Key result
Perceval sutureless bioprostheses trigger ~44% more transient platelet reduction vs stented valves with similar clinical outcomes.
Why the study?
Platelet count reduction is common but not fully understood after aortic valve replacement with bioprosthesis implantation.
Does Perceval sutureless aortic bioprosthesis implantation increase platelet count reduction compared to standard sutured stented bioprosthetic aortic valves in patients undergoing aortic valve replacement?
RCT
open-label
randomized
Does Perceval sutureless aortic bioprosthesis implantation increase platelet count reduction compared to standard sutured stented bioprosthetic aortic valves in patients undergoing aortic valve replacement?
Absolute Event Rate: 46% vs 32%
Sutureless aortic bioprosthesis implantation is associated with a higher rate of transient platelet reduction compared to stented bioprostheses, but without adverse clinical consequences.
Perceval raises transient platelet reduction without clinical impact; confirms comparable safety versus stented valves in AVR.
OBJECTIVES: Platelet count reduction is a common but not fully understood phenomenon after aortic valve replacement (AVR) with bioprosthesis implantation. The aim of the present study was to investigate the occurrence and the clinical impact of platelet count reduction in patients receiving the Perceval bioprosthesis compared to those receiving standard sutured stented bioprosthetic aortic valve in a randomized, controlled AVR study. METHODS: PERceval Sutureless Implant versus STandard Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016-September 2018) to AVR with a sutureless or stented valve. Ad hoc analyses have been performed to evaluate the occurrence of platelet count reduction and the clinical impact of the platelet variations in the 2 groups. RESULTS: The Perceval group showed a higher platelet reduction than the control group (46% vs 32%). The phenomenon was transient in both groups, with a slow recovery of the platelet count by hospital discharge. No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events. CONCLUSIONS: The Perceval sutureless aortic bioprosthesis implantation is associated with higher rate of transient platelet reduction as compared to stented bioprostheses for AVR. However, the platelet count reduction is transient and the decline does not affect the patient's clinical outcomes. Current explanations for this phenomenon are speculative, and further investigations are required to elucidate it. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697-ClinicalTrials.gov-4 February 2016.
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Lorusso et al. (2021) conducted an RCT in aortic valve replacement. Perceval sutureless bioprosthesis vs. standard sutured stented bioprosthetic aortic valve was evaluated on platelet count reduction. Perceval sutureless aortic bioprosthesis implantation resulted in a higher rate of transient platelet reduction compared to stented bioprostheses (46% vs 32%), with no difference in clinical outcomes.
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