Key result
The INNOVANCE PFA P2Y cartridge had a lower detection rate for von Willebrand disease (64%) compared to conventional CEPI (80%) and CADP (76%) cartridges.
Why the study?
How does the INNOVANCE PFA P2Y cartridge perform in detecting pre-existing defects in primary haemostasis compared to conventional cartridges in patients with assumed bleeding disorders?
Observational (n=176)
How does the INNOVANCE PFA P2Y cartridge perform in detecting pre-existing defects in primary haemostasis compared to conventional cartridges in patients with assumed bleeding disorders?
Absolute Event Rate: 64% vs 80%
Low von Willebrand factor activity can significantly influence the closure times of the P2Y cartridge, which must be considered when using it to monitor antiplatelet therapy.
Supports caution with INNOVANCE PFA P2Y in von Willebrand screening; leaves open cartridge selection for primary haemostasis evaluation.
Recently, the INNOVANCE® PFA P2Y (P2Y) cartridge of the PFA-100® system (Siemens Healthcare Diagnostics, Marburg, Germany) has been developed for the monitoring of adenosine diphosphate (ADP) P2Y(12) receptor inhibition in patients under dual antiplatelet therapy. The aim of this study was to evaluate the influence of pre-existing defects in primary haemostasis on the P2Y cartridge independent from specific antiplatelet medication. Therefore, the closure time (CT) of the P2Y cartridge was measured in a cohort of 176 patients with assumed bleeding disorders and compared with the results of established methods for the assessment of primary haemostasis. Von Willebrand disease (VWD) was found in 25 patients (14%). The detection rate of the P2Y cartridge regarding VWD was 64% and lower compared to the two conventional cartridges (collagen/epinephrine cartridge, CEPI, 80%; collagen/ADP cartridge, CADP, 76%). In the subgroup of VWD patients with VWF:RCo < 60 IU/dL (n = 22), the correlation analysis and the inter-rater agreement revealed only limited accordance with the two established cartridges. The correlation with the CADP cartridge (C(r) = 0.767, R(2) = 0.461; Kappa = 0.41) was higher than the correlation with the CEPI cartridge. Except for severe forms, platelet function disorders (9 patients, 5%) did not prolong the CT of the P2Y cartridge. Interestingly, the P2Y cartridge was less interference-prone to unspecific medications (23 patients, 13%). As the main conclusion, it must be taken into account that low von Willebrand factor activity can significantly influence the CTs of the P2Y cartridge when using it for the monitoring of antiplatelet therapy.
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Koessler et al. (2011) conducted an observational in assumed bleeding disorders (n=176). INNOVANCE PFA P2Y cartridge vs. conventional cartridges (CEPI and CADP) was evaluated on Detection rate of von Willebrand disease. The INNOVANCE PFA P2Y cartridge had a lower detection rate for von Willebrand disease (64%) compared to conventional CEPI (80%) and CADP (76%) cartridges.
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