CLINICAL RESEARCH: CLINICAL TRIAL
A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts
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
* J. W. Goethe Universität, Frankfurt/Main, Germany
Kerckhoffklinik Bad Nauheim, Bad Nauheim, Germany
Universitätsklinik Eppendorf, Hamburg, Germany
Universitätsklinikum Essen, Essen, Germany
|| Krankenhaus Siegburg, Siegburg, Germany
¶ Städtisches Klinikum Fulda, Fulda, Germany
# Rotes-Kreuz Krankenhaus Frankfurt/Main, Frankfurt/Main, Germany
** Allgemeines Krankenhaus Wien, Wien, Austria
Klinikum d. Rhein. Westf. TH Aachen, Aachen, Germany
Deutsches Herzzentrum München, München, Germany
Krankenhaus München Neuperlach, München, Germany
|||| Universitätskliniken des Saarlandes, Homburg/Saar, Germany
¶¶ Jomed GmbH, Rangendingen, Germany
Manuscript received March 10, 2003;
revised manuscript received May 7, 2003,
accepted June 13, 2003.
* 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
schaechinger{at}em.uni-frankfurt.de
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.
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Abbreviations and Acronyms
| | CK | = creatine kinase | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty | | PTFE | = polytetrafluoroethylene | | STING | = Stents IN Grafts trial |
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