2018

Save the date for Scientific Sessions 2019

We are already making plans for Scientific Sessions 2019 Nov. 16-18, 2019, in Philadelphia. Be sure to mark your calendars so you can join us to learn about all of the new science that will affect your daily work.

Also, check out the dates for AHA/ASA 2019 specialty conferences.

INTERNATIONAL STROKE CONFERENCE
Feb. 6-8, 2019 | Honolulu

EPIDEMIOLOGY, PREVENTION, LIFESTYLE & CARDIOMETABOLIC HEALTH
March 5-8, 2019 | Houston

QUALITY OF CARE & OUTCOMES RESEARCH
April 5-6, 2019 | Arlington, Virginia

VASCULAR DISCOVERY: FROM GENES TO MEDICINE
May 14-16, 2019 | Boston

BASIC CARDIOVASCULAR SCIENCES
July 29-Aug. 1, 2019 | Boston

HYPERTENSION
Sept. 5-8, 2019 | New Orleans

RESUSCITATION SCIENCE SYMPOSIUM
Nov. 16-17, 2019 | Philadelphia

Click here for more information.

Attendees rack up steps in Walking Challenge

Attendees at Scientific Sessions 2018 tracked their daily steps and watched them feed into a leaderboard, comparing their steps to leading walkers.

In 2018, attendees took a total of 1,626,634 steps. The top three walkers identified by their handles: Mregen18 with 98,322 steps, StemAlchemist with 82,600 steps, and Polimeno with 73,074 steps.

The Walking Challenge was brought to Scientific Sessions 2018 by the U.S. Department of Health and Human Services’ Physical Activity Guidelines for Americans.

Let’s hack

Smart Socks won the first AHA Rise Above Heart Failure Hackathon during Scientific Sessions 2018.

Smart Socks and other teams of five were challenged to brainstorm a non-therapy (non-medicine) innovative solution to optimize heart patient care.

The winning concept uses socks to measure weight gain and water retention through stretching, tracks activity through vibration and informs of a social connection to a support community.

Team concepts were judged on originality, immediate impact for patients and medical professionals, and an easily understood pitch.

HHS releases second edition of Physical Activity Guidelines for Americans: Q&A with Don Wright, MD, MPH

The U.S. Department of Health and Human Services released the second edition of the Physical Activity Guidelines for Americans.

HHS released the federal government’s first science-based recommendations on physical activity to prevent disease and promote health in 2008.

Admiral Brett P. Giroir, MD, HHS assistant secretary for health, led a panel of federal and non-federal experts in a discussion of the science behind the recommendations and new evidence supporting the connections between physical activity, disease prevention, quality of life and health care strategies to help Americans get moving.

Don Wright, MD, MPH, HHS deputy assistant secretary for health and director of the Office of Disease Prevention and Health Promotion, spoke to the Daily News about the guidelines’ implications.

What are the Physical Activity Guidelines for Americans, and why are they important?
Wright: The Physical Activity Guidelines for Americans serve as the primary, authoritative voice of the federal government for evidence-based guidance on physical activity, fitness and health for Americans. The guidelines provide recommendations for adults and youth to safely get the physical activity they need. The guidelines also provide information on how physical activity can promote health and reduce the risk of chronic disease.

Currently, only 26 percent of men, 19 percent of women and 20 percent of adolescents in the United States meet the recommendations. This has health and economic consequences for the nation, with nearly $117 billion in annual health care costs and 10 percent of all premature mortality attributable to our failure to meet recommended levels of aerobic physical activity. Increasing the number of Americans meeting these recommendations will save lives, improve quality of life across the population and decrease the burden of chronic disease on our health care system.

What did attendees learn at the keynote session on the guidelines?
(From the Editors: During the session, Admiral Giroir discussed what was new in the guidelines, including extensive new knowledge gained since the publication of the first edition. Following his remarks, other speakers provided an overview on the methodology and science used to update the second edition and discussed strategies for implementation. William E. Kraus, MD, from Duke University, discussed the science connecting physical activity to cardiovascular disease mortality, all-cause mortality and other health outcomes, while Russell R. Pate, PhD, from the University of South Carolina, discussed the impact of partnerships to increase physical activity across the nation. Both are members of the advisory committee that completed the scientific review that informed the second edition of the guidelines. Janet Fulton, PhD, from the CDC, discussed implementation strategies.)

Wright: The session underscored that physical activity is one of the most effective preventive health interventions. Increasing the number of Americans who follow the recommendations will require individuals as well as community and national leaders to take action.

How can physicians use the guidelines in practice?
Wright: Physicians are trusted sources of health information for their patients, and uniquely positioned to counsel patients on the importance of physical activity. Physicians can talk to their patients, learn about their barriers to physical activity and advise them on how to best fit physical activity into their daily routines. Providers also can reassure their patients about the safety of physical activity, even for those with disabilities and underlying health conditions. They can also prescribe an exercise program that accounts for these concerns (https://www.prescriptionforactivity.org/).

Where can readers learn more about the guidelines?
Wright: The second edition of the Physical Activity Guidelines for Americans and a suite of resources for health professionals are available at https://health.gov/PAGuidelines/.

Highlights of the 2018 Guideline on the Management of Blood Cholesterol

Importance of Cholesterol Management

The “2018 Guideline on the Management of Blood Cholesterol” is an update to the 2013 guideline on diagnosing, treating, and monitoring high cholesterol.

Fifty-six million (48.6%) US adults over 40 years of age are eligible for statin therapy on the basis of the 2013 guideline for managing blood cholesterol from the American College of Cardiology and the American Heart Association. This is significant when you consider that having a high level of low-density lipoprotein cholesterol (LDL-C) is a major risk factor for atherosclerotic cardiovascular disease (ASCVD). Because LDL-C contributes to fatty buildups and narrowing of the arteries (atherosclerosis), it’s often called the “bad” cholesterol, and in fact, high LDL-C at any age can cumulatively increase the risk for heart disease and stroke.

While there is no ideal target blood level for LDL-C, the 2018 guideline recognizes, in principle, that “lower is better.” Studies suggest that an optimal total cholesterol level is about 150 mg/dL, with LDL-C at or below 100 mg/dL, and adults with LDL-C in this level have lower rates of heart disease and stroke.

Risk Assessment

The 2018 guideline recommends that healthcare providers conduct a detailed risk assessment with their patients through an ASCVD risk calculator (static.heart.org/riskcalc/app/index.html#!/baseline-risk), which providers can use to discuss risks and treatment options with patients. A consumer-facing risk calculator is available as well at www.heart.org/ccccalculator. This calculator combines all major risk factors to estimate a patient’s probability for developing ASCVD. Risk factors include smoking, high blood pressure, abnormal cholesterol, and diabetes. Because atherosclerosis progresses over a lifetime, age counts as a risk factor, too. When the ASCVD risk status is uncertain, a coronary artery calcium test may clarify risk for patients ages 40 to 75, and it may also help decide whether to start or restart statin therapy.

Along with traditional cardiovascular disease risk factors like smoking, high blood pressure, high cholesterol, and high blood sugar, the guideline now calls for further review in some people ages 40 to 75 of risk-enhancing factors such as family history and other health conditions. The presence or absence of risk-enhancing factors in this age group without diabetes and 10-year risk of 7.5% to 19.9% can help further determine whether patients should start or intensify statin therapy.

Patients with extremely high LDL-C (190 mg/dL or more) or other conditions that can increase their ASCVD risk, and those who have been diagnosed with cardiovascular disease, need immediate intervention with high-intensity statins to manage their cholesterol without further risk assessment.

The 2018 guideline also recognizes the importance of identifying and managing high LDL-C in children, adolescents, and young adults to reduce their lifetime exposure to the health effects of high cholesterol. Most children can reduce their lifetime ASCVD risk by practicing healthier lifestyles. In some cases, high cholesterol in children can point to a genetic issue like familial hypercholesteremia, prompting screening of family members to identify those who are at increased risk.

Primary Prevention

The 2018 guideline recommends that for adults 20 years or older who are free from ASCVD (and not on lipid-lowering therapy), measure LDL-C with either a fasting or nonfasting plasma lipid profile when estimating ASCVD risk, and document baseline LDL-C. For adults 20 years or older who have an initial nonfasting lipid profile with triglycerides 400 mg/dL or higher, repeat the lipid profile with the patient fasting to establish fasting triglyceride levels and baseline LDL-C.

As with children, most patients can reduce their lifetime ASCVD risk through healthier lifestyle practices. Encourage patients to reduce their caloric intake of saturated fat and dietary cholesterol and to eliminate trans fat completely. In addition to these dietary changes, patients should strive for an average of 40 minutes of moderate to vigorous physical activity 3 to 4 times per week. But even moderate amounts of activity can reduce risk for patients who achieve this goal, and patients with metabolic syndrome may also benefit from physical activity.

When lifestyle interventions alone are not enough to lower LDL-C, statins generally provide the most effective lipid-lowering treatment. There are 3 main treatment regimens for statins:
High intensity, which typically lowers LDL-C by 50% or more
Moderate intensity, which lowers LDL-C by 30% to 49%
Low intensity, which lowers LDL-C by 30% or less

Use a stepwise approach to manage high cholesterol, adding therapies as tolerated until the cholesterol levels are lowered adequately. If a patient has problems taking a statin or if a statin alone doesn’t sufficiently lower LDL-C additional drug options are available. Adding a bile acid sequestrant or ezetimibe to a statin regimen further lowers LDL-C by approximately 15% to 30% and 13% to 20%, respectively. And adding a PCSK9 inhibitor to a statin regimen has been shown to further reduce LDL-C by 43% to 64%.

Patients with extremely high LDL-C (190 mg/dL or higher) have a high lifetime risk for a cardiovascular event. For patients ages 20 to 75, providers should prescribe a maximally tolerated statin.

Adults ages 40 to 75 who have diabetes are usually considered at moderate to high risk for cardiovascular disease. The guideline recommends moderate-intensity statins, regardless of the patient’s estimated 10-year risk for ASCVD (Figure 1).

Figure 1. Primary prevention. apoB indicates apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; hsCRP, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein cholesterol; and Lp(a), lipoprotein (a).

Secondary Prevention

For patients who have had a serious cardiovascular incident or procedure, secondary prevention may reduce the risk of another event. Providers should use an ideal LDL-C threshold of less than 70 mg/dL when considering adding ezetimibe and PCSK9 inhibitors to an existing statin therapy (Figure 2).

Figure 2. Secondary prevention. ACS indicates acute coronary syndrome; ASCVD, atherosclerotic cardiovascular disease; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; and PCSK9i, PCSK9 inhibitor. *Very high risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.

Monitoring

Once patients begin a treatment plan, providers should reassess at 4 to 12 weeks with a fasting or nonfasting lipid test and check for statin intolerance, and retest every 3 to 12 months if needed. Using the percentage reduction in LDL-C (rather than total cholesterol) in follow-up monitoring of patients can help you estimate how well the statin medication is working.

Lowering LDL-C levels by 1% generally equals about 1% reduction in heart disease and stroke risk, but the effect can be even greater when starting with higher baseline levels of LDL-C. On the basis of several large studies, it’s estimated that reducing LDL-C levels with statins by about 38.7 mg/dL can reduce heart disease and stroke risk by about 21%, based on the results of several large studies.

Implementing the 2018 Guideline Recommendations

When initiating treatment plans and before prescribing therapy, providers should

  • Allow patients to ask questions and express concerns and preferences about their ability and likelihood to follow and stick to the lifestyle and medication plan
  • Emphasize the potential for lowering the patient’s cardiovascular disease risk
  • Discuss any possible drug interactions and adverse effects
  • Address issues that factor into, or may become a barrier to, a shared-decision plan, such as costs and the patient’s overall health

The 2018 guideline recommends offering options such as phone and calendar reminders, educational activities, and simplified medication doses to help patients stick to their treatment plans. The 2018 guideline also includes considerations for special populations in the United States:

  • Racial/ethnic groups (Section 4.5.1)
  • Women (Section 4.5.3)
  • People with diabetes (Section 4.3)
  • People with chronic kidney disease (Section 4.5.4)
  • People with chronic inflammatory conditions/HIV (Section 4.5.5)
  • Older adults (Section 4.4.4.1)
  • People with hypertriglyceridemia (Section 4.5.2)

To download the full version of the 2018 Cholesterol Guideline, please visit https://professional.heart.org/professional/ScienceNews/UCM_502791_2018-Cholesterol-Management-Guideline.jsp.

REGROUP trial: Major adverse cardiac events results similar for endoscopic vein harvesting compared to open vein harvesting for CABG

There were no significant differences in major adverse cardiac events for endoscopic vein harvesting compared to open vein harvesting for CABG, according to Randomized Endovein Graft Prospective (REGROUP) results presented at Scientific Sessions 2018 in Chicago.

In the intent-to-treat, two-arm, parallel design, multicenter study, 1,150 people in 16 Veterans Health Administration centers were randomized to endoscopic vein harvesting or open (non-endoscopic) vein harvesting, with a median follow-up of 2.78 years.

Of the two surgical methods for CABG, “endoscopic vein harvesting is minimally invasive and only requires a small incision,” said Marco Zenati, MD, MSc, professor of surgery at Harvard Medical School in Cambridge, Massachusetts. “But from the provider, it requires a steep learning curve to become an expert.”

In REGROUP, the harvesting operation needed to be done on pump on the arrested heart, “and, crucially, the endoscopic harvest had to be performed by an expert, with excess of 100 EVH cases,” Zenati said.
The trial had to be large enough for a meaningful primary outcome of major adverse cardiac events: a composite of all-cause mortality, non-fatal myocardial infarction or repeat revascularization, Zenati said. Off-pump CABG patients were excluded. The characteristics of patients were balanced in both study arms.

The rates of major adverse cardiac events for endoscopic versus open harvest were 13.9 percent vs. 15.5 percent, P=0.47, primary outcome, with fewer leg wound healing problems associated with the minimally invasive method.

“We also saw a trend toward fewer recurrent events after the endoscopic approach,” said Zenati, who is also chief of cardiothoracic surgery at Boston Healthcare System and associate surgeon at Brigham and Women’s Hospital.

Longer-term follow-up and additional studies that include graft patency data are needed, he said.

Further studies are needed to establish standards for harvester expertise to ensure the safety of patients and effectiveness of the procedure.

PIONEER-HF: Sacubitril/valsartan reduced cardiovascular biomarker in patients with reduced ejection fraction hospitalized for acute decompensated heart failure

Compared to enalapril, sacubitril/valsartan was associated with a greater reduction in the biomarker N-terminal pro-brain natriuretic peptide and re-hospitalization for heart failure, according to a study presented at Scientific Sessions 2018 in Chicago.

PIONEER-HF (Angiotensin Receptor-Neprilysin Inhibition in Patients Hospitalized With Acute Decompensated Heart Failure) — a prospective, multicenter, double-blind, randomized, active-controlled trial — compared the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan (n = 440) with enalapril (n = 441) in hemodynamically stabilized patients with acute heart failure and reduced ejection fraction.

Presenter Eric Velazquez, MD, professor of medicine in cardiology at Yale University School of Medicine in New Haven, Connecticut, said guideline-directed therapy for acute decompensated heart failure has been limited despite accounting for more than 1 million hospitalizations annually in the United States.

The current standard of care includes decongestion with diuretics and hemodynamic support with vasodilators and inotropes.

Study drug doses were titrated over eight weeks following in-hospital initiation of treatment. The titration algorithm was based on systolic blood pressure and aimed at target doses of sacubitril/valsartan 97/103 mg twice daily or enalapril 10 mg twice daily.

Researchers evaluated a biomarker surrogate of efficacy, safety, tolerability and clinical outcomes.

Key entry criteria included an SBP of at least 100 millimeters of mercury and no symptomatic hypotension, no increase in intravenous diuretics, no IV vasodilators and no IV inotropes within the prior 24 hours.

The primary endpoint was the proportional change in NT-proBNP from baseline to the mean of weeks four and eight. NT-proBNP is a biomarker of neurohormonal activation, hemodynamic stress and subsequent cardiovascular events.

Safety endpoints included worsening renal function, symptomatic hypotension, hyperkalemia and angioedema.

Exploratory clinical outcomes were:

  • Serious clinical composite: death, re-hospitalization for HF, left ventricular assist device or listing for cardiac transplant
  • Expanded composite: serious composite plus addition of HF medication, unplanned outpatient IV diuretics or a greater than 50 percent increase in dose

At baseline, about a third of patients had no prior HF diagnosis; 25-30 percent were women; and 36 percent self-identified as African-American.

  • For the primary endpoint of percent change in NT-proBNP, the reduction was 29 percent greater with sacubitril/valsartan (CI 19 percent, 37 percent; P<0.0001). There were no significant differences in safety events between the sacubitril/valsartan and enalapril treatment groups.
  • For the serious composite clinical endpoint, the event rate for sacubitril/valsartan was 9.3 percent versus 16.8 percent, which was statistically significantly lower (HR 0.54; 95 percent CI 0.37, 0.79; P=0.001).
  • Of the exploratory clinical endpoints, only re-hospitalization for HF was statistically significantly different between treatment groups: 8 percent in the sacubitril/valsartan group versus 13.8 percent in the enalapril group (HR 0.56; P=0.005). There were no statistically significant interactions in subgroup analyses of the primary endpoint or the serious composite endpoint.

Larry Allen, MD, professor of medicine in cardiology at the University of Colorado School of Medicine in Aurora, said sacubitril/valsartan use may be low due to clinical inertia.

He also noted that the median age of 62 years of the study participants was 10 years younger than the typical HF population and that relatively few patients with Stage D HF were included because of the exclusion criteria.

“In a post-PIONEER world, one of the great things about this study is that it keeps it simple,” Allen said. “This simpler algorithm for inpatient and subsequent outpatient HR rRF management is better for both clinicians and patients. It also reinforces the importance and safety of aggressive guideline-determined medical therapy in most patients.”

BRIDGE trial suggests quality improvement interventions may increase use of evidence-based therapies

The BRIDGE Cardiovascular Prevention Cluster Randomized Trial found that a multifaceted quality improvement educational intervention significantly increased the use of evidence-based therapies for cardiovascular disease in a low- and middle-income setting.

Otavio Berwanger, MD, PhD, director of the Research Institute HCor at Heart Hospital in Sao Paulo, Brazil, presented the results of BRIDGE CV, a multifaceted intervention to narrow the evidence-based gap in the treatment of high cardiovascular risk patients.

Although large-scale, randomized trials have established the efficacy of antiplatelet therapy, statins, ACE inhibitors and ARBs for the management of high-risk cardiovascular disease, adopting these modalities in practice is suboptimal, particularly in low- and middle-income settings, which account for up to 80 percent of the global CVD burden. Quality improvement interventions have rarely been evaluated in these settings.

BRIDGE CV enrolled 1,619 stable patients with high-risk, established CV disease, including prior coronary artery disease, prior stroke or symptomatic peripheral artery disease from 40 clusters of outpatient clinics from tertiary hospitals or primary care units in Brazil. Clusters were randomly assigned to a multifaceted QI intervention (18 clusters, 726 patients) or to routine care (22 clusters, 893 patients). Allocation to the interventions was concealed and adjudication of the endpoints was blinded.

Patients in both groups had screening and randomization visits as well as additional visits at one, six and 12 months. The primary endpoint of the study was adherence to antiplatelet therapy, statins and ACE inhibitors or ARBs at 12 months in an all-or-none approach.

In addition to the primary endpoint, secondary endpoints at 12 months included:

  • Individual components of the primary endpoint
  • Percentage of eligible patients with LDL below 70 mg/dL and below 50 mg/dL
  • Adherence to high-dose statins by patients with no contraindications
  • Adherence to beta-blockers in patients after myocardial infarction
  • Combined endpoint of CV mortality, non-fatal MI, or non-fatal stroke, and control of risk factors such as hypertension, diabetes or smoking cessation

The QI intervention was based on behavioral marketing. The first intervention included three steps.

  1. In a pre-physician visit, a case manager evaluated each patient using a one-page form with four colored sections to capture anti-hyperlipidemic, anti-diabetic, anti-platelet and anti-hypertensive medications. Case managers were trained in treatment guidelines. Care gaps, such as lack of recommended medical treatment, were noted with stickers
  2. Established reminders and physician prompting before the physician visit.
  3. During the physician visit, a similar four-colored, one-page decision support tool summarized treatment guidelines to facilitate the intervention. During the discussion, Berwanger said guidelines are “great, but they are complicated and long documents,” hence the use of a one-page summary.

During the second part of the intervention, audit and feedback reports were generated monthly for individual measures, such as lipid levels and medication use, as well as for the all-or-none adherence to antiplatelet therapy, ACE inhibitors/ARBs and
statins. Information on lifestyle modification was provided for patients.

The two intervention groups were generally well matched for baseline characteristics, with a median age of about 65 years; 63 percent were male, and about half had a previous MI. Cluster baseline characteristics were also well balanced.

The intervention significantly improved the primary endpoint (complete adherence to statins, anti-platelet therapy and ACEi or ARB at 12 months, with 73.5 percent complete adherence in the intervention group versus 58.7 percent in the control group (P=0.01).

The intervention also significantly improved the secondary endpoints of statin adherence, with 93.6 percent adherence in the intervention group versus 81.7 percent in the control group (P<0.01). It also improved adherence to anti-platelet therapy, with 94 percent in the intervention group versus 86.3 percent in the control group (P<0.01). Smoking cessation also significantly improved after the intervention.

There were no significant differences between treatment groups for adherence to ACEi or ARB, use of high-dose statins, use of beta-blockers post-MI, LDL less than 70 mg/dL, blood pressure below 140/90 millimeters of mercury, systolic blood pressure less than 120 mm Hg, or HbA1c ≤7.0 percent in patients with diabetes. There was no significant difference between groups in major adverse cardiovascular events.

In a subgroup analysis, there was better adherence to statins, anti-platelet therapy and ACEi or ARB in teaching units than in non-teaching units (P=0.02). Berwanger speculated that the personnel in teaching units might be more motivated to use the intervention tools.

He concluded that the tools tested in the trial could be used to develop QI programs to maximize the use of evidence-based interventions to manage the care of patients with established CVD, particularly in limited resource settings.

Trial to improve adherence to evidence-based stroke, TIA treatments yields mixed results

A multifaceted quality intervention didn’t significantly increase the composite adherence score for use of evidence-based therapies for acute ischemic stroke and transient ischemic attack patients, according to results presented Saturday in a Late-Breaking Clinical Science session.

Maria Julia Machline Carrion, MD, MHS, PhD, coordinator of the Bridge-Stroke Project at Heart Hospital in Sao Paulo, Brazil, presented results of BRIDGE stroke, a cluster randomized quality improvement trial conducted in Argentina, Brazil and Peru.

However, when using a more conservative all-or-none approach of complete adherence, the QI intervention improved adherence to evidence-based therapies and significantly increased the use of thrombolysis and smoking cessation education.

The uptake of interventions with established efficacy for managing patients with AIS and TIA has been suboptimal, particularly in low- and middle-income countries, and there are few robust QI trials in these settings, Carrion said.

The trial enrolled patients in 36 clusters that were randomly assigned to the multifaceted QI intervention (19 clusters with 817 patients) or to a control group following routine practice (17 clusters with 807 patients).

Clusters were hospitals with 24/7 emergency departments, central nervous system imaging capability and the ability to administer tissue plasminogen activator (Rt-PA). It included 1,624 consecutive patients with AIS or TIA who were admitted within 24 hours of the onset of symptoms.

The primary endpoint was a composite adherence score to 10 in-hospital quality measures, including early antithrombotics, Rt-PA within therapeutic window, deep vein thrombosis prophylaxis, door-to-needle time of less than 60 minutes, screening for dysphagia, assessment for rehabilitation, antithrombotics at discharge, anticoagulants for atrial fibrillation or flutter, statins for LDL greater than 100 mg/dL or not documented and smoking cessation education.

The secondary endpoints included complete adherence to 10 in-hospital quality measures, Rt-PA in patients admitted within 24 hours, antihypertensives, DTNT less than 45 minutes and 90-day clinical events (mortality, disability and stroke recurrence).

The QI intervention included the use of a colored wristband for patient identification and a printed poster of reminders that the patients should receive special care. A therapeutic plan/algorithm for care management included recommendations of evidence-based therapies for these patients.

Trained nurse case managers ensured all components of the QI intervention were used. Educational materials containing evidence-based recommendations were also provided. Periodic feedback reports were generated on adherence to quality measures.

Patient baseline characteristics were well matched between intervention and control groups. The majority of patients had AIS as a diagnosis. At baseline, intervention clusters were somewhat more likely to have a stroke unit, although all clusters in both groups had a stroke protocol available.

There was no significant difference in composite adherence score between the intervention group (85.3%) and the control group (77.8%; intraclass correlation coefficient, 0.32). Complete adherence to in-hospital quality measures was 49.2 percent in the intervention group and 25.2 percent in the control group (population average odds ratio = 2.59; 95% CI, 1.05-6.1; ICC = 0.25).

Of the in-hospital quality measures assessed, only Rt-PA use within the therapeutic window and smoking cessation education were statistically significantly better in the intervention group than in the control group (55.0% versus 39.9%, P=0.01; and 72.1% versus 48.5%, P=0.04, respectively).

BRIDGE stroke may be a “first step in quality improvement in Latin America,” said Carrion, who suggested tailoring interventions to each location. “The other component that is very important from my end is the audit and feedback system.”

Results from DECLARE trials show drug may reduce CV death or hospitalizations for HF patients with Type 2 diabetes

The SGLT-2 inhibitor dapagliflozin met one primary composite endpoint with a statistically significant reduction in heart failure hospitalization or cardiovascular death versus placebo, according to results presented in a Late-Breaking Clinical Trial session at Scientific Sessions 2018 in Chicago.

The Dapagliflozin Effect on Cardiovascular Events-TIMI 58 (DECLARE) trial showed that dapagliflozin also met the primary safety endpoint of non-inferiority for major adverse cardiovascular events. However, the other primary composite endpoint of major adverse cardiovascular events wasn’t met.

DECLARE is a phase 3, double-blind, randomized, cardiovascular outcomes trial in 17,160 patients with Type 2 diabetes and multiple cardiovascular risk factors (n = 10,186) or established cardiovascular disease (n = 6,974).

The trial evaluated the effects of 10 mg dapagliflozin (n = 8582) daily versus placebo (n = 8,578) in 33 countries with a median follow-up of 4.2 years.

Stephen D. Wiviott, MD, senior investigator with the Thrombolysis in Myocardial Infarction Study Group and cardiovascular medicine specialist at Brigham and Women’s Hospital in Boston, presented the DECLARE results.

Enrollment criteria included diagnosis of Type 2 diabetes and established atherosclerotic cardiovascular disease including ischemic heart disease, cerebrovascular disease or peripheral artery disease (secondary prevention subgroup) or multiple risk factors for ASCVD (primary prevention subgroup). The latter group included men age >55 and women age >60 who had at least one additional risk factor such as dyslipidemia, hypertension or current tobacco use.

There were no significant differences in baseline characteristics or medication use between treatment arms, said Wiviott, who is also associate professor of medicine at Harvard Medical School in Boston. Medications were as expected in the trial patient population and included glucose-lowering therapies and cardiovascular therapies.

In the primary safety outcome analysis, dapagliflozin:

  • Met the prespecified endpoint for non-inferiority to placebo for MACE (P<0.001).
  • Didn’t result in a lower rate of MACE (8.8%) versus placebo (9.4%) (HR 0.93; CI 0.84-1.03; P=0.17 for superiority).
  • Reduced cardiovascular death or hospitalization for heart failure (4.9%) versus placebo (5.8%) (HR 0.83; CI 0.73-0.95; P=0.005 for superiority.

Because both primary endpoints weren’t met, Wiviott said the secondary endpoints have to be considered exploratory.

All-cause mortality wasn’t statistically significantly different between treatment groups. However, for the first renal composite endpoint of a 40-percent decrease in estimated glomerular filtration rate, end-stage renal disease, or renal or cardiovascular death, there were fewer events in the dapagliflozin group (4.3%) than in the placebo group (5.6%) (HR 0.76; CI 0.67-0.87; P<0.001).

Dapagliflozin was safe and generally well tolerated, with an increase in genital infections and diabetic ketoacidosis, no difference in amputation, stroke or fracture, and decreased hypoglycemia and bladder cancer, Wiviott said.

There were significantly more treatment-emergent serious adverse events in the dapagliflozin group (34.1%) versus placebo (36.2%; P<0.001), although treatment-emergent adverse events leading to drug discontinuation were higher in the dapagliflozin group (8.1%) than with placebo (6.9% P=0.01).

Specific adverse events that were higher in the dapagliflozin group than with placebo included diabetic ketoacidosis (0.3% versus 0.1% ; P=0.02) and genital infection (0.9% versus 0.1%; P<0.001). These are known adverse events to be associated with dapagliflozin. Hypoglycemia was lower with dapagliflozin than with placebo (0.7% versus 1.0%; P=0.02) as was cancer of the bladder (0.3% versus 0.5%; P=0.02).

There were no statistically significant differences between treatments for amputation, fracture, symptoms of volume depletion, urinary tract infection, Fournier’s gangrene, malignancy event or hepatic event.

Wiviott concluded that these data extend the benefit of SGLT-2 inhibition to a broader population of patients for primary and secondary prevention.

DECLARE was well conducted and stands out for the large proportion of patients with risk factors but without established atherosclerotic cardiovascular disease, said discussant Javed Butler, MD, MPH, MBA, Patrick H. Lehan Chair in Cardiovascular Research and chair of the Department of Medicine and professor of Medicine and Physiology at the University of Mississippi in Oxford.

Controlling the risk factors of HbA1c, smoking, LDLc, blood pressure and albuminuria reduced the risks of acute myocardial infarction and stroke in patients with Type 2 diabetes, but didn’t reduce the incidence of heart failure, Butler said.

“Anything that reduces the risk of heart failure is a welcome addition,” he said.

“Type 2 diabetes patients similar to those in trials of SGLT-2 inhibitors should be prescribed drugs to reduce the risk of heart failure regardless of their effect on MACE outcomes,” Butler said. For those patients with no risk factors or with heart failure, more data are needed.

Yoga may have potential for cardiac rehab in low- and middle-income settings

Yoga-based cardiac rehabilitation may have potential in post-myocardial infarction patients compared with enhanced standard care, according to a multicenter randomized controlled trial in India.

Presented during a Late-Breaking Clinical Trial session at Scientific Sessions 2018 in Chicago, the two primary outcomes of Yoga-based Cardiac Rehabilitation (Yoga-CaRe) were:

  • Time to occurrence of first cardiac event (composite of death, nonfatal MI and stroke) and emergency cardiac admissions
  • Quality of life at 12 weeks

Secondary outcomes included return to pre-infarct daily activities, smoking cessation and compliance to prescribed medications at 12 weeks, said Dorairaj Prabhakaran, MD, DM, executive director at the Center for Chronic Disease Control in New Delhi, India.

To be included in Yoga-CaRe, participants had to be within 14 days of acute myocardial infarction and willing and able to attend the complete cardiac rehabilitation program, Prabhakaran said. Participants self-reporting a current practice of yoga for more than three hours a week were excluded.

The yoga-based intervention was structured similar to cardiac rehabilitation programs and included lifestyle, meditation, breathing and yoga training sessions by trained yoga instructors for 13 weeks followed by self-practice at home.

The control group received ESC from a nurse or other member of the cardiac care team individually or in groups for five sessions.

The two treatment groups — 1,970 evaluable patients in Yoga-CaRe and 1,989 evaluable patients in ESC — were well-matched for baseline characteristics such as revascularization and cardiac medications. Median age was 53.4 years, which is typical for a cardiac event in the Indian population. Women represented only about 14 percent of the trial patients.

There were no statistically significant differences between the groups for the first co-primary outcome of death, non-fatal MI, non-fatal stroke or emergency cardiovascular hospitalizations.

Less than half the number of events occurred compared with the original assumption, so the study was underpowered. However, in patients who completed 10 or more Yoga-CaRe sessions, the incidence of cardiovascular events was significantly lower than those in the control group (HR 0.54; CI 0.38, 0.76; log rank test, P<0.0001).

For the second co-primary outcome, the mean change in EQ-5D VAS score, a measure of self-reported quality of life from baseline to three months was 9.2 in the ESC group versus 10.7 in the Yoga-CaRe group (P=0.002). It remained significant after adjusting for baseline covariates, risk profiles and treatments at discharge.

Yoga-based cardiac rehabilitation is safe, feasible, improves quality of life and encourages return to pre-infarct activities, Prabhakaran said. It has the potential to be an alternative to conventional cardiac rehabilitation programs and to address the unmet needs of patients in low- and middle-income countries for low-cost, culturally acceptable and effective cardiac rehabilitation, Prabhakaran said.

Three components of cardiac rehabilitation — stress reduction, exercise and lifestyle changes such as smoking cessation and healthier diet — could be addressed by yoga.

There are questions about whether Yoga-CaRe could apply to populations that are older, female or with more severe cardiac disease, according to discussant Vera Bittner, MD, MSPH, section head of General Cardiology, Prevention and Imaging in the Division of Cardiovascular Disease at the University of Alabama at Birmingham.

Patients in the ESC group had fewer contacts with study staff than the yoga group and didn’t have a physical activity intervention, so it is not known if they would have benefited from more contacts and physical activity. Only 53 percent of the yoga group completed at least 10 sessions, and Bittner wondered if adherence would have been worse outside of a clinical trial setting.

Other questions remain to be addressed, such as the potential for yoga to be integrated into existing treatment protocols, and whether it can be applied to other health care settings and populations.

Top