Final results of the STent versus directional coronary Atherectomy Randomized Trial (START)

OBJECTIVES This study was designed to compare primary stenting with optimal directional coronary atherectomy (DCA). BACKGROUND No previous prospective randomized trial comparing stenting and DC has been performed. METHODS One hundred and twenty-two lesions suitable for both Palmaz-Schatz stenting and DC were randomly assigned to stent (62 lesions) or DC (60 lesions) arm. Single or multiple stents were implanted with high-pressure dilation in the stent arm. Aggressive debulking using intravascular ultrasound (IVUS) was performed in the DC arm. Serial quantitative angiography and IVUS were performed preprocedure, postprocedure and at six months. The primary end point was restenosis, defined as greater-than over equal to50% diameter stenosis at six months. Clinical event rates at one year were also assessed. RESULTS Baseline characteristics were similar. Procedural success was achieved in all lesions. Although the postprocedural lumen diameter was similar (2.79 vs. 2.90 mm, stent vs. DCA), the follow-up lumen diameter was significantly smaller (1.89 vs. 2.18 mm; p = 0.023) in the stent arm. The IVUS revealed that intimal proliferation was significantly larger in the stent arm than in the DC arm (3.1 vs. 1.1 mm2; p < 0.0001), which accounted for the significantly smaller follow-up lumen are of the stent arm (5.3 vs. 7.0 mm2; p = 0.030). Restenosis was significantly lower (32.8% vs. 15.8%; p = 0.032), and target vessel failure at one year tended to be lower in the DC arm (33.9% vs. 18.3%; p = 0.056). CONCLUSIONS These results suggest that aggressive DC may provide superior angiographic and clinical outcomes to primary stenting.