Combining the direct thrombin inhibitor bivalirudin (Angiomax) with vascular closure devices was associated with the lowest rate of bleeding complications in patients undergoing percutaneous coronary intervention (PCI), a large database analysis showed.
Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.
The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.
Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):
6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin
But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.
By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.
"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.
"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.
The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.
Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.
Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.
Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.
One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.
"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.
In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.
"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."
Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."
"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.
"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.
The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."
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