A prospective evaluation of bleeding risk of interventional techniques in chronic pain

Pain Physician. Jul-Aug 2011;14(4):317-29.

Abstract

Background: The role of antithrombotic therapy is well known for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were continued. However, it has been a common practice to discontinue antiplatelet therapy prior to performing interventional techniques, which may potentially increase the risk of acute cerebral and cardiovascular events.

Study design: A prospective study of 3,179 patients undergoing interventional techniques with 12,000 encounters and 18,472 procedures from May 2008 to December 2009.

Study setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.

Objective: To assess the rates of adverse events in patients undergoing interventional techniques on antithrombotic therapy with cessation or without cessation and compare them to a group of patients without antithrombotic therapy.

Methods: Measurable outcomes employed were intravascular entry of the needle, bruising, local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness.The prospective evaluation was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement which was developed with recommendations to improve the quality of reporting observational studies.

Results: The results of this study illustrated that in one-quarter (3,087) of patient encounters utilizing interventional pain management techniques, antithrombotic therapy was included. Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was continued during the interventional techniques, whereas, for 45%, or 1376 encounters, antithrombotic therapy was discontinued. Overall, these results illustrate that while intravascular penetration and oozing were higher in patients with continued antithrombotic therapy, bruising and local bleeding were higher in patients with discontinued antithrombotic therapy without any difference either statistical or clinical in any of the other aspects, either intraoperative, post procedure in the recovery room, or postoperative period.

Limitations: Limitations include the nonrandomized observational nature of the study and that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix).

Conclusion: No significant prevalence of adverse events was observed in those who continued with or ceased antithrombotic therapy.

Trial registration: ClinicalTrials.gov NCT00625248.

Publication types

  • Clinical Trial

MeSH terms

  • Cardiovascular Diseases / prevention & control
  • Chronic Disease
  • Female
  • Fibrinolytic Agents / administration & dosage
  • Fibrinolytic Agents / adverse effects
  • Hemorrhage / epidemiology*
  • Humans
  • Male
  • Middle Aged
  • Neurosurgical Procedures / adverse effects*
  • Orthopedic Procedures / adverse effects*
  • Pain / surgery*
  • Prospective Studies
  • Risk Factors
  • Thrombolytic Therapy / adverse effects*

Substances

  • Fibrinolytic Agents

Associated data

  • ClinicalTrials.gov/NCT00625248