Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study,CardioVascular and Interventional Radiology

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Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study
CardioVascular and Interventional Radiology ( IF 2.9 ) Pub Date : 2024-01-25 , DOI: 10.1007/s00270-023-03646-0
Klaus Hausegger , Wiebke Kurre , Henrik Schröder , Johannes Dambach , Stefanie Stahnke , Christian Loewe , Karl Schürmann , Roman Fischbach , Jochen Textor , Stephan Schäfer , Stephan Müller-Hülsbeck

Purpose

This follow-up study was designed as a reopen of the completed Freeway Stent Study and collected mortality and clinical outcome data for at least 5 years after enrollment to evaluate long-term patient safety and treatment efficacy. The primary study enrolled 204 patients with stenosis or occlusion in the superficial femoral artery and proximal popliteal artery. Patients were randomized to primary nitinol stenting followed by standard PTA or primary nitinol stenting followed by FREEWAY™ paclitaxel-eluting balloon PTA.

Methods

Previous patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected.

Results

No increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032.

Conclusion

The safety results presented support the recent conclusions that the use of paclitaxel technology does not lead to an increase in mortality. At the same time, the efficacy results clearly demonstrate that the potential benefits of drug-eluting balloon treatment are maintained over a 5-year period.

Graphical Abstract

中文翻译：

随机 Freeway 支架研究患者的长期随访和死亡率

目的

这项后续研究旨在重新启动已完成的 Freeway 支架研究，并收集入组后至少 5 年内的死亡率和临床结果数据，以评估长期患者安全性和治疗效果。主要研究纳入了 204 名股浅动脉和腘动脉近端狭窄或闭塞的患者。患者被随机分配接受初次镍钛诺支架置入术，随后接受标准 PTA 治疗或初次镍钛诺支架置入术，随后接受 FREEWAY™ 紫杉醇洗脱球囊 PTA。

方法

通过电话或在例行医院就诊期间重新联系以前的患者，并审查医疗记录。收集生命和临床状态信息。

结果

5 年时未观察到晚期死亡率增加，FREEWAY 药物洗脱球囊组的全因死亡率为 12.0%，而非紫杉醇 PTA 组的全因死亡率为 15.0%。两组均未观察到任何死亡原因的累积，也与紫杉醇的使用剂量没有任何相关性。与标准 PTA 组 (72.7%) 相比，FREEWAY 药物洗脱球囊组 (85.3%) 5 年时免于临床驱动的靶病变血运重建的情况显着较高，对数秩 p = 0.032。