethnic groups (Pacific Islander youth: 26.71% [95% CI, 14.54%-40.72]; Indigenous youth: 26.48% [95% CI, 17.34-36.74]; White youth: 20.95% [95% CI, 12.65-30.57]; African American youth: 19.04% [95% CI, 12.01-27.23]; Hispanic/Latino youth: 15.11% [95% CI, 6.56-26.30]; Asian youth: 18.37% [95% CI, 9.49-29.23]).

Assessment of the studies reporting albuminuria suggested a prevalence of 22.17% (95% CI, 17.34-27.38). While there were no differences observed based on patient sex, investigators pointed out prevalence was greater among Pacific Islander, Indigenous, and Asian youth than White youth (Pacific Islander youth: 31.84% [95% CI, 11.90-55.47]; Indigenous youth: 24.27% [95% CI, 14.39-35.73]; Asian youth: 23.00% [95% CI, 18.85-27.41]; White youth: 12.59% [95% CI, 7.75-18.33]). Investigators highlighted heterogeneity was high among studies, with a low to moderate risk of bias observed.

“Hypertension and albuminuria were frequent comorbidities of pediatric type 2 diabetes, and Pacific Islander and Indigenous youth had a disproportionately higher burden of these conditions than youth from other racial groups,” wrote investigators. “There is a critical need for personalized screening and treatment strategies to provide renoprotection from prolonged hyperglycemia and obesity to prevent end-stage kidney disease, future cardiovascular disease, and improve life expectancy.”

Prevalence of Hypertension and Albuminuria in Pediatric Type 2 Diabetes

A systematic review and meta-analysis of studies examining pediatric type 2 diabetes indicate hypertension or albuminuria was present among approximately 20% of children with type 2 diabetes. 

Hypertension, Albuminuria Common Among Pediatric Type 2 Diabetes

A study from Beth Israel Deaconess Medical Center is underlining the importance of cross-specialty collaboration when managing patients with hypertension.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES), results suggest 19% of patients with 

 reported using at least 1 medication known to raise blood pressure.

“Even small increases in blood pressure can have meaningful impacts on cardiovascular disease. Based on our findings, we need to be more aware of polypharmacy in older adults who also have the highest burden of high blood pressure,” said lead investigator John Vitarello, MD, an internal medicine resident at Beth Israel Deaconess Medical Center (BIDMC), 

With previous research outlining the impact of hypertension on cardiovascular risk, emphasis on blood pressure management has been paramount in recent years—despite this, uncontrolled hypertension remains an issue in the US. Released ahead of the American College of Cardiology's 70th Annual Scientific Session (ACC.21), the current study was designed by VItarello and a pair of BIDMC colleagues to provide a recent estimate of the presence and impact of polypharmacy on hypertension in the US.

With this in mind, investigators designed the ACC.21 study as a serial cross-sectional analysis of NHANES data from 2009-2018. Using the ACC/AHA guidelines as reference, investigators hoped to assess medications associated with blood pressure elevation on an individual and population level. Additionally, investigators planned to use multivariate regression models with post-estimation predictions to estimate the impact of stopping blood pressure-raising medications.

Among 10,676 NHANES participants, which investigators noted is representative of 232,701,297 US adults, 47.2% (95% CI, 45.5-48.9) had hypertension. Investigators pointed out the mean age of the cohort was 56±15 years and 47.5% were female.

Upon analysis, investigators found 79.5% (95% CI, 77.3-81.8%) of patients with hypertension had blood pressure above the ACC/AHA goal of 130/80 mmHg. Additionally, 19.0% (95% CI, 17.4-20.0) of patients with hypertension reported using at least 1 or more medications that may increase blood pressure and 3.3% (95% CI, 2.4-4.1) reported using multiple.

Among patients reporting use of a medication that may raise blood pressure, the most common classes of medications used were antidepressants (8.9%; 95% CI, 7.7-10.0), non-steroidal anti-inflammatories (7.2%; 95% CI, 6.1-8.4), and steroids (2.2%; 95% CI, 1.8-2.6). When using predictive modeling, results indicated stopping a single blood pressure-raising medication could improve population-level control rates by 4.8% (95% CI, 1.4-8.1).

“Using data from a nationally representative survey, we find that nearly 1-in-5 adults with hypertension report using a medication that may raise blood pressure. Clinicians should review their prescription and over-the-counter medication use of their patients with hypertension and consider deprescribing of medications that raise blood pressure or seek therapeutic alternatives,” added Vitarello during a web briefing ahead of ACC.21.

Use and Estimated Impacts of Medications that Raise Blood Pressure Among US Adults with Hypertension: National Cross-Sectional Study,

Data from an analysis of NHANES suggest nearly 1-in-5 adults with hypertension were also taking medication that may increase blood pressure. 

Many Adults with Hypertension Also Taking Medications that Raise Blood Pressure

New research from a team in Canada is detailing the potential cardiovascular benefits seen as a result of undergoing bariatric surgery for patients with severe obesity and 

The study, which was a retrospective matched cohort study of nearly 7000 patients in Canada, found undergoing bariatric surgery was associated with a slew of benefits, including a 68% reduction in cardiac mortality and 34% reduction in cardiac events.

“Overall, this study reinforces that the glycemic benefit of bariatric surgery found in randomized clinical trials likely translates to a mortality benefit over time, and it supports the use of surgery as a first-line treatment for individuals with obesity and diabetes,” wrote investigators.

Led by Dennis Hong, MD, of the Division of General Surgery, St Joseph’s Healthcare, a team of investigators from multiple institutions throughout Ontario, Canada sought to provide within-strata data related to outcomes among patients with type 2 diabetes and obesity undergoing bariatric surgery or nonsurgical management. To do so, the team designed a retrospective, population-based matched cohort study using information derived from multiple linked administrative databases containing data of patients treated within the Ontario Bariatric Network from January 2010-December 2016.

The investigators’ initial search yielded more than 27,00 patients who underwent bariatric surgery during the study period. After exclusion of those with missing information and without type 2 diabetes, investigators identified 5986 potentially eligible patients for inclusion. Using data from the linked databases, investigators were able to match 3455 of these patients to 3455 nonsurgical controls. Of note, all patients included in the study had severe obesity, which was defined as a BMI of 35 kg/m2.

The study population had a mean BMI of 44.67 (SD, 7.9) kg/m2, mean age of 52.04 (SD, 9.45) years, 71.6% were women, and a median follow-up time of 4.6 (3.22-6.35) years. Among patients who underwent bariatric surgery, the most common procedure was gastric bypass (86.7%).

Data related to age, baseline BMI, sex, comorbidities, duration of diabetes diagnosis, health care utilization, socioeconomic status, smoking status, substance abuse, cancer screening, and psychiatric history were obtained from EMR data and included in investigators’ analyses as confounding factors.

For the purpose of analysis, investigators chose all-cause mortality as the primary outcome of their analyses. Secondary outcomes included cause-specific mortality and diabetes-related outcomes, which included composite cardiovascular and composite renal outcomes. The composite cardiovascular outcome was defined as cardiovascular mortality, nonfatal myocardial infarction, stroke, percutaneous coronary intervention, coronary artery bypass graft, transient ischemic stroke, deep vein thrombosis, or pulmonary embolism. The composite renal outcome was defined as new dialysis treatment or transplantation.

During the follow-up period, 83 (2.4%) patients in the surgery group died compared to 178 patients in the control group (HR, 0.53; 95% CI, 0.41-0.69; 

 <.001). Compared to nonsurgical management, bariatric surgery was associated with a 68% reduction in risk of cardiovascular mortality (HR, 0.32; 95% CI, 0.15-0.66; 

=.002) and a 32% lower risk of the composite cardiovascular outcome (HR, 0.68; 95% CI,0.55-0.85; 

 <.001) . Additionally, undergoing bariatric surgery was associated with a 42% reduction in risk of the composite renal outcome (HR, 0.58; 95% CI, 0.35-0.95).

Further analysis identified multiple subgroups that appeared to have the greatest absolute benefit from bariatric surgery. The greatest benefit for mortality was seen among men (Absolute Risk Reduction [ARR], 3.7%; 95% CI, 1.7-5.7%), those with a duration of diabetes greater than 15 years (ARR, 4.3%; 95% CI, 0.8-7.8%), and those 55 years of age or older (ARR, 4.7%; 95% CI, 3.0-6.4%).

Association Between Bariatric Surgery and Major Adverse Diabetes Outcomes in Patients With Diabetes and Obesity

An analysis of claims data from more than 7k patients suggests patients with severe obesity and type 2 diabetes who underwent bariatric surgery experienced a 68% reduction in cardiac mortality and 34% reduction in cardiac events compared against standard medical management.

Bariatric Surgery Linked to Lower Risk of Cardiovascular Death, Adverse Events in Patients with T2D

The American Heart Association has released a scientific statement calling for an increased emphasis on close monitoring for cardiovascular risk among patients receiving treatment for prostate or breast cancer that includes hormones.

With no formal guidance related to management of hormone therapy-related cardiovascular risks, the writing committee is hopeful the statement can provide perspective on the issue and, possibly, reduce the risk of cardiovascular death among these patients.

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” said Tochi Okwuosa, DO, chair of the scientific statement writing group, an associate professor of medicine and cardiology and director of Cardio-Oncology Services at Rush University Medical Center in Chicago

. “A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietician, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment.”

An 18-page document citing nearly 90 sources, Okwuosa and members of the writing committee sought to outline risk of cardiovascular disease associated with use of hormonal cancer therapies, which has recently begun to gain more attention as a leading cause of death among these patients. Pooling data from observational studies, randomized clinical trials, and meta-analyses, investigators created multiple tables and graphs to describe the risks associated with different therapies and recommendations for risk assessment and management.

Data Summary

Impact of Hormonal Therapies for Treatment of Hormone-Dependent Cancers (Breast and Prostate) on the Cardiovascular System: Effects and Modifications: A Scientific Statement From the American Heart Association

Circulation: Genomic and Precision Medicine.

The AHA has released a scientific statement aimed at outlining the current knowledge base related to risk of cardiovascular disease associated with hormonal therapies used in the treatment of breast and prostate cancer.

AHA Provides Overview of CV Risk Associated with Hormone Therapies Used in Breast, Prostate Cancer Treatment 

A prespecified analysis of the ISCHEMIA trial has returned mixed results related to the impact of initial management strategy on days alive and out of the hospital in patients with stable ischemic heart disease (SIHD). 

Results of the analysis suggest use of a conservative strategy resulted in greater days alive out of hospital at 1 month, 1 year, and 2 years, but investigators highlighted there was no difference was observed between the study arms at 4 years of follow-up and the early differences were mostly driven by protocol-assigned stays mandated within the invasive management approach.

“This analysis of DAOH in the ISCHEMIA trial showed that randomization to the conservative management group compared with the invasive management group was associated with significantly more DAOH during the first 2 years, with no significant difference beyond 2 years. The differences were small and no greater than 6.3 days at any analyzed time point,” wrote investigators.

With an interest in exploring the risks and benefits of initial invasive versus conservative management in patients with SIHD beyond traditional trial end points, ISCHEMIA investigators designed the current prespecified analysis to compare days alive out of hospital according to initial management strategy among patients within the landmark trial. Briefly, the ISCHEMIA trial was 

 and concluded that an early invasive approach reduced angina among these patients but provided no overall benefit compared to conservative management.

For the current analysis, investigators hoped to compare days alive and out of hospital, including invasive protocol-assigned stays, at 1 month, 1 year, 2 years, and 4 years after randomization. For the purpose of analysis, stays included overnight stays in hospital or extended care facilities, such as a skilled nursing facility, rehabilitation, or a nursing home.

From the 5179 patients included in the analysis, investigators identified 5899 stays. Of the 5899 stays included in the analysis, 4002 occurred in the invasive management group and 1897 occurred in the conservative management group.

At 1 month, estimated cumulative mean days alive out of hospital was 2.4 days greater among those in the conservative group compared to those randomized to invasive management (30.8 vs 28.4; difference: 2.4; 95% CI, 2.2-2.6; 

 <.001). At 1 year, the mean additional days alive out of hospital for the conservative management group was 6.3 days greater than those randomized to invasive management (362.2 vs 355.9; difference: 6.3; 95% CI, 4.8-7.7; 

<.001). At 2 years, the mean additional days alive out of hospital was 6.3 days greater among patients randomized to initial conservative management than invasive management (718.4 vs 712.1; difference, 6.3; 95% CI, 2.4-10.2; 

At 4 years, there was no significant difference in mean days alive out of hospital with 1412.2 and 1415.0 among patients randomized to invasive management and conservative management, respectively (

=.001). Further analysis indicated 2434 of 4002 stays among the invasive management group were protocol-assigned procedures. When excluding these stays, investigators were unable to identify clear differences at any time point based on management group.

Additionally, after exclusion of these stays, there were fewer stays among those randomized to an invasive approach (n=1568) than among those randomized to a conservative approach (n=1897; 

=.001). When assessing cardiovascular says followed initial assigned procedures, investigators found a lower number of stays among those randomized to invasive rather than conservative management (685 of 4002 [17.1%] vs 1095 of 1897 [57.8%]; 

 >.001) and this was driven by decreased spontaneous myocardial infarction stays (65 [1.6%] vs 123 [6.5%]; 

 <.001) and unstable angina stays (119 [3.0%] vs 216 [11.4%]; 

“DAOH provides a patient-focused metric that can be used by clinicians and patients in shared decision-making for the management of stable coronary artery disease,” wrote investigators.

Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management

New data from an analysis of the ISCHEMIA trial is providing insight into the days alive out of hospital with an initial invasive or conservative approach to the management of stable ischemic heart disease. 

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Comparing Days Alive and Out of Hospital with Invasive vs Conservative Management in ISCHEMIA