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Monday, April 11 2005

CADILLAC: Body Size May Contribute to Higher Death Rate for Female Heart Attack Patients
By Julie McKeel

A new analysis of the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial data shows that while women, like men, benefited from stenting, more than twice as many women as men died in the trial. The study, reported in the latest issue of Circulation, indicates that the smaller body surface area (BSA) in women is a "critical factor" in this finding, along with older age, existing conditions, and more frequent complications during their treatment procedures.

[CADILLAC studied the use of stents versus angioplasty in patients suffering from an acute myocardial infarction (AMI), commonly called a heart attack. The trial also tested the effectiveness of abciximab, an anti-clotting drug from a class called GP IIb/IIIa inhibitors, with these two procedures. DCRI served as a study site for the original trial and coordinated the Clinical Events Committee (CEC). The DCRI's Dr. James Tcheng was a co-author of the paper published this week.]

According to the study authors, gender was not an independent risk factor of death, thus dismissing the idea of a biological risk associated with women.

In general, women with AMI have had higher death rates than men, regardless of the type of treatment procedures used. The authors hoped to pinpoint the best AMI treatment approach in women by examining the procedural characteristics and outcomes in women enrolled in the CADILLAC trial.

As with the overall findings from the trial, the researchers found that stenting with or without abciximab resulted in lower target vessel revascularization (TVR) rates and lower MACE (major adverse cardiac events) rates. Adding abciximab in women who received stents lowered the 30-day TVR rates but had no impact on TVR at one year.

There was a longer delay in hospitalization for women after the onset of symptoms (e.g., chest pain) than for men (2.05 versus 1.68 hours). The delay between hospitalization and actual treatment was also longer (2.18 hours for women versus 1.95 hours for men). Women were more likely to have in-hospital complications, including hypotension, congestive heart failure, CPR, and death, and they also had higher MACE rates. Bleeding was more common in women than men at all stages in the trial.

The authors note that after adjusting for baseline characteristics"female gender was an independent correlate of death at one year." When the body surface area was factored into the analysis, gender remained a significant predictor of MACE and bleeding complications, but not of death.

BSA is sometimes overlooked in risk analyses in spite of the evidence that the smaller body surface area in women can contribute to a higher death rate. The implications behind this increased risk are not entirely clear but may be due to increased procedural complications in small vessels, such as dissections and perforations, and drug dosing that is not weight-adjusted. However, the authors state that GP IIb/IIIa inhibitor doses were weight-adjusted in CADILLAC and are weight-adjusted in contemporary angioplasty.

The current paper also points to the differences in the delay of treatment. Education campaigns are already underway to address the problem of seeking treatment. However, healthcare providers must focus on the all-too-common delay in treatment once hospitalization occurs and use this information as an opportunity for improving outcomes in women.

     
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