Comparison between paclitaxel-coated balloon and standard uncoated balloon in the treatment of femoropopliteal long lesions in diabetics

Medicine (Baltimore). 2019 Mar;98(13):e14840. doi: 10.1097/MD.0000000000014840.

Abstract

Atherosclerotic diseases may include femoropopliteal artery stenosis or occlusion. Percutaneous transluminal angioplasty (PTA) is an effective and minimally invasive treatment strategy for atherosclerotic femoropopliteal artery stenosis/occlusion disease. Balloon angioplasty is a widely used technique in the management of occlusive disease in almost all arterial segments.We enrolled 111 diabetics with long femoropopliteal lesions, among which 54 received PTA with paclitaxel-coated balloon (the Paclitaxel group), and 57 with standard balloon catheters (the Control group).The primary outcome was set as angiographic late lumen loss (LLL) within 6 months; the secondary angiographic outcome was binary restenosis. Clinical outcomes included Rutherford clarification, ankle-brachial index (ABI) and rate of clinically driven target lesion revascularization (TLR). Two groups had similar basal clinical features, angiographic and procedural characteristics. Compared to controls, the Paclitaxel group had a significantly lower 6-month LLL rate, 12-month binary restenosis rate, 12-month TLR, lower Rutherford grades at 3 and 6 months, and higher ABI at 3 months. For all factors which might influence outcomes, fasting blood glucose was negatively correlated with ABI; the blood urea nitrogen (BUN) was positively related with the Rutherford clarification grades. In addition, the coronary heart disease (CHD) and smoking histories were positively correlated with residual stenosis after treatment.Collectively, the paclitaxel-coated balloon angioplasty can yield more favorable angiographic and clinical outcomes than standard uncoated balloon angioplasty, even in the more challenging lesions (the long and occlusive femoropopliteal lesions) in diabetics, when it had a similar safety profile to the traditional balloon. Blood glucose, BUN, CHD, and smoking imply poor curative effects.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Aged
  • Angiography / methods
  • Angioplasty / adverse effects
  • Angioplasty / methods*
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / methods*
  • Angioplasty, Balloon / statistics & numerical data
  • Antineoplastic Agents, Phytogenic / therapeutic use
  • Arterial Occlusive Diseases / pathology
  • Arterial Occlusive Diseases / therapy
  • Atherosclerosis / complications
  • Coated Materials, Biocompatible / adverse effects
  • Coated Materials, Biocompatible / standards
  • Coated Materials, Biocompatible / therapeutic use*
  • Diabetes Complications
  • Diabetes Mellitus / epidemiology*
  • Female
  • Femoral Artery / diagnostic imaging
  • Femoral Artery / pathology*
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage
  • Paclitaxel / therapeutic use
  • Peripheral Arterial Disease / pathology
  • Peripheral Arterial Disease / therapy
  • Popliteal Artery / diagnostic imaging
  • Popliteal Artery / pathology*
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Coated Materials, Biocompatible
  • Paclitaxel