Author + information
- Received March 10, 2003
- Revision received May 7, 2003
- Accepted June 13, 2003
- Published online October 15, 2003.
- Volker Schächinger, MD*,* (, )
- Christian W Hamm, MD, FACC†,
- Thomas Münzel, MD‡,
- Michael Haude, MD‡,
- Stephan Baldus, MD‡,
- Eberhard Grube, MD, FACC∥,
- Tassilo Bonzel, MD¶,
- Thomas Konorza, MD§,
- Ralf Köster, MD‡,
- Roman Arnold, MD†,
- Jürgen Haase, MD#,
- Peter Probst, MD, FACC**,
- Jürgen vom Dahl, MD††,
- Franz-Josef Neumann, MD‡‡,
- Harald Mudra, MD§§,
- Benno Hennen, MD∥∥,
- Ludger Thiele¶¶,
- Andreas M Zeiher, MD*,
- STING (STents IN Grafts) Investigators
- ↵*Reprint requests and correspondence:
Dr. Volker Schächinger, J. W. Goethe Universität, Department of Medicine IV/Division of Cardiology, Theodor-Stern-Kai 7, 60590 Frankfurt, a. M., Germany
Objectives 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.
Background 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.
Methods 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.
Results 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).
Conclusions 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.
☆ Supported by an unrestricted grant by Jomed GmbH, Rangendingen, Germany.
- Received March 10, 2003.
- Revision received May 7, 2003.
- Accepted June 13, 2003.
- American College of Cardiology Foundation