Angiographic analysis of the angioplasty versus rotational atherectomy for the treatment of diffuse in-stent restenosis trial (ARTIST).

Patients with diffuse in-stent restenoses (ISRs) are at high risk for recurrent restenosis after percutaneous transluminal balloon angioplasty (PTCA). Percutaneous transluminal rotational ablation (PTCR) has proved effective in removing neointimal burden in ISRs. This study compares the acute and long-term results of PTCA and PTCR for the treatment of diffuse ISR in a randomized, multicenter investigation. The primary end point was the comparison of the minimum luminal diameter (MLD) between both groups at 6-month follow-up. Patients with symptomatic, diffuse, or high-grade ISRs were included; 146 patients were randomized to PTCA and 152 patients to PTCR. Diameter stenosis was reduced from 80 +/- 12% to 29 +/- 10% and from 80 +/- 11% to 28 +/- 12%, respectively, and MLD increased from 0.55 +/- 0.3 to 1.9 +/- 0.3 mm in the PTCA group and from 0.54 +/- 0.3 mm to 1.9 +/- 0.4 mm in the PTCR group. Spasm in the treated vessel and an intermittent slow flow phenomenon occurred more often after rotational ablation (17.7% vs 8.6%, p = 0.001; 5.3% vs 0%, p = 0.007). Minimum stenosis diameter at 6-month follow-up was smaller in the PTCR group than in the PTCA group (1.0 +/- 0.6 vs 1.2 +/- 0.6 mm, p = 0.008) and the restenosis rate was higher (64.9% vs 51.2%, p = 0.027). Procedural factors did not influence long-term outcome. In the PTCR group, the restenosis rate increased with decreasing vessel size, whereas this was not seen in the PTCA group. The lesion length and the baseline diameter stenosis were found to be predictive of restenosis with both treatment strategies; however, a residual diameter stenosis of <30% predicted absence of a restenosis only in the PTCR group. Thus, PTCA and PTCR of diffuse ISRs yield comparable acute angiographic results. The recurrence of a restenosis is higher after PTCR than after PTCA.

Clinical and angiographic safety and efficacy trial with a new coronary stent: the RESTOR study of the R Stent.

The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a significant single, de novo coronary lesion (average reference vessel diameter 2.84 +/- 0.54 mm, average lesion length 10.53 +/- 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin greater than or equal to 100 mg/day. The angiographic success rate (< 30% diameter stenosis post-procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic follow-up at 6 months. Minimal lumen diameter pre-/post-procedure and at follow-up was 0.98 +/- 0.37, 2.64 +/- 0.38 and 1.85 +/- 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.