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Balance needed in managing ischemic, bleeding risks

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SAN FRANCISCO — Both ischemic complications and bleeding play important roles in patient outcomes after PCI, and managing them requires careful practice and a thorough understanding of their dynamic and evolving roles.

“You’ve got to understand that they’re equally important, one is not more important than the other,” Roxana Mehran, MD, of Mount Sinai School of Medicine in New York, said at TCT 2013. The impact of ischemia has long been appreciated, but numerous trials have also shown that bleeding has substantial impact on mortality. For example, the 6,012-patient REPLACE-2 trial showed a 1-year mortality rate of 8.8% in patients undergoing elective or urgent PCI who had a major bleeding event; the rate was 5.7% in patients with MI. Those without MI had a mortality rate of 1.9%, and those without a major bleed had a similar rate of 2.0%.

More recently, the ACUITY trial showed a 1-year mortality rate of 14.9% in patients with a major bleed compared with 3.6% in those without. Even in patients with STEMI, bleeding has been shown to be a major factor: in the HORIZONS-AMI trial, major bleeding yielded a HR for mortality of 3.39 (95% CI, 2.29-5.03; P<.0001). These results led to an understanding that bleeding should be standardized as much as MI has been; Mehran led the group that created the BARC scale for bleeding definitions published in 2011.

 

Roxana Mehran

There is evidence that the ongoing shift from femoral to radial access for PCI may reduce bleeding complications, but Mehran noted that bleeding is not at all limited to access site bleeds. With that in mind, agents like bivalirudin (Angiomax, The Medicines Company) are particularly important: in one study published in 2011, bivalirudin reduced all non-access site bleeds substantially (RR=0.62; 95% CI, 0.51-0.75; P<.0001). But balancing the ischemia risk with agents used to control bleeding can be a challenge. Mehran said that some new agents, such as the dual drug system pegnivacogin/anivamersen will help navigate that risk by allowing reversible control of clotting pathways.

“If you want to optimize the outcomes of PCI, you must balance ischemic and bleeding risks,” said Mehran, who is Associate Medical Editor of Cardiology Today’s Intervention. “This is not easy … We’re going to get there with better trial designs and perhaps with controlled anticoagulation with reversal agents to deal with the bleeding complication when we need it.”

For more information:

Mehran R. How to Treat Theater: Coronary Artery Disease II. Presented at: TCT 2013; Oct. 27-Nov. 1, 2013; San Francisco.

Disclosure: Mehran reports serving on the advisory board of Covidien, Janssen Pharmaceuticals and Sanofi-Aventis, and receiving grant/research support and consultant fees/honoraria from several device and pharmaceutical manufacturers.