Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry

Abstract

Background: There are limited data on femoropopliteal artery stent thrombosis (ST), which is a serious adverse outcome of peripheral artery interventions.

Methods and results: Index procedures resulting in femoropopliteal ST were compared with stent procedures without subsequent ST in the Excellence in Peripheral Artery Disease registry. The study data had a total of 724 cases of stent procedures and 604 unique patients. Femoropopliteal ST occurred in 26 of 604 patients (4.3%) over a median follow-up of 6 months post procedure. ST was more likely to occur in men (96.3% versus 82.2%; P=0.026) and to have an initial intervention for chronic total occlusions (88.5% versus 64.0%; P=0.01). There was no significant difference in ST between drug-coated and bare-metal stents (4.4% versus 3.4%; P=0.55), but the rate of ST was significantly higher with self-expanding covered stent grafts compared with bare-metal stents (10.6% versus 3.4%; P=0.02). ST was significantly associated with an increased risk of 12-month major adverse limb events (hazard ratio, 4.99; 95% confidence interval, 2.31-10.77; P<0.001) compared with no ST. On multivariate analysis, treatment of chronic total occlusion lesions (odds ratio, 3.46; 95% confidence interval, 0.98-12.20; P=0.05) and in-stent restenosis lesions (odds ratio, 5.30; 95% confidence interval, 1.83-15.32; P=0.002) were independently associated with an increased risk of ST.

Conclusions: In a multicenter peripheral interventional registry, femoropopliteal ST occurred in 4.3% of patients who underwent stent procedures, and it was associated with treatment of chronic total occlusions and in-stent restenosis lesions, and had higher 12-month major adverse limb events.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01904851.

Keywords: confidence intervals; odds ratio; peripheral artery disease; stent; thrombosis.

© 2016 American Heart Association, Inc.

Figures

Figure 1

Case of definite stent thrombosis

Figure 1

Case of definite stent thrombosis

Figure 1

Case of definite stent thrombosis

Figure 1

Case of definite stent thrombosis

Figure 2

Flowchart describing stent thrombosis

Figure 3

Kaplan-Meier curve: Stent Thrombosis. • Censored at death and follow-up 15 months.

Figure 4a

Rate of stent thrombosis (ST) by stent type (overall ST rate = 4.3%) Note: P-values are Tukey-Kramer adjusted p-values.

Figure 4b

Rate of stent thrombosis (ST) by chronic total occlusion

Figure 5a

Kaplan-Meier curves of MALE between stent thrombosis (ST) and no ST groups Note: Censored at death and follow up months

Figure 5b

Kaplan-Meier curves of MACE between stent thrombosis (ST) and no ST groups Note: Censored at death and follow up months