Brilakis ES, et al. - The risks and benefits of using drug-eluting stents (DES) vs bare-metal stents (BMS) in de-novo saphenous vein bypass graft (SVG) lesions was evaluated. Researchers reported no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up in patients undergoing stenting of these lesions. These findings have important economic implications in countries with high DES prices such as the US, since they show that lower-cost BMSs could be used in SVG lesions without compromising either safety or effectiveness.

Methods

• For this research, patients were selected to the double-blind, randomized controlled trial from 25 US Department of Veterans Affairs centers.
• Eligible members were at least 18 years of age and had at least one significant de-novo SVG lesion (50–99% stenosis of a 2.25–4.5 mm diameter SVG) needing percutaneous coronary intervention with intent to use embolic protection devices.
• Enlisted patients were randomized in a 1:1 ratio via a phone system to receive a DES or BMS.
• Stratification of randomization was carried out, considering the presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors.
• Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation.
• The 12-month incidence of target vessel failure was the primary endpoint, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization.

Results

• Five hundred and ninety-nine patients were randomly assigned to the stent groups between Jan 1, 2012, and Dec 31, 2015, and the data for 597 patients were used.
• Data reported that the patients' mean age was 68.6 (SD 7.6) years, and 595 (>99%) patients were men.
• For most baseline characteristics, the two stent groups were similar.
• The incidence of target vessel failure was 17% (51 of 292) in the DES group vs 19% (58 of 305) in the BMS group (adjusted hazard ratio 0.92, 95% CI 0.63–1.34, p=0.70) at 12 months.
• Serious adverse events, stent thrombosis, and differences in the components of the primary endpoint between groups were not significant
• They observed that enrolment was stopped before the revised target sample size of 762 patients was reached.