Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.

Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.  

The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.

In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.

Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.

More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
 

Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.

Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.  

The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.

In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.

Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.

More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
 

Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.

Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.  

The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.

In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.

Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.

More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
 

Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.

Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.

After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.

The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.

The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.

Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.

Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.

After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.

The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.

The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.

Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.

Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.

After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.

The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.

The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.

Welcome to the new Practice Management Toolbox.

The AGA Practice Management and Economics Committee (PMEC) is pleased to host an updated Practice Management Toolbox column featuring contemporary GI practice management issues and news. As chair of the PMEC, I am excited to bring you this content on behalf of my colleagues on the committee. Each month we will highlight a timely topic relevant to gastroenterologists in practice. The AGA and PMEC strive to be at the forefront of changes to the field of gastroenterology, providing you with tools and resources to succeed. If there is an article topic you would like to suggest, please reach out to Jacob Manthey, Practice and Quality Manager at [email protected] .
 

Anton Decker, MD, AGAF
Chair, Practice Management and Economics Committee

Last year, Medicare began laying groundwork for major changes to coding and payment for common evaluation and management (E/M) services and two high-volume GI endoscopy procedures beginning January 1, 2021 with expected adoption by commercial payers. Learn about these potential changes now to help prepare your practice for the financial impact.

2021 E/M Changes: New guidelines, new payments

The Centers for Medicare and Medicaid Services (CMS), also commonly referred to as Medicare, announced in its 2019 Physician Fee Schedule proposed rule that it wanted to reduce administrative burden and improve payment accuracy for office/outpatient new and established patient codes (99201-99205 and 99211-99215) by paying level 2–5 codes at a single payment rate and simplifying documentation to support only a level 2 E/M visit, except when using time for documentation (Table).

In the original proposal, those who reported mostly level 2 and 3 E/M visits would have experienced modest payment increases while those who reported mostly level 4 and 5 E/M visits would have endured payment cuts between 20%-40%. Ultimately, the physician community, including AGA and its sister societies, opposed the proposed payment consolidation and pressured CMS not to finalize most of its proposed changes and preserve the current payment rates. The 2019 MPFS final rule made no changes to the relative values for office/outpatient new and established patient codes 99201-99205 and 99211-99215, but did outline a new plan “for paying a single rate for E/M office/outpatient visit levels 2 through 4 for established and new patients while maintaining the payment rate for E/M office/outpatient visit level 5 in order to better account for the care and needs of complex patients.” CMS agreed to continue to accept input on improvements to the proposal before CMS’ planned implementation in 2021.

A proposal to simplify E/M guidelines within Current Procedural Terminology (CPT) and preserve the individual levels of the new and established patient office/outpatient E/M codes, except 99201 which was proposed for deletion, was presented to the American Medical Association (AMA) CPT Editorial Panel, the body responsible for creating and maintaining CPT codes, and approved at its February 2019 meeting. The approved changes will not be publicly available until the CPT 2021 book is released in August 2020. In the meantime, the AMA Specialty Society Relative-value scale Update Committee (RUC) will make recommendations to CMS on potential new relative values for the E/M codes.

It is unclear whether CMS will accept the AMA CPT Editorial Panel’s changes and potential new values or move forward with the plan for three levels of E/M for office/outpatient new and established patient codes. However, any changes to the current guidelines will undoubtedly involve a learning curve for both physicians and coders and it is unclear whether approximately four months from the time the 2021 CPT book is released and the time the new rates will be implemented on January 1, 2021 is enough to master the changes and update internal systems. In addition, any changes to reimbursement will impact each practice’s bottom line.
 

2021 potential payment changes for CPT codes 43239 and 45385

In the same proposed rule, CMS announced that an unnamed party had nominated seven CPT codes, including esophagogastroduodenoscopy (EGD) with biopsy (CPT code 43239) and colonoscopy with snare polypectomy (CPT code 45385), as potentially overvalued and recommended reducing their reimbursement based on data from the 2017 Urban Institute report for CMS. The AGA and its sister societies pointed out to CMS major flaws in the Urban Institute study’s methods that should have prevented its use as evidence that the codes were misvalued and we provided data from the GI societies’ robust sample of physicians to support the current values.

In the 2019 MPFS final rule, CMS revealed Anthem, a major U.S. health insurance company, as the nominating party sparking concern that this unprecedented development may result in other payers using the flawed Urban Institute study to influence CMS to revalue other services.

Codes CMS identified as potentially misvalued in the 2019 MPFS final rule were referred to the RUC for resurvey of physician work and practice expense for consideration at the April 2019 RUC meeting. The AGA and its sister societies conducted a survey of a random sample of our memberships during February and March and presented our recommendations based on the data we collected. CMS’ proposed values will be published in July 2020 in the 2021 MPFS proposed rule and finalized in the final rule that November.
 

Next steps

CMS will announce changes to E/M coding and documentation guidelines and any new payment changes to CPT codes 43239 and 45385 in the 2021 MPFS proposed rule in July 2020. Be prepared to use this information to model the financial impact to your practice so you can determine what, if any changes, should be made. Contact your coding and billing staff, consultants and software providers to find out how they plan to implement any changes. Additional E/M training may be required for your providers and staff. The GI Societies remain vigilant and continue to advocate on the behalf of its members to advise and shape these policy evaluations and changes.
 

Dr. Kuo is assistant professor, director of the Center for Neurointestinal Health, GI Unit, Massachusetts General Hospital, Harvard Medical School, Boston; AGA CPT Advisor; he has no conflicts of interest. Dr. Mehta is assistant professor, Perelman School of Medicine; associate chief innovation officer, Penn Medicine, Philadelphia; AGA RUC Advisor; he has no conflicts of interest.

Welcome to the new Practice Management Toolbox.

The AGA Practice Management and Economics Committee (PMEC) is pleased to host an updated Practice Management Toolbox column featuring contemporary GI practice management issues and news. As chair of the PMEC, I am excited to bring you this content on behalf of my colleagues on the committee. Each month we will highlight a timely topic relevant to gastroenterologists in practice. The AGA and PMEC strive to be at the forefront of changes to the field of gastroenterology, providing you with tools and resources to succeed. If there is an article topic you would like to suggest, please reach out to Jacob Manthey, Practice and Quality Manager at [email protected] .
 

Anton Decker, MD, AGAF
Chair, Practice Management and Economics Committee

Last year, Medicare began laying groundwork for major changes to coding and payment for common evaluation and management (E/M) services and two high-volume GI endoscopy procedures beginning January 1, 2021 with expected adoption by commercial payers. Learn about these potential changes now to help prepare your practice for the financial impact.

2021 E/M Changes: New guidelines, new payments

The Centers for Medicare and Medicaid Services (CMS), also commonly referred to as Medicare, announced in its 2019 Physician Fee Schedule proposed rule that it wanted to reduce administrative burden and improve payment accuracy for office/outpatient new and established patient codes (99201-99205 and 99211-99215) by paying level 2–5 codes at a single payment rate and simplifying documentation to support only a level 2 E/M visit, except when using time for documentation (Table).

In the original proposal, those who reported mostly level 2 and 3 E/M visits would have experienced modest payment increases while those who reported mostly level 4 and 5 E/M visits would have endured payment cuts between 20%-40%. Ultimately, the physician community, including AGA and its sister societies, opposed the proposed payment consolidation and pressured CMS not to finalize most of its proposed changes and preserve the current payment rates. The 2019 MPFS final rule made no changes to the relative values for office/outpatient new and established patient codes 99201-99205 and 99211-99215, but did outline a new plan “for paying a single rate for E/M office/outpatient visit levels 2 through 4 for established and new patients while maintaining the payment rate for E/M office/outpatient visit level 5 in order to better account for the care and needs of complex patients.” CMS agreed to continue to accept input on improvements to the proposal before CMS’ planned implementation in 2021.

A proposal to simplify E/M guidelines within Current Procedural Terminology (CPT) and preserve the individual levels of the new and established patient office/outpatient E/M codes, except 99201 which was proposed for deletion, was presented to the American Medical Association (AMA) CPT Editorial Panel, the body responsible for creating and maintaining CPT codes, and approved at its February 2019 meeting. The approved changes will not be publicly available until the CPT 2021 book is released in August 2020. In the meantime, the AMA Specialty Society Relative-value scale Update Committee (RUC) will make recommendations to CMS on potential new relative values for the E/M codes.

It is unclear whether CMS will accept the AMA CPT Editorial Panel’s changes and potential new values or move forward with the plan for three levels of E/M for office/outpatient new and established patient codes. However, any changes to the current guidelines will undoubtedly involve a learning curve for both physicians and coders and it is unclear whether approximately four months from the time the 2021 CPT book is released and the time the new rates will be implemented on January 1, 2021 is enough to master the changes and update internal systems. In addition, any changes to reimbursement will impact each practice’s bottom line.
 

2021 potential payment changes for CPT codes 43239 and 45385

In the same proposed rule, CMS announced that an unnamed party had nominated seven CPT codes, including esophagogastroduodenoscopy (EGD) with biopsy (CPT code 43239) and colonoscopy with snare polypectomy (CPT code 45385), as potentially overvalued and recommended reducing their reimbursement based on data from the 2017 Urban Institute report for CMS. The AGA and its sister societies pointed out to CMS major flaws in the Urban Institute study’s methods that should have prevented its use as evidence that the codes were misvalued and we provided data from the GI societies’ robust sample of physicians to support the current values.

In the 2019 MPFS final rule, CMS revealed Anthem, a major U.S. health insurance company, as the nominating party sparking concern that this unprecedented development may result in other payers using the flawed Urban Institute study to influence CMS to revalue other services.

Codes CMS identified as potentially misvalued in the 2019 MPFS final rule were referred to the RUC for resurvey of physician work and practice expense for consideration at the April 2019 RUC meeting. The AGA and its sister societies conducted a survey of a random sample of our memberships during February and March and presented our recommendations based on the data we collected. CMS’ proposed values will be published in July 2020 in the 2021 MPFS proposed rule and finalized in the final rule that November.
 

Next steps

CMS will announce changes to E/M coding and documentation guidelines and any new payment changes to CPT codes 43239 and 45385 in the 2021 MPFS proposed rule in July 2020. Be prepared to use this information to model the financial impact to your practice so you can determine what, if any changes, should be made. Contact your coding and billing staff, consultants and software providers to find out how they plan to implement any changes. Additional E/M training may be required for your providers and staff. The GI Societies remain vigilant and continue to advocate on the behalf of its members to advise and shape these policy evaluations and changes.
 

Dr. Kuo is assistant professor, director of the Center for Neurointestinal Health, GI Unit, Massachusetts General Hospital, Harvard Medical School, Boston; AGA CPT Advisor; he has no conflicts of interest. Dr. Mehta is assistant professor, Perelman School of Medicine; associate chief innovation officer, Penn Medicine, Philadelphia; AGA RUC Advisor; he has no conflicts of interest.

Welcome to the new Practice Management Toolbox.

The AGA Practice Management and Economics Committee (PMEC) is pleased to host an updated Practice Management Toolbox column featuring contemporary GI practice management issues and news. As chair of the PMEC, I am excited to bring you this content on behalf of my colleagues on the committee. Each month we will highlight a timely topic relevant to gastroenterologists in practice. The AGA and PMEC strive to be at the forefront of changes to the field of gastroenterology, providing you with tools and resources to succeed. If there is an article topic you would like to suggest, please reach out to Jacob Manthey, Practice and Quality Manager at [email protected] .
 

Anton Decker, MD, AGAF
Chair, Practice Management and Economics Committee

Last year, Medicare began laying groundwork for major changes to coding and payment for common evaluation and management (E/M) services and two high-volume GI endoscopy procedures beginning January 1, 2021 with expected adoption by commercial payers. Learn about these potential changes now to help prepare your practice for the financial impact.

2021 E/M Changes: New guidelines, new payments

The Centers for Medicare and Medicaid Services (CMS), also commonly referred to as Medicare, announced in its 2019 Physician Fee Schedule proposed rule that it wanted to reduce administrative burden and improve payment accuracy for office/outpatient new and established patient codes (99201-99205 and 99211-99215) by paying level 2–5 codes at a single payment rate and simplifying documentation to support only a level 2 E/M visit, except when using time for documentation (Table).

In the original proposal, those who reported mostly level 2 and 3 E/M visits would have experienced modest payment increases while those who reported mostly level 4 and 5 E/M visits would have endured payment cuts between 20%-40%. Ultimately, the physician community, including AGA and its sister societies, opposed the proposed payment consolidation and pressured CMS not to finalize most of its proposed changes and preserve the current payment rates. The 2019 MPFS final rule made no changes to the relative values for office/outpatient new and established patient codes 99201-99205 and 99211-99215, but did outline a new plan “for paying a single rate for E/M office/outpatient visit levels 2 through 4 for established and new patients while maintaining the payment rate for E/M office/outpatient visit level 5 in order to better account for the care and needs of complex patients.” CMS agreed to continue to accept input on improvements to the proposal before CMS’ planned implementation in 2021.

A proposal to simplify E/M guidelines within Current Procedural Terminology (CPT) and preserve the individual levels of the new and established patient office/outpatient E/M codes, except 99201 which was proposed for deletion, was presented to the American Medical Association (AMA) CPT Editorial Panel, the body responsible for creating and maintaining CPT codes, and approved at its February 2019 meeting. The approved changes will not be publicly available until the CPT 2021 book is released in August 2020. In the meantime, the AMA Specialty Society Relative-value scale Update Committee (RUC) will make recommendations to CMS on potential new relative values for the E/M codes.

It is unclear whether CMS will accept the AMA CPT Editorial Panel’s changes and potential new values or move forward with the plan for three levels of E/M for office/outpatient new and established patient codes. However, any changes to the current guidelines will undoubtedly involve a learning curve for both physicians and coders and it is unclear whether approximately four months from the time the 2021 CPT book is released and the time the new rates will be implemented on January 1, 2021 is enough to master the changes and update internal systems. In addition, any changes to reimbursement will impact each practice’s bottom line.
 

2021 potential payment changes for CPT codes 43239 and 45385

In the same proposed rule, CMS announced that an unnamed party had nominated seven CPT codes, including esophagogastroduodenoscopy (EGD) with biopsy (CPT code 43239) and colonoscopy with snare polypectomy (CPT code 45385), as potentially overvalued and recommended reducing their reimbursement based on data from the 2017 Urban Institute report for CMS. The AGA and its sister societies pointed out to CMS major flaws in the Urban Institute study’s methods that should have prevented its use as evidence that the codes were misvalued and we provided data from the GI societies’ robust sample of physicians to support the current values.

In the 2019 MPFS final rule, CMS revealed Anthem, a major U.S. health insurance company, as the nominating party sparking concern that this unprecedented development may result in other payers using the flawed Urban Institute study to influence CMS to revalue other services.

Codes CMS identified as potentially misvalued in the 2019 MPFS final rule were referred to the RUC for resurvey of physician work and practice expense for consideration at the April 2019 RUC meeting. The AGA and its sister societies conducted a survey of a random sample of our memberships during February and March and presented our recommendations based on the data we collected. CMS’ proposed values will be published in July 2020 in the 2021 MPFS proposed rule and finalized in the final rule that November.
 

Next steps

CMS will announce changes to E/M coding and documentation guidelines and any new payment changes to CPT codes 43239 and 45385 in the 2021 MPFS proposed rule in July 2020. Be prepared to use this information to model the financial impact to your practice so you can determine what, if any changes, should be made. Contact your coding and billing staff, consultants and software providers to find out how they plan to implement any changes. Additional E/M training may be required for your providers and staff. The GI Societies remain vigilant and continue to advocate on the behalf of its members to advise and shape these policy evaluations and changes.
 

Dr. Kuo is assistant professor, director of the Center for Neurointestinal Health, GI Unit, Massachusetts General Hospital, Harvard Medical School, Boston; AGA CPT Advisor; he has no conflicts of interest. Dr. Mehta is assistant professor, Perelman School of Medicine; associate chief innovation officer, Penn Medicine, Philadelphia; AGA RUC Advisor; he has no conflicts of interest.

The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).

This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients. In one trial, 96.4% of patients who were treated with Sixmo responded, compared with 87.6% of patients treated with sublingual buprenorphine.

Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.

The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.

The full release can be found on the EMA website.

[email protected]

The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).

This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients. In one trial, 96.4% of patients who were treated with Sixmo responded, compared with 87.6% of patients treated with sublingual buprenorphine.

Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.

The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.

The full release can be found on the EMA website.

[email protected]

The European Medicines Agency announced April 26 that its human medicines committee has recommended granting a marketing authorization for Sixmo, a long-lasting implant delivering buprenorphine as treatment for opioid use disorder (OUD).

This recommendation is a step toward making the product available to patients with OUD in the European Union, according to a press release from the EMA. Safety and efficacy of the implant were studied in three trials with a total of 628 patients. In one trial, 96.4% of patients who were treated with Sixmo responded, compared with 87.6% of patients treated with sublingual buprenorphine.

Standard treatment of OUD includes psychological and social counseling, as well as substitution opioid therapy – such as methadone or buprenorphine. The Sixmo implant involves four small rods implanted in the patient’s upper arm under local anesthetic.

The most common adverse events associated with the medicine were in keeping with the known events associated with buprenorphine – headache, constipation, and insomnia. Insertion and removal were associated with pain, severe itching, and hematoma at the implant site.

The full release can be found on the EMA website.

[email protected]

Medical cannabis is safe, effective, and may reduce opioid use in elderly patients with chronic medical conditions, results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.

LPETTET/Getty Images

“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.

The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.

With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.

While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.

Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.

Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.

The study was supported by the Dent Family Foundation.

SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.

Medical cannabis is safe, effective, and may reduce opioid use in elderly patients with chronic medical conditions, results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.

LPETTET/Getty Images

“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.

The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.

With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.

While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.

Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.

Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.

The study was supported by the Dent Family Foundation.

SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.

Medical cannabis is safe, effective, and may reduce opioid use in elderly patients with chronic medical conditions, results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.

LPETTET/Getty Images

“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.

The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.

With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.

While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.

Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.

Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.

The study was supported by the Dent Family Foundation.

SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.

The Food and Drug Administration has approved Eticovo (etanercept-ykro), a biosimilar of Enbrel (etanercept), for the treatment of several different rheumatologic and dermatologic conditions.

FDA approval was based in part on the results of a phase 3 trial in which 596 patients with moderate to severe rheumatoid arthritis uncontrolled by methotrexate received either Eticovo or Enbrel. The American College of Rheumatology 20% response rate after 24 weeks was 78.1% for Eticovo and 80.3% for Enbrel; the two drugs were statistically equivalent. Both groups had statistically equivalent rates of treatment-emergent adverse events (55.2% vs. 58.2%).

According to the label, Eticovo is a tumor necrosis factor blocker approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older. The most common adverse events associated with the drug include infections and injection site reactions.

Eticovo is the second etanercept biosimilar approved by the FDA. The first FDA-approved etanercept biosimilar, etanercept-szzs (Erelzi), is currently facing a legal challenge from Amgen, the manufacturer of Enbrel.

[email protected]

The Food and Drug Administration has approved Eticovo (etanercept-ykro), a biosimilar of Enbrel (etanercept), for the treatment of several different rheumatologic and dermatologic conditions.

FDA approval was based in part on the results of a phase 3 trial in which 596 patients with moderate to severe rheumatoid arthritis uncontrolled by methotrexate received either Eticovo or Enbrel. The American College of Rheumatology 20% response rate after 24 weeks was 78.1% for Eticovo and 80.3% for Enbrel; the two drugs were statistically equivalent. Both groups had statistically equivalent rates of treatment-emergent adverse events (55.2% vs. 58.2%).

According to the label, Eticovo is a tumor necrosis factor blocker approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older. The most common adverse events associated with the drug include infections and injection site reactions.

Eticovo is the second etanercept biosimilar approved by the FDA. The first FDA-approved etanercept biosimilar, etanercept-szzs (Erelzi), is currently facing a legal challenge from Amgen, the manufacturer of Enbrel.

[email protected]

The Food and Drug Administration has approved Eticovo (etanercept-ykro), a biosimilar of Enbrel (etanercept), for the treatment of several different rheumatologic and dermatologic conditions.

FDA approval was based in part on the results of a phase 3 trial in which 596 patients with moderate to severe rheumatoid arthritis uncontrolled by methotrexate received either Eticovo or Enbrel. The American College of Rheumatology 20% response rate after 24 weeks was 78.1% for Eticovo and 80.3% for Enbrel; the two drugs were statistically equivalent. Both groups had statistically equivalent rates of treatment-emergent adverse events (55.2% vs. 58.2%).

According to the label, Eticovo is a tumor necrosis factor blocker approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older. The most common adverse events associated with the drug include infections and injection site reactions.

Eticovo is the second etanercept biosimilar approved by the FDA. The first FDA-approved etanercept biosimilar, etanercept-szzs (Erelzi), is currently facing a legal challenge from Amgen, the manufacturer of Enbrel.

[email protected]

VIENNA – Treatment of individuals chronically infected with hepatitis B virus (HBV) with the nucleotide analog tenofovir disoproxil fumarate significantly linked with a substantial cut in the incidence of hepatocellular carcinoma (HCC) compared with those who received the nucleoside analog entecavir, according to a review of more than 29,000 Hong Kong patients.

Mitchel L. Zoler/MDedge News

This is the second reported study to find that association. In January 2019, a study of more than 24,000 Korean residents chronically infected with HBV showed a similar, statistically significant link between treatment with tenofovir disoproxil fumarate (Viread) and a lower incidence of HCC compared with patients treated with entecavir (Baraclude) (JAMA Oncol. 2019 Jan;5[1]:30-6), Grace L.H. Wong, MD, said at the meeting, sponsored by the European Association for the Study of the Liver (EASL).

However, another report published just a few days before Dr. Wong spoke failed to find an association between tenofovir disoproxil treatment of HBV and the subsequent rate of HCC compared with patients treated with entecavir. That study comprised nearly 2,900 HBV patients treated at any of four Korean medical centers (J Hepatol. 2019 Apr. doi: 10.1016/j.jhep.2019.03.028).

Dr. Wong noted that although current guidelines from EASL cite both tenofovir disoproxil and entecavir (as well as tenofovir alafenamide [Vemlidy]) as first-line treatments for chronic HBV infection (J Hepatol. 2017 Aug;67[2]:370-98), some evidence suggests that tenofovir disoproxil might produce effects subtly different from those of entecavir.

At the meeting in Vienna, for example, a report on 176 Japanese patients with chronic HBV showed that those who were treated with a nucleotide analog such as tenofovir disoproxil produced higher serum levels of interferon-lamda3 compared with patients treated with entecavir, and increased levels of this interferon could improve clearance of HBV surface antigen (J Hepatol. 2019 April;70[1]:e477). The most recent EASL guidelines for treatment of chronic hepatitis B infection also list tenofovir disoproxil, entecavir, and tenofovir alafenamide as preferred agents (Hepatology. 2018 April;67[4]:1560-99).

The data Dr. Wong and her associates analyzed came from health records kept for about 80% of Hong Kong’s population in the Clinical Data Analysis and Recording System of the Hospital Authority of Hong Kong. From January 2010 to June 2018, this database included 28,041 consecutive patients chronically infected with HBV and treated with entecavir, and 1,309 consecutive patients treated with tenofovir disoproxil. These numbers excluded patients treated for less than 6 months, patients coinfected with hepatitis C or D virus, patients with cancer diagnosed or a liver transplanted before or during their first 6 months on treatment, and patients previously treated with an interferon or nucleos(t)ide.

During an average follow-up of 2.8 years of tenofovir disoproxil treatment, 8 patients developed HCC, and during an average follow-up of 3.7 years of entecavir treatment, 1,386 patients developed HCC, reported Dr. Wong, a hepatologist and professor of medicine at the Chinese University of Hong Kong.

In a multivariate analysis that adjusted for demographic and clinical differences, treatment with tenofovir disoproxil linked with a statistically significant 68% reduced rate of HCC development compared with the entecavir-treated patients, she said. In a propensity score–weighted analysis, tenofovir disoproxil linked with a statistically significant 64% reduced rate of incident HCC, and in a propensity score–matched analysis tenofovir disoproxil linked with a 58% reduced rate of HCC, although in this analysis, which excluded many of the entecavir-treated patients and hence had less statistical power, the difference just missed statistical significance.

As an additional step to try to rule out the possible effect of unadjusted confounders, Dr. Wong and associates analyzed the links between tenofovir disoproxil and entecavir treatment and two negative-control outcomes, the incidence of lung cancer and the incidence of acute myocardial infarction. Neither of these outcomes showed a statistically significant link with one of the HBV treatments, suggesting that the link between treatment and HCC incidence did not appear because of an unadjusted confounding bias, Dr. Wong said. The Hong Kong database did not include enough patients treated with tenofovir alafenamide to allow assessment of this drug, she added.

Dr. Wong has been an adviser to Gilead and a speaker for Abbott, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Roche. Tenofovir disoproxil fumarate is marketed by Gilead, and entecavir is marketed by Bristol-Myers Squibb. 

[email protected]

SOURCE: Wong GL et al. J Hepatol. 2019 April;70[1]:e128.

VIENNA – Treatment of individuals chronically infected with hepatitis B virus (HBV) with the nucleotide analog tenofovir disoproxil fumarate significantly linked with a substantial cut in the incidence of hepatocellular carcinoma (HCC) compared with those who received the nucleoside analog entecavir, according to a review of more than 29,000 Hong Kong patients.

Mitchel L. Zoler/MDedge News

This is the second reported study to find that association. In January 2019, a study of more than 24,000 Korean residents chronically infected with HBV showed a similar, statistically significant link between treatment with tenofovir disoproxil fumarate (Viread) and a lower incidence of HCC compared with patients treated with entecavir (Baraclude) (JAMA Oncol. 2019 Jan;5[1]:30-6), Grace L.H. Wong, MD, said at the meeting, sponsored by the European Association for the Study of the Liver (EASL).

However, another report published just a few days before Dr. Wong spoke failed to find an association between tenofovir disoproxil treatment of HBV and the subsequent rate of HCC compared with patients treated with entecavir. That study comprised nearly 2,900 HBV patients treated at any of four Korean medical centers (J Hepatol. 2019 Apr. doi: 10.1016/j.jhep.2019.03.028).

Dr. Wong noted that although current guidelines from EASL cite both tenofovir disoproxil and entecavir (as well as tenofovir alafenamide [Vemlidy]) as first-line treatments for chronic HBV infection (J Hepatol. 2017 Aug;67[2]:370-98), some evidence suggests that tenofovir disoproxil might produce effects subtly different from those of entecavir.

At the meeting in Vienna, for example, a report on 176 Japanese patients with chronic HBV showed that those who were treated with a nucleotide analog such as tenofovir disoproxil produced higher serum levels of interferon-lamda3 compared with patients treated with entecavir, and increased levels of this interferon could improve clearance of HBV surface antigen (J Hepatol. 2019 April;70[1]:e477). The most recent EASL guidelines for treatment of chronic hepatitis B infection also list tenofovir disoproxil, entecavir, and tenofovir alafenamide as preferred agents (Hepatology. 2018 April;67[4]:1560-99).

The data Dr. Wong and her associates analyzed came from health records kept for about 80% of Hong Kong’s population in the Clinical Data Analysis and Recording System of the Hospital Authority of Hong Kong. From January 2010 to June 2018, this database included 28,041 consecutive patients chronically infected with HBV and treated with entecavir, and 1,309 consecutive patients treated with tenofovir disoproxil. These numbers excluded patients treated for less than 6 months, patients coinfected with hepatitis C or D virus, patients with cancer diagnosed or a liver transplanted before or during their first 6 months on treatment, and patients previously treated with an interferon or nucleos(t)ide.

During an average follow-up of 2.8 years of tenofovir disoproxil treatment, 8 patients developed HCC, and during an average follow-up of 3.7 years of entecavir treatment, 1,386 patients developed HCC, reported Dr. Wong, a hepatologist and professor of medicine at the Chinese University of Hong Kong.

In a multivariate analysis that adjusted for demographic and clinical differences, treatment with tenofovir disoproxil linked with a statistically significant 68% reduced rate of HCC development compared with the entecavir-treated patients, she said. In a propensity score–weighted analysis, tenofovir disoproxil linked with a statistically significant 64% reduced rate of incident HCC, and in a propensity score–matched analysis tenofovir disoproxil linked with a 58% reduced rate of HCC, although in this analysis, which excluded many of the entecavir-treated patients and hence had less statistical power, the difference just missed statistical significance.

As an additional step to try to rule out the possible effect of unadjusted confounders, Dr. Wong and associates analyzed the links between tenofovir disoproxil and entecavir treatment and two negative-control outcomes, the incidence of lung cancer and the incidence of acute myocardial infarction. Neither of these outcomes showed a statistically significant link with one of the HBV treatments, suggesting that the link between treatment and HCC incidence did not appear because of an unadjusted confounding bias, Dr. Wong said. The Hong Kong database did not include enough patients treated with tenofovir alafenamide to allow assessment of this drug, she added.

Dr. Wong has been an adviser to Gilead and a speaker for Abbott, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Roche. Tenofovir disoproxil fumarate is marketed by Gilead, and entecavir is marketed by Bristol-Myers Squibb. 

[email protected]

SOURCE: Wong GL et al. J Hepatol. 2019 April;70[1]:e128.

VIENNA – Treatment of individuals chronically infected with hepatitis B virus (HBV) with the nucleotide analog tenofovir disoproxil fumarate significantly linked with a substantial cut in the incidence of hepatocellular carcinoma (HCC) compared with those who received the nucleoside analog entecavir, according to a review of more than 29,000 Hong Kong patients.

Mitchel L. Zoler/MDedge News

This is the second reported study to find that association. In January 2019, a study of more than 24,000 Korean residents chronically infected with HBV showed a similar, statistically significant link between treatment with tenofovir disoproxil fumarate (Viread) and a lower incidence of HCC compared with patients treated with entecavir (Baraclude) (JAMA Oncol. 2019 Jan;5[1]:30-6), Grace L.H. Wong, MD, said at the meeting, sponsored by the European Association for the Study of the Liver (EASL).

However, another report published just a few days before Dr. Wong spoke failed to find an association between tenofovir disoproxil treatment of HBV and the subsequent rate of HCC compared with patients treated with entecavir. That study comprised nearly 2,900 HBV patients treated at any of four Korean medical centers (J Hepatol. 2019 Apr. doi: 10.1016/j.jhep.2019.03.028).

Dr. Wong noted that although current guidelines from EASL cite both tenofovir disoproxil and entecavir (as well as tenofovir alafenamide [Vemlidy]) as first-line treatments for chronic HBV infection (J Hepatol. 2017 Aug;67[2]:370-98), some evidence suggests that tenofovir disoproxil might produce effects subtly different from those of entecavir.

At the meeting in Vienna, for example, a report on 176 Japanese patients with chronic HBV showed that those who were treated with a nucleotide analog such as tenofovir disoproxil produced higher serum levels of interferon-lamda3 compared with patients treated with entecavir, and increased levels of this interferon could improve clearance of HBV surface antigen (J Hepatol. 2019 April;70[1]:e477). The most recent EASL guidelines for treatment of chronic hepatitis B infection also list tenofovir disoproxil, entecavir, and tenofovir alafenamide as preferred agents (Hepatology. 2018 April;67[4]:1560-99).

The data Dr. Wong and her associates analyzed came from health records kept for about 80% of Hong Kong’s population in the Clinical Data Analysis and Recording System of the Hospital Authority of Hong Kong. From January 2010 to June 2018, this database included 28,041 consecutive patients chronically infected with HBV and treated with entecavir, and 1,309 consecutive patients treated with tenofovir disoproxil. These numbers excluded patients treated for less than 6 months, patients coinfected with hepatitis C or D virus, patients with cancer diagnosed or a liver transplanted before or during their first 6 months on treatment, and patients previously treated with an interferon or nucleos(t)ide.

During an average follow-up of 2.8 years of tenofovir disoproxil treatment, 8 patients developed HCC, and during an average follow-up of 3.7 years of entecavir treatment, 1,386 patients developed HCC, reported Dr. Wong, a hepatologist and professor of medicine at the Chinese University of Hong Kong.

In a multivariate analysis that adjusted for demographic and clinical differences, treatment with tenofovir disoproxil linked with a statistically significant 68% reduced rate of HCC development compared with the entecavir-treated patients, she said. In a propensity score–weighted analysis, tenofovir disoproxil linked with a statistically significant 64% reduced rate of incident HCC, and in a propensity score–matched analysis tenofovir disoproxil linked with a 58% reduced rate of HCC, although in this analysis, which excluded many of the entecavir-treated patients and hence had less statistical power, the difference just missed statistical significance.

As an additional step to try to rule out the possible effect of unadjusted confounders, Dr. Wong and associates analyzed the links between tenofovir disoproxil and entecavir treatment and two negative-control outcomes, the incidence of lung cancer and the incidence of acute myocardial infarction. Neither of these outcomes showed a statistically significant link with one of the HBV treatments, suggesting that the link between treatment and HCC incidence did not appear because of an unadjusted confounding bias, Dr. Wong said. The Hong Kong database did not include enough patients treated with tenofovir alafenamide to allow assessment of this drug, she added.

Dr. Wong has been an adviser to Gilead and a speaker for Abbott, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Roche. Tenofovir disoproxil fumarate is marketed by Gilead, and entecavir is marketed by Bristol-Myers Squibb. 

[email protected]

SOURCE: Wong GL et al. J Hepatol. 2019 April;70[1]:e128.

LOS ANGELES – Coronary artery calcium scores can provide crucial insight into atherosclerosis risk in patients with diabetes, according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.

In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”

According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.

In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.

Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.

“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”

And this advice holds up regardless of the gender, age, or ethnicity of a patient.

However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A_1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”

What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.

What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.

CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.

“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.

Dr. Budoff offered other insights into CAC and diabetes.

First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).

However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.

Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).

“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”

The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”

Dr. Budoff reported receiving grant funding from GE Healthcare.

LOS ANGELES – Coronary artery calcium scores can provide crucial insight into atherosclerosis risk in patients with diabetes, according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.

In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”

According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.

In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.

Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.

“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”

And this advice holds up regardless of the gender, age, or ethnicity of a patient.

However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A_1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”

What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.

What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.

CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.

“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.

Dr. Budoff offered other insights into CAC and diabetes.

First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).

However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.

Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).

“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”

The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”

Dr. Budoff reported receiving grant funding from GE Healthcare.

LOS ANGELES – Coronary artery calcium scores can provide crucial insight into atherosclerosis risk in patients with diabetes, according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.

In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.

“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”

According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.

In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.

Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.

“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”

And this advice holds up regardless of the gender, age, or ethnicity of a patient.

However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A_1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”

What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.

What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.

CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.

“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.

Dr. Budoff offered other insights into CAC and diabetes.

First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).

However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.

Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).

“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”

The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”

Dr. Budoff reported receiving grant funding from GE Healthcare.

Professional soccer players may be at increased risk of amyotrophic lateral sclerosis (ALS), according to Italian researchers who reviewed trading cards of about 25,000 male professional soccer players who played in Italy. The researchers then scanned news reports to find which of those players developed the rare neurologic disease. Players who developed ALS were a much younger age at diagnosis when compared with the general population, according to the researchers, who will present their findings at the annual meeting of the American Academy of Neurology.

While the findings might implicate professional-level soccer in the development of ALS, there could be other factors at work, said lead author Ettore Beghi, MD, of the Mario Negri Institute for Pharmacological Research, Milan. “Repeated traumatic events, heavy physical exercise, and substance use could also be factors in the increased ALS risk among soccer players,” Dr. Beghi said in a news release. “In addition, genetics may play a role.”

The ALS-related deaths of several Italian pro soccer players sparked suggestions that the disease and the sport could be somehow linked, according to Dr. Beghi and colleagues. To determine whether professional soccer players are at increased ALS risk, they reviewed the archives of the country’s major soccer card publisher from the years 1959 to 2000, recording the name, date, and place of birth; field position; and team history for the tens of thousands of players they identified.

News reports revealed that 33 players in that cohort developed ALS, compared with 17.6 cases that would be expected based on Italian general population estimates, according to Dr. Beghi and colleagues.

The number of cases per 100,000 person-years was 1.9 for all the soccer players, and 4.7 for those who were younger than 45 years at diagnosis, researchers said. In general, soccer players were younger at diagnosis, with a median age of ALS onset of 43.3 years, versus 62.5 years in the general population, they added.

These findings cannot be applied to those who play soccer below the professional level, since only professional athletes were studied, Dr. Beghi said. Moreover, the results should not be construed to suggest that people avoid playing soccer, he said, adding that the researchers had few specific details on the players’ ALS diagnoses.

Patients with ALS more often report head injuries, compared with the general population, while links between exercise and ALS have been found in some studies, but not others, according to the researchers.

“Clinical and experimental observations suggest an association between ALS and use of nonsteroidal anti-inflammatory agents and dietary supplements, including branched chain amino acids,” researchers added in the abstract for their report.

The study by Dr. Beghi and colleagues was supported by the Mario Negri Institute in Milan.

Source: Beghi E et al. AAN 2019, Abstract S1.001.

Professional soccer players may be at increased risk of amyotrophic lateral sclerosis (ALS), according to Italian researchers who reviewed trading cards of about 25,000 male professional soccer players who played in Italy. The researchers then scanned news reports to find which of those players developed the rare neurologic disease. Players who developed ALS were a much younger age at diagnosis when compared with the general population, according to the researchers, who will present their findings at the annual meeting of the American Academy of Neurology.

While the findings might implicate professional-level soccer in the development of ALS, there could be other factors at work, said lead author Ettore Beghi, MD, of the Mario Negri Institute for Pharmacological Research, Milan. “Repeated traumatic events, heavy physical exercise, and substance use could also be factors in the increased ALS risk among soccer players,” Dr. Beghi said in a news release. “In addition, genetics may play a role.”

The ALS-related deaths of several Italian pro soccer players sparked suggestions that the disease and the sport could be somehow linked, according to Dr. Beghi and colleagues. To determine whether professional soccer players are at increased ALS risk, they reviewed the archives of the country’s major soccer card publisher from the years 1959 to 2000, recording the name, date, and place of birth; field position; and team history for the tens of thousands of players they identified.

News reports revealed that 33 players in that cohort developed ALS, compared with 17.6 cases that would be expected based on Italian general population estimates, according to Dr. Beghi and colleagues.

The number of cases per 100,000 person-years was 1.9 for all the soccer players, and 4.7 for those who were younger than 45 years at diagnosis, researchers said. In general, soccer players were younger at diagnosis, with a median age of ALS onset of 43.3 years, versus 62.5 years in the general population, they added.

These findings cannot be applied to those who play soccer below the professional level, since only professional athletes were studied, Dr. Beghi said. Moreover, the results should not be construed to suggest that people avoid playing soccer, he said, adding that the researchers had few specific details on the players’ ALS diagnoses.

Patients with ALS more often report head injuries, compared with the general population, while links between exercise and ALS have been found in some studies, but not others, according to the researchers.

“Clinical and experimental observations suggest an association between ALS and use of nonsteroidal anti-inflammatory agents and dietary supplements, including branched chain amino acids,” researchers added in the abstract for their report.

The study by Dr. Beghi and colleagues was supported by the Mario Negri Institute in Milan.

Source: Beghi E et al. AAN 2019, Abstract S1.001.

Professional soccer players may be at increased risk of amyotrophic lateral sclerosis (ALS), according to Italian researchers who reviewed trading cards of about 25,000 male professional soccer players who played in Italy. The researchers then scanned news reports to find which of those players developed the rare neurologic disease. Players who developed ALS were a much younger age at diagnosis when compared with the general population, according to the researchers, who will present their findings at the annual meeting of the American Academy of Neurology.

While the findings might implicate professional-level soccer in the development of ALS, there could be other factors at work, said lead author Ettore Beghi, MD, of the Mario Negri Institute for Pharmacological Research, Milan. “Repeated traumatic events, heavy physical exercise, and substance use could also be factors in the increased ALS risk among soccer players,” Dr. Beghi said in a news release. “In addition, genetics may play a role.”

The ALS-related deaths of several Italian pro soccer players sparked suggestions that the disease and the sport could be somehow linked, according to Dr. Beghi and colleagues. To determine whether professional soccer players are at increased ALS risk, they reviewed the archives of the country’s major soccer card publisher from the years 1959 to 2000, recording the name, date, and place of birth; field position; and team history for the tens of thousands of players they identified.

News reports revealed that 33 players in that cohort developed ALS, compared with 17.6 cases that would be expected based on Italian general population estimates, according to Dr. Beghi and colleagues.

The number of cases per 100,000 person-years was 1.9 for all the soccer players, and 4.7 for those who were younger than 45 years at diagnosis, researchers said. In general, soccer players were younger at diagnosis, with a median age of ALS onset of 43.3 years, versus 62.5 years in the general population, they added.

These findings cannot be applied to those who play soccer below the professional level, since only professional athletes were studied, Dr. Beghi said. Moreover, the results should not be construed to suggest that people avoid playing soccer, he said, adding that the researchers had few specific details on the players’ ALS diagnoses.

Patients with ALS more often report head injuries, compared with the general population, while links between exercise and ALS have been found in some studies, but not others, according to the researchers.

“Clinical and experimental observations suggest an association between ALS and use of nonsteroidal anti-inflammatory agents and dietary supplements, including branched chain amino acids,” researchers added in the abstract for their report.

The study by Dr. Beghi and colleagues was supported by the Mario Negri Institute in Milan.

Source: Beghi E et al. AAN 2019, Abstract S1.001.

NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFR_CT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFR_CT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.

“The lower rates of revascularization and clinical events in patients with FFR_CT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.

ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFR_CT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFR_CT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.

That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFR_CT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFR_CT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFR_CT of 0.80 or less. As a result, 72% of patients with an FFR_CT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFR_CT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).

The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFR_CT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFR_CT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFR_CT group. And 93% of patients placed on medical therapy alone after receiving their FFR_CT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.

Bruce Jancin/MDedge News

Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFR_CT-based screening strategy in patients with clinical suspicion of obstructive CAD.

“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.

Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFR_CT strategy.

The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.

Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).

[email protected]

NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFR_CT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFR_CT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.

“The lower rates of revascularization and clinical events in patients with FFR_CT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.

ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFR_CT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFR_CT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.

That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFR_CT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFR_CT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFR_CT of 0.80 or less. As a result, 72% of patients with an FFR_CT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFR_CT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).

The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFR_CT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFR_CT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFR_CT group. And 93% of patients placed on medical therapy alone after receiving their FFR_CT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.

Bruce Jancin/MDedge News

Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFR_CT-based screening strategy in patients with clinical suspicion of obstructive CAD.

“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.

Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFR_CT strategy.

The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.

Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).

[email protected]

NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFR_CT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFR_CT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.

“The lower rates of revascularization and clinical events in patients with FFR_CT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.

ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFR_CT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFR_CT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.

That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFR_CT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFR_CT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFR_CT of 0.80 or less. As a result, 72% of patients with an FFR_CT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFR_CT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).

The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFR_CT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFR_CT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFR_CT group. And 93% of patients placed on medical therapy alone after receiving their FFR_CT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.

Bruce Jancin/MDedge News

Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFR_CT-based screening strategy in patients with clinical suspicion of obstructive CAD.

“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.

Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFR_CT strategy.

The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.

Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).

[email protected]