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

Background: 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. Methods: 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. Results: The DES and BMS groups had similar age (71 6 8 years vs. 70 6 7 years, P 5 1.0), diabetes (45% vs. 36%, P 5 0.3), history of MI (58% vs. 51%, P 5 0.6), EF (44% vs. 47%, P 5 0.2) and previous PCI (40% vs. 35%, P 5 0.4). Reference vessel diameter (3.15 6 0.5 mm vs. 3.5 6 0.5 mm. P 5 0.001) and stent size (3.3 6 0.4 mm vs. 3.9 6 0.5 mm, P 5 0.001) were smaller in the DES group; however, the BMS were longer (24 6 10 mm vs. 21 6 6 mm, P 5 0.05). At one year there was a trend (P 5 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 5 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). Conclusion: 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. '

A Randomized Controlled Trial of a Paclitaxel-Eluting Stent Versus a Similar Bare-Metal Stent in Saphenous Vein Graft Lesions

“…However, there is a paucity of prospective data on DES in SVG interventions, although BMS is associated with high restenosis rates in SVG lesions. The results of mostly retrospective observational series comparing DES with BMS in SVGs have been conflicting: 6 studies showed better results with DES (9 -14) and 9 suggested no difference between BMS and DES (15)(16)(17)(18)(19)(20)(21)(22)(23).…”

Drug-Eluting or Bare Metal Stents for the Treatment of Saphenous Vein Graft Disease

“…The majority of trials compared both SES and paclitaxel-eluting stents (PES) with BMS. In 1 trial, 28 SES, PES, and tacrolimuseluting stents were compared with BMS. Zotarolimus-eluting stents were used in a minority of patients (8%) in 1 study.…”

“…Periprocedural treatment with clopidogrel was more disparate among eligible studies. In most trials, clopidogrel was prescribed for at least 1 month after BMS placement 13,[17][18][19][21][22][23]25,[27][28][29]36 and for at least 3 18 -20,22,25,28 or 6 months 13,14,17,19,21,23,25,27,28,32,33,36,37 after DES implantation. In the DELAYED RISCC study, 12 clopidogrel was administered for at least 2 months in all patients.…”

Drug-Eluting Stents for Saphenous Vein Graft Lesions

“…Two newer reports have continued the trend of presenting null or positive results. Gioia et al (5) reported that 106 patients treated with DES for SVG lesions had similar rates of event-free survival (81% vs. 82%, p ϭ 0.9), target vessel revascularization (14% vs. 14%, p ϭ 1.0), or death (6% vs. 6%, p ϭ 1.0) at 2 years, compared with 119 patients treated with bare-metal stents. Brodie et al (6) reported that 825 patients treated with DES for SVG lesions had lower rates of target vessel revascularization at 9 months than 361 patients with bare-metal stents (7.5% vs. 9.4%, p Ͻ 0.05).…”