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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.

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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