Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A second trial has shown benefit of stopping aspirin 3 months after stenting and continuing solely with ticagrelor monotherapy.

The Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI (TICO) study shows very similar results as the TWILIGHT trial reported last year. But whereas TWILIGHT enrolled a more general PCI population, TICO included only patients with acute coronary syndrome (ACS).

The South Korean TICO trial was presented today at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

Presenting the study, senior investigator Yangsoo Jang, MD, PhD, professor of cardiology at Yonsei University College of Medicine in Seoul, South Korea, concluded: “Ticagrelor monotherapy after 3-month dual antiplatelet therapy  showed a significantly lower risk of net adverse clinical events than currently recommended ticagrelor-based 12-month dual antiplatelet therapy. The reduced risk was mainly due to decreased major bleeding.”

These findings indicate that ticagrelor monotherapy “could be an optimal strategy that balances both ischemic and bleeding risks for patients with ACS,” he added.

Discussant of the TICO study, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, said: “This is an independent confirmation of TWILIGHT. To have two independent trials reaching the same conclusion — that the regimen of ticagrelor monotherapy after 3 months dual antiplatelet therapy essentially cuts major bleeding in half — is very comforting.”

Michelle O’Donoghue, MD, also from Brigham and Women’s and chair of the ACC session at which the study was presented, added, “A particular strength of this trial was that you had an all-ACS population.”

Enough to Change Guidelines?

Discussing the trial at an ACC press conference, Claire Duvernoy, MD, University of Michigan, Ann Arbor, suggested that the results from TICO and TWILIGHT together are “enough evidence to change the guidelines. I think we are there,” she added.  

“TICO adds to our expanding body of evidence for newer, more potent, P2Y12 inhibitors as monotherapy. This trial stands out as the only exclusive ACS study looking at this and the only trial enrolling a significant population of STEMI patients,” Duvernoy said.

She pointed out one caveat — the need to discontinue ticagrelor because of dyspnea, which she said occurs in around 10%-15% of patients in her practice.

“Also, both TICO and TWILIGHT used the latest second-generation drug-eluting stents, which may have better safety and allows us to get away with less antiplatelet therapy,” Duvernoy noted.  

The TICO trial, conducted at 38 centers in South Korea, enrolled 3056 patients with ACS (average age 61 years) undergoing PCI and stenting with the second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stents (Biotronik).

All patients received ticagrelor plus aspirin for 3 months, then were randomly assigned to continue treatment with ticagrelor and aspirin or ticagrelor alone.

The primary study endpoint was a net clinical benefit composite of death, MI, stroke, stent thrombosis, revascularization, or TIMI major bleeding at 12 months. This occurred in 3.9% of those randomly assigned to ticagrelor alone vs 5.9% of those who continued on dual antiplatelet therapy, giving a hazard ratio of 0.66 (P = .01).

The curves separated early with a marked difference in event rate being seen at 3 months after randomization. At this point, rates of the composite endpoint were 1.4% in the ticagrelor monotherapy group vs 3.5% in the dual antiplatelet therapy group (HR, 0.41; P = .001). 

The benefit was driven by a reduced risk of major bleeding in the ticagrelor monotherapy group. At 1 year, the rate of TIMI major bleeding was 1.7% in the ticagrelor alone group vs 3% in the dual antiplatelet group (HR, 0.56; P = .02).

There was no difference in ischemic events between the two groups. The rate of death/MI/ stroke/stent thrombosis/revascularization at 1 year was 2.3% in the ticagrelor alone group vs 3.4% for those on dual antiplatelet therapy (P = .09)

Yang noted that limitations of the study included an open-label design, no placebo used, and exclusion of patients with an elevated risk for bleeding (defined as aged 80 years or older, having had a stroke within the past year, or having had brain surgery or a traumatic brain injury within the past 6 months).

As part of his discussion, Bhatt asked how these results can be reconciled with trials such as CHARISMA and PEGASUS, which showed higher rates of MI with abbreviated durations of dual antiplatelet therapy

Jang replied: “Maybe for STEMI patients, if the duration of [dual antiplatelet therapy] is prolonged ischemic events may be reduced, especially if clopidogrel is used. But my opinion is when ticagrelor or prasugrel are used — they are very strong P2Y12 inhibitors — you can reduce duration of dual therapy by dropping aspirin. I think aspirin just makes the bleeding.”

Also commenting on the TICO study, Jacqueline Tamis-Holland, MD, Mount Sinai Saint Luke’s Hospital, New York City, pointed out that there was an interaction between the number of diseased vessels, and asked for more information on the complexity of disease in the patients in this trial.

“We had very few CTOs (total chronic occlusions) and left main disease,” Jang replied. “Dual antiplatelet duration is related to total atherosclerotic burden I think, so if you have very high atherosclerotic burden and multivessel disease, dual therapy may be more important. But our data show that the ticagrelor monotherapy group is not inferior to conventional dual therapy, so this suggests that even in multivessel disease, 3 months dual antiplatelet therapy is enough if you use a potent agent like ticagrelor as monotherapy after.”

This study was funded by Biotronik, manufacturer of the stents used. Jang has disclosed no relevant financial relationships. Bhatt reports consultant fees/honoraria from Elsevier Practice Update Cardiology, Medtelligence/WebMD, MJH Life Sciences, and WebMD; and research grants from Abbott, Afimmune, Amarin, Amgen, Astra Zeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, Eisai, Eli Lilly, Ethicon, FlowCo, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Medtronic, Novo Nordisk, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, sanofi-aventis, Synaptic, Takeda, The Medicines Company.

This article first appeared on Medscape.com.

A second trial has shown benefit of stopping aspirin 3 months after stenting and continuing solely with ticagrelor monotherapy.

The Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI (TICO) study shows very similar results as the TWILIGHT trial reported last year. But whereas TWILIGHT enrolled a more general PCI population, TICO included only patients with acute coronary syndrome (ACS).

The South Korean TICO trial was presented today at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

Presenting the study, senior investigator Yangsoo Jang, MD, PhD, professor of cardiology at Yonsei University College of Medicine in Seoul, South Korea, concluded: “Ticagrelor monotherapy after 3-month dual antiplatelet therapy  showed a significantly lower risk of net adverse clinical events than currently recommended ticagrelor-based 12-month dual antiplatelet therapy. The reduced risk was mainly due to decreased major bleeding.”

These findings indicate that ticagrelor monotherapy “could be an optimal strategy that balances both ischemic and bleeding risks for patients with ACS,” he added.

Discussant of the TICO study, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, said: “This is an independent confirmation of TWILIGHT. To have two independent trials reaching the same conclusion — that the regimen of ticagrelor monotherapy after 3 months dual antiplatelet therapy essentially cuts major bleeding in half — is very comforting.”

Michelle O’Donoghue, MD, also from Brigham and Women’s and chair of the ACC session at which the study was presented, added, “A particular strength of this trial was that you had an all-ACS population.”

Enough to Change Guidelines?

Discussing the trial at an ACC press conference, Claire Duvernoy, MD, University of Michigan, Ann Arbor, suggested that the results from TICO and TWILIGHT together are “enough evidence to change the guidelines. I think we are there,” she added.  

“TICO adds to our expanding body of evidence for newer, more potent, P2Y12 inhibitors as monotherapy. This trial stands out as the only exclusive ACS study looking at this and the only trial enrolling a significant population of STEMI patients,” Duvernoy said.

She pointed out one caveat — the need to discontinue ticagrelor because of dyspnea, which she said occurs in around 10%-15% of patients in her practice.

“Also, both TICO and TWILIGHT used the latest second-generation drug-eluting stents, which may have better safety and allows us to get away with less antiplatelet therapy,” Duvernoy noted.  

The TICO trial, conducted at 38 centers in South Korea, enrolled 3056 patients with ACS (average age 61 years) undergoing PCI and stenting with the second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stents (Biotronik).

All patients received ticagrelor plus aspirin for 3 months, then were randomly assigned to continue treatment with ticagrelor and aspirin or ticagrelor alone.

The primary study endpoint was a net clinical benefit composite of death, MI, stroke, stent thrombosis, revascularization, or TIMI major bleeding at 12 months. This occurred in 3.9% of those randomly assigned to ticagrelor alone vs 5.9% of those who continued on dual antiplatelet therapy, giving a hazard ratio of 0.66 (P = .01).

The curves separated early with a marked difference in event rate being seen at 3 months after randomization. At this point, rates of the composite endpoint were 1.4% in the ticagrelor monotherapy group vs 3.5% in the dual antiplatelet therapy group (HR, 0.41; P = .001). 

The benefit was driven by a reduced risk of major bleeding in the ticagrelor monotherapy group. At 1 year, the rate of TIMI major bleeding was 1.7% in the ticagrelor alone group vs 3% in the dual antiplatelet group (HR, 0.56; P = .02).

There was no difference in ischemic events between the two groups. The rate of death/MI/ stroke/stent thrombosis/revascularization at 1 year was 2.3% in the ticagrelor alone group vs 3.4% for those on dual antiplatelet therapy (P = .09)

Yang noted that limitations of the study included an open-label design, no placebo used, and exclusion of patients with an elevated risk for bleeding (defined as aged 80 years or older, having had a stroke within the past year, or having had brain surgery or a traumatic brain injury within the past 6 months).

As part of his discussion, Bhatt asked how these results can be reconciled with trials such as CHARISMA and PEGASUS, which showed higher rates of MI with abbreviated durations of dual antiplatelet therapy

Jang replied: “Maybe for STEMI patients, if the duration of [dual antiplatelet therapy] is prolonged ischemic events may be reduced, especially if clopidogrel is used. But my opinion is when ticagrelor or prasugrel are used — they are very strong P2Y12 inhibitors — you can reduce duration of dual therapy by dropping aspirin. I think aspirin just makes the bleeding.”

Also commenting on the TICO study, Jacqueline Tamis-Holland, MD, Mount Sinai Saint Luke’s Hospital, New York City, pointed out that there was an interaction between the number of diseased vessels, and asked for more information on the complexity of disease in the patients in this trial.

“We had very few CTOs (total chronic occlusions) and left main disease,” Jang replied. “Dual antiplatelet duration is related to total atherosclerotic burden I think, so if you have very high atherosclerotic burden and multivessel disease, dual therapy may be more important. But our data show that the ticagrelor monotherapy group is not inferior to conventional dual therapy, so this suggests that even in multivessel disease, 3 months dual antiplatelet therapy is enough if you use a potent agent like ticagrelor as monotherapy after.”

This study was funded by Biotronik, manufacturer of the stents used. Jang has disclosed no relevant financial relationships. Bhatt reports consultant fees/honoraria from Elsevier Practice Update Cardiology, Medtelligence/WebMD, MJH Life Sciences, and WebMD; and research grants from Abbott, Afimmune, Amarin, Amgen, Astra Zeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, Eisai, Eli Lilly, Ethicon, FlowCo, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Medtronic, Novo Nordisk, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, sanofi-aventis, Synaptic, Takeda, The Medicines Company.

This article first appeared on Medscape.com.

A second trial has shown benefit of stopping aspirin 3 months after stenting and continuing solely with ticagrelor monotherapy.

The Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI (TICO) study shows very similar results as the TWILIGHT trial reported last year. But whereas TWILIGHT enrolled a more general PCI population, TICO included only patients with acute coronary syndrome (ACS).

The South Korean TICO trial was presented today at the “virtual” American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology.

Presenting the study, senior investigator Yangsoo Jang, MD, PhD, professor of cardiology at Yonsei University College of Medicine in Seoul, South Korea, concluded: “Ticagrelor monotherapy after 3-month dual antiplatelet therapy  showed a significantly lower risk of net adverse clinical events than currently recommended ticagrelor-based 12-month dual antiplatelet therapy. The reduced risk was mainly due to decreased major bleeding.”

These findings indicate that ticagrelor monotherapy “could be an optimal strategy that balances both ischemic and bleeding risks for patients with ACS,” he added.

Discussant of the TICO study, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, said: “This is an independent confirmation of TWILIGHT. To have two independent trials reaching the same conclusion — that the regimen of ticagrelor monotherapy after 3 months dual antiplatelet therapy essentially cuts major bleeding in half — is very comforting.”

Michelle O’Donoghue, MD, also from Brigham and Women’s and chair of the ACC session at which the study was presented, added, “A particular strength of this trial was that you had an all-ACS population.”

Enough to Change Guidelines?

Discussing the trial at an ACC press conference, Claire Duvernoy, MD, University of Michigan, Ann Arbor, suggested that the results from TICO and TWILIGHT together are “enough evidence to change the guidelines. I think we are there,” she added.  

“TICO adds to our expanding body of evidence for newer, more potent, P2Y12 inhibitors as monotherapy. This trial stands out as the only exclusive ACS study looking at this and the only trial enrolling a significant population of STEMI patients,” Duvernoy said.

She pointed out one caveat — the need to discontinue ticagrelor because of dyspnea, which she said occurs in around 10%-15% of patients in her practice.

“Also, both TICO and TWILIGHT used the latest second-generation drug-eluting stents, which may have better safety and allows us to get away with less antiplatelet therapy,” Duvernoy noted.  

The TICO trial, conducted at 38 centers in South Korea, enrolled 3056 patients with ACS (average age 61 years) undergoing PCI and stenting with the second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stents (Biotronik).

All patients received ticagrelor plus aspirin for 3 months, then were randomly assigned to continue treatment with ticagrelor and aspirin or ticagrelor alone.

The primary study endpoint was a net clinical benefit composite of death, MI, stroke, stent thrombosis, revascularization, or TIMI major bleeding at 12 months. This occurred in 3.9% of those randomly assigned to ticagrelor alone vs 5.9% of those who continued on dual antiplatelet therapy, giving a hazard ratio of 0.66 (P = .01).

The curves separated early with a marked difference in event rate being seen at 3 months after randomization. At this point, rates of the composite endpoint were 1.4% in the ticagrelor monotherapy group vs 3.5% in the dual antiplatelet therapy group (HR, 0.41; P = .001). 

The benefit was driven by a reduced risk of major bleeding in the ticagrelor monotherapy group. At 1 year, the rate of TIMI major bleeding was 1.7% in the ticagrelor alone group vs 3% in the dual antiplatelet group (HR, 0.56; P = .02).

There was no difference in ischemic events between the two groups. The rate of death/MI/ stroke/stent thrombosis/revascularization at 1 year was 2.3% in the ticagrelor alone group vs 3.4% for those on dual antiplatelet therapy (P = .09)

Yang noted that limitations of the study included an open-label design, no placebo used, and exclusion of patients with an elevated risk for bleeding (defined as aged 80 years or older, having had a stroke within the past year, or having had brain surgery or a traumatic brain injury within the past 6 months).

As part of his discussion, Bhatt asked how these results can be reconciled with trials such as CHARISMA and PEGASUS, which showed higher rates of MI with abbreviated durations of dual antiplatelet therapy

Jang replied: “Maybe for STEMI patients, if the duration of [dual antiplatelet therapy] is prolonged ischemic events may be reduced, especially if clopidogrel is used. But my opinion is when ticagrelor or prasugrel are used — they are very strong P2Y12 inhibitors — you can reduce duration of dual therapy by dropping aspirin. I think aspirin just makes the bleeding.”

Also commenting on the TICO study, Jacqueline Tamis-Holland, MD, Mount Sinai Saint Luke’s Hospital, New York City, pointed out that there was an interaction between the number of diseased vessels, and asked for more information on the complexity of disease in the patients in this trial.

“We had very few CTOs (total chronic occlusions) and left main disease,” Jang replied. “Dual antiplatelet duration is related to total atherosclerotic burden I think, so if you have very high atherosclerotic burden and multivessel disease, dual therapy may be more important. But our data show that the ticagrelor monotherapy group is not inferior to conventional dual therapy, so this suggests that even in multivessel disease, 3 months dual antiplatelet therapy is enough if you use a potent agent like ticagrelor as monotherapy after.”

This study was funded by Biotronik, manufacturer of the stents used. Jang has disclosed no relevant financial relationships. Bhatt reports consultant fees/honoraria from Elsevier Practice Update Cardiology, Medtelligence/WebMD, MJH Life Sciences, and WebMD; and research grants from Abbott, Afimmune, Amarin, Amgen, Astra Zeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, Eisai, Eli Lilly, Ethicon, FlowCo, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Medtronic, Novo Nordisk, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, sanofi-aventis, Synaptic, Takeda, The Medicines Company.

This article first appeared on Medscape.com.

Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.

Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).

The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events). 

There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).

However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.

Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.

The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.

Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.

“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.

The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.

“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”

The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.

Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.

The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).

During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.

“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.

Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.

Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.

“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”

As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”

Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine  in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.

Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.

Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.

She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”

Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.

Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.

The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.

This article first appeared on Medscape.com.

Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.

Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).

The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events). 

There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).

However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.

Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.

The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.

Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.

“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.

The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.

“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”

The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.

Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.

The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).

During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.

“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.

Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.

Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.

“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”

As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”

Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine  in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.

Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.

Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.

She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”

Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.

Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.

The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.

This article first appeared on Medscape.com.

Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.

Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).

The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events). 

There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).

However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.

Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.

The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.

Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.

“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.

The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.

“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”

The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.

Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.

The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).

During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.

“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.

Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.

Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.

“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”

As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”

Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine  in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.

Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.

Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.

She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”

Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.

Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.

The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.

This article first appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

Residents of low-income communities in the District of Columbia have restricted access to a pharmacy registered and activated with iPLEDGE, results from a survey demonstrated.

Prescription of isotretinoin is regulated by the iPLEDGE program, which strives to ensure that no female patient starts isotretinoin therapy if pregnant and that no female patient on isotretinoin therapy becomes pregnant. “Over the years, many studies have criticized the program by demonstrating that iPLEDGE has promoted health care disparities,” Nidhi Shah said during a virtual meeting held by the George Washington University department of dermatology. “For example, racial minorities and women are more likely to be underprescribed isotretinoin, as well as face more delays in treatment.”

In an effort to evaluate the geographic distribution of iPLEDGE pharmacies in Washington DC, and its correlation with sociodemographic factors, Ms. Shah, a third-year medical student at the George Washington University, Washington, and colleagues obtained a list of active pharmacies in Washington from the local government. They also surveyed each outpatient pharmacy in the District of Columbia to verify their iPLEDGE registration status, for a total of 146 pharmacies.

Ms. Shah reported that 82% of all outpatient pharmacies were enrolled in iPLEDGE. However, enrollment significantly varied by the type of pharmacy. For example, 100% of chain pharmacies were enrolled, compared with 46% of independent pharmacies and 60% of hospital-based pharmacies.

When the researchers evaluated the number and type of iPLEDGE pharmacy by each of the eight wards in Washington, they observed a high density of pharmacies in wards 1 and 2, communities with a generally low proportion of residents who live in poverty, and low density of pharmacies in wards 7 and 8, communities with a higher proportion of residents who live in poverty. In addition, there were more independent than chain pharmacies in wards 7 and 8, and residents in those wards had a greater distance to travel to reach an iPLEDGE pharmacy, compared with residents who live in the other wards.

When Ms. Shah and colleagues examined the correlation between pharmacies per 10,000 residents and specific sociodemographic factors, they observed a strong, positive correlation between iPLEDGE pharmacy density and median household income (P = .0003). On the other hand, there was a strong negative correlation between iPLEDGE pharmacy density and the percentage of individuals with public insurance (P less than .0001), as well as the percentage of nonwhite individuals (P = .0009).

“Our study highlights the lack of isotretinoin-dispensing pharmacies in low-income communities,” Ms. Shah concluded. “Not only are there fewer such pharmacies available in low income communities, but the residents must also travel further to reach them. The spatial heterogeneity of iPLEDGE pharmacies may be an important patient barrier to timely access of isotretinoin, especially for female patients who have a strict 7-day window to collect their medication. We hope that future public health reform works to close this gap.”

The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled because of the COVID-19 pandemic. Ms. Shah reported having no disclosures.

[email protected]

Residents of low-income communities in the District of Columbia have restricted access to a pharmacy registered and activated with iPLEDGE, results from a survey demonstrated.

Prescription of isotretinoin is regulated by the iPLEDGE program, which strives to ensure that no female patient starts isotretinoin therapy if pregnant and that no female patient on isotretinoin therapy becomes pregnant. “Over the years, many studies have criticized the program by demonstrating that iPLEDGE has promoted health care disparities,” Nidhi Shah said during a virtual meeting held by the George Washington University department of dermatology. “For example, racial minorities and women are more likely to be underprescribed isotretinoin, as well as face more delays in treatment.”

In an effort to evaluate the geographic distribution of iPLEDGE pharmacies in Washington DC, and its correlation with sociodemographic factors, Ms. Shah, a third-year medical student at the George Washington University, Washington, and colleagues obtained a list of active pharmacies in Washington from the local government. They also surveyed each outpatient pharmacy in the District of Columbia to verify their iPLEDGE registration status, for a total of 146 pharmacies.

Ms. Shah reported that 82% of all outpatient pharmacies were enrolled in iPLEDGE. However, enrollment significantly varied by the type of pharmacy. For example, 100% of chain pharmacies were enrolled, compared with 46% of independent pharmacies and 60% of hospital-based pharmacies.

When the researchers evaluated the number and type of iPLEDGE pharmacy by each of the eight wards in Washington, they observed a high density of pharmacies in wards 1 and 2, communities with a generally low proportion of residents who live in poverty, and low density of pharmacies in wards 7 and 8, communities with a higher proportion of residents who live in poverty. In addition, there were more independent than chain pharmacies in wards 7 and 8, and residents in those wards had a greater distance to travel to reach an iPLEDGE pharmacy, compared with residents who live in the other wards.

When Ms. Shah and colleagues examined the correlation between pharmacies per 10,000 residents and specific sociodemographic factors, they observed a strong, positive correlation between iPLEDGE pharmacy density and median household income (P = .0003). On the other hand, there was a strong negative correlation between iPLEDGE pharmacy density and the percentage of individuals with public insurance (P less than .0001), as well as the percentage of nonwhite individuals (P = .0009).

“Our study highlights the lack of isotretinoin-dispensing pharmacies in low-income communities,” Ms. Shah concluded. “Not only are there fewer such pharmacies available in low income communities, but the residents must also travel further to reach them. The spatial heterogeneity of iPLEDGE pharmacies may be an important patient barrier to timely access of isotretinoin, especially for female patients who have a strict 7-day window to collect their medication. We hope that future public health reform works to close this gap.”

The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled because of the COVID-19 pandemic. Ms. Shah reported having no disclosures.

[email protected]

Residents of low-income communities in the District of Columbia have restricted access to a pharmacy registered and activated with iPLEDGE, results from a survey demonstrated.

Prescription of isotretinoin is regulated by the iPLEDGE program, which strives to ensure that no female patient starts isotretinoin therapy if pregnant and that no female patient on isotretinoin therapy becomes pregnant. “Over the years, many studies have criticized the program by demonstrating that iPLEDGE has promoted health care disparities,” Nidhi Shah said during a virtual meeting held by the George Washington University department of dermatology. “For example, racial minorities and women are more likely to be underprescribed isotretinoin, as well as face more delays in treatment.”

In an effort to evaluate the geographic distribution of iPLEDGE pharmacies in Washington DC, and its correlation with sociodemographic factors, Ms. Shah, a third-year medical student at the George Washington University, Washington, and colleagues obtained a list of active pharmacies in Washington from the local government. They also surveyed each outpatient pharmacy in the District of Columbia to verify their iPLEDGE registration status, for a total of 146 pharmacies.

Ms. Shah reported that 82% of all outpatient pharmacies were enrolled in iPLEDGE. However, enrollment significantly varied by the type of pharmacy. For example, 100% of chain pharmacies were enrolled, compared with 46% of independent pharmacies and 60% of hospital-based pharmacies.

When the researchers evaluated the number and type of iPLEDGE pharmacy by each of the eight wards in Washington, they observed a high density of pharmacies in wards 1 and 2, communities with a generally low proportion of residents who live in poverty, and low density of pharmacies in wards 7 and 8, communities with a higher proportion of residents who live in poverty. In addition, there were more independent than chain pharmacies in wards 7 and 8, and residents in those wards had a greater distance to travel to reach an iPLEDGE pharmacy, compared with residents who live in the other wards.

When Ms. Shah and colleagues examined the correlation between pharmacies per 10,000 residents and specific sociodemographic factors, they observed a strong, positive correlation between iPLEDGE pharmacy density and median household income (P = .0003). On the other hand, there was a strong negative correlation between iPLEDGE pharmacy density and the percentage of individuals with public insurance (P less than .0001), as well as the percentage of nonwhite individuals (P = .0009).

“Our study highlights the lack of isotretinoin-dispensing pharmacies in low-income communities,” Ms. Shah concluded. “Not only are there fewer such pharmacies available in low income communities, but the residents must also travel further to reach them. The spatial heterogeneity of iPLEDGE pharmacies may be an important patient barrier to timely access of isotretinoin, especially for female patients who have a strict 7-day window to collect their medication. We hope that future public health reform works to close this gap.”

The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled because of the COVID-19 pandemic. Ms. Shah reported having no disclosures.

[email protected]