RESUMO
BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.
Assuntos
Stents Farmacológicos , Procedimentos Endovasculares , Oclusão de Enxerto Vascular , Efeitos Adversos de Longa Duração , Paclitaxel , Doença Arterial Periférica/cirurgia , Vigilância de Produtos Comercializados , Antineoplásicos Fitogênicos/economia , Antineoplásicos Fitogênicos/farmacologia , Materiais Revestidos Biocompatíveis/farmacologia , Qualidade de Produtos para o Consumidor , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/economia , Stents Farmacológicos/estatística & dados numéricos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/mortalidade , Humanos , Efeitos Adversos de Longa Duração/etiologia , Efeitos Adversos de Longa Duração/mortalidade , Metanálise como Assunto , Neointima/prevenção & controle , Paclitaxel/economia , Paclitaxel/farmacologia , Vigilância de Produtos Comercializados/economia , Vigilância de Produtos Comercializados/métodosRESUMO
OBJECTIVE: We evaluated the early pharmacodynamic profile of the combined 30 mg intravenous and 1 mg/kg subcutaneous enoxaparin loading utilized in the TIMI 11B and ExTRACT TIMI 25 trials. BACKGROUND: It has not been reported whether anti-Xa levels appropriate for percutaneous coronary intervention (PCI) can be reliably achieved within 2 h utilizing this regimen. METHODS: Twenty-six patients with acute coronary syndrome (ACS) treated with this regimen had anti-Xa levels measured at 5 min, 2, 4, 6 and 8 h. RESULTS: Seventy-six percent of patients had anti-Xa levels above 0.5 IU/ml at 5 min. Dose-response curves showed all patients to have anti-Xa levels above 0.5 IU/ml within 1 h. Anti-Xa remained in the targeted range for PCI (0.5 to 1.8 IU/ml) at 2, 4, 6 and 8 h in all patients. CONCLUSION: This regimen is well suited for ACS treatment with an invasive strategy, including the rapid transition to early and rescue PCI.