Vascular closure devices, bivalirudin reduce bleeding in PCI
MedWire News: Use of vascular closure devices (VCDs) and treatment with bivalirudin are associated with reduced bleeding rates among patients undergoing percutaneous coronary intervention (PCI), according to an analysis of registry data.
The greatest benefits were seen in patients at highest risk for bleeding, yet these patients were the least likely to receive either strategy, and the most likely to receive manual compression of the arterial access site.
“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,” the study authors comment in the Journal of the American Medical Association.
Steven Marso (University of Missouri Kansas City, USA) and colleagues compared bleeding rates among over 1.5 million patients undergoing PCI and receiving strategies to mitigate bleeding, using data from the National Cardiovascular Data Registry (NCDR) CathPCI registry.
They report that 30,654 (2%) patients had a bleeding event. Manual compression, VCDs, bivalirudin, or VCDs plus bivalirudin were used in 35%, 24%, 23%, and 18% of patients, respectively.
Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1%, 1.6%, and 0.9% of patients receiving VCDs, bivalirudin, and both strategies, respectively (p<0.001).
According to the NCDR CathPCI bleeding risk model, preprocedural bleeding risk was classified as low (<1%) in 475,152 (31%) patients, intermediate (1–3%) in 746,727 (49%) patients, and high (>3%) in 301,056 (20%) patients.
As preprocedural bleeding risk increased so the difference in actual bleeding rates among strategies became more pronounced. In the low-risk group, manual compression was associated with a bleeding rate of 0.9%, compared with 0.9% for VCDs, 0.6% for bivalirudin, and 0.4% for VCDs plus bivalirudin, while in the intermediate-risk group the corresponding rates were 2.3% versus 1.9%, 1.4%, and 0.8%. And in the high-risk group the corresponding rates were 6.1% versus 4.6%, 3.8%, and 2.3%, respectively.
The association persisted following adjustment for propensity scores and site. In the high-risk group, the 3.8% absolute lower bleeding rate with VCDs plus bivalirudin compared with manual bleeding translated into an estimated number needed to treat (NNT) to prevent one bleeding event of 33, compared with a corresponding NNT of 80 in the intermediate-risk group, and 188 in the low-risk group.
Despite these findings, manual compression was used more often in the high-risk group than in the intermediate- and low-risk groups, at 40.3% versus 35.0% and 30.8%, respectively (p<0.001). Conversely, use of VCDs and bivalirudin was highest in low-risk patients (21.0%) and lower in intermediate (17.8%) and high-risk (14.4%) patients (p<0.001).
In a related editorial, Deepak Bhatt (Harvard Medical School, Boston, Massachusetts, USA) notes that a similar treatment paradox has also been documented for coronary angiography and revascularization in an acute coronary syndrome registry analysis.
Given that no randomized trial has yet found any clear advantage with VCDs, Bhatt writes: “Thus, extensive registry data such as these – with appropriate adjustment for measured confounders – are of great use in guiding clinical decision making, even though ideally a randomized controlled trial should still be performed.”
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By Caroline Price