A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts.
We compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft. The use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts. This prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography. Acute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93). This controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.
Schächinger
Volker
V
J W Goethe Universität, Frankfurt/Main, Germany. schaechinger@em.uni-frankfurt.de
Hamm
Christian W
CW
Münzel
Thomas
T
Haude
Michael
M
Baldus
Stephan
S
Grube
Eberhard
E
Bonzel
Tassilo
T
Konorza
Thomas
T
Köster
Ralf
R
Arnold
Roman
R
Haase
Jürgen
J
Probst
Peter
P
vom Dahl
Jürgen
J
Neumann
Franz-Josef
FJ
Mudra
Harald
H
Hennen
Benno
B
Thiele
Ludger
L
Zeiher
Andreas M
AM
D000368:Aged; D001807:Blood Vessel Prosthesis; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013997:Time Factors
D020099:Coated Materials, Biocompatible; D008567:Membranes, Artificial; D011138:Polytetrafluoroethylene