FAST: No Advantage to Nitinol Stents in Short Lesions
FAST results show tendency toward lower restenosis rates in some patient subgroups.
The FAST trial failed to achieve the expected 44% relative risk reduction for restenosis in patients receiving the Bard Luminexx nitinol stent compared with patients undergoing percutaneous transluminal angioplasty (PTA).
In 12-month results presented yesterday by Hans Krankenberg, MD, of the Hamburg University Cardiovascular Center, incidence of restenosis at one year was 38.6% in patients treated with PTA vs. 31.7% in patients who received nitinol stents in an intent-to-treat analysis (P = .377).
When analyzed according to treatment received, restenosis rates were still equivalent between stent- and PTA-treated patients (Figure).
There were no major procedural complications and limited major adverse events. There were 10 stent fractures accounting for 12% of the study group, but fracture had no impact on restenosis.
Subgroup analyses
There was a trend toward reduced restenosis in patients receiving stents who were male, had diabetes, or who were smokers. There was a trend toward lower restenosis rates in women who underwent PTA, but these differences were not statistically significant, according to the study.
There was a 35% reduction in restenosis in patients who received stents where the vessel was totally occluded and a 39% reduction in patients with more than one distal vessel occluded, but these differences were also not statistically significant, according to the study.
Multivariate analysis showed that patients with normal cholesterol levels had lower rates of restenosis when treated with stenting. Patients who had a stent, hyperlipidemia, hypertension, diabetes or more than one distal vessel occluded; women; and smokers were at increased risk of restenosis. Patients with lesions longer than 5 cm or who had total occlusion had an increased risk of restenosis.
More studies needed
Further prospective randomized trials are needed in specific patient populations, most notably patients with diabetes, total occlusions, and with impaired distal run-off, Krankenberg said.
In terms of impact on treatment, this trial suggests that it may not be possible to show a difference between stenting and PTA in patients with shorter lesions, said commentator James D. Joye, DO, from El Camino Hospital in Mountain View, Calif. In these patients, the tendency to regard stents as the default treatment approach may not be appropriate and further study is warranted, Joye said.
Study design
The FAST trial comprised 244 patients in 11 European centers, with 121 randomized to treatment with PTA and 123 randomized to receive a stent. All patients had single lesions 1 cm to 10 cm long with 70% to 100% restenosis at baseline. Researchers had expected a 45% restenosis rate in patients undergoing PTA and 25% among patients who received a stent.