ACC Day 3: Finishing strong in Late-Breaking Clinical Trial Sessions

 

On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.

“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 

ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.

 

On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.

“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 

ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.

 

On the third and final day of the annual meeting of the American College of Cardiology in Orlando, two very different studies were emphasized by the meeting’s vice chair, Andrew Kates, MD, in a media briefing: Blood Pressure Reductions in Black Barbershops and ANNEXA 4.

Blood Pressure Reductions in Black Barbershops

Ronald G. Victor, MD, of Cedars-Sinai Medical Center in Los Angeles, has been studying the considerable strength of barbershops in African American communities for years. In the joint ACC/New England Journal of Medicine Late-Breaking Clinical Trial Session, 8:00 a.m.-9:15 a.m. in the Main Tent, Dr. Victor and will present such a study of 330 patients in 53 barbershops.

In the study, barbers in those 53 shops were trained to measure clients’ blood pressure and refer those with high readings to a community pharmacist for confirmation of uncontrolled high blood pressure and development of a hypertension management plan. The primary outcome is a 6-month blood pressure reading of less than 135/85 mm Hg.

“This stood out for highlighting because we’re now realizing the importance of barbershops in the community” in education and perhaps improving treatment. The data may reinforce the use of barbershops to improve hypertension,” said Dr. Kates, professor of medicine, Washington University, St. Louis.

 

 

ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.