ABSTRACT
OBJECTIVE: The VOYAGER-PAD trial demonstrated the interest in dual pathway inhibition (DPI) (low dose rivaroxaban plus aspirin) to reduce limb and cardiovascular events after revascularisation for peripheral artery disease (PAD), but its applicability in clinical practice has not yet been assessed. This study aimed to assess the number of patients revascularised in France for PAD and to estimate the proportion of those matching the VOYAGER-PAD trial selection criteria. A secondary objective was to examine the prognosis of revascularised patients in a real world setting. METHODS: This observational retrospective study was conducted on the national hospital discharge database and included all patients with PAD who underwent lower extremity revascularisation for PAD (without lower extremity revascularisation in the two years prior to inclusion) from 1 January 2016 to 31 December 2019. Available VOYAGER-PAD selection criteria were then applied to the study population. RESULTS: In total, 180 870 patients were included (mean age 72.0 ± 12.2 years, 30.9% female), with approximately 45 000 patients revascularised annually. Among them, 90 379 (50.0%) matched the VOYAGER-PAD trial criteria (VOYAGER-PAD eligible subgroup; mean age 69.8 ± 12.1 years, 29.5% female). In the study population and the VOYAGER-PAD eligible subgroup, 33.9% and 26.6% of patients had diabetes, 28.1% and 19.9% had chronic coronary artery disease, and 14.6% and 5.7% had renal failure, respectively. Overall, 73.1% of study patients were treated by an endovascular approach (75.5% in the VOYAGER-PAD eligible subgroup). In patients with more than one year of follow up, 45.4% of study patients and 36.0% of the VOYAGER-PAD eligible subgroup experienced a limb or cardiovascular event. The median time until the first event and in hospital death was 4.8 months and 7.8 months, respectively (6.7 months and 12.9 months in the VOYAGER-PAD eligible subgroup). CONCLUSION: The burden of PAD for revascularisation and secondary events is considerable. One half of revascularised patients in France are eligible for DPI therapy. Those patients are younger, with fewer comorbidities, and better outcomes.
Subject(s)
Peripheral Arterial Disease , Humans , Peripheral Arterial Disease/surgery , Aged , France/epidemiology , Female , Retrospective Studies , Male , Middle Aged , Aged, 80 and over , Rivaroxaban/therapeutic use , Patient Selection , Aspirin/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Treatment Outcome , Lower Extremity/blood supply , Vascular Surgical Procedures/adverse effects , Factor Xa Inhibitors/therapeutic useABSTRACT
Medication errors (ME) are frequently encountered and present at every step of the therapeutic process. This study's aims were to take stock of the ME reported to the region's pharmacovigilance (CRPV) and poison control centers (CAPTV) and to identify potential regional actions. A 2-months (January and February 2017) prospective gathering of the calls to the CAPTV regarding the ME and of the ME declarations to the region's CRPV (Clermont-Ferrand, Grenoble, Lyon, Saint-Etienne) has been carried out. The place of occurrence, the event's description and its consequences and data regarding the patient were collected. In addition to that, the regional drug observatory OMEDIT analysis has allowed to determine the ME's types (REMED characterization, never event?) and to look for the results of a potential thorough analysis. The study reported 580 calls for 590 ME and 583 patients. ME mostly affected the ambulatory/domicile sector (76%), the medico-social sector (14%) and the healthcare facilities sector (7%). It usually was about dose errors, medication errors and patient errors with a different profile in each sector. The majority of errors (85%) occurred at the administration step. Almost all the observed ME were confirmed errors having reached the patient (99.5%) but only a few had serious consequences. One out of 5 ME was eligible for a thorough analysis but even less were subjected to that kind of analysis. The main never event concerned the unidose in the ambulatory sector. The health products involved were mostly a single medication (75%) and then the patient's full treatment (12%). The CRPV/CAPTV/OMEDIT's skills are complementary for the gathering, the analysis and the management of the ME. Training campaigns and support are to be considered for the professionals and especially within the medico-social facilities.
