Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter

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• 作者：S. William Stavropoulos ; MD^a ; ^{stav@uphs.upenn.edu" class="auth_mail" title="E-mail the corresponding author} ; James X. Chen ; MD^a ; Ronald F. Sing ; DO^c ; Fakhir Elmasri ; MD^d ; Mitchell J. Silver ; DO^e ; Alex Powell ; MD^f ; Frank C. Lynch ; MD^b ; Ahmed Kamel Abdel Aal ; MD ; PhD^g ; Alexandra Lansky ; MD^h ; Bart E. Muhs ; MD ; PhDⁱ ; for the DENALI Trial Investigators
• 关键词：CEC ; clinical events committee ; CI ; confidence interval ; DVT ; deep vein thrombosis ; FDA ; Food and Drug Administration ; IVC ; inferior vena cava ; PE ; pulmonary embolism
• 刊名：Journal of Vascular and Interventional Radiology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：27
• 期：10
• 页码：1531-1538.e1
• 全文大小：466 K

文摘

To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE).

Materials and Methods

This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt.

Results

Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5–736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up.

Conclusions

The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.