Urgent surgery vs fibrinolytic therapy for left-sided prosthetic valve thrombosis: a randomized trial.

Abstract

Left-sided mechanical prosthetic valve thrombosis (PVT) is common in low-resource settings. Treatment is either by fibrinolytic therapy (FT) or urgent surgery. This is the first randomized controlled trial (RCT) comparing urgent surgery with FT for symptomatic left-sided PVT. This is a single-centre RCT comparing urgent surgery with FT (low-dose, slow-infusion tissue plasminogen activator [t-PA]) in patients with symptomatic left-sided PVT. The primary outcome was complete clinical response, defined as discharge from hospital with completely restored valve function, without major complications. The primary safety outcome was a composite of death, non-fatal stroke, non-fatal major bleed, or systemic embolism, at discharge. Outcomes were assessed by investigators blinded to treatment allocation. Over a 6-year period, 79 patients were randomized to urgent surgery (n = 39) or FT (n = 40). Patients most often had a thrombosed mitral prosthesis (72%) with 43% in New York Heart Association class III/IV. All patients allocated to FT received t-PA. Of the 32 patients who had surgery, 17 (53%) underwent the procedure within 48 h. In the intention-to-treat population, the primary outcome was not significantly different between the two arms (odds ratio [OR] 1.22, 95% confidence interval [CI] 0.46-3.19; P = .689). However, the composite safety outcome occurred more often with surgery (OR 5.14, 95% CI 1.28-20.5; P = .021), driven by the difference in deaths (7/39 vs 1/40; P = .035). Twenty-five percent of patients undergoing FT (10/40) had residual valve dysfunction. In symptomatic left-sided PVT, urgent surgery is not more efficacious than FT. Surgery is associated with a higher risk of complications, including death, while FT is more often associated with residual valve dysfunction.