Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access : 6-month interim results from a prospective randomized controlled trial
PURPOSE: To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).
METHODS: The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures).
RESULTS: Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).
CONCLUSION: PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2012 |
|---|---|
| Erschienen: |
2012 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
|---|---|
| Enthalten in: |
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists - 19(2012), 2 vom: 26. Apr., Seite 263-72 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Katsanos, Konstantinos [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Cardiovascular Agents |
|---|
| Anmerkungen: |
Date Completed 27.08.2012 Date Revised 18.03.2022 published: Print ClinicalTrials.gov: NCT01174472 Citation Status MEDLINE |
|---|
| doi: |
10.1583/11-3690.1 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM217409032 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM217409032 | ||
| 003 | DE-627 | ||
| 005 | 20231224034011.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231224s2012 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1583/11-3690.1 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0724.xml |
| 035 | |a (DE-627)NLM217409032 | ||
| 035 | |a (NLM)22545894 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Katsanos, Konstantinos |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access |b 6-month interim results from a prospective randomized controlled trial |
| 264 | 1 | |c 2012 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.08.2012 | ||
| 500 | |a Date Revised 18.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01174472 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG) | ||
| 520 | |a METHODS: The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures) | ||
| 520 | |a RESULTS: Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006) | ||
| 520 | |a CONCLUSION: PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Cardiovascular Agents |2 NLM | |
| 650 | 7 | |a Paclitaxel |2 NLM | |
| 650 | 7 | |a P88XT4IS4D |2 NLM | |
| 700 | 1 | |a Karnabatidis, Dimitris |e verfasserin |4 aut | |
| 700 | 1 | |a Kitrou, Panagiotis |e verfasserin |4 aut | |
| 700 | 1 | |a Spiliopoulos, Stavros |e verfasserin |4 aut | |
| 700 | 1 | |a Christeas, Nikolaos |e verfasserin |4 aut | |
| 700 | 1 | |a Siablis, Dimitris |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists |d 2000 |g 19(2012), 2 vom: 26. Apr., Seite 263-72 |w (DE-627)NLM106995987 |x 1545-1550 |7 nnns |
| 773 | 1 | 8 | |g volume:19 |g year:2012 |g number:2 |g day:26 |g month:04 |g pages:263-72 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1583/11-3690.1 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 19 |j 2012 |e 2 |b 26 |c 04 |h 263-72 | ||