Author + information
- Received October 28, 2010
- Accepted November 16, 2010
- Published online March 1, 2011.
- Gregg W. Stone, MD⁎,⁎ (, )
- Sheldon Goldberg, MD†,
- Charles O'Shaughnessy, MD‡,
- Mark Midei, MD§,
- Robert M. Siegel, MD∥,
- Ecaterina Cristea, MD⁎,
- George Dangas, MD⁎,
- Alexandra J. Lansky, MD⁎ and
- Roxana Mehran, MD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, New York Presbyterian Hospital, The Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022
Objectives We sought to evaluate the utility of the JOSTENT polytetrafluoroethylene (PTFE) stent-graft (Jomed GmbH, Rangendingen, Germany) in patients with diseased saphenous vein grafts (SVGs) undergoing percutaneous coronary intervention (PCI).
Background Prior trials of the JOSTENT stent-graft did not mandate high-pressure implantation or prolonged dual antiplatelet therapy, and were limited by short-term follow-up.
Methods A total of 243 patients at 47 centers with 1 to 2 discrete lesions in SVGs were prospectively randomized to JOSTENT implantation (≥18 atm.) versus bare-metal stents (BMS). The JOSTENT patients were treated with aspirin indefinitely and clopidogrel for ≥8 months. Routine angiographic follow-up was performed at 8 months, and all patients were followed for 5 years.
Results The primary end point of in-lesion binary restenosis occurred in 31.8% of lesions treated with the JOSTENT versus 28.4% of lesions treated with BMS (relative risk: 1.12, 95% confidence interval [CI]: 0.72 to 1.75, p = 0.63). At 9 months, the major secondary end point of target vessel failure (death, myocardial infarction, or clinically driven target vessel revascularization) occurred in 32.2% of patients treated with the JOSTENT versus 22.1% of patients treated with BMS (hazard ratio: 1.54, 95% CI: 0.94 to 2.53, p = 0.08). During long-term follow-up, significantly more events accrued in the JOSTENT arm such that by 5 years target vessel failure had occurred in 68.3% of JOSTENT patients versus 51.8% of BMS patients (hazard ratio: 1.59, 95% CI: 1.13 to 2.23, p = 0.007).
Conclusions The long-term prognosis for diseased SVGs requiring PCI is dismal. The JOSTENT PTFE stent-graft results in inferior outcomes compared with BMS, despite high-pressure implantation and prolonged dual antiplatelet therapy, a finding that becomes more evident with longer-term follow-up.
Dr. Stone reports receiving research grants from Jomed, and serving on the scientific advisory board for and receiving honoraria from Abbott Vascular and Boston Scientific. Dr. Goldberg reports receiving research grants from Jomed. Dr. O'Shaughnessy reports receiving research support from Abbott Vascular and serving on their advisory board. Dr. Dangas reports that his spouse has received speaker honoraria from Abbott Vascular. Dr. Mehran reports serving as a consultant/advisory board member for Abbott Vascular, AstraZeneca, Cardiva, Cordis, The Medicines Company, and she received research grants from Bristol-Myers Squibb/Sanofi-Aventis. Drs. Midei, Siegel, Cristea, and Lansky report that they have no relationships to disclose.
- Received October 28, 2010.
- Accepted November 16, 2010.
- American College of Cardiology Foundation