Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Abstract

Small randomized trials have shown short-term improved outcome with drug-eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in-stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. From among 250 patients who underwent SVG stenting, 225 patients with available follow-up were selected from data bases at the three participating institutions. One-hundred-six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S-T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow-up was obtained by mailed interviews or telephone calls and review of the hospital chart. The DES and BMS groups had similar age (71 +/- 8 years vs. 70 +/- 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 +/- 0.5 mm vs. 3.5 +/- 0.5 mm. P = 0.001) and stent size (3.3 +/- 0.4 mm vs. 3.9 +/- 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 +/- 10 mm vs. 21 +/- 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2-year follow-up.