Use of the Peripheral Cutting Balloon to Treat Hemodialysis-related Stenoses

https://doi.org/10.1097/01.RVI.0000190928.19701.DDGet rights and content

PURPOSE

To compare the effectiveness and safety of use of the peripheral cutting balloon (PCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of hemodialysis-related stenoses.

MATERIALS AND METHODS

This prospective, randomized multicenter clinical trial included 340 patients with stenotic or thrombosed hemodialysis grafts who were randomized to receive treatment with the PCB or PTA for venous outflow stenosis. One hundred seventy-three patients underwent treatment with the PCB, 101 with stenotic grafts and 72 with thrombosed grafts. PTA was used to treat 167 patients, 94 patients with stenotic grafts and 73 with thrombosed grafts. The follow-up period extended for 6 months.

RESULTS

The procedural success rates were 80.8% and 75.4% for the PCB and PTA groups, respectively (P = .24). With use of the PCB, the primary patency rates of the target lesions were 84.3%, 65.8%, and 47.9% at 1 month, 3 months, and 6 months, respectively. With PTA, the primary patency rates of the target lesions were 77.7%, 63.4%, and 40.5% at 1 month, 3 months, and 6 months, respectively. The primary patency rates of the entire vascular access circuit were 82.6%, 61.0%, and 43.3% at 1 month, 3 months, and 6 months, respectively, with use of the PCB. For patients who were treated with PTA, the primary patency rates of the vascular access circuit were 75.9%, 61.0%, and 36.3% at 1 month, 3 months, and 6 months, respectively. When comparing the PCB and PTA, there was no difference in the 6-month primary patency rates in the target lesion (P = .373) or the entire vascular access circuit (P = .531). There were nine device-related complications in the PCB group (5.2%): five venous ruptures (2.9%), three venous dissections (1.7%), and one case of thrombosis (0.6%). There were no device-related complications in the PTA group.

CONCLUSION

This prospective, randomized trial comparing use of the PCB versus standard PTA for treatment of hemodialysis-related venous stenoses demonstrated that the PCB provides equivalent 6-month patency to PTA for stenotic and thrombosed grafts.

Section snippets

MATERIALS AND METHODS

This clinical trial was performed at 27 medical centers in the United States (Appendix 1). The investigational protocol was approved by the institutional review board at each medical center before patient enrollment. Informed consent was obtained after the nature of the procedure was described to each patient. This study was funded by Boston Scientific Corporation, Natick, MA.

Primary Endpoint

The primary endpoint for this clinical investigation was primary patency of the target lesion at 6 months. The initial comparative analysis of this endpoint combined the data from both patient groups, those with stenotic grafts and those with thrombosed grafts. In the 167 patients who underwent conventional PTA, the primary patency rates of the target lesions were 77.7%, 63.4%, and 40.5% at 1 month, 3 months, and 6 months, respectively. In the 173 patients who underwent treatment with the PCB,

DISCUSSION

The PCB was designed to decrease the local vascular trauma caused by conventional balloon angioplasty. In 1991, Barath and colleagues (7) described their experience with use of the cutting balloon in normal porcine arteries. By creating longitudinal incisions into the medial layer of the vascular wall while simultaneously dilating the lesion, the cutting balloon causes less stretching and less injury to the surrounding vascular smooth muscle. These investigators suggested that limiting the

APPENDIX: PRINCIPAL INVESTIGATORS AND SITES OF THE CLINICAL TRIAL

Jeff Siegel, MD, Vascular Access Center, Dallas TX; James Swischuk, MD, St. Francis Medical Center, Peoria, IL; Terry Reynolds, MD, Memorial Medical Center, Savannah, GA; John Ross, MD, Bamberg County Hospital, Bamberg, SC; Dennis Kay, MD, Ochsner Medical Foundation, New Orleans, LA; Rod Raabe, MD, Sacred Heart Medical Center, Spokane, WA; William Romano, MD, William Beaumont Hospital, Royal Oak, MI; Tony Smith, MD, Duke University Medical Center, Durham, NC; John Fischer, MD, St. Luke's

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    Citation Excerpt :

    It also places a heavy burden on the health care system both in terms of financially and increased workload. Various available endovascular options include bare-metal stent (primary 6-month patency rate of 39.3%2), cutting balloon (primary 6-month patency rate at 47.9%3), and covered stent which enhances the 6-month primary patency rate of poly-tetra-flour-ethylene grafts to 51% after-stent graft implantation in venous outflow stenoses.4 Drug-coated balloons (DCB) for dialysis access show promising results in the Katsanos study with a 6-month primary patency of 70% in paclitaxel-coated balloon (DCB) versus 25% in plain old balloon angioplasty (POBA) [P = 0.001].5

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This study was funded by Boston Scientific Corporation, Natick, MA.

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