Key result
An ultraslow thrombolytic regimen of rtPA achieved complete thrombosis resolution in 85.0% of patients versus 78.3% with a fast regimen (OR 1.58; 95% CI 0.25-1.63; P=0.34).
Why the study?
Randomized clinical trials had not yet tested the safety and efficacy of a proposed ultraslow thrombolytic infusion regimen for mechanical prosthetic valve thrombosis.
Does an ultraslow thrombolytic infusion regimen improve complete resolution and safety compared to a fast regimen in adult patients with acute obstructive mechanical prosthetic valve thrombosis?
RCT (n=120)
Open-label
randomized
No
Does an ultraslow thrombolytic infusion regimen improve complete resolution and safety compared to a fast regimen in adult patients with acute obstructive mechanical prosthetic valve thrombosis?
Odds Ratio: 1.58 (95% CI 0.25–1.63)
Absolute Event Rate: 85% vs 78.3%
p-value: p=0.34
An ultraslow rtPA infusion regimen for mechanical prosthetic valve thrombosis achieved high rates of resolution comparable to a fast regimen, with a potentially lower risk of major neurological complications.
Ultraslow thrombolysis showed high resolution without major complications in this pilot; larger RCTs needed before practice change.
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 mg of 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, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). The key safety outcome was a Bleeding Academic Research Consortium 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 [odds ratio 1.58; 95% confidence interval (CI) 0.25-1.63; P = 0.34]. One case of transient ischaemic attack and three cases of intracranial haemorrhage (absolute risk difference -6.6%; 95%CI -12% -0.3%; P = 0.07) were observed only in the fast-regimen group. CONCLUSION: The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials.
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Sadeghipour et al. (2021) conducted an RCT in Acute obstructive mechanical prosthetic valve thrombosis (n=120). Ultraslow thrombolytic regimen (rtPA) vs. Fast thrombolytic regimen (50 mg infused in 6 h) was evaluated on 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) (OR 1.58, 95% CI 0.25-1.63, p=0.34). An ultraslow thrombolytic regimen of rtPA achieved complete thrombosis resolution in 85.0% of patients versus 78.3% with a fast regimen (OR 1.58; 95% CI 0.25-1.63; P=0.34).
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