BASKET-SAVAGE: DES Reign for Saphenous Vein Graft PCI Amid Declining Use
ROME, Italy—Surprising no one, the BASKET-SAVAGE results confirm that drug-eluting stents remain the best choice for PCI in saphenous vein graft (SVG) lesions, even as use of this conduit appears to drop from most, if not all, cath labs.
Raban Jeger, MD (University of Basel, Switzerland), presented the small study—stopped early for slow enrollment—here at the European Society of Cardiology (ESC) Congress 2016. As he noted in his presentation, SVGs have a different pathophysiology than native coronary vessels such that PCI of these vessels is associated with notoriously poor outcomes. This is due in part, he said, to peripheral embolization of friable material, atherosclerotic disease progression, and a high incidence of restenosis.
The few randomized clinical trials in this arena enrolled very few patients and were conducted with earlier generation drug-eluting stents. Some, noted Jeger, suggested that mortality actually increased at 1 year post-PCI in DES-treated patients as compared with bare-metal stents.
BASKET-SAVAGE was planned as a 240-patient trial randomizing subjects with SVG disease 1:1 to PCI using a Taxus Liberté or to a bare-metal Liberté (Boston Scientific). At the time the trial was stopped, 173 patients had been enrolled.
At 12 months, major adverse cardiac events had occurred in 17.9% of BMS-treated patients as compared with 2.3% of DES-treated patients (P < 0.001). By 3 years, 29.8% of BMS-treated patients had experienced a MACE, compared with 12.4% of patients treated with a DES. (P = 0.0012). This difference was driven by target vessel revascularization, which was 19.1% and 4.5% at 3 years in the BMS and DES groups, respectively. Cardiac deaths were no different between the groups at both the early and later time point.
A key limitation of the trial was the devices used: neither the drug-eluting or bare-metal Liberté stents are still in use. That seemed to matter little to cardiologists watching the hotline presentation, who appear to have long ago accepted that the antiproliferative properties of modern DES make them well suited to the setting of saphenous vein graft disease. DES are already a class IA recommendation in the current ESC PCI guidelines.
Moreover, many centers are no longer using saphenous vein grafts in CABG. Francois Schiele, MD (Université de Franche Comté, Besançon, France), who spoke with TCTMD before the ESC Congress, said he didn’t expect the BASKET-SAVAGE results to have much of an impact because the conduit is so rarely used. Indeed, he added, it is “never” used at his center because most of the patients treated with saphenous vein grafts have died or been reoperated.
Asked about continuing SVG use during a morning press conference, Jeger said this was a question “for a surgeon” but that he believes, in circumstances when the left internal or right internal mammary artery cannot be used, that “[the saphenous vein] is still a good option.”
However, Bernard Chevalier, MD (ICPS, Massy, France), who discussed BASKET-SAVAGE following Jeger’s presentation, said that SVGs are becoming “a relatively rare animal” in CABG. “I checked in my practice in the last 12 months, and it was less than 1% of all interventions for coronary artery disease,” he reported. This was 12 out of 2,065 procedures.
However, Kaare Harald Bønaa, MD (St. Olav’s University Hospital, Trondheim, Norway), who presented the NORSTENT results comparing DES and BMS in all-comers coronary artery disease during the same hotline session, noted that of the more than 9,000 patients in NORSTENT, 400 had SVG disease.
That figure prompted Steen Dalby Kristensen, MD, DMSc (Cardiovascular. Research Centre, Aarhus University, Skejby, Denmark), the press conference moderator, to say that SVG disease remains “a common problem.”
- NORSTENT: Do Modern-day Bare-Metal Stents Stand Up to Drug-Eluting Stents?
- Hybrid Revascularization for Multivessel Disease Appears Feasible, Safe
Jeger R. BASKET-SAVAGE: Drug-eluting vs. bare metal stents in saphenous vein grafts. Presented at: European Society of Cardiology Congress 2016. August 30, 2016. Rome, Italy.
- Jeger reports research contracts from the Swiss National Science Foundation, the Basel Cardiovascular Research Foundation, and Boston Scientific (Germany).
- Chevalier reports consulting for Abbott Vascular, Colibri, Cordis, Medtronic, Terumo, and being a minor shareholder and general director for CERC (CRO).