Many heart attack patients may be needlessly treated in ICU

April 15, 2019 – A new study finds that more than 80 percent of stable STEMI patients are treated in the ICU.

Many patients who suffer a type of heart attack known as an ST-elevation myocardial infarction (STEMI) are treated in the intensive care unit (ICU), despite a relatively low risk of developing a complication requiring ICU care, according to a new study published in JACC: Cardiovascular Interventions.

A STEMI is caused by a blocked blood supply to the heart and is the most severe type of heart attack.

“In recent years, treatment for STEMI patients has improved so much that cardiologists have seen the risk of developing a complication requiring care has significantly decreased,” said Jay S. Shavadia, MD, a cardiologist and researcher from the DCRI and the study’s lead author. “We wanted to quantify the risk and see whether ICUs are being overutilized for STEMI patients.”

The researchers analyzed data from the Chest Pain-MI Registry, which includes patients admitted to participating hospitals with STEMI or non-STEMI (NSTEMI). They examined patterns of ICU use among STEMI patients ages 65 years and older treated with PCI who were stable when they were first seen in the hospital. This meant they were not in cardiac arrest, were not in shock or had had a procedural complication.

“We know those patients [with shock] need to be in an ICU, so we didn’t include them in the study,” he said.

Of 19,507 stable STEMI patients treated at 707 hospitals, 82.3 percent were treated in an ICU with a median one-day ICU stay. Overall, 16.2 percent of patients developed complications requiring ICU care while hospitalized. The study found 3.7 percent died, 3.7 percent experienced cardiac arrest, 8.7 percent experienced shock, 0.9 percent suffered a stroke, 4.1 percent had a blockage of electrical signals between the heart’s upper and lower chambers (atrioventricular block) and 5.7 percent experienced respiratory failure. These complications were not limited to those related to heart problems.

“As patients get older, their risk of non-cardiovascular complications requiring an ICU stay increases, such as other causes of shock or respiratory failure, sepsis for instance,” Shavadia said.

Patients who waited longer to receive treatment were more likely to develop at least one complication. Those who received treatment within an hour of being evaluated by emergency medical service (EMS) personnel or going directly to the hospital without being seen by EMS, had a complication rate of 13.4 percent, compared with 18.7 percent for those who were not treated for at least 90 minutes.

“Although 16 percent is not a small number of STEMI patients who should be in the ICU, we found the majority of patients don’t need to be there,” Shavadia said.

He said that patients age 65 years and older are more likely to develop complications than younger patients, so the overall risk for STEMI patients of all ages who need ICU care may be even lower than 16 percent.

The study did not address which stable STEMI patients will need ICU care.

“We’re now trying to identify which patients are at greatest risk of complications, so we can predict who needs to be treated in the ICU,” Shavadia said.

In an accompanying editorial, Suartcha Prueksaritanond, MD, and Ahmed Abdel-Latif, MD, PhD, of the Gill Heart and Vascular Institute and division of cardiovascular medicine at the University of Kentucky, and the Lexington VA Medical Center in Lexington, Kentucky, wrote, “The high ICU utilization pattern despite declining complications following PPCI [primary percutaneous coronary intervention] calls for a new approach. This is particularly important as the overall health care cost continues to grow and calls for optimal resource utilization prevail.”

They noted that until a more comprehensive, simple-to-follow algorithm for stratifying risk in STEMI patients is developed, “the ICU admission decision for STEMI patients will continue to be based on individual judgment and traditional protocols rather than robust and evidence-based risk prediction models.”

Organizations join forces to create global alliance against antibiotic resistance

April 13, 2019 – The ARLG and COMBACTE will work together on a number of initiatives designed to fight drug-resistant infections.

The U.S.-based Antibacterial Resistance Leadership Group (ARLG), part of the DCRI, and the University Medical Center (UMC) Utrecht, the managing entity of the COMBACTE (Combatting Bacterial Resistance in Europe) consortium, will work together to solidify a comprehensive global community to combat the threat of antibiotic resistance around the world.

This collaboration is expected to take several forms, including joint design and implementation of clinical research, working meetings at scientific conferences like the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), and IDWeek, cross-entity working groups with diverse functional group participation, clinical trial innovations, data and protocol exchanges, and, contractual, regulatory, and systems harmonization.

ARLG logo“We at the ARLG have long admired the work being done by COMBACTE to increase the efficacy of antimicrobial drug development,” said Vance Fowler, MD, an investigator at the DCRI and co-principal investigator of the ARLG. “Combining our efforts will allow us to maximize the work we both do to stop the advancement of antibacterial resistance.”

Both organizations have been working toward the same mission since each launched in 2013, and now, the two groups will share their work to increase synergy and avoid duplicative efforts in clinical research.

“We have already made efforts to expand our reach across Europe, where an increasing number of people suffer from infections caused by antibiotic-resistant bacteria,” said Marc Bonten, MD, coordinator of COMBACTE and a professor at UMC Utrecht. “But by collaborating and sharing our progress with the ARLG, we can make a truly global impact beyond this population — an important consideration in a globally connected era in which epidemics travel across oceans quickly.”

As part of the agreement, the ARLG will have the opportunity to lead and coordinate U.S.-based studies for all clinical research initiated by COMBACTE, while COMBACTE will have the opportunity to lead and coordinate ARLG-initiated projects in Europe.

Earlier this year the European Clinical Research Alliance on Infectious Diseases (ECRAID) was formed, merging COMBACTE’s more than 850 clinical trial sites and 650 laboratories with the network of primary care sites coordinated by The Platform for European Preparedness Against (Re-)Emerging Epidemics (PREPARE) to form a European-wide sustainable clinical research organization for infectious diseases and antimicrobial resistance. The ARLG, with established collaborations in 19 countries, will help to expand these efforts outside of Europe. The alliance will enable innovative, flexible, and adaptive collaboration between the DCRI and UMC Utrecht.

“This is an exciting year for PREPARE to expand its work in reducing a serious public health threat,” said Herman Goossens, MD, coordinator of PREPARE and professor at University of Antwerp and UMC Utrecht. “First, we joined forces with COMBACTE by forming ECRAID, and now, we welcome a partnership with the ARLG, which will help all three organizations leverage a wider set of resources and a deeper pool of expertise.”

The ARLG is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under Award Number UM1AI104681. COMBACTE-NET, COMBACTE-CARE, and COMBACTE-MAGNET receive support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115523 | 115620 | 115737 resources of which are composed of financial contribution from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution. COMBACTE-CDI receives support from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement n° 777362 resources of which are composed of financial contribution from the European Union’s Horizon 2020 research and innovation programme, and EFPIA. PREPARE is funded by the European Union’s FP7 Programme n° 602525. ECRAID is funded by the European Union’s Horizon 2020 Programme n° 825715.

ECHO program set to begin expansive child health research

April 9, 2019 – The DCRI serves as the Coordinating Center for the program, which received single IRB approval to proceed with its expansive observational research.

The National Institutes of Health’s (NIH’s) ECHO Program has received single Institutional Review Board (sIRB) approval for its ECHO-wide Cohort Data Collection Protocol, clearing the program to start answering high-impact research questions related to early influences on child health outcomes. The DCRI serves as ECHO’s coordinating center to help the program meet its mission to enhance the health of the nation’s children.

“The ECHO-wide Cohort Data Collection Protocol includes hundreds of interacting variables, and the DCRI played a central role in uniting collaborators to bring it to life,” said the DCRI’s P. Brian Smith, MD, MPH, MHS, who serves as a principal investigator for the ECHO coordinating center. “This sIRB approval gives us the green light to begin ECHO’s important research, delivering answers that will help our nation’s children live happier, healthier lives.”

ECHO is a seven-year NIH-supported program that is trying to better understand the effects of a broad range of influences—including physical, chemical, biological, social, behavioral, natural, and built environments—on child health outcomes. The ECHO-wide Cohort is made up of more than 70 individual cohorts of mothers and children from ongoing research projects. Researchers follow participants through different life stages, some starting before birth and through adolescence. Together, they form a massive virtual “cohort of cohorts” that includes more than 50,000 children from diverse backgrounds across the United States. By bringing together data collected under a single protocol, ECHO researchers can answer high-impact, complex research questions.

While many past research projects have looked at children through a single, narrow lens, the ECHO Program is taking a multidisciplinary approach that will offer a richer understanding of child health and development. Researchers from 44 states, Puerto Rico, and the District of Columbia are involved in the ECHO-wide Cohort Data Collection Protocol.

As ECHO’s coordinating center, the DCRI plays a crucial role in ECHO’s mission. The DCRI is responsible for organizing and managing activities and logistics for all collaborative components of the ECHO Program. Nearly 40 DCRI employees work on ECHO.

“ECHO has a huge scale and an ambitious vision, which is why it is such an important program for the DCRI,” said the DCRI’s Elisabeth Schweins, MS, who serves as project director for the ECHO Coordinating Center. “As ECHO’s Coordinating Center, the DCRI is poised to make a real difference in the lives of children across our nation, uncovering insights that can potentially improve their lives for generations to come. It is an exciting opportunity, and we are eager to get started.”

One of the first steps of protocol implementation is training site staff on the specific measurements in the ECHO-wide Cohort Data Collection Protocol. Consistency in data collection and measurement between cohorts will be critical to obtaining quality data. The coordinating center is committed to supporting the training of site staff and has created an integrated plan of training communications, online Learning Management System modules, and in-person training sessions for site staff to gain necessary protocol experience.

Few people with heart failure take guideline-recommended drug

April 8, 2019 – DCRI researchers found that heart failure patients are much more likely to take a guideline-recommended medication if they are started on the drug while still in the hospital.

Heart failure patients who could possibly benefit from a newer class of drug to lower their heart rate were more likely to take the medication if it was prescribed before hospital discharge rather than in a follow-up doctor’s visit, according to preliminary research presented at the American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions in Arlington, Virginia.

“The hospitalization rate in heart failure patients is quite high despite a number of good therapies, yet we have ivabradine, a relatively new therapy that can reduce hospitalization, and we still aren’t using it to the extent possible,” said the DCRI’s Robert Mentz, MD, lead author of the study (pictured).

When people have heart failure and less than 35 percent of the blood in the heart is pumped out with each contraction (a reduced ejection fraction), having a lower heart rate (less than 70 beats per minute) is associated with better outcomes. Current standard care for heart failure with reduced ejection fraction is to use beta-blocker medications in most patients. Beta-blockers can lower heart rate and have many other beneficial effects that improve outcomes for patients with reduction ejection fraction. Research has shown that adding ivabradine, which works in a different way to lower heart rate, may also be helpful in those patients who have a faster heart rate despite being on the highest dose of beta-blockers they can tolerate.

In 2016, the American Heart Association and the American College of Cardiology issued a focused update to heart failure guidelines to reflect newer medication options, including ivabradine, more recently proven successful in helping improve outcomes for heart failure patients, including reduced re-hospitalization.

The current study, called PRIME-HF, evaluated 104 patients (average age 57.5 years, 36 percent women, 64 percent African American) who had been hospitalized at one of 23 U.S. hospitals with worsening heart failure and were appropriate candidates to receive ivabradine. In the randomized, open-label study, researchers compared rates of medication use six months later between those whose hospital physicians were asked to initiate ivabradine prior to discharge and those whose physicians were instructed to provide usual care with consideration of starting the medication during follow-up visits.

Six months after hospitalization, the researchers found that patients whose physicians were asked to initiate ivabradine prior to discharge:

  • Were far more likely to be using ivabradine (40.4 percent vs. 11.5 percent);
  • Had a greater reduction in heart rate (10 bpm vs. 0.7 bpm, average heart rate 77 bpm vs 86 bpm);
  • Had not reduced their dose of beta-blockers; and
  • Did not develop abnormally low blood pressure or heart rate.

“This was a small study, but it provides important evidence of the safety and efficacy of starting this medication in the hospital period,” Mentz said. “There’s often a tendency to just say, ‘Let’s wait until we see the patient back in the clinic in a couple of weeks after hospital discharge.’ But the reality is that so often things are incredibly busy in the outpatient setting and many patients never get started on the right medications if we delay. Our message is to act now and help patients get the greatest benefits as early as possible.”

Patients in both groups encountered barriers to obtaining ivabradine, with 30.6 percent having trouble getting their initial prescription and 58.1 percent having trouble getting ivabradine at some point during the six-month study. Frequent barriers were high price, insurers declining to pay, and physicians deciding to stop the drug.

“When we designed the trial, we thought that more people would be using this medication in routine practice. The reality has been that adoption of the therapy has been very slow and only a fraction of potential patients are receiving it.” Mentz said. “Some of this is related to cost while some is also related to providers’ lack of familiarity with the medication and how best to use it. We are looking into how we can better support the early adoption of novel therapies in patients with heart failure to improve their outcomes.”

Because of slow recruitment, the study was terminated early, so the sample is too small to assess outcomes such as survival and re-hospitalization.

In addition to Mentz, the study’s authors include Adam D. DeVore, MD; Gudaye Tasissa, PhD; John F. Heitner, MD; Ileana L. Pina, MD; Anuradha Lala, MD; Robert T. Cole, MD; David D. Lanfear, MD; Chetan B. Patel, MD; Mahazarin Ginwalla, MD; Wayne Old, MD; Abraham S. Salacata, MD; Robert Bigelow, PhD; Tim T. Peterson, BS; Gregg C. Fonarow, MD; and Adrian F. Hernandez, MD. Author disclosures are on the abstract.

Amgen funded this investigator-initiated study.

Study finds lower death rates for TAVR centers that do more procedures

April 4, 2019 – The findings could inform a CMS decision on volume as a criterion for Medicare coverage.

Hospitals that perform the highest volume of transcatheter-aortic valve replacement (TAVR) procedures have significantly lower mortality rates than centers that do fewer of the minimally invasive surgeries, according to an analysis by a collaboration that included the DCRI.

The finding, published April 3 in the New England Journal of Medicine, comes as the Centers for Medicare & Medicaid Services is reconsidering the procedure’s coverage parameters, which established a center’s volume as a key criterion for reimbursement.

Approved in 2011, TAVR is largely performed on older patients insured by Medicare, and has grown into a multi-billion-dollar annual industry. As the number of procedures has escalated and the technique and devices have evolved, questions arose over the necessity of volume standards for CMS coverage.

“What we found is that there is still a very real relationship with annual volume and 30-day mortality at the hospital level, even taking into account the new devices and the learning curve that new centers face in the first 12 months of initiating a program,” said lead author and DCRI cardiologist Sreekanth Vemulapalli, MD (pictured).

“TAVR is different from most other cardiac procedures – it’s not a single-person effort,” Vemulapalli said. The procedure involves putting a replacement valve over a damaged aortic valve using a catheter rather than open-chest surgery, similar to the way a stent is placed in coronary arteries. “Patients are evaluated by a surgeon and an interventional cardiologist, and there is usually also a cardiac imaging specialist involved in the procedure. That team approach is very important, which is why we looked at the data from a hospital level.”

Even so, the authors said, the relationship between higher TAVR volumes and lower mortality was also evident at the individual proceduralist level, suggesting that repeated practice does improve outcomes.

Vemulapalli and colleagues launched their analysis last summer after CMS announced it would reevaluate coverage criteria. Using a database called the Transcatheter Valve Registry — which includes all of the commercial procedures in the United States, including those covered by Medicare — the researchers focused on volumes and outcomes from 2015–2017.

This timeframe rooted out earlier procedures that used outdated techniques and devices. The researchers also removed a hospital’s first 12 months of cases to account for the learning curve. More than 500 hospitals were included and segmented into four groups based on volume, from lowest to highest.

Among nearly 100,000 transfemoral TAVR cases included in the analysis, the researchers found that hospitals in the group with the lowest volume had the highest 30-day mortality rate, at 3.19 percent, compared to hospitals in the group with highest volumes at 2.66 percent. This represents a relative reduction in patient mortality of 19.45 percent between the lowest- and highest-volume centers.

“This was the most comprehensive analysis of the outcomes of more than 100,000 people recently receiving TAVR in the U.S.,” said John Carroll, MD, professor of medicine at the University of Colorado School of Medicine and director of Interventional Cardiology at the UCHealth University of Colorado Hospital.

“The results definitively reaffirm an inverse relationship between the volume of procedures and the risk of death following the procedure,” added Carroll, who is also the vice-chair of the STS-ACC TVT Registry Steering Committee. “The study’s conclusive data should be incorporated by CMS in their final coverage policy to provide Americans with the best results from this transformative non-surgical therapy for the increasingly common condition of aortic stenosis, one of the most serious valve disease problems.”

“These findings suggest a clear relationship between the volume of TAVR procedures and death at 30 days, both at the hospital level and at the individual operator level, and should be factored into the CMS revised National Coverage Determination related to TAVR until a validated quality outcome metric can be established,” said co-author Michael Mack, MD. “This relationship held true even after eliminating the first 12 months, meaning this is not just a ‘learning curve.’”

In addition to Vemulapalli, Carroll and Mack, study authors include Zhuokai Li, David Dai, Andrzej S. Kosinski, Dharam J. Kumbhani, Carlos Ruiz, Vinod H. Thourani, George Hanzel, Thomas G. Gleason, Howard C Herrmann, Ralph G. Brindis and Joseph E. Bavaria.

Funding for the study was provided by the Society of Thoracic Surgeons and American College of Cardiology through the National Cardiovascular Data Registry.

Lack of physician guidance, fear of side effects lead to lower statin adherence

March 27, 2019 – Despite national guidelines indicating that statins can lower risk of heart attack and stroke, many patients who could benefit do not take them.

Despite national guidelines indicating that statins can lower risk of heart attack and stroke, many patients who could benefit do not take them. More than half of eligible patients say they were never offered the cholesterol-lowering drugs; the experience of side effects or fear of side effects were reasons for stopping or refusing statins, according to new research by Duke and DCRI researchers in Journal of the American Heart Association.

Corey BradleyAnn Marie NavarStatins lower the amount of low-density lipoprotein (LDL, or “bad” cholesterol) and have been shown to lower the risk of heart attack and strokes. Because statins are proven effective and have a low risk of side effects, guidelines from the American Heart Association/American College of Cardiology recommend doctors use an atherosclerotic and cardiovascular disease risk calculator to give a detailed assessment of a person’s 10-year risk for heart disease and to help create a personalized plan.

“We need to focus our efforts on improving how doctors identify patients who need to be on a statin, and how they present information to patients to ensure that no one is missing the opportunity to improve their heart health,” said Corey Bradley, MD, lead author of the study (pictured left).

To find out whether eligible patients use statins, and why they sometimes decline or discontinue the drugs, researchers surveyed 5,693 adults (average age 68) who participated in a registry for those receiving medical care at a cardiology, primary care, or endocrinology practice.

Researchers found:

  • Of the 1,511 (26.5 percent) who were not currently taking statins, 59.2 percent reported that they had never been offered them.
  • Patients were more likely to report never being offered a statin if they were female (22 percent higher than others), black (48 percent higher than others), or without insurance (38 percent higher than others).
  • Patients seen in cardiology practices were more likely to be offered a statin than those in primary care.

“It is possible that some people did not remember being offered a statin, so we may have over-estimated the percent who were never offered one. However, we believe that if the patient did not remember the conversation, the discussion likely was not an effective one,” Bradley said.

Of the patients who declined (10.1 percent) or discontinued (30.7 percent) statins, the most common reasons given were a fear of side effects and perceived side effects. Compared with statin users, non-users were less likely to believe statins are safe.

“Although there are risks associated with statins, the public fear of side effects is out of proportion to the actual risks,” said the DCRI’s Ann Marie Navar, MD, PhD, senior author of the study (pictured right). “Misconceptions about statins are everywhere and are fueled by false information on the internet. We need better tools to help combat this type of misinformation.”

Despite their concerns, in the survey 59.7 percent of patients who discontinued a statin would consider retrying it.

“Physicians should not hesitate to re-approach the conversation about starting or re-trying statin therapy in patients who could benefit but are currently not on the therapy,” Bradley said.

In addition to Bradley and Navar, the study’s authors included Tracy Y. Wang, MD, MHS, MSc; Shuang Li, MS; Jennifer G. Robinson, MD, MPH; Veronique L. Roger, MD; Anne C. Goldberg, MD; Salim S. Virani, MD; Michael J. Louis, MD, MPH, MSc; L. Veronica Lee, MD; and Eric D. Peterson, MD, MPH.

Sanofi, Regeneron, and the National Heart, Lung, and Blood Institute funded the study.

Large accountable care organizations committed to overhauled Medicare program

March 21, 2019 -Dropout rates for the program remain relatively low among ACOs, researchers found.

While most Accountable Care Organizations (ACOs) have committed to continue participating in the recently overhauled flagship Medicare Shared Savings Program (MSSP), physician-led ACOS are leaving at a higher rate than in 2017, new research from the Duke-Margolis Center for Health Policy and Leavitt Partners shows.

Highlights of this research were published this month in Health Affairs. The DCRI’s Donald Taylor, PhD, is one of the study’s authors.

The most recent tracking showed that more than 1,000 public and private ACOs provide health care coverage to approximately 33 million Americans. In 2018, more than half of these ACOs participated in the Centers for Medicare & Medicaid Services (CMS) MSSP program.

Late last year however, CMS released its Pathways to Success rule, overhauling MSSP, its largest ACO program. The new 2019 MSSP participant list showed that 74 ACOs dropped out of MSSP at the end of 2018, representing 13 percent of participating ACOs.

Duke and Leavitt researchers examined this data to determine the early impact of the new rule, and found:

  • Hospital-led ACOs, which tend to be large, as well as large ACOs of any type, had lower dropout rates at the end of 2018. This early look at new dropouts from the MSSP program suggest the rule is not driving large ACOs out of the program, but rather that they are willing to accept increasing risk for the cost of the care they provide, also known as downside risk.
  • Overall, the ACO dropout rate increased modestly at the end of 2018, in contrast to the two previous years when it decreased.
  • As part of its overhaul of MSSP, CMS assigned different downside risk requirements for high-revenue and low-revenue ACOs to reflect their different capacity to bear risk, and to encourage more small and physician-led ACOs to participate in the program. So far, revenue status does not appear to be consistently correlated with ACO dropout rates, and is not highly correlated with ACO size or physician ownership.
  • Physician-led ACOs, which tend to be smaller, had higher dropout rates than hospital-led ACOs, despite new policies to support low-revenue ACO.  Small physician-led ACOs had the highest dropout rate at the end of 2018, so how well “low revenue” status supports these particular types of ACOs bears close watching.

“If the ACOs leaving were not likely to succeed, or were not seriously engaged in changing care delivery to improve value, then lower participation is not a bad outcome,” said Mark McClellan, MD, PhD, director of the Duke-Margolis Center. “If organizations that were likely to succeed are exiting, especially smaller physician-led organizations that have had promising results to date, then further policy adjustments may be needed.”

ACC 2019: 12-month results show ticagrelor safe in STEMI patients treated with thrombolysis

March 18, 2019 – When comparing ischemic endpoints, no significant difference was found between patients who received ticagrelor and patients who received clopidogrel.

According to results presented as a late-breaking clinical trial in New Orleans at the 2019 American College of Cardiology’s Scientific Sessions and published in the Journal of the American College of Cardiology, ticagrelor is as safe as clopidogrel when administered to patients with ST-elevation myocardial infarction (STEMI) who were treated with thrombolysis.

The TicagRElor in pAtients with ST-elevation myocardial infarction treated with pharmacological Thrombolysis (TREAT) trial was led by Otavio Berwanger, MD, PhD, chair of the TREAT Trial Steering Committee. Previous literature had shown that ticagrelor is superior to clopidogrel in both patients with STEMI and non-ST-elevation myocardial infarction, but patients who were treated with thrombolysis were excluded from previous trials. Because thrombolysis is associated with greater bleeding risk, there had been concern about using the more potent option, said the DCRI’s Renato D. Lopes, MD, MHS, PhD, who served on the steering committee and as the clinical events classification (CEC) chair for the trial.

TREAT enrolled 3,799 patients younger than 75 in 10 countries and randomized participants to one of two treatment arms: ticagrelor or clopidogrel. The initial results, which were published in JAMA Cardiology last year, showed no significant difference in major bleeding between the treatment groups after 30 days.

The 12-month results presented at the ACC again examined bleeding, as well as ischemic endpoints, such as death, recurring myocardial infarction (MI), stroke, and vascular death. Again, there was no significant difference between the two groups:

  • Composite outcome of death from vascular causes, MI, or stroke: 6.7 percent of patients who received ticagrelor versus 7.3 percent of patients who received clopidogrel;
  • Composite outcome of death from vascular causes, MI, stroke, severe recurrent ischemia, transient ischemic attack, or other arterial thrombotic events: 8.0 percent of ticagrelor patients, as compared to 9.1 percent of patients on clopidogrel.

These results confirm, 12 months after treatment, ticagrelor’s safety as compared to clopidogrel in patients who received thrombolysis.

“Investigators and clinicians can be encouraged by these results, which extend ticagrelor’s safety in patients who received thrombolysis from 30 days to 12 months,” Berwanger said. “We can now be confident in using a more antiplatelet agent without compromising the safety of our patients.”

This trial represents the largest trial of ticagrelor in STEMI patients treated with thrombolysis. This was an investigator-initiated trial funded by AstraZeneca.

ACC 2019: Use of guideline-directed medical therapies for comorbidities may improve outcomes for patients with atrial fibrillation

March 17, 2019 – Although nearly two-thirds of the study population did not receive all the guideline-directed medical therapies for which they were eligible, use of all therapies was linked to better outcomes in specific populations, such as patients with heart failure.

Most atrial fibrillation patients with comorbidities do not receive all the guideline-directed medical therapies (GDMT) they are eligible for, but new evidence from the DCRI suggests use of these therapies is associated with better outcomes in populations with certain comorbidities.

A study led by DCRI Fellow Zak Loring, MD, examined GDMT use for a range of conditions that are often seen in conjunction with atrial fibrillation, including coronary artery disease, diabetes, congestive heart failure, hyperlipidemia, hypertension, peripheral vascular disease, and obstructive sleep apnea. The findings were presented Sunday at the annual Scientific Sessions of American College of Cardiology in New Orleans.

After examining a population of 20,434 patients from the Outcomes for Better Informed Treatment of AF (ORBIT-AF) registry, the study team found that only about 33 percent of patients receive all the therapies for which they are eligible.

GDMT use varied widely by comorbidity type. Hyperlipidemia had a high GDMT ratio, with 75.6 percent of patients on a statin, while only 43.1 percent diabetes patients were treated with all therapies for which they were eligible.

The team was also interested in how patient outcomes were associated with both overall GDMT use and comorbidity-specific GDMT use. While the researchers did see a downward trend in all-cause mortality and major adverse cardiac or neurological events associated with GDMT use, the difference between patients who received all the therapies for which they were eligible and patients who did not was not statistically significant.

However, significant trends did emerge in specific comorbidity types. In patients with congestive heart failure, patients who used all the GDMT they were eligible for saw a 23 percent decrease in all-cause mortality compared to patients who received only some or no GDMT.

“These results are really interesting because it tells us there’s an interaction between the comorbidities and outcomes with atrial fibrillation patients,” Loring said. “For example, previous research has shown that catheter ablation as a treatment for atrial fibrillation can improve outcomes in heart failure patients. It makes us think about the interrelationship among those different conditions because treating one has an effect on the outcomes of the other.”

Not only can treatments for atrial fibrillation have an effect on comorbidities, but the team’s findings show that treatments for comorbidities can also affect the severity of atrial fibrillation. Use of continuous positive airway pressure to treat sleep apnea was associated in a reduction in the progression of atrial fibrillation.

“The associations our team found suggest that if you can get a patient on all the GDMT for which they are eligible, they are likely to experience a better outcome,” Loring said.

Other DCRI contributors to this project include Peter Shrader, MA; Rosalia Blanco, MS; Karen Pieper, MS; Eric Peterson, MD; and Jonathan Piccini, MD, MHS.

ACC 2019: Study confirms diagnostic accuracy of non-invasive technology for heart pain

March 17, 2019 – Patients with negative FFR-CT scans had a low, one-year risk of a heart attack or death.

One-year follow-up results show that a newer, non-invasive technology to evaluate heart pain provided a reliable way to identify which patients had dangerous artery blockages, according to a study co-led by the DCRI.

The findings, reported Sunday at the annual College of Cardiology meeting in New Orleans, suggest that fractional flow reserve CT (FFR-CT) scans are effective in helping doctors determine which patients need more aggressive treatments.

“Our study shows that in clinical practice, when new technology provides a negative result regarding the chance for a physiologically significant stenosis, the patient and physician should be reassured that the chances of major adverse cardiac events are low,” said lead author Manesh Patel, MD, chief of the Division of Cardiology at Duke University School of Medicine.

Patel and colleagues analyzed data from more than 5,000 patients who underwent FFR-CT scans for clinically suspected coronary artery disease. In patients with moderate-to-severe coronary artery disease, a negative FFR-CT was associated with a low, one-year risk of a major cardiac event such as heart attack or death compared to patients with a positive FFR-CT.

Specifically, the researchers found that among those with an FFR-CT reading above 0.80, suggesting blood flow is not dangerously restricted, the cardiovascular death and heart attack risks were significantly lower, and revascularization was significantly lower (5.8 percent vs. 38.4 percent) and was unlikely after 90 days.

“This research, with one-year follow-up, suggests that an FFR-CT test can be trusted when used as it was in this real-world observational registry,” Patel said. “And while we don’t have perfect warranties in medicine, a negative FFR-CT result was seen to have low risk for a major heart event in the following year.”

In addition to Patel, study authors include Bjarne Linde Nørgaard, Timothy A. Fairbairn, Koen Nieman, Takashi Akasaka, Daniel S. Berman, Gilbert L. Raff, Lynne M. Hurwitz Koweek Gianluca Pontone, Tomohiro Kawasaki, Niels Peter Rønnow Sand, Jesper M. Jensen, Tetsuya Amano, Michael Poon, Kristian A. Øvrehus, Jeroen Sonck, Mark G. Rabbat, Sarah Mullen, Bernard De Bruyne, Campbell Rogers, Hitoshi Matsuo, Jeroen J. Bax and Jonathon Leipsic.

The study, called ADVANCE Registry was funded by HeartFlow, Inc., which markets FFR-CT technology. Patel reported receiving research grants from Heartflow.