Rome, Italy – 30 August 2016: - Drug-eluting stents had a clear advantage over bare metal stents in patients undergoing revascularisation of saphenous (leg) vein grafts, results of the BASKET-SAVAGE trial show.
“This is currently the largest trial with long-term outcome data comparing these two types of stents in saphenous vein graft disease, and will reassure clinicians about the use of DES for this specific indication,” noted principal investigator Raban Jeger, MD, from University Hospital, in Basel, Switzerland.
Findings from BASKET-SAVAGE, (which stands for Basel Kosten Effektivitäts Trial – SAphenous Venous Graft Angioplasty Using Glycoprotein 2b/3a Receptor Inhibitors and Drug-Eluting Stents) were presented in a Hot Line session at ESC Congress 2016.
The results address inconsistency in the published literature regarding long-term outcomes after stenting of saphenous vein grafts (SVG), added Prof. Jeger.
Saphenous veins from the legs may be used to bridge plaque-filled coronary arteries as part of coronary bypass surgery, but eventually they too can become blocked (atherosclerosis) and require stents to keep them open.
The BASKET-SAVAGE trial randomised 173 patients with SVG disease to undergo percutaneous coronary intervention (PCI) with either bare metal stents (BMS, n=84) or paclitaxel drug-eluting stents (DES, n=89). (The trial reached only 72% of its target sample size before being terminated early due to limited enrolment).
The patients were a median age of 72 years and had received their SVGs a median of 13 years earlier.
During the procedure, most patients also received glycoprotein IIb/IIIa inhibitors (74%) to prevent clotting, and distal protection devices (66%) to catch any dislodged plaque debris.
The primary endpoint, which was major adverse cardiac events (MACE) at 12 months, occurred significantly less often in the DES compared to the BMS group (2% vs. 18%, hazard ratio [HR] 0.15, P<0.001). This difference was driven largely by a 12% rate of repeat procedures in the target graft among BMS-treated patients compared to none in the DES group (HR 0.04, P<0.001), as well as a significantly higher rate of nonfatal myocardial infarctions in BMS-treated patients (12% vs 2%, HR 0.24, P=0.025).
Longer follow-up to 3 years among a subgroup of patients showed that MACE rates were 67% lower in the DES compared with the BMS group (30% vs 12%, HR 0.33, P=0.0012), and the safety profile was similar in both arms.
Due to different pathophysiology, SVG atherosclerosis is potentially more demanding to treat compared to coronary artery disease in native vessels, but combining distal protection devices and glycoprotein IIb/IIIa inhibitors with DES resulted in MACE rates comparable to those seen after native vessel stenting, said Prof. Jeger.
“DES should remain the standard of care in patients with SVG lesions undergoing percutaneous coronary interventions,” he concluded.