159 - Adverse Event Patterns by Stent Type and Anatomic Location in Superficial Femoral and Popliteal Artery Stenting: Insights from the FDA MAUDE Database
Physician Northwestern Memorial Hospital, United States
Purpose: Stent outcomes in the superficial femoral and popliteal arteries are shaped by both device characteristics and biomechanical forces associated with vessel anatomic differences. Drug-eluting stents (DES) may reduce neointimal hyperplasia, but adverse event patterns may differ when considering non–drug-eluting stents (BMS) and anatomic location. This study compared event profiles for DES vs. BMS in the SFA and across suprapopliteal, popliteal, and infrapopliteal sites using the FDA MAUDE database.
Materials and Methods: Adverse event reports were extracted and categorized by stent type and location. Frequencies of variables associated with patient demographics, treatment factors, complications, and device issues were compared between groups.
Results: In the stent-type analysis (n=3,903), 2,805 (71.9%) were BMS and 1,098 (28.1%) DES. Demographics were similar. DES were more frequently reported with combination product use (98.5% vs. 24.2%, p< 0.0001). DES had higher reported rates of restenosis (40.3% vs. 30.9%, p< 0.0001), vascular occlusion (47.4% vs. 33.7%, p< 0.0001), dissection (4.7% vs. 2.4%, p=0.0043), and immune reactions (2.0% vs. 0.3%, p< 0.0001). Bleeding was less common (1.8% vs. 4.3%, p=0.0043). BMS more often showed structural/mechanical (28.1% vs. 18.7%, p< 0.0001), positioning/placement (15.2% vs. 6.8%, p< 0.0001), and flow obstruction issues (12.8% vs. 0.2%, p< 0.0001).
In the anatomic analysis (n=4,315), restenosis and occlusion were highest infrapopliteally (56.5% and 53.5%) compared with suprapopliteal (36.0%, 35.3%) and popliteal (47.4%, 47.7%; p< 0.0001). Mechanical problems were most common suprapopliteally (27.4% vs. 15.5% popliteal, 9.0% infrapopliteal; p< 0.0001). Asymptomatic reports were more frequent suprapopliteally (25.8% vs. 12.4% popliteal, 6.0% infrapopliteal; p< 0.0001).
Conclusion: MAUDE data show DES adverse events associated with more biologic complications but fewer structural issues compared with BMS adverse events. By location, infrapopliteal stents carried the highest restenosis/occlusion risk, while suprapopliteal stents were more prone to mechanical problems, as predicted by findings from existing literature. Understanding the likely nature of adverse event when one occurs with a given stent type and anatomical location may better help characterize risk profile for use of different stent types in specific anatomy.
