Overall, complication rates related to PCI procedures have been drastically reduced, but bleeding complications remain the last barrier to safety. However, ongoing research has shed light on how some techniques and drugs may or may not be effective in reducing bleeding.
Big improvements—far enough?
“In the last 10 years, the safety of PCI has vastly improved, and in particular, the urgent revascularization rate has lowered to 0.1 percent—even less in many registries—due to improved strategies and technologies,” says Steven P. Marso, MD, an interventional cardiologist at Mid America Heart Institute at St. Luke’s Hospital in Kansas City, Mo. Likewise, the current U.S. mortality risk following PCI is 0.4 to 0.5 percent, and the restenosis rate is approximately 6 percent at six to nine months. Therefore, bleeding, with rates as high as 9 percent, is the last common and costly morbid complication that needs to be addressed in the PCI population.
One problem with assessing post-PCI bleeds is the lack of a unified definition of bleeding, according to Sunil V. Rao, MD, director of the cardiac cath lab at the Durham VA Medical Center in Durham, N.C. “The definition that a provider utilizes will clearly influence reported rates,” he adds. This was confirmed by Steinhubl et al in a meta-analysis of 13 trials evaluating antithrombotic drugs in more than 178,000 patients with acute coronary syndrome (ACS). The researchers noted that “it is undoubtedly true” that variations in major bleeding definitions have led to differences in reported rates (Am Heart J 2007;154:3-11).
“While some studies have used either the GUSTO or TIMI definition, others have used both, and yet others have combined selected elements of both scales,” wrote Vavelle and Rao (Interv Cardiol 2009;1:51-62).
However, there are certain elements of consensus for defining a bleed, including: overt bleeding, bleeding that requires a transfusion and bleeding severe enough to cause the hemoglobin to decrease by 3 grams. “If you combine these three data elements and examine the large registry data, the bleeding risk associated with PCI—whether for STEMI, non-STEMI or elective PCI—tends to be in the 7 to 9 percent range,” Rao says. Also, bleeding rates tend to be higher in women.
While bleeding rates have gradually decreased after PCI due to smaller catheters and targeted anticoagulant therapies, higher risk patients, such as those with STEMI or non-ST-elevation ACS, have experienced no change in bleeding complication rates—maintaining at about 10 percent, Rao says.
However, preventive measures can and should be employed whenever possible. “Even though experienced operators typically are better at preventing and managing complications, practices can always reduce their complication rates further,” says Gregory J. Mishkel, MD, an interventional cardiologist at Prairie Cardiovascular in Springfield, Ill. “Prevention is always preferable to treatment. Before PCI is undertaken, it needs to be assessed whether the risk of the procedure is worth the potential outcome.”
What’s in a bleed?
Among the more than one million PCIs performed annually in U.S. hospitals, bleeding occurs with wide variability and has wide-ranging effects on costs and healthcare resources. Major bleeding events result in an average four- to six-day increase in length of stay, and an average increase of hospital costs by $6,000 to $8,000 (Am J Cardiol 2003;92:930–935). However, certain facilities incur more expenses. For instance, every bleeding event costs the St. Luke’s Health System between $11,000 and $13,000.
Rao points to specific increased resource utilization with bleeds, including consultations, vascular surgery and increased imaging. “It’s a stepwise association, so the worse the bleeding, the more resources are utilized,” he says.
Also, research, such as the ACUITY trial, has shown that major bleeding complications are associated with short-term and long-term morbidity and mortality, which includes recurrent MI, stent thrombosis, stroke and death (J Am Coll Cardiol 2007;49:1362-1368). However, the majority of bleeds have not been found to be causal.
Despite a heightened focus on post-PCI bleeding, very few U.S. practices assess an individual’s risk for bleeding pre-procedurally. At St. Luke’s, however, caregivers recently began to systematically quantify every individual’s risk for bleeding. The software-driven calculated data are presented to the interventional cardiologist and