학술논문
Fast vs. ultraslow thrombolytic infusion regimens in patients with obstructive mechanical prosthetic valve thrombosis: a pilot randomized clinical trial
Document Type
Academic Journal
Author
Sadeghipour, Parham; Saedi, Sedigheh; Saneei, Leila; Rafiee, Farnaz; Yoosefi, Siamak; Parsaee, Mozhgan; Siami, Rashide; Saberi, Milad; Pouraliakbar, Hamidreza; Ghadrdoost, Behshid; Bakhshandeh, Hooman; Peighambari, Mohammad Mehdi; Farrashi, Melody; Mohebbi, Bahram; Naderi, Nasim; Amin, Ahmad; Maleki, Majid; Khajali, Zahra; Caterina, Raffaele De
Source
European Heart Journal: Cardiovascular Pharmacotherapy. November 2022, Vol. 8 Issue 7, p668, 9 p.
Subject
Language
English
ISSN
2055-6837
Abstract
Introduction Mechanical prosthetic valve thrombosis (MPVT) is a serious and often fatal complication after heart valve replacement surgery. (1,2) Its incidence is estimated at 0.5-8% for left-sided valves, 20% for [...]
Aims Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test the safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. Methods and results This single-centre, 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 25 h] and a fast thrombolytic regimen (50 mg of rtPA infused in 6 h). If thrombolysis failed, a repeated dose of 25 mgof rtPA for 6 h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. The primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, Conclusion The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials. Keywords Prosthetic valve dysfunction * Mechanical prosthetic valve thrombosis * Thrombolytic therapy * Thrombolysis * Cardiac surgery
Aims Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test the safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. Methods and results This single-centre, 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 25 h] and a fast thrombolytic regimen (50 mg of rtPA infused in 6 h). If thrombolysis failed, a repeated dose of 25 mgof rtPA for 6 h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. The primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, Conclusion The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials. Keywords Prosthetic valve dysfunction * Mechanical prosthetic valve thrombosis * Thrombolytic therapy * Thrombolysis * Cardiac surgery