CORRESPONDENCE: LETTER TO THE EDITOR
Reply
Harvey D. White, DSc, FACC*,
Gregg W. Stone, MD, FACC on behalf of the ACUITY Investigators
* Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, Auckland, 1030, New Zealand (Email: HarveyW{at}adhb.govt.nz).
We would like to thank Drs. Mishra and Walters for their interest in our work (1). As they accurately point out, there were differences in 2 of the more than 20 baseline characteristics. However, although patients in the heparin plus glycoprotein IIb/IIIa inhibitor (GPI) group more frequently had increased creatine kinase-myocardial band, troponin levels, or electrocardiogram changes, multivariate logistic regression confirmed the results of the univariate analysis. This adjusted analysis demonstrated that switching from heparin plus a GPI to bivalirudin monotherapy resulted in similar rates of composite ischemia (odds ratio [OR]: 0.97; 95% confidence interval [CI]: 0.76 to 1.23; p = 0.77), and significantly less non-coronary artery bypass graft major bleeding (OR: 0.47; 95% CI: 0.34 to 0.66; p < 0.0001) and net clinical events (OR: 0.76; 95% CI: 0.62 to 0.94; p = 0.01).
Regarding why we elected not to display the results of the bivalirudin plus GPI group, in the main ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial (2), bivalirudin plus GPI showed no incremental benefit over bivalirudin alone in terms of reducing ischemia but did result in more bleeding. Given these facts, the more expensive bivalirudin plus GPI regimen is unlikely to enter routine clinical practice and, thus, we did not include these data in the article.
The third point Drs. Mishra and Walters make is that the ACUITY trial was designed to assess the addition of a treatment (bivalirudin) to guideline-recommended therapy. We believe that this is the appropriate way to perform trials; it would be detrimental for patients to test new treatments in the absence of guideline-recommended therapies.
Finally, in respect to cost effectiveness, preliminary analysis shows bivalirudin to be very cost effective. A prospective analysis (3) showed that 30-day costs were lowest with bivalirudin monotherapy compared with heparin plus GPI (cost savings ranging from $123 per patient with bivalirudin monotherapy vs. heparin + GPI administration in the catheterization laboratory to $422 per patient with bivalirudin monotherapy vs. heparin + upstream GPI).
Thus, adjusted analysis of the switch cohort demonstrates that the results with bivalirudin monotherapy remain consistent despite slight differences in baseline characteristics. The present study supports the safety and efficacy of switching to bivalirudin from unfractionated heparin or enoxaparin in moderate- and high-risk patients with non–ST-segment elevation acute coronary syndromes and preserves the 50% reduction in major bleeding seen with bivalirudin, with comparable rates of ischemia and, thus, improved overall patient outcomes.
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References
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- White HD, Chew D, Hoekstra J, et al. Safety and efficacy of switching from either unfractionated heparin or enoxaparin to bivalirudin in patients with non–ST-segment elevation acute coronary syndromes managed with an invasive strategy: results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial J Am Coll Cardiol 2008;51:1734-1741.[Abstract/Free Full Text]
- Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes N Engl J Med 2006;355:2203-2216.[Abstract/Free Full Text]
- Pinto DS, Stone GW, Shi C, et al. Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes 2008Paper presented at: the American College of Cardiology 57th Annual Scientific Sessions; March 29 to April 1,; Chicago, IL.
Related Article
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IIb or Not IIb
- Akshay Mishra and Darren Walters
J. Am. Coll. Cardiol. 2008 52: 1277-1278.
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