Published Online
on June 23, 2003

A more recent version of this article appeared on July 8, 2003

This Article Full Text (PDF) All Versions of this Article: 108/1/37    most recent 01.CIR.0000079106.71097.1Cv1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Stankovic, G. Search for Related Content PubMed PubMed Citation Articles by Stankovic, G. Pubmed/NCBI databases Substance via MeSH Hazardous Substances DB TEFLON Related Collections Restenosis Catheter-based coronary interventions: stents

Submitted on January 21, 2003
Revised on April 1, 2003
Accepted on April 4, 2003

Randomized Evaluation of Polytetrafluoroethylene-Covered Stent in Saphenous Vein Grafts. The Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial

Goran Stankovic MD, Antonio Colombo MD^*, Patrizia Presbitero MD, Frank van den Branden MD, Luigi Inglese MD, Carmelo Cernigliaro MD, Luigi Niccoli MD, Antonio L. Bartorelli MD, Paolo Rubartelli MD, Nicholaus Reifart MD, Guy R. Heyndrickx MD, Kari Saunamäki MD, Marie Claude Morice MD, Fabio A. Sgura MD, Carlo Di Mario MD, and for the RECOVERS Investigators

From Columbus Hospital, Milan, Italy (G.S., A.C., C.D.M.); Istituto Clinico Humanitas (P.P.), Rozzano, Italy; Middelheim Ziekenhuis (F.v.d.B.), Antwerpen, Belgium; Ospedale Clinicizzato (L.I.), San Donato, Milan, Italy; Azienda Ospedaliera (C.C.), Novara, Italy; Ospedale Civile (L.N.), Brescia, Italy; Centro Cardiologico Monzino IRCCS (A.L.B.), University of Milan, Milan, Italy; Ospedale San Martino (P.R.), Genova, Italy; Kardiologisches Institut Main-Taunus (N.R.), Bad Soden, Germany; Cardiovascular Center Aalst (G.R.H.), Aalst, Belgium; Rigshospitalet/hjertecenter (K.S.), Kobenhavn, Denmark; Institute Jacques Cartier (M.C.M.), Massy, France; and San Raffaele Hospital (A.C., F.A.S., C.D.M.), Milan, Italy.

^* To whom correspondence should be addressed. E-mail: info{at}emocolumbus.it.

Background--Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis.

Methods and Results--We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153).

Conclusions--The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Key words: polytetrafluoroethylene • grafting • restenosis

This article has been cited by other articles:

				R. Lorusso, G. De Cicco, F. Ettori, S. Curello, S. Gelsomino, and C. Fucci Emergency Surgery After Saphenous Vein Graft Perforation Complicated by Catheter Balloon Entrapment and Hemorrhagic Shock Ann. Thorac. Surg., September 1, 2008; 86(3): 1002 - 1004. [Abstract] [Full Text] [PDF]

				G. V. Gonzalez-Stawinski and B. W. Lytle Coronary Artery Reoperations Card. Surg. Adult, January 1, 2008; 3(2008): 711 - 732. [Full Text]

				F. Gomez, W. Escobar, A.M. Gomez, J.F. Gomez, and C.A. Anaya Treatment of Carotid Cavernous Fistulas Using Covered Stents: Midterm Results in Seven Patients AJNR Am. J. Neuroradiol., October 1, 2007; 28(9): 1762 - 1768. [Abstract] [Full Text] [PDF]

				L. Mauri, C. Rogers, and D. S. Baim Devices for Distal Protection During Percutaneous Coronary Revascularization Circulation, June 6, 2006; 113(22): 2651 - 2656. [Full Text] [PDF]

				P. W. Serruys, M. J.B. Kutryk, and A. T.L. Ong Coronary-Artery Stents N. Engl. J. Med., February 2, 2006; 354(5): 483 - 495. [Full Text] [PDF]

				G Maleux, J Pirenne, R Aerts, and F Nevens Hepatic artery pseudoaneurysm after liver transplantation: definitive treatment with a stent-graft after failed coil embolisation Br. J. Radiol., May 1, 2005; 78(929): 453 - 456. [Abstract] [Full Text] [PDF]

				L. Ge, I. Iakovou, G. M. Sangiorgi, A. Chieffo, G. Melzi, J. Cosgrave, M. Montorfano, I. Michev, F. Airoldi, M. Carlino, et al. Treatment of saphenous vein graft lesions with drug-eluting stents: Immediate and midterm outcome J. Am. Coll. Cardiol., April 5, 2005; 45(7): 989 - 994. [Abstract] [Full Text] [PDF]

				Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]

				W. W. O'Neill and S. R. Dixon The year in interventional cardiology J. Am. Coll. Cardiol., March 3, 2004; 43(5): 875 - 890. [Full Text] [PDF]