Ferraresi R, Centola M, Biondi-Zoccai G
Cardiovascular Interventional Unit, Istituto Clinico Città Studi, Milan, Italy.
J Cardiovasc Surg (Torino). 2012 Apr;53(2):205-13.
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, and high rates of restenosis and disease progression. The BASIL study has established the substantial equivalence between bypass surgery and percutaneous transluminal angioplasty in this setting, at least at mid-term follow-up, but percutaneous techniques and devices have seen major developments since the publication of this pivotal trial in 2005. A major breakthrough has indeed been the introduction of drug-eluting balloons, which have several theoretical advantages in comparison to standard balloons and metallic stents for infra-popliteal lesions. Two clinical trials have already been reported with favorable results for the In.Pact Amphirion paclitaxel-eluting balloon, when employed for below-the-knee lesions. We hereby discuss the rationale for the use of drug-eluting balloons in this complex setting and the main findings of the study by Schmidt et al. and the DEBATE-BTK trial.
由于患者常伴有多种合并症、血管广泛受累以及再狭窄和疾病进展发生率高，因膝下疾病导致的严重肢体缺血的治疗仍然具有挑战性。BASIL研究已经证实，在这种情况下，至少在中期随访时，旁路手术和经皮腔内血管成形术具有实质等效性，但自2005年这项关键试验发表以来，经皮技术和器械有了重大发展。一个重大突破确实是药物洗脱球囊的引入，与标准球囊和金属支架相比，药物洗脱球囊在治疗腘下病变方面具有若干理论优势。已经有两项临床试验报告了In.Pact Amphirion紫杉醇洗脱球囊用于膝下病变时的良好结果。在此，我们讨论在这种复杂情况下使用药物洗脱球囊的基本原理，以及施密特等人的研究和DEBATE - BTK试验的主要发现。
