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Peri-Interventional Management of Novel Oral Anticoagulants in Daily Care: Results From the Prospective Dresden NOAC Registry
Study Questions:
What is the effectiveness and safety of peri-interventional novel oral anticoagulant (NOAC) management and use daily in a large cohort of patients?
Methods:
Effectiveness and safety data were collected from an ongoing, prospective, non-interventional registry of >2,100 NOAC patients. Outcome events were adjudicated using standard event definitions. Differences in baseline variables or outcome event rates were compared using the Student’s t-test, Mann–Whitney U-test, Fisher’s exact test, or χ2 test, as appropriate.
Results:
Of 2,179 registered patients, 595 (27.3%) underwent 863 procedures (15.6% minimal, 74.3% minor, and 10.1% major procedures). Until day 30 ± 5 post-procedure, major cardiovascular events occurred in 1.0% of patients (95% confidence interval [CI], 0.5–2.0) and major bleeding complications in 1.2% (95% CI, 0.6-2.1). Cardiovascular and major bleeding complications were highest after major procedures (4.6 and 8.0%, respectively). Heparin bridging did not reduce cardiovascular events, but led to significantly higher rates of major bleeding complications (2.7%; 95% CI, 1.1-5.5) compared with no bridging (0.5%; 95% CI, 0.1-1.4; p = 0.010). Multivariate analysis demonstrated diabetes (odds ratio [OR], 13.2) and major procedures (OR, 7.3) as independent risk factors for cardiovascular events. Major procedures (OR, 16.8) were an independent risk factor for major bleeding complications. However, if major and nonmajor procedures were separately assessed, heparin bridging was not an independent risk factor for major bleeding.
Conclusions:
The authors concluded that continuation or short-term interruption of NOAC is a safe strategy for most invasive procedures.
Perspective:
These data indicate that interventional procedures are common in anticoagulated patients and mostly consist of minimal or minor procedures. Complication rates are low and fatal complications seem to be very rare, indicating that peri-interventional short-term interruption of NOAC for minor procedures is safe. However, patients at cardiovascular risk who need to undergo major procedures may benefit from heparin bridging, because the risk for cardiovascular adverse outcomes appears to be increased in these individuals. Additional research is necessary to identify patients at risk for thromboembolic and bleeding complications, and to help develop preventive measures to avoid these potentially devastating complications.
Keywords: Multivariate Analysis, Statistics, Nonparametric, Heparin, Cardiovascular Diseases, Risk Factors, Hemorrhage, Diabetes Mellitus
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