Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs

Abstract

In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel–Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.

Results of clinical effectiveness of conventional versus Mirasol‐treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial

“…Together, the findings potentially suggest the increase in number of days with grade ≥2 bleeding observed in MiPLATE reflects lower CCI's observed in all PR clinical trials and potentially decreased hemostatic function inherent in the PRT 11,18–23 . The MiPLATE results are consistent with a recent systematic review of PRT clinical trials which evaluated bleeding events including the MiPLATE trial, which reported a slight but statistically significant increase in bleeding between PR treated and Control PLTs among nine trials (five Intercept and four Mirasol, 3033 participants, RR 1.16, 95% CI 1.02–1.32, p = .03) despite heterogeneity of the studies 24 …”

“…11,[18][19][20][21][22][23] The MiPLATE results are consistent with a recent systematic review of PRT clinical trials which evaluated bleeding events including the MiPLATE trial, which reported a slight but statistically significant increase in bleeding between PR treated and Control PLTs among nine trials (five Intercept and four Mirasol, 3033 participants, RR 1.16, 95% CI 1.02-1.32, p = .03) despite heterogeneity of the studies. 24 Another potential explanation for the increase in number of days with grade ≥2 bleeding in MIRASOL may be due to PLT damage from the combination of the PR process followed by irradiation. Previous clinical trials have reported <10% Mirasol-treated PLTs were also irradiated.…”

Therapeutic efficacy and safety of pathogen‐reduced platelet components: Results of a meta‐analysis of randomized controlled trials

“…We are aware that five previous meta-analyses have been published elsewhere on this transfusion medicine topic [3,[20][21][22][23]. However, we decided to perform the current study for several reasons.…”

Challenges for the maintaining the microbiological safety of the UK blood supply

“…34 Blood safety platelet inactivation. 29 These technologies can inactivate a range of microbial infections and, thus, could offer some benefit from both known and unknown infections. PITs might also minimise the risk of transfusion-associated graft-versus-host disease and avoid the need to provide irradiated blood components for patients at risk.…”