Antiplatelet drug appears effective for women

One doctor examines a patient

while another doctor looks on

Photo courtesy of NCI

An analysis of data from the CHAMPION PHOENIX trial suggests cangrelor is more effective than clopidogrel for preventing complications in women undergoing percutaneous coronary intervention (PCI).

Rates of severe bleeding did not differ significantly between the treatment arms, but women who received cangrelor had a higher rate of moderate bleeding than those who received clopidogrel.

Researchers relayed these results in Circulation.

The CHAMPION PHOENIX trial was funded by The Medicines Company, which manufactures cangrelor.

For this phase 3 trial, researchers compared the safety and efficacy of clopidogrel and cangrelor in 11,145 patients who were undergoing elective or urgent PCI.

In the initial analysis of trial data, cangrelor reduced the overall odds of complications from PCI, which included death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis.

But cangrelor also resulted in significantly higher rates of major and minor bleeding when compared to clopidogrel. The rates of severe bleeding were similar between the treatment arms.

With the current analysis, researchers wanted to determine if the effects of cangrelor and clopidogrel differed between men and women.

“In the past, questions have been raised about the safety and efficacy of blood thinners in women,” said study author Michelle O’Donoghue, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“This study provides important reassurance, overall, that [cangrelor] appears to offer as much benefit for women as it does for men.”

The primary efficacy endpoint was the composite of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours. The primary safety endpoint was GUSTO severe bleeding at 48 hours.

Sex differences

Of the 11,451 patients in this trial, 3051 (28%) were female. These patients were more likely than males to be older and to have a history of diabetes mellitus, hypertension, hyperlipidemia, prior stroke, or transient ischemic attack.

Women were more likely than men to be enrolled with stable angina or non ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction was more common in men.

The women were less likely to have a prior history of myocardial infarction or coronary revascularization, and they had lower baseline hemoglobin and hematocrit levels than men.

Men were more likely than women to receive aspirin, but there was no difference between the sexes when it came to the choice of clopidogrel loading dose and the use of unfractionated heparin and bivalirudin. The median duration of PCI was longer in men than women, but the choice of access site was similar.

When the researchers adjusted for potentially confounding factors, they found that being female was independently associated with higher odds of the primary efficacy outcome (adjusted odds ratio [aOR]=1.30) and GUSTO moderate or severe bleeding (aOR=2.70).

Efficacy and safety

For women, cangrelor was associated with a significant decrease in the odds of achieving the primary efficacy endpoint. Men were less likely to achieve the endpoint when on cangrelor as well, but the difference between the cangrelor and clopidogrel arms was not statistically significant for men.

The percentage of women who met criteria for the primary efficacy endpoint was 4.8% in the cangrelor arm and 6.9% in the clopidogrel arm (aOR=0.65, P=0.01). The percentage of men who did so was 4.7% in the cangrelor arm and 5.5% in the clopidogrel arm (aOR=0.86, P=0.14, P interaction=0.23).

Cangrelor was associated with a significantly lower risk of stent thrombosis at 48 hours for women but not men.

For women, the incidence of stent thrombosis was 0.8% in the cangrelor arm and 1.9% in the clopidogrel arm (aOR=0.39, P=0.01). For men, the rates were 0.9% and 1.1%, respectively (aOR=0.84, P=0.44, P interaction=0.11).

There was no significant difference in severe bleeding between the treatment arms for men or women, but women had a significantly higher risk of moderate bleeding if they received cangrelor.

For women, the rate of severe bleeding was 0.3% in the cangrelor arm and 0.2% in the clopidogrel arm (aOR=2.37, P=0.30). For men, the rates were 0.1% in both arms (aOR=2.04, P=0.41, P interaction=0.88 ).

For women, the rate of moderate bleeding was 0.9% in the cangrelor arm and 0.3% in the clopidogrel arm (aOR=3.63, P=0.02). For men, the rates were 0.2% in both arms (aOR=0.81, P=0.68, P interaction=0.04).

One doctor examines a patient

while another doctor looks on

Photo courtesy of NCI

An analysis of data from the CHAMPION PHOENIX trial suggests cangrelor is more effective than clopidogrel for preventing complications in women undergoing percutaneous coronary intervention (PCI).

Rates of severe bleeding did not differ significantly between the treatment arms, but women who received cangrelor had a higher rate of moderate bleeding than those who received clopidogrel.

Researchers relayed these results in Circulation.

The CHAMPION PHOENIX trial was funded by The Medicines Company, which manufactures cangrelor.

For this phase 3 trial, researchers compared the safety and efficacy of clopidogrel and cangrelor in 11,145 patients who were undergoing elective or urgent PCI.

In the initial analysis of trial data, cangrelor reduced the overall odds of complications from PCI, which included death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis.

But cangrelor also resulted in significantly higher rates of major and minor bleeding when compared to clopidogrel. The rates of severe bleeding were similar between the treatment arms.

With the current analysis, researchers wanted to determine if the effects of cangrelor and clopidogrel differed between men and women.

“In the past, questions have been raised about the safety and efficacy of blood thinners in women,” said study author Michelle O’Donoghue, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“This study provides important reassurance, overall, that [cangrelor] appears to offer as much benefit for women as it does for men.”

The primary efficacy endpoint was the composite of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours. The primary safety endpoint was GUSTO severe bleeding at 48 hours.

Sex differences

Of the 11,451 patients in this trial, 3051 (28%) were female. These patients were more likely than males to be older and to have a history of diabetes mellitus, hypertension, hyperlipidemia, prior stroke, or transient ischemic attack.

Women were more likely than men to be enrolled with stable angina or non ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction was more common in men.

The women were less likely to have a prior history of myocardial infarction or coronary revascularization, and they had lower baseline hemoglobin and hematocrit levels than men.

Men were more likely than women to receive aspirin, but there was no difference between the sexes when it came to the choice of clopidogrel loading dose and the use of unfractionated heparin and bivalirudin. The median duration of PCI was longer in men than women, but the choice of access site was similar.

When the researchers adjusted for potentially confounding factors, they found that being female was independently associated with higher odds of the primary efficacy outcome (adjusted odds ratio [aOR]=1.30) and GUSTO moderate or severe bleeding (aOR=2.70).

Efficacy and safety

For women, cangrelor was associated with a significant decrease in the odds of achieving the primary efficacy endpoint. Men were less likely to achieve the endpoint when on cangrelor as well, but the difference between the cangrelor and clopidogrel arms was not statistically significant for men.

The percentage of women who met criteria for the primary efficacy endpoint was 4.8% in the cangrelor arm and 6.9% in the clopidogrel arm (aOR=0.65, P=0.01). The percentage of men who did so was 4.7% in the cangrelor arm and 5.5% in the clopidogrel arm (aOR=0.86, P=0.14, P interaction=0.23).

Cangrelor was associated with a significantly lower risk of stent thrombosis at 48 hours for women but not men.

For women, the incidence of stent thrombosis was 0.8% in the cangrelor arm and 1.9% in the clopidogrel arm (aOR=0.39, P=0.01). For men, the rates were 0.9% and 1.1%, respectively (aOR=0.84, P=0.44, P interaction=0.11).

There was no significant difference in severe bleeding between the treatment arms for men or women, but women had a significantly higher risk of moderate bleeding if they received cangrelor.

For women, the rate of severe bleeding was 0.3% in the cangrelor arm and 0.2% in the clopidogrel arm (aOR=2.37, P=0.30). For men, the rates were 0.1% in both arms (aOR=2.04, P=0.41, P interaction=0.88 ).

For women, the rate of moderate bleeding was 0.9% in the cangrelor arm and 0.3% in the clopidogrel arm (aOR=3.63, P=0.02). For men, the rates were 0.2% in both arms (aOR=0.81, P=0.68, P interaction=0.04).

One doctor examines a patient

while another doctor looks on

Photo courtesy of NCI

An analysis of data from the CHAMPION PHOENIX trial suggests cangrelor is more effective than clopidogrel for preventing complications in women undergoing percutaneous coronary intervention (PCI).

Rates of severe bleeding did not differ significantly between the treatment arms, but women who received cangrelor had a higher rate of moderate bleeding than those who received clopidogrel.

Researchers relayed these results in Circulation.

The CHAMPION PHOENIX trial was funded by The Medicines Company, which manufactures cangrelor.

For this phase 3 trial, researchers compared the safety and efficacy of clopidogrel and cangrelor in 11,145 patients who were undergoing elective or urgent PCI.

In the initial analysis of trial data, cangrelor reduced the overall odds of complications from PCI, which included death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis.

But cangrelor also resulted in significantly higher rates of major and minor bleeding when compared to clopidogrel. The rates of severe bleeding were similar between the treatment arms.

With the current analysis, researchers wanted to determine if the effects of cangrelor and clopidogrel differed between men and women.

“In the past, questions have been raised about the safety and efficacy of blood thinners in women,” said study author Michelle O’Donoghue, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“This study provides important reassurance, overall, that [cangrelor] appears to offer as much benefit for women as it does for men.”

The primary efficacy endpoint was the composite of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours. The primary safety endpoint was GUSTO severe bleeding at 48 hours.

Sex differences

Of the 11,451 patients in this trial, 3051 (28%) were female. These patients were more likely than males to be older and to have a history of diabetes mellitus, hypertension, hyperlipidemia, prior stroke, or transient ischemic attack.

Women were more likely than men to be enrolled with stable angina or non ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction was more common in men.

The women were less likely to have a prior history of myocardial infarction or coronary revascularization, and they had lower baseline hemoglobin and hematocrit levels than men.

Men were more likely than women to receive aspirin, but there was no difference between the sexes when it came to the choice of clopidogrel loading dose and the use of unfractionated heparin and bivalirudin. The median duration of PCI was longer in men than women, but the choice of access site was similar.

When the researchers adjusted for potentially confounding factors, they found that being female was independently associated with higher odds of the primary efficacy outcome (adjusted odds ratio [aOR]=1.30) and GUSTO moderate or severe bleeding (aOR=2.70).

Efficacy and safety

For women, cangrelor was associated with a significant decrease in the odds of achieving the primary efficacy endpoint. Men were less likely to achieve the endpoint when on cangrelor as well, but the difference between the cangrelor and clopidogrel arms was not statistically significant for men.

The percentage of women who met criteria for the primary efficacy endpoint was 4.8% in the cangrelor arm and 6.9% in the clopidogrel arm (aOR=0.65, P=0.01). The percentage of men who did so was 4.7% in the cangrelor arm and 5.5% in the clopidogrel arm (aOR=0.86, P=0.14, P interaction=0.23).

Cangrelor was associated with a significantly lower risk of stent thrombosis at 48 hours for women but not men.

For women, the incidence of stent thrombosis was 0.8% in the cangrelor arm and 1.9% in the clopidogrel arm (aOR=0.39, P=0.01). For men, the rates were 0.9% and 1.1%, respectively (aOR=0.84, P=0.44, P interaction=0.11).

There was no significant difference in severe bleeding between the treatment arms for men or women, but women had a significantly higher risk of moderate bleeding if they received cangrelor.

For women, the rate of severe bleeding was 0.3% in the cangrelor arm and 0.2% in the clopidogrel arm (aOR=2.37, P=0.30). For men, the rates were 0.1% in both arms (aOR=2.04, P=0.41, P interaction=0.88 ).

For women, the rate of moderate bleeding was 0.9% in the cangrelor arm and 0.3% in the clopidogrel arm (aOR=3.63, P=0.02). For men, the rates were 0.2% in both arms (aOR=0.81, P=0.68, P interaction=0.04).