Thrombolytic in mechanical prosthetic valve thrombosis

Not Applicable

Conditions: Mechanical prosthetic valve thrombosis.
Mechanical complication of heart valve prosthesis
T82.0

Registration Number: IRCT20181022041406N2

Lead Sponsor: Rajaie cardiovascular medical and research center

Brief Summary: Background Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. Methods and Results This single-center, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen (25 mg of recombinant tissue-type plasminogen activator [rtPA] infused in 25h) and a fast thrombolytic regimen (50 mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25 mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. Primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). Key safety outcome was a BARC type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3 years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group (OR, 1.58; 95% CI, 0.25 to 1.63; P = 0.34). One case of transient ischemic attack and 3 cases of intracranial hemorrhage (absolute risk difference, -12.5%; 95% CI, -23.1% to -1.0%; P = 0.04). were observed only in the fast-regimen group. Conclusions The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials (IRCT20181022041406N2).

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 120

Inclusion Criteria

Provision of signed and dated informed consent form
Patients with prosthetic mechanical valve thrombosis approved by echocardiography
Men and women = 18 year-old

Exclusion Criteria

Contraindication of thrombolytic therapy
Dyspnea of functional class 4
Thrombus size larger than 0.8 cm2

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of valve opening. Timepoint: Hospitalization. Method of measurement: Echocardiography.;Thrombus size. Timepoint: Hospitalization. Method of measurement: Echocardiography.;Clinical functional class. Timepoint: Hospitalization. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Bleeding. Timepoint: Hospitalization. Method of measurement: CT angiography.;Thromboembolic events. Timepoint: Hospitalization. Method of measurement: CT angiography.