Thrombosis

BOSTON – Avoiding missed doses of venous thromboembolism (VTE) prophylaxis could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.

Andrew Bowser/MDedge News

The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.

By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.

That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.

“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.

The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.

These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.

After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.

Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.



Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).

“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.

Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
 

SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.

BOSTON – Avoiding missed doses of venous thromboembolism (VTE) prophylaxis could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.

Andrew Bowser/MDedge News

The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.

By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.

That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.

“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.

The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.

These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.

After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.

Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.



Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).

“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.

Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
 

SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.

BOSTON – Avoiding missed doses of venous thromboembolism (VTE) prophylaxis could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.

Andrew Bowser/MDedge News

The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.

By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.

That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.

“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.

The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.

These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.

After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.

Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.



Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).

“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.

Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
 

SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.

The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).

OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.

The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.

Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.

Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.

Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.

At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.

These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).

Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.

The mean platelet count increased from 18,100 x 10⁶/mL at baseline to 52,300 x 10⁶/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).

The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.

[email protected]

The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).

OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.

The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.

Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.

Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.

Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.

At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.

These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).

Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.

The mean platelet count increased from 18,100 x 10⁶/mL at baseline to 52,300 x 10⁶/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).

The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.

[email protected]

The Food and Drug Administration has granted OMS721 orphan designation for the treatment of hematopoietic stem cell transplant–associated thrombotic microangiopathy (HSCT-TMA).

OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.

The FDA previously granted OMS721 breakthrough therapy designation for HSCT-TMA and orphan designation for the prevention of complement-mediated TMA, including HSCT-TMA.

Omeros, the company developing OMS721, has established a compassionate use program for OMS721, which is active in the United States and Europe.

Phase 3 clinical programs are in progress for OMS721 in atypical hemolytic uremic syndrome, immunoglobulin A nephropathy, and HSCT-TMA. Two phase 2 trials of OMS721 – one in TMA and one in immunoglobulin A nephropathy – are ongoing.

Omeros announced results from the phase 2 TMA trial (NCT02222545) in February. The study includes adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post transplant. Patients receive weekly OMS721 treatments for 4-8 weeks at the discretion of the investigator.

At the time of Omeros’s announcement, 18 HSCT-TMA patients had been treated.

These patients had a significantly longer median overall survival at 347 days, compared with historical controls at 21 days (P less than .0001).

Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.

The mean platelet count increased from 18,100 x 10⁶/mL at baseline to 52,300 x 10⁶/mL (P = .017). The mean lactate dehydrogenase decreased from 591 U/L to 250 U/L (P less than .001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P = .003).

The most commonly reported adverse events were diarrhea and neutropenia. Four deaths occurred during the study. One of these – attributable to acute renal and respiratory failure – was considered possibly related to OMS721.

[email protected]

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

Laparoscopic gynecologic surgery is associated with a significantly lower risk of postoperative venous thromboembolism (VTE) than laparotomy, according to a study published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

The retrospective cohort study looked at data from 37,485 patients who underwent 43,751 gynecologic surgical procedures, including hysterectomy and myomectomy, at two tertiary care academic hospitals.

Overall, 96 patients (0.2%) were diagnosed with postoperative venous thromboembolism. However patients who underwent laparoscopic or vaginal surgery had a significant 78% and 93% lower risk of venous thromboembolism, respectively, than those who underwent laparotomy, even after adjusting for potential confounders such as age, cancer, race, pharmacologic thromboprophylaxis, and surgical time.

The incidence of postoperative thromboembolism was significantly higher among patients undergoing gynecologic surgery for cancer (1.1%). The incidence among those undergoing surgery for benign indications was only 0.2%, and the highest incidence was among patients with cancer who underwent laparotomy (2.2%).

“This study adds to data demonstrating that venous thromboembolism is rare in gynecologic surgery, particularly when a patient undergoes a minimally invasive procedure for benign indications,” wrote Dr. Elisa M. Jorgensen of Beth Israel Deaconess Medical Center, and her coauthors.

Among the 8,273 patients who underwent a hysterectomy, there were 55 cases of venous thromboembolism – representing an 0.7% incidence. However patients who underwent laparotomy had a 1% incidence of postoperative venous thromboembolism, while those who underwent laparoscopic hysterectomy had an 0.3% incidence and those who underwent vaginal hysterectomy had an 0.1% incidence.

Laparotomy was the most common mode of surgery for hysterectomy – accounting for 57% of operations – while 34% were laparoscopic and 9% were vaginal.

However, the authors noted that the use of laparoscopy increased and laparotomy declined over the 9 years of the study. In 2006, 12% of hysterectomies were laparoscopic, compared with 55% in 2015, while over that same period the percentage of laparotomies dropped from 74% to 41%, and the percentage of vaginal procedures declined from 14% to 4%.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

“Because current practice guidelines do not account for mode of surgery, we find them to be insufficient for the modern gynecologic surgeon to counsel patients on their individual venous thromboembolism risk or to make ideal decisions regarding selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Only 5 patients of the 2,851 who underwent myomectomy developed postoperative VTE – an overall incidence of 0.2% – and the authors said numbers were too small to analyze. Vaginal or hysteroscopic myomectomy was the most common surgical method, accounting for 62% of procedures, compared with 23% for laparotomies and 15% for laparoscopies.

More than 90% of patients who experienced postoperative thromboembolism had received some form of thromboprophylaxis before surgery, either mechanical, pharmacologic, or both. In comparison, only 55% of the group who didn’t experience thromboembolism had received thromboprophylaxis.

“The high rate of prophylaxis among patients who developed postoperative venous thromboembolism may reflect surgeons’ abilities to preoperatively identify patients at increased risk, guiding appropriate selection of thromboprophylaxis,” Dr. Jorgenson and her associates wrote.

Addressing the study’s limitations, the authors noted that they were not able to capture data on patients’ body mass index and also were unable to account for patients who might have been diagnosed and treated for postoperative VTE at other hospitals.

No conflicts of interest were declared.

SOURCE: Jorgensen EM et al. Obstet Gynecol. 2018 Nov;132:1275-84.

Photo by Sage Ross

Putting patients on aspirin following a knee replacement is a safe, cost-effective alternative to treatment with anticoagulants, according to researchers.

A study of more than 40,000 patients revealed a similar incidence of venous thromboembolism (VTE) or death after total knee arthroplasty (TKA) in patients receiving aspirin and patients receiving anticoagulants.

“Aspirin alone may provide similar protection compared to anticoagulation treatments,” said Brian R. Hallstrom, MD, of the University of Michigan in Ann Arbor.

He and his colleagues compared aspirin to anticoagulants after TKA and detailed their findings in JAMA Surgery.

The researchers evaluated 41,537 patients who underwent TKA and received:

• No pharmacological VTE prophylaxis (n=668; 1.6%)
• Aspirin only (n=12,831; 30.9%)
• Only an anticoagulant (n=22,620; 54.5%)
• Both aspirin and an anticoagulant (n=5418; 13.0%).

Anticoagulants included low-molecular-weight heparin, warfarin, and factor Xa inhibitors.

About 87% of all patients (n=36,113) were also using intermittent pneumatic compression stockings.

Safety and efficacy

The study’s primary outcome was a composite of VTE and death. It occurred in:

• 4.79% (32/668) of patients not on pharmacological prophylaxis
• 1.16% (149/12,831) of patients who received aspirin alone
• 1.42% (321/22,620) of patients on anticoagulation alone
• 1.31% (71/5418) of patients who received both aspirin and anticoagulation.

In a multivariable analysis adjusted for confounding, aspirin was noninferior to the other prophylaxis regimens for the outcome of VTE or death. The adjusted odds ratio was 0.85 (P=0.007).

Bleeding was a secondary outcome of this study, and it occurred in:

• 1.50% (10/668) of patients not on pharmacological prophylaxis
• 0.90% (116/12,831) of patients who received aspirin alone
• 1.14% (258/22,620) of patients who received anticoagulation
• 1.35% (73/5,418) of patients who received both aspirin and anticoagulation.

In an adjusted analysis, aspirin was noninferior to the other prophylaxis regimens for the outcome of bleeding. The adjusted odds ratio was 0.80 (P<0.001).

Other benefits

Aspirin provides other benefits aside from similar safety and efficacy as anticoagulants, according to the researchers.

“Aspirin is easy to take and much less expensive,” Dr. Hallstrom noted. “Patients can get it over the counter for pennies, while the other anticoagulants require monitoring, injections, frequent dose adjustments and are extremely expensive.”

Dr. Hallstrom and his colleagues said the reported cost for a 30-day supply of rivaroxaban is approximately $379 to $450, and the estimated cost of heparin is $450 to $890.

Although warfarin costs a few dollars for a 30-day supply, its cost approaches that of the other anticoagulants when doctor visits for monitoring are factored in, the researchers noted.

In contrast, aspirin costs approximately $2 a month.

Dr. Hallstrom and his colleagues did note that, although this study suggests aspirin can prevent VTE as well as anticoagulants, doctors need to consider factors such as a patient’s history of clots, obesity, and ability to mobilize after surgery.

Photo by Sage Ross

Putting patients on aspirin following a knee replacement is a safe, cost-effective alternative to treatment with anticoagulants, according to researchers.

A study of more than 40,000 patients revealed a similar incidence of venous thromboembolism (VTE) or death after total knee arthroplasty (TKA) in patients receiving aspirin and patients receiving anticoagulants.

“Aspirin alone may provide similar protection compared to anticoagulation treatments,” said Brian R. Hallstrom, MD, of the University of Michigan in Ann Arbor.

He and his colleagues compared aspirin to anticoagulants after TKA and detailed their findings in JAMA Surgery.

The researchers evaluated 41,537 patients who underwent TKA and received:

• No pharmacological VTE prophylaxis (n=668; 1.6%)
• Aspirin only (n=12,831; 30.9%)
• Only an anticoagulant (n=22,620; 54.5%)
• Both aspirin and an anticoagulant (n=5418; 13.0%).

Anticoagulants included low-molecular-weight heparin, warfarin, and factor Xa inhibitors.

About 87% of all patients (n=36,113) were also using intermittent pneumatic compression stockings.

Safety and efficacy

The study’s primary outcome was a composite of VTE and death. It occurred in:

• 4.79% (32/668) of patients not on pharmacological prophylaxis
• 1.16% (149/12,831) of patients who received aspirin alone
• 1.42% (321/22,620) of patients on anticoagulation alone
• 1.31% (71/5418) of patients who received both aspirin and anticoagulation.

In a multivariable analysis adjusted for confounding, aspirin was noninferior to the other prophylaxis regimens for the outcome of VTE or death. The adjusted odds ratio was 0.85 (P=0.007).

Bleeding was a secondary outcome of this study, and it occurred in:

• 1.50% (10/668) of patients not on pharmacological prophylaxis
• 0.90% (116/12,831) of patients who received aspirin alone
• 1.14% (258/22,620) of patients who received anticoagulation
• 1.35% (73/5,418) of patients who received both aspirin and anticoagulation.

In an adjusted analysis, aspirin was noninferior to the other prophylaxis regimens for the outcome of bleeding. The adjusted odds ratio was 0.80 (P<0.001).

Other benefits

Aspirin provides other benefits aside from similar safety and efficacy as anticoagulants, according to the researchers.

“Aspirin is easy to take and much less expensive,” Dr. Hallstrom noted. “Patients can get it over the counter for pennies, while the other anticoagulants require monitoring, injections, frequent dose adjustments and are extremely expensive.”

Dr. Hallstrom and his colleagues said the reported cost for a 30-day supply of rivaroxaban is approximately $379 to $450, and the estimated cost of heparin is $450 to $890.

Although warfarin costs a few dollars for a 30-day supply, its cost approaches that of the other anticoagulants when doctor visits for monitoring are factored in, the researchers noted.

In contrast, aspirin costs approximately $2 a month.

Dr. Hallstrom and his colleagues did note that, although this study suggests aspirin can prevent VTE as well as anticoagulants, doctors need to consider factors such as a patient’s history of clots, obesity, and ability to mobilize after surgery.

Photo by Sage Ross

Putting patients on aspirin following a knee replacement is a safe, cost-effective alternative to treatment with anticoagulants, according to researchers.

A study of more than 40,000 patients revealed a similar incidence of venous thromboembolism (VTE) or death after total knee arthroplasty (TKA) in patients receiving aspirin and patients receiving anticoagulants.

“Aspirin alone may provide similar protection compared to anticoagulation treatments,” said Brian R. Hallstrom, MD, of the University of Michigan in Ann Arbor.

He and his colleagues compared aspirin to anticoagulants after TKA and detailed their findings in JAMA Surgery.

The researchers evaluated 41,537 patients who underwent TKA and received:

• No pharmacological VTE prophylaxis (n=668; 1.6%)
• Aspirin only (n=12,831; 30.9%)
• Only an anticoagulant (n=22,620; 54.5%)
• Both aspirin and an anticoagulant (n=5418; 13.0%).

Anticoagulants included low-molecular-weight heparin, warfarin, and factor Xa inhibitors.

About 87% of all patients (n=36,113) were also using intermittent pneumatic compression stockings.

Safety and efficacy

The study’s primary outcome was a composite of VTE and death. It occurred in:

• 4.79% (32/668) of patients not on pharmacological prophylaxis
• 1.16% (149/12,831) of patients who received aspirin alone
• 1.42% (321/22,620) of patients on anticoagulation alone
• 1.31% (71/5418) of patients who received both aspirin and anticoagulation.

In a multivariable analysis adjusted for confounding, aspirin was noninferior to the other prophylaxis regimens for the outcome of VTE or death. The adjusted odds ratio was 0.85 (P=0.007).

Bleeding was a secondary outcome of this study, and it occurred in:

• 1.50% (10/668) of patients not on pharmacological prophylaxis
• 0.90% (116/12,831) of patients who received aspirin alone
• 1.14% (258/22,620) of patients who received anticoagulation
• 1.35% (73/5,418) of patients who received both aspirin and anticoagulation.

In an adjusted analysis, aspirin was noninferior to the other prophylaxis regimens for the outcome of bleeding. The adjusted odds ratio was 0.80 (P<0.001).

Other benefits

Aspirin provides other benefits aside from similar safety and efficacy as anticoagulants, according to the researchers.

“Aspirin is easy to take and much less expensive,” Dr. Hallstrom noted. “Patients can get it over the counter for pennies, while the other anticoagulants require monitoring, injections, frequent dose adjustments and are extremely expensive.”

Dr. Hallstrom and his colleagues said the reported cost for a 30-day supply of rivaroxaban is approximately $379 to $450, and the estimated cost of heparin is $450 to $890.

Although warfarin costs a few dollars for a 30-day supply, its cost approaches that of the other anticoagulants when doctor visits for monitoring are factored in, the researchers noted.

In contrast, aspirin costs approximately $2 a month.

Dr. Hallstrom and his colleagues did note that, although this study suggests aspirin can prevent VTE as well as anticoagulants, doctors need to consider factors such as a patient’s history of clots, obesity, and ability to mobilize after surgery.

Concerns may be unfounded for risks of earlier-onset cardiovascular disease in men with hemophilia A, according to investigators.

Cardiovascular comorbidities between groups were generally comparable, regardless of hemophilia A status, reported lead author Thomas J. Humphries, MD, of Bayer, and his colleagues.

“To date, there have been conflicting data in the literature regarding the risks of [cardiovascular] comorbidities in patients with hemophilia A, compared with the general population,” the investigators wrote in Advances in Medical Sciences. “Some studies have reported lower mortality from [cardiovascular] diseases and/or decreased atherogenesis in patients with hemophilia … conversely, other reports indicate comparable or higher [cardiovascular] comorbidities in patients with hemophilia, compared with the general population.”

In two previous commercial database reviews conducted by Dr. Humphries and his colleagues, cardiovascular disease appeared to occur more commonly and at a younger age in men with hemophilia A. More concerning, patients aged under 40 years showed elevated incidence of stroke and thrombosis. The authors sought to clarify these findings in the present study.

The retrospective chart review involved 74 men with hemophilia A and 222 men without the condition, matched by study year, payer type, race, and age. Patients presented at any of 31 medical facilities within the Henry Ford Health System in Detroit. Diagnoses were made between Jan. 1, 1995, and Dec. 31, 2014.

For the most part there were no significant differences in cardiovascular disease prevalence between the two cohorts. Rates of hypertension, obesity, coronary artery disease, heart failure, stroke, venous and arterial thrombosis, ventricular arrhythmias, atrial fibrillation, and chronic renal disease were numerically higher in the control group, but those differences were not statistically significant. There were significantly higher prevalence rates for diabetes (P = .0108) and hyperlipidemia (P = .0001) in the control group versus patients with hemophilia A.

The investigators pointed out that meaningful statistical differences using standardized differences were not reached for venous and arterial thrombosis and atrial fibrillation.

“It is worth noting that in the hemophilia A group, hypertension appeared first in the 18- to 29-year age group, as did venous thrombosis,” the investigators wrote, suggesting that monitoring, starting in the late teens, may be warranted.

The investigators also noted multiple study limitations, notably the small sample size, compared with commercial databases that were reviewed in previous studies. Additionally, the severity of disease was unknown for some of the hemophilia A patients and the study only followed patients for 1 year.

“The results of this retrospective chart review did not confirm diffuse statistically significant differences in [cardiovascular] comorbidities and their earlier onset in hemophilia A versus controls,” the investigators concluded.

The study was funded by Bayer. Three of the authors were employed by Bayer when the study was conducted. Other authors reported employment with Xcenda and the Henry Ford Health System and research funding from Xcenda.

SOURCE: Humphries TJ et al. Adv Med Sci. 2018;63(2):329-33.

Concerns may be unfounded for risks of earlier-onset cardiovascular disease in men with hemophilia A, according to investigators.

Cardiovascular comorbidities between groups were generally comparable, regardless of hemophilia A status, reported lead author Thomas J. Humphries, MD, of Bayer, and his colleagues.

“To date, there have been conflicting data in the literature regarding the risks of [cardiovascular] comorbidities in patients with hemophilia A, compared with the general population,” the investigators wrote in Advances in Medical Sciences. “Some studies have reported lower mortality from [cardiovascular] diseases and/or decreased atherogenesis in patients with hemophilia … conversely, other reports indicate comparable or higher [cardiovascular] comorbidities in patients with hemophilia, compared with the general population.”

In two previous commercial database reviews conducted by Dr. Humphries and his colleagues, cardiovascular disease appeared to occur more commonly and at a younger age in men with hemophilia A. More concerning, patients aged under 40 years showed elevated incidence of stroke and thrombosis. The authors sought to clarify these findings in the present study.

The retrospective chart review involved 74 men with hemophilia A and 222 men without the condition, matched by study year, payer type, race, and age. Patients presented at any of 31 medical facilities within the Henry Ford Health System in Detroit. Diagnoses were made between Jan. 1, 1995, and Dec. 31, 2014.

For the most part there were no significant differences in cardiovascular disease prevalence between the two cohorts. Rates of hypertension, obesity, coronary artery disease, heart failure, stroke, venous and arterial thrombosis, ventricular arrhythmias, atrial fibrillation, and chronic renal disease were numerically higher in the control group, but those differences were not statistically significant. There were significantly higher prevalence rates for diabetes (P = .0108) and hyperlipidemia (P = .0001) in the control group versus patients with hemophilia A.

The investigators pointed out that meaningful statistical differences using standardized differences were not reached for venous and arterial thrombosis and atrial fibrillation.

“It is worth noting that in the hemophilia A group, hypertension appeared first in the 18- to 29-year age group, as did venous thrombosis,” the investigators wrote, suggesting that monitoring, starting in the late teens, may be warranted.

The investigators also noted multiple study limitations, notably the small sample size, compared with commercial databases that were reviewed in previous studies. Additionally, the severity of disease was unknown for some of the hemophilia A patients and the study only followed patients for 1 year.

“The results of this retrospective chart review did not confirm diffuse statistically significant differences in [cardiovascular] comorbidities and their earlier onset in hemophilia A versus controls,” the investigators concluded.

The study was funded by Bayer. Three of the authors were employed by Bayer when the study was conducted. Other authors reported employment with Xcenda and the Henry Ford Health System and research funding from Xcenda.

SOURCE: Humphries TJ et al. Adv Med Sci. 2018;63(2):329-33.

Concerns may be unfounded for risks of earlier-onset cardiovascular disease in men with hemophilia A, according to investigators.

Cardiovascular comorbidities between groups were generally comparable, regardless of hemophilia A status, reported lead author Thomas J. Humphries, MD, of Bayer, and his colleagues.

“To date, there have been conflicting data in the literature regarding the risks of [cardiovascular] comorbidities in patients with hemophilia A, compared with the general population,” the investigators wrote in Advances in Medical Sciences. “Some studies have reported lower mortality from [cardiovascular] diseases and/or decreased atherogenesis in patients with hemophilia … conversely, other reports indicate comparable or higher [cardiovascular] comorbidities in patients with hemophilia, compared with the general population.”

In two previous commercial database reviews conducted by Dr. Humphries and his colleagues, cardiovascular disease appeared to occur more commonly and at a younger age in men with hemophilia A. More concerning, patients aged under 40 years showed elevated incidence of stroke and thrombosis. The authors sought to clarify these findings in the present study.

The retrospective chart review involved 74 men with hemophilia A and 222 men without the condition, matched by study year, payer type, race, and age. Patients presented at any of 31 medical facilities within the Henry Ford Health System in Detroit. Diagnoses were made between Jan. 1, 1995, and Dec. 31, 2014.

For the most part there were no significant differences in cardiovascular disease prevalence between the two cohorts. Rates of hypertension, obesity, coronary artery disease, heart failure, stroke, venous and arterial thrombosis, ventricular arrhythmias, atrial fibrillation, and chronic renal disease were numerically higher in the control group, but those differences were not statistically significant. There were significantly higher prevalence rates for diabetes (P = .0108) and hyperlipidemia (P = .0001) in the control group versus patients with hemophilia A.

The investigators pointed out that meaningful statistical differences using standardized differences were not reached for venous and arterial thrombosis and atrial fibrillation.

“It is worth noting that in the hemophilia A group, hypertension appeared first in the 18- to 29-year age group, as did venous thrombosis,” the investigators wrote, suggesting that monitoring, starting in the late teens, may be warranted.

The investigators also noted multiple study limitations, notably the small sample size, compared with commercial databases that were reviewed in previous studies. Additionally, the severity of disease was unknown for some of the hemophilia A patients and the study only followed patients for 1 year.

“The results of this retrospective chart review did not confirm diffuse statistically significant differences in [cardiovascular] comorbidities and their earlier onset in hemophilia A versus controls,” the investigators concluded.

The study was funded by Bayer. Three of the authors were employed by Bayer when the study was conducted. Other authors reported employment with Xcenda and the Henry Ford Health System and research funding from Xcenda.

SOURCE: Humphries TJ et al. Adv Med Sci. 2018;63(2):329-33.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

Photo from Bayer

Health Canada has approved Jivi^® (antihemophilic factor [recombinant, B-domain deleted, PEGylated]) for use in patients with hemophilia A.

Jivi (formerly BAY94-9027) is a DNA-derived, factor VIII concentrate developed by Bayer.

Health Canada has approved Jivi for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in previously treated hemophilia A patients age 12 and older.

Jivi is also approved for the control and prevention of episodic bleeding and for perioperative management of bleeding.

The recommended initial dosing for Jivi as prophylaxis is twice weekly, with the ability to dose every 5 days and further adjust dosing based on bleeding episodes.

Health Canada’s approval of Jivi is based on the PROTECT VIII trial. Results from this trial are available in the U.S. prescribing information for Jivi.

PROTECT VIII enrolled previously treated adults and adolescents (ages 12 to 65) with severe hemophilia A.

In part A, researchers evaluated different dosing regimens for Jivi used as prophylaxis and on-demand treatment. An optional extension study was available to patients who completed part A. In part B, Jivi was used for perioperative management of bleeding.

Efficacy

In part A, there were 132 patients in the intent‐to‐treat population—112 in the prophylaxis group and 20 in the on-demand group.

Patients received Jivi for 36 weeks. For the first 10 weeks, patients in the prophylaxis group received twice-weekly dosing at 25 IU/kg.

Patients with more than one bleed during this time went on to receive 30–40 IU/kg twice weekly. Patients with one or fewer bleeds were eligible for randomization to dosing every 5 days (45–60 IU/kg) or every 7 days (60 IU/kg).

The median annualized bleeding rate (ABR) was 4.1 for the patients who were treated twice weekly and were not eligible for randomization (n=13) and 1.9 for patients who were eligible for randomization but continued on twice-weekly treatment (n=11).

The median ABR was 1.9 for patients who were randomized to treatment every 5 days (n=43) and 0.96 for patients who completed prophylaxis with dosing every 7 days (32/43).

The median ABR for patients treated on demand was 24.1.

There were 388 treated bleeds in the on-demand group and 317 treated bleeds in the prophylaxis group. Overall, 73.3% of responses to treatment were considered “excellent” or “good,” 23.3% were considered “moderate,” and 3.3% were considered “poor.”

There were 17 patients who underwent 20 major surgeries in part B or the extension study and 10 patients who underwent minor surgeries in part A. Jivi provided “good” or “excellent” hemostatic control during all surgeries.

Safety

Safety data are available for 148 patients age 12 and older.

Adverse events in these patients included abdominal pain (3%), nausea (5%), vomiting (3%), injection site reactions (1%), pyrexia (5%), hypersensitivity (2%), dizziness (2%), headache (14%), insomnia (3%), cough (7%), erythema (1%), pruritus (1%), rash (2%), and flushing (1%).

A factor VIII inhibitor was reported in one adult patient, but repeat testing did not confirm the report.

One adult with asthma had a clinical hypersensitivity reaction and a transient increase of IgM anti-PEG antibody titer, which was negative upon retesting.

Photo from Bayer

Health Canada has approved Jivi^® (antihemophilic factor [recombinant, B-domain deleted, PEGylated]) for use in patients with hemophilia A.

Jivi (formerly BAY94-9027) is a DNA-derived, factor VIII concentrate developed by Bayer.

Health Canada has approved Jivi for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in previously treated hemophilia A patients age 12 and older.

Jivi is also approved for the control and prevention of episodic bleeding and for perioperative management of bleeding.

The recommended initial dosing for Jivi as prophylaxis is twice weekly, with the ability to dose every 5 days and further adjust dosing based on bleeding episodes.

Health Canada’s approval of Jivi is based on the PROTECT VIII trial. Results from this trial are available in the U.S. prescribing information for Jivi.

PROTECT VIII enrolled previously treated adults and adolescents (ages 12 to 65) with severe hemophilia A.

In part A, researchers evaluated different dosing regimens for Jivi used as prophylaxis and on-demand treatment. An optional extension study was available to patients who completed part A. In part B, Jivi was used for perioperative management of bleeding.

Efficacy

In part A, there were 132 patients in the intent‐to‐treat population—112 in the prophylaxis group and 20 in the on-demand group.

Patients received Jivi for 36 weeks. For the first 10 weeks, patients in the prophylaxis group received twice-weekly dosing at 25 IU/kg.

Patients with more than one bleed during this time went on to receive 30–40 IU/kg twice weekly. Patients with one or fewer bleeds were eligible for randomization to dosing every 5 days (45–60 IU/kg) or every 7 days (60 IU/kg).

The median annualized bleeding rate (ABR) was 4.1 for the patients who were treated twice weekly and were not eligible for randomization (n=13) and 1.9 for patients who were eligible for randomization but continued on twice-weekly treatment (n=11).

The median ABR was 1.9 for patients who were randomized to treatment every 5 days (n=43) and 0.96 for patients who completed prophylaxis with dosing every 7 days (32/43).

The median ABR for patients treated on demand was 24.1.

There were 388 treated bleeds in the on-demand group and 317 treated bleeds in the prophylaxis group. Overall, 73.3% of responses to treatment were considered “excellent” or “good,” 23.3% were considered “moderate,” and 3.3% were considered “poor.”

There were 17 patients who underwent 20 major surgeries in part B or the extension study and 10 patients who underwent minor surgeries in part A. Jivi provided “good” or “excellent” hemostatic control during all surgeries.

Safety

Safety data are available for 148 patients age 12 and older.

Adverse events in these patients included abdominal pain (3%), nausea (5%), vomiting (3%), injection site reactions (1%), pyrexia (5%), hypersensitivity (2%), dizziness (2%), headache (14%), insomnia (3%), cough (7%), erythema (1%), pruritus (1%), rash (2%), and flushing (1%).

A factor VIII inhibitor was reported in one adult patient, but repeat testing did not confirm the report.

One adult with asthma had a clinical hypersensitivity reaction and a transient increase of IgM anti-PEG antibody titer, which was negative upon retesting.

Photo from Bayer

Health Canada has approved Jivi^® (antihemophilic factor [recombinant, B-domain deleted, PEGylated]) for use in patients with hemophilia A.

Jivi (formerly BAY94-9027) is a DNA-derived, factor VIII concentrate developed by Bayer.

Health Canada has approved Jivi for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in previously treated hemophilia A patients age 12 and older.

Jivi is also approved for the control and prevention of episodic bleeding and for perioperative management of bleeding.

The recommended initial dosing for Jivi as prophylaxis is twice weekly, with the ability to dose every 5 days and further adjust dosing based on bleeding episodes.

Health Canada’s approval of Jivi is based on the PROTECT VIII trial. Results from this trial are available in the U.S. prescribing information for Jivi.

PROTECT VIII enrolled previously treated adults and adolescents (ages 12 to 65) with severe hemophilia A.

In part A, researchers evaluated different dosing regimens for Jivi used as prophylaxis and on-demand treatment. An optional extension study was available to patients who completed part A. In part B, Jivi was used for perioperative management of bleeding.

Efficacy

In part A, there were 132 patients in the intent‐to‐treat population—112 in the prophylaxis group and 20 in the on-demand group.

Patients received Jivi for 36 weeks. For the first 10 weeks, patients in the prophylaxis group received twice-weekly dosing at 25 IU/kg.

Patients with more than one bleed during this time went on to receive 30–40 IU/kg twice weekly. Patients with one or fewer bleeds were eligible for randomization to dosing every 5 days (45–60 IU/kg) or every 7 days (60 IU/kg).

The median annualized bleeding rate (ABR) was 4.1 for the patients who were treated twice weekly and were not eligible for randomization (n=13) and 1.9 for patients who were eligible for randomization but continued on twice-weekly treatment (n=11).

The median ABR was 1.9 for patients who were randomized to treatment every 5 days (n=43) and 0.96 for patients who completed prophylaxis with dosing every 7 days (32/43).

The median ABR for patients treated on demand was 24.1.

There were 388 treated bleeds in the on-demand group and 317 treated bleeds in the prophylaxis group. Overall, 73.3% of responses to treatment were considered “excellent” or “good,” 23.3% were considered “moderate,” and 3.3% were considered “poor.”

There were 17 patients who underwent 20 major surgeries in part B or the extension study and 10 patients who underwent minor surgeries in part A. Jivi provided “good” or “excellent” hemostatic control during all surgeries.

Safety

Safety data are available for 148 patients age 12 and older.

Adverse events in these patients included abdominal pain (3%), nausea (5%), vomiting (3%), injection site reactions (1%), pyrexia (5%), hypersensitivity (2%), dizziness (2%), headache (14%), insomnia (3%), cough (7%), erythema (1%), pruritus (1%), rash (2%), and flushing (1%).

A factor VIII inhibitor was reported in one adult patient, but repeat testing did not confirm the report.

One adult with asthma had a clinical hypersensitivity reaction and a transient increase of IgM anti-PEG antibody titer, which was negative upon retesting.

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

[email protected]

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

[email protected]

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

ATLANTA – Acute myocardial infarction is associated with a risk of stroke that extends beyond the 1-month time window currently considered the at-risk period, according to an analysis of Medicare data.

“The results of our study may allow clinicians to more accurately counsel patients regarding their stroke etiology and may allow refinement of stroke etiology classification systems and clinical trial selection criteria,” lead study author Alexander E. Merkler, MD, said in an interview in advance of the annual meeting of the American Neurological Association.

In an effort to better understand the duration of heightened stroke risk after acute myocardial infarction, Dr. Merkler, a neurologist at New York–based Weill Cornell Medicine, and his colleagues conducted a retrospective cohort study using inpatient and outpatient claims during 2008-2015 from a nationally representative 5% sample of Medicare beneficiaries who were at least 66 years old. They used previously validated ICD-9-CM diagnosis codes to ascertain the exposure variable of acute MI and the outcome of ischemic stroke but excluded strokes that occurred during an acute MI hospitalization.


Patients were censored at the time of ischemic stroke, death, end of Medicare coverage, or by Sept. 30, 2015. The researchers fit Cox regression models separately for the groups with and without acute MI to examine its association with ischemic stroke after adjusting for demographics, stroke risk factors, and Charlson comorbidities. Next, they used the corresponding survival probabilities to compute the hazard ratio (HR) in each 4-week interval after discharge, up to week 12. They also conducted a subgroup analysis to evaluate the duration of heightened ischemic stroke risk by MI type: ST-segment elevation MI (STEMI) versus non-STEMI (NSTEMI).

Dr. Merkler and his colleagues drew from data on 1.7 million eligible beneficiaries. Of these, 46,182 were hospitalized for acute MI and 80,466 for ischemic stroke. After they adjusted for demographics, stroke risk factors, and Charlson comorbidities, the researchers found that the risk of ischemic stroke was highest in the first 4 weeks after discharge from the MI hospitalization (HR, 2.7), yet remained elevated during weeks 5-8 (HR, 2.0) and weeks 9-12 (HR, 1.6). It was no longer significantly elevated afterward. The prolonged period of heightened ischemic stroke risk was evident in patients with both STEMI and NSTEMI.

“We were surprised by how long the risk of stroke lasts after MI,” Dr. Merkler said. He acknowledged certain limitations of the analysis, including the fact that patients were all over the age of 65 years. “In addition, we lack granular detail such as severity of MI [and] the extent of stroke work-up,” he said.

Dr. Merkler disclosed that he is supported by a grant from the National Institutes of Health and by the Leon Levy Foundation in Neuroscience. Most of his coauthors are also supported by NIH grants.

[email protected]

Source: Ann Neurol. 2018;84[S22]:S146-7, Abstract M122.

Warfarin tablets

Researchers say they have identified single-nucleotide polymorphisms (SNPs) that are associated with increased bleeding risk in African-American patients on warfarin.

A retrospective study revealed four SNPs associated with increased bleeding risk in African Americans with an international normalized ratio (INR) of less than 4.

One of these SNPs was seen in more than a third of bleeding cases and less than 5% of controls.

These preliminary findings could have implications for patients of African descent, but independent validation of the study results are needed, according to Minoli A. Perera, PharmD, PhD, of Northwestern University in Chicago, and her coauthors.

The researchers reported their findings in JAMA.

The report covered findings in a discovery cohort of African-American patients from a genome-wide study conducted at the University of Chicago and a replication cohort of patients who self-identified as African American and had routinely received care at University of Chicago hospitals.

The discovery cohort included 31 patients with major bleeding that occurred at an INR less than 4 and 184 controls with no documented history of bleeding related to warfarin.

In that cohort, Dr. Perera and her colleagues found four SNPs in linkage disequilibrium on chromosome 6 associated with warfarin-related bleeding:

• rs115112393
• rs16871327
• rs78132896
• rs114504854.

In particular, rs78132896 was found in 35.5% of cases (11/31) and 4.9% of controls (9/184), with an odds ratio of 8.31 (95% confidence interval [CI], 3.2-21.5).

The replication cohort, including 40 cases and 148 warfarin-treated controls, was genotyped specifically for rs78132896. The SNP was similarly found in 35.0% of cases (14/40) and 4.8% of controls (7/148), with an odds ratio of 8.24 (95% CI, 3.1-25.3).

“Genome-wide significance of this cohort was achieved when the cohorts were combined via meta-analysis,” the researchers wrote. They reported an odds ratio of 8.27 for that analysis (95% CI, 4.18-16.38).

Further analysis showed that, compared with wild-type alleles, the rs16871327 and rs78132896 risk alleles increased EPHA7 gene transcription.

Expression of the EPHA7 gene on vascular endothelial cells and peripheral lymphocytes is increased during inflammation, according to Dr. Perera and her coauthors. Increased EPHA7 expression might lead to bleeding in patients who are taking warfarin.

“This haplotype might also have potential implications for bleeding risk with direct oral anticoagulants,” the researchers wrote.

Dr. Perera and her coauthors reported no conflicts of interest related to their work on this study, which was funded by grants from the National Heart, Lung, and Blood Institute; the National Institute of General Medicine; the National Institutes of Health; and the American Heart Association Midwest Affiliate; as well as a research award from the University of Illinois at Chicago College of Pharmacy.

Warfarin tablets

Researchers say they have identified single-nucleotide polymorphisms (SNPs) that are associated with increased bleeding risk in African-American patients on warfarin.

A retrospective study revealed four SNPs associated with increased bleeding risk in African Americans with an international normalized ratio (INR) of less than 4.

One of these SNPs was seen in more than a third of bleeding cases and less than 5% of controls.

These preliminary findings could have implications for patients of African descent, but independent validation of the study results are needed, according to Minoli A. Perera, PharmD, PhD, of Northwestern University in Chicago, and her coauthors.

The researchers reported their findings in JAMA.

The report covered findings in a discovery cohort of African-American patients from a genome-wide study conducted at the University of Chicago and a replication cohort of patients who self-identified as African American and had routinely received care at University of Chicago hospitals.

The discovery cohort included 31 patients with major bleeding that occurred at an INR less than 4 and 184 controls with no documented history of bleeding related to warfarin.

In that cohort, Dr. Perera and her colleagues found four SNPs in linkage disequilibrium on chromosome 6 associated with warfarin-related bleeding:

• rs115112393
• rs16871327
• rs78132896
• rs114504854.

In particular, rs78132896 was found in 35.5% of cases (11/31) and 4.9% of controls (9/184), with an odds ratio of 8.31 (95% confidence interval [CI], 3.2-21.5).

The replication cohort, including 40 cases and 148 warfarin-treated controls, was genotyped specifically for rs78132896. The SNP was similarly found in 35.0% of cases (14/40) and 4.8% of controls (7/148), with an odds ratio of 8.24 (95% CI, 3.1-25.3).

“Genome-wide significance of this cohort was achieved when the cohorts were combined via meta-analysis,” the researchers wrote. They reported an odds ratio of 8.27 for that analysis (95% CI, 4.18-16.38).

Further analysis showed that, compared with wild-type alleles, the rs16871327 and rs78132896 risk alleles increased EPHA7 gene transcription.

Expression of the EPHA7 gene on vascular endothelial cells and peripheral lymphocytes is increased during inflammation, according to Dr. Perera and her coauthors. Increased EPHA7 expression might lead to bleeding in patients who are taking warfarin.

“This haplotype might also have potential implications for bleeding risk with direct oral anticoagulants,” the researchers wrote.

Dr. Perera and her coauthors reported no conflicts of interest related to their work on this study, which was funded by grants from the National Heart, Lung, and Blood Institute; the National Institute of General Medicine; the National Institutes of Health; and the American Heart Association Midwest Affiliate; as well as a research award from the University of Illinois at Chicago College of Pharmacy.

Warfarin tablets

Researchers say they have identified single-nucleotide polymorphisms (SNPs) that are associated with increased bleeding risk in African-American patients on warfarin.

A retrospective study revealed four SNPs associated with increased bleeding risk in African Americans with an international normalized ratio (INR) of less than 4.

One of these SNPs was seen in more than a third of bleeding cases and less than 5% of controls.

These preliminary findings could have implications for patients of African descent, but independent validation of the study results are needed, according to Minoli A. Perera, PharmD, PhD, of Northwestern University in Chicago, and her coauthors.

The researchers reported their findings in JAMA.

The report covered findings in a discovery cohort of African-American patients from a genome-wide study conducted at the University of Chicago and a replication cohort of patients who self-identified as African American and had routinely received care at University of Chicago hospitals.

The discovery cohort included 31 patients with major bleeding that occurred at an INR less than 4 and 184 controls with no documented history of bleeding related to warfarin.

In that cohort, Dr. Perera and her colleagues found four SNPs in linkage disequilibrium on chromosome 6 associated with warfarin-related bleeding:

• rs115112393
• rs16871327
• rs78132896
• rs114504854.

In particular, rs78132896 was found in 35.5% of cases (11/31) and 4.9% of controls (9/184), with an odds ratio of 8.31 (95% confidence interval [CI], 3.2-21.5).

The replication cohort, including 40 cases and 148 warfarin-treated controls, was genotyped specifically for rs78132896. The SNP was similarly found in 35.0% of cases (14/40) and 4.8% of controls (7/148), with an odds ratio of 8.24 (95% CI, 3.1-25.3).

“Genome-wide significance of this cohort was achieved when the cohorts were combined via meta-analysis,” the researchers wrote. They reported an odds ratio of 8.27 for that analysis (95% CI, 4.18-16.38).

Further analysis showed that, compared with wild-type alleles, the rs16871327 and rs78132896 risk alleles increased EPHA7 gene transcription.

Expression of the EPHA7 gene on vascular endothelial cells and peripheral lymphocytes is increased during inflammation, according to Dr. Perera and her coauthors. Increased EPHA7 expression might lead to bleeding in patients who are taking warfarin.

“This haplotype might also have potential implications for bleeding risk with direct oral anticoagulants,” the researchers wrote.

Dr. Perera and her coauthors reported no conflicts of interest related to their work on this study, which was funded by grants from the National Heart, Lung, and Blood Institute; the National Institute of General Medicine; the National Institutes of Health; and the American Heart Association Midwest Affiliate; as well as a research award from the University of Illinois at Chicago College of Pharmacy.

Uterine serous carcinoma patients may have a high risk of venous thromboembolism (VTE), not just in the postoperative period, but throughout the natural history of the disease, results of a retrospective analysis suggest.

Most patients developed VTE either before staging surgery or more than 6 months postoperatively, according to results of the analysis reported in Obstetrics & Gynecology.

Nearly one-third (31%) of the women developed VTE while receiving chemotherapy, reported Gregory M. Gressel, MD, a gynecologic oncology fellow at Montefiore Medical Center, New York, and his coinvestigators.

The risk was highest in women with cardiovascular disease, hypertension, and stage III and IV disease, they said.

“Although this is a retrospective study, it generates the hypothesis that venous thromboembolism prophylaxis may be beneficial in women with active uterine serous carcinoma, at least while receiving treatment such as neoadjuvant or adjuvant chemotherapy,” Dr. Gressel and his coauthors noted.

Historically, clinical practice guidelines have focused on risk stratification in the perioperative period due to the strong association between cancer-related VTE and surgery, the authors wrote.

To better assess the timing and risk factors associated with clot development, Dr. Gressel and his colleagues abstracted clinical data from the medical records of 413 patients with uterine serous carcinoma between 1999 and 2016 at one center in New York, about half of whom identified as black and one-quarter as Hispanic.

Eighty-four percent of the patients were diagnosed with VTE before or after the 6-week postoperative window when thromboprophylaxis typically is recommended, and 31% developed clots during chemotherapy, the investigators reported. The median time to clot development was 7.2 months after diagnosis, and, after excluding patients who developed clots preoperatively or during chemotherapy, the investigators found the median time from surgery to VTE was 13.2 months.

Patients with stage III and IV disease were, respectively, 2.6 and 4 times more likely to develop thrombosis, compared with patients with stage I disease. Conversely, age, body mass index, and race were not associated with VTE diagnosis.

Patients who developed VTE on chemotherapy had a median Khorana score of 1, which corresponds to an intermediate risk of VTE, the investigators said, adding that pharmacologic prophylaxis is recommended only in patients with scores of 3 or higher.

“Ours is not the first report to posit that currently available venous thromboembolism risk stratification tools are of limited utility in gynecologic oncology patients,” said Dr. Gressel and his coauthors.

However, larger prospective studies are needed, not only to look at the utility of Khorana scoring in this high-risk histologic subtype, they said, but also to test their hypothesis that VTE prophylaxis may be beneficial during chemotherapy or other active treatment.

Dr. Gressel and his colleagues reported no conflicts of interest. The study was supported by the National Institutes of Health and a grant from the National Center for Advancing Translational Science.

SOURCE: Gressel GM et al. Obstet Gynecol. 2018 Oct 5;132:1130-6.

Uterine serous carcinoma patients may have a high risk of venous thromboembolism (VTE), not just in the postoperative period, but throughout the natural history of the disease, results of a retrospective analysis suggest.

Most patients developed VTE either before staging surgery or more than 6 months postoperatively, according to results of the analysis reported in Obstetrics & Gynecology.

Nearly one-third (31%) of the women developed VTE while receiving chemotherapy, reported Gregory M. Gressel, MD, a gynecologic oncology fellow at Montefiore Medical Center, New York, and his coinvestigators.

The risk was highest in women with cardiovascular disease, hypertension, and stage III and IV disease, they said.

“Although this is a retrospective study, it generates the hypothesis that venous thromboembolism prophylaxis may be beneficial in women with active uterine serous carcinoma, at least while receiving treatment such as neoadjuvant or adjuvant chemotherapy,” Dr. Gressel and his coauthors noted.

Historically, clinical practice guidelines have focused on risk stratification in the perioperative period due to the strong association between cancer-related VTE and surgery, the authors wrote.

To better assess the timing and risk factors associated with clot development, Dr. Gressel and his colleagues abstracted clinical data from the medical records of 413 patients with uterine serous carcinoma between 1999 and 2016 at one center in New York, about half of whom identified as black and one-quarter as Hispanic.

Eighty-four percent of the patients were diagnosed with VTE before or after the 6-week postoperative window when thromboprophylaxis typically is recommended, and 31% developed clots during chemotherapy, the investigators reported. The median time to clot development was 7.2 months after diagnosis, and, after excluding patients who developed clots preoperatively or during chemotherapy, the investigators found the median time from surgery to VTE was 13.2 months.

Patients with stage III and IV disease were, respectively, 2.6 and 4 times more likely to develop thrombosis, compared with patients with stage I disease. Conversely, age, body mass index, and race were not associated with VTE diagnosis.

Patients who developed VTE on chemotherapy had a median Khorana score of 1, which corresponds to an intermediate risk of VTE, the investigators said, adding that pharmacologic prophylaxis is recommended only in patients with scores of 3 or higher.

“Ours is not the first report to posit that currently available venous thromboembolism risk stratification tools are of limited utility in gynecologic oncology patients,” said Dr. Gressel and his coauthors.

However, larger prospective studies are needed, not only to look at the utility of Khorana scoring in this high-risk histologic subtype, they said, but also to test their hypothesis that VTE prophylaxis may be beneficial during chemotherapy or other active treatment.

Dr. Gressel and his colleagues reported no conflicts of interest. The study was supported by the National Institutes of Health and a grant from the National Center for Advancing Translational Science.

SOURCE: Gressel GM et al. Obstet Gynecol. 2018 Oct 5;132:1130-6.

Uterine serous carcinoma patients may have a high risk of venous thromboembolism (VTE), not just in the postoperative period, but throughout the natural history of the disease, results of a retrospective analysis suggest.

Most patients developed VTE either before staging surgery or more than 6 months postoperatively, according to results of the analysis reported in Obstetrics & Gynecology.

Nearly one-third (31%) of the women developed VTE while receiving chemotherapy, reported Gregory M. Gressel, MD, a gynecologic oncology fellow at Montefiore Medical Center, New York, and his coinvestigators.

The risk was highest in women with cardiovascular disease, hypertension, and stage III and IV disease, they said.

“Although this is a retrospective study, it generates the hypothesis that venous thromboembolism prophylaxis may be beneficial in women with active uterine serous carcinoma, at least while receiving treatment such as neoadjuvant or adjuvant chemotherapy,” Dr. Gressel and his coauthors noted.

Historically, clinical practice guidelines have focused on risk stratification in the perioperative period due to the strong association between cancer-related VTE and surgery, the authors wrote.

To better assess the timing and risk factors associated with clot development, Dr. Gressel and his colleagues abstracted clinical data from the medical records of 413 patients with uterine serous carcinoma between 1999 and 2016 at one center in New York, about half of whom identified as black and one-quarter as Hispanic.

Eighty-four percent of the patients were diagnosed with VTE before or after the 6-week postoperative window when thromboprophylaxis typically is recommended, and 31% developed clots during chemotherapy, the investigators reported. The median time to clot development was 7.2 months after diagnosis, and, after excluding patients who developed clots preoperatively or during chemotherapy, the investigators found the median time from surgery to VTE was 13.2 months.

Patients with stage III and IV disease were, respectively, 2.6 and 4 times more likely to develop thrombosis, compared with patients with stage I disease. Conversely, age, body mass index, and race were not associated with VTE diagnosis.

Patients who developed VTE on chemotherapy had a median Khorana score of 1, which corresponds to an intermediate risk of VTE, the investigators said, adding that pharmacologic prophylaxis is recommended only in patients with scores of 3 or higher.

“Ours is not the first report to posit that currently available venous thromboembolism risk stratification tools are of limited utility in gynecologic oncology patients,” said Dr. Gressel and his coauthors.

However, larger prospective studies are needed, not only to look at the utility of Khorana scoring in this high-risk histologic subtype, they said, but also to test their hypothesis that VTE prophylaxis may be beneficial during chemotherapy or other active treatment.

Dr. Gressel and his colleagues reported no conflicts of interest. The study was supported by the National Institutes of Health and a grant from the National Center for Advancing Translational Science.

SOURCE: Gressel GM et al. Obstet Gynecol. 2018 Oct 5;132:1130-6.