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The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.
Monteleone, Peter P; Banerjee, Subhash; Kothapalli, Priya; Stern, Ariel Dora; Fehder, Daniel; Ginor, Ron; Vollmar, Dominic; Fry, Edward T A; Pirwitz, Mark J.
Affiliation
  • Monteleone PP; Seton Heart Institute, The University of Texas at Austin Dell School of Medicine, 1301 West 38th Street, Suite 400, Austin, TX 78701 USA. peter.monteleone@austin.utexas.edu.
J Invasive Cardiol ; 32(1): 18-24, 2020 Jan.
Article in En | MEDLINE | ID: mdl-31611426
ABSTRACT

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.
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Collection: 01-internacional Database: MEDLINE Main subject: Product Surveillance, Postmarketing / Paclitaxel / Drug-Eluting Stents / Peripheral Arterial Disease / Endovascular Procedures / Long Term Adverse Effects / Graft Occlusion, Vascular Type of study: Diagnostic_studies / Etiology_studies / Prognostic_studies / Systematic_reviews Limits: Humans Language: En Journal: J Invasive Cardiol Journal subject: CARDIOLOGIA Year: 2020 Document type: Article
Search on Google
Collection: 01-internacional Database: MEDLINE Main subject: Product Surveillance, Postmarketing / Paclitaxel / Drug-Eluting Stents / Peripheral Arterial Disease / Endovascular Procedures / Long Term Adverse Effects / Graft Occlusion, Vascular Type of study: Diagnostic_studies / Etiology_studies / Prognostic_studies / Systematic_reviews Limits: Humans Language: En Journal: J Invasive Cardiol Journal subject: CARDIOLOGIA Year: 2020 Document type: Article
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