WASHINGTON, D.C.—Boston Scientific’s Taxus paclitaxel-eluting stent (PES) had very similar clinical outcomes and safety features compared to bare-metal stents (BMS) in treating saphenous vein graft lesions, according to a late breaking clinical trial presented Tuesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The prospective, randomized, multi-center SOS [Stenting of Saphaneous Vein Grafts] trial compared the 12-month angiographic and 24-month clinical outcomes between PES and BMS in SVG lesions
Emmanouil S. Brilakis, MD, PhD, at the Veterans Affairs North Texas Healthcare System in Dallas, and colleagues enrolled 80 patients with 112 lesions between 2005 and 2007 in five clinical sites in the U.S. and Europe.
The investigators implanted BMS in 39 patients with 55 lesions and PES in 41 patients with 57 lesions. In the BMS arm, there was 12-month angiographic follow-up of 33 patients with 47 lesions and the same follow-up in 33 patients with 43 lesions in the PES arm.
According to Brilakis, procedural success was achieved in 97 patients: one patient in both groups had acute stent thrombosis and one patient in the PES group had emergency coronary artery bypass graft surgery.
Brilakis reported that in-stent late loss was 1.29 mm in the BMS group and 0.42 mm in the PES group. In-segment late loss was 1.17 mm in the BMS group and 0.36 mm in the PES group. He said that “the BMS group had significantly lower late loss, both in-stent and in-segment.”
The primary study endpoint in-segment binary angiographic restenosis at 12-month follow-up angiography was significantly reduced from 51 percent in the BMS group to 9 percent in the PES group, which corresponds to an 82 percent relative and 42 percent absolute risk reduction
The PES group had significantly less target lesion revascularization (TLR), 5 percent vs. 28 percent in the BMS group); any coronary revascularization, including target-vessel and non-target vessel revascularization (TVR), 20 vs. 21 percent in the BMS group); and target vessel failure (TVF), 22 vs. 46 percent in the BMS group.
He also noted that there was no significant difference in use of clopidogrel at six months, 12 months, 18 months and 24 months.
In conclusion, Brilakis said he and his colleagues found that saphenous vein graft lesions, compared to a similar BMS, the Taxus PES resulted in:
• Significant reduction in 12-month binary angiographic restenosis, TLR and TVR;
• Trends for lower TVR, MI; and
• No difference in mortality and stent thrombosis.
“While this trial was not powered for safety, it does seem that the Taxus stent performs as well as bare-metal stents,” Brilakis concluded.