周围动脉化的静脉内溶液:随机破坏PAD III试验的中期结果
Gunnar Tepe1, Marianne Brodmann2, William Bachinsky3
1Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany.
概括
与皮肤透光血管血管造膜术 (PTA) 相比,静脉内静脉造膜术 (IVL) 显示出更好的1年和2年的骨动脉初级通透性. 这种方法减少了用于治疗化外围动脉疾病的支架使用.
科学领域:
- 血管外科 血管外科
- 干预心脏病学 干预心脏病学
- 血管内干预 血管内干预
背景情况:
- 化的外周动脉病变的内血管治疗带来了挑战,包括低于最佳的扩张和长期减少的通透性.
- 此前,Disrupt PAD III随机对照试验 (RCT) 已经显示了血管内溶解术 (IVL) 在皮肤透光血管造膜术 (PTA) 上的优越程序成功.
研究的目的:
- 通过IVL和PTA对化骨动脉进行血管内治疗后1年和2年的初级通透率进行评估.
- 评估IVL在治疗复杂的外围动脉疾病中的长期有效性和安全性.
主要方法:
- 扰乱PADIIIRCT招募了306名患有中度至严重化的股骨动脉的患者.
- 患者被随机分配,在药物涂层气球 (DCB) 治疗或支架之前接受IVL (n=153) 或PTA (n=153).
- 主要通透性被定义为无临床驱动的目标病变重血管化和恢复性,通过双重超声波评估.
主要成果:
- 一年后的初级通透率在IVL组 (80.5%) 与PTA组 (68.0%;P=.017) 相比显著更高.
- 在IVL (4.6%) 与PTA (18.3%;P<.0001) 相比,临时支架的需要明显较低.
- 在2年后,IVL的初级通透率与PTA (51.3%;P=.003) 相比,IVL (70.3%) 的初级通透率仍然显著增加.
结论:
- 该研究满足了其二次终点,证明了IVL的优越1年初级通透性.
- 接着DCB治疗的IVL为严重化的股骨动脉提供了一种安全有效的持久方法,往往避免了支架的需要.
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