Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial

JACC Cardiovasc Imaging. 2013 Feb;6(2):206-16. doi: 10.1016/j.jcmg.2012.10.016.

Abstract

Objectives: The aim of this prospective study was to identify the most effective and safest regimen among different thrombolytic treatment strategies.

Background: The best treatment strategies for prosthetic valve thrombosis have been controversial.

Methods: Transesophageal echocardiography-guided thrombolytic treatment was administered to 182 consecutive patients with prosthetic valve thrombosis in 220 different episodes (156 women; mean age, 43.2 ± 13.06 years) between 1993 and 2009 at a single center. These regimens chronologically included rapid (Group I), slow (Group II) streptokinase, high-dose (100 mg) tissue plasminogen activator (t-PA) (Group III), a half-dose (50 mg) and slow infusion (6 h) of t-PA without bolus (Group IV), and a low dose (25 mg) and slow infusion (6 h) of t-PA without bolus (Group V). The endpoints were thrombolytic success, in-hospital mortality, and nonfatal complication rates.

Results: The overall success rate in the whole series was 83.2%; it did not differ significantly among Groups I through V (68.8%, 85.4%, 75%, 81.5%, and 85.5%, respectively; p = 0.46). The overall complication rate in the whole series was 18.6%. Although the overall complication rate was similar among Groups I through IV (37.5%, 24.4 %, 33.3%, and 29.6%, respectively; p > 0.05 for each comparison), it was significantly lower in Group V (10.5%, p < 0.05 for each). The combined rates of mortality and nonfatal major complications were also lower in Group V than in the other groups, with all differences significant except for comparison of Groups IV and V. By multivariate analysis, the predictors of combined mortality plus nonfatal major complications were any thrombolytic therapy regimen other than Group V (odds ratios for Groups I through IV: 8.2, 3.8, 8.1, and 4.1, respectively; p < 0.05 for each) and a history of stroke/transient ischemic attack (odds ratio: 3.5, p = 0.011). In addition, there was no mortality in Group V.

Conclusions: Low-dose slow infusion of t-PA repeated as needed without a bolus provides effective and safe thrombolysis in patients with prosthetic valve thrombosis. (Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis; NCT01451320).

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Chi-Square Distribution
  • Drug Administration Schedule
  • Echocardiography, Transesophageal*
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hospital Mortality
  • Humans
  • Infusions, Parenteral
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Odds Ratio
  • Predictive Value of Tests
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure*
  • Risk Factors
  • Streptokinase / administration & dosage*
  • Streptokinase / adverse effects
  • Thrombolytic Therapy / adverse effects
  • Thrombolytic Therapy / methods*
  • Thrombolytic Therapy / mortality
  • Thrombosis / diagnostic imaging
  • Thrombosis / drug therapy*
  • Thrombosis / etiology
  • Thrombosis / mortality
  • Time Factors
  • Tissue Plasminogen Activator / administration & dosage*
  • Tissue Plasminogen Activator / adverse effects
  • Treatment Outcome
  • Turkey
  • Young Adult

Substances

  • Fibrinolytic Agents
  • Streptokinase
  • Tissue Plasminogen Activator

Associated data

  • ClinicalTrials.gov/NCT01451320