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Universal definition of bleeding needed, researchers suggest
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Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting
According to two researchers, the time has come for a universal definition of bleeding, which would facilitate communication and comparative effectiveness.
According to Sunil V. Rao, MD, of the Duke Clinical Research Institute in Durham, N.C., agreeing upon a universal bleeding definition is important because of significant differences in current bleeding definitions. “Catastrophic” bleeds, for example, might be as low as 1.2% using some clinical trial definitions, but could be more than 8% using others. This variability, in turn, drives prescription practices and could lead to underprescribing or overprescribing of bleeding medications.
Rao said among clinical trials that used varying definitions of bleeding, many agree on the basics of severe bleeding events (ie, fatality and intracranial hemorrhage), while others differ. Part of the GUSTO definition of severe bleeding, for example, includes the fact that it must cause hemodynamic compromise that requires intervention. In the CURE definition, severe bleeding events are defined simply as those requiring surgery.
“This leads to confusion in the clinical development community, because you are expected to report a variety of bleeding definitions,” Rao said.
Working with the Bleeding Academic Research Consortium (BARC), Rao and colleagues proposed an updated model for standard bleeding conditions. The BARC model proposes using a number system to prioritize bleeding severity. The BARC system also includes CABG-related bleeding.
Rao told audience members to anticipate forthcoming data compiled using the BARC definition and added that he hopes this model will help standardize current bleeding definitions.
Steven P. Marso, MD, of the Mid America Heart and Vascular Institute in Kansas City, Mo., presented data gathered from the National Cardiovascular Data Registry (NCDR) suggesting that nearly 2% of 1.5 million PCI patients experience post-PCI bleeding.
Marso also highlighted an analysis of data from the NCDR CathPCI registry that he published in the Journal of the American Medical Association suggesting that the use of bivalirudin plus a vascular closure device was associated with an absolute 3.8% decreased risk of PCI-related bleeding in high-risk patients. In order to prevent one bleeding event in high-risk patients, Marso said, it would require treatment in 33 patients with the combination of vascular closure devices and bivalirudin.
Marso cited data from Mehta and colleagues indicating that the use of a bleeding risk strata (incorporating clinical elements such as STEMI, female sex, previous congestive HF, no previous PCI, age, peripheral vascular disease and estimated glomerular filtration rate) can also assist in the prioritization of therapeutic options.
Disclosures:
- Dr. Marso reports receiving grant funds from Amylin Pharmaceuticals, The Medicines Company, Terumo and Volcano Corp.
- Dr. Rao reports being a consultant and receiving honoraria from AstraZeneca, Daiichi-Sankyo, Eli Lilly, BMS/Sanofi-Aventis, The Medicines Company, Terumo Corporation, and receiving research funding from Cordis Corp., Momenta Pharmaceuticals and Portola Pharmaceuticals.