A study published in the British Medical Journal (BMJ) has found that first-pass effect (FPE), restoring complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] 2c-[SM1] 3) in a single pass, used as an endovascular treatment of acute ischaemic stroke, not only provides better clinical results, but also lowers health costs. Researchers found a lower cost potential per stroke patient annually, in every country studied.
The objective of the study was to assess the economic impact of achieving complete or near complete reperfusion after FPE, compared with the need for multiple passes to achieve the same level of reperfusion.
Study authors noted that, “Complete reperfusion of brain tissue is the primary goal in treatment of acute ischaemic stroke. Rapid revascularisation is vital as reduced time from symptom onset to revascularisation is strongly correlated with improved clinical and functional outcomes. Complete revascularisation with mechanical thrombectomy, a cost-effective treatment for patients with acute stroke, might require multiple passes, which prolongs procedure time and increases the risk of arterial endothelial injury.”
The analysis of revascularisation in ischaemic stroke with emboTrap study (ARISE II study) is, a prospective, single-arm, international, multicentre clinical trial, investigating the efficacy and safety of the EmboTrap device (Cerenovus) in 227 treated patients. Patient level data from the ARISE II study was used to conduct post hoc analyses on patient outcomes. The target population were patients for whom mTICI 2c–3 was achieved (n=172). Therefore, the patients from this study were split into two groups. The first was the FPE group, patients for whom mTICI 2c–3 was achieved on the first pass. The second was the non-FPE group:, patients who only achieved mTICI 2c–3 after multiple passes. Data from the ARISE II study were used to establish baseline characteristics, clinical outcomes, and healthcare resources for both the FPE and non-FPE cohorts.
The researchers then used peer reviewed literature and public market research reports to calculate the cost consequence of FPE or non-FPE results, using a determinist approach from two different perspectives: , provider and payer. These data were country specific, looking at healthcare systems in the USA, France, Germany, Italy, Spain, Sweden, and the UK with two separate time horizons. The cost analysis was based on total hospital length of stay (LOS), days in the intensive care unit, standard bed days, and devices used during the procedure. This was calculated for both FPE and non-FPE groups, which was then applied to the country specific data, creating a cost estimate for both outcomes. Finally, total costs per patient in an acute care setting were calculated from a provider perspective.
From the ARISE II study, researchers found that 76% of patients received complete or near complete reperfusion; among these, 53% were in the FPE group. Investigators reported that a higher proportion of patients in the FPE group achieved good or functional outcomes compared with the non-FPE group. Additionally, patients in the FPE group required only a single EmboTrap device, whereas 35% of patients in the non-FPE group required at least one additional device.
With regard to cost, researchers found that FPE led to potential per-patient cost savings in every country studied (US$6575 for the USA, €1560 [US$1833] for France, €2202 [US$2587] for Germany, €2901 [US$3409] for Italy, €4548 [US$5343] for Spain, Kr 29 468 [US$3364] for Sweden, and £1751 [US$2285] for the UK. Furthermore, achieving FPE led to potential per-patient annual care cost savings in the first year after stroke in every country studied (US$4116 for the USA, €2131 [US$2503] for France, €701 [US$823] for Italy, Kr 13 333 for Sweden [US$1522], and £2132 [US$2783] for the UK.
Lead author of the study Osama Zaidat (Mercy Saint Vincent Medical Center, Toledo, USA), commented, “This article showed that in patients who achieved FPE with the EmboTrap clot retrieval Device, not only achieved a better clinical outcome with single attempt vessel opening, but also resulted were also associated with significant cost saving. This should focus the future clinical research and technical innovation on identifying the best approach, devices, and clot features that would lead to this important target.”