Final results of the CAPAS trial.

BACKGROUND: The Cutting Balloon (Interventional Technologies Inc) is a new-concept balloon that incorporates 3 to 4 blades to create sharp incisions on the luminal surface of the lesion during dilation without causing severe tearing injury to the vessel wall. It may reduce restenosis and improve clinical outcome. METHODS: Two hundred forty-eight lesions were randomly assigned to Cutting Balloon angioplasty (CBA, 120 lesions) or conventional balloon angioplasty (PTCA, 128 lesions). Inclusion criteria were type B/C lesions (American College of Cardiology/American Heart Association classification) and reference diameter <3.0 mm by visual image on angiogram. Quantitative coronary angiography was performed before and after percutaneous coronary angioplasty and at 3-month follow-up. The primary end point was restenosis, defined as >/=50% diameter stenosis at follow-up. Clinical event rates at 1 year were assessed. RESULTS: Baseline characteristics were similar. Reference diameter was small in both groups (2.16 vs 2.18 mm, CBA vs PTCA). Preprocedural percent diameter stenosis (%DS) was similar (69.8% vs 69.6%). However, postprocedural and follow-up %DS were lower (26.2% vs 28.9%, P =.072; 40.8% vs 47.5%, P =.011) in the CBA group. Restenosis was significantly lower (25.2% vs 41.5%, P =.009) in the CBA group. At 1 year, event-free survival was achieved in 72.8% of the CBA group and in 61.0% of the PTCA group (P =.047). CONCLUSION: These findings suggest that CBA provides superior angiographic and clinical outcomes in comparison with PTCA in small coronary arteries.

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 DCA has been performed. METHODS: One hundred and twenty-two lesions suitable for both Palmaz-Schatz stenting and DCA were randomly assigned to stent (62 lesions) or DCA (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 DCA arm. Serial quantitative angiography and IVUS were performed preprocedure, postprocedure and at six months. The primary end point was restenosis, defined as > or =50% 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 DCA arm (3.1 vs. 1.1 mm ; p < 0.0001), which accounted for the significantly smaller follow-up lumen area 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 DCA arm (33.9% vs. 18.3%; p = 0.056). CONCLUSIONS: These results suggest that aggressive DCA may provide superior angiographic and clinical outcomes to primary stenting.

Percutaneous revascularization of lesions with saphenous vein graft failure: influence of chronic total occlusion on early outcome.

The purpose of this study was to evaluate a therapeutic strategy of percutaneous transluminal coronary angioplasty (PTCA) in patients with recurrent angina following coronary artery bypass grafting. The study looked at 112 branches associated with graft failure, excluding new lesions in the native coronary artery (NCA). Chronic total occlusion (CTO) was observed in 50% of NCA (56/112) and in 68% of the grafts (76/112). Thirty-three branches (29%) showed CTO in both NCA and the graft. The overall success rate was 86% (96/112). The success rate on NCA was 98% (44/45) in non-CTO, while in CTO it was significantly lower at 62% (18/29). As to grafts, the success rate was 94% (32/34) in non-CTO, while it was 50% (2/4) in CTO. These characteristics, with respect to lesion morphology and the prevalence of CTO, exerted an influence on the selection of the access vessels for revascularization. Early outcome depended on the result of treatment of CTO.

Comparison of quantitative coronary angiographic results after directional coronary atherectomy and balloon angioplasty of protected left main coronary stenosis.

We compared the angiographic and clinical outcomes after directional coronary atherectomy (DCA, 13 patients) with those after conventional balloon angioplasty (BA, 21 patients) in patients with protected left main coronary artery stenosis. The initial success rate was 100% in the DCA group and 81% (17 of 21) in the BA group. Restenosis was present in 2 of 11 patients in the DCA group and 9 of 16 patients in the BA group (18% vs. 56%, P < 0.05). DCA and BA improved a minimal lumen diameter. The initial gain after DCA was greater than that after BA. At follow-up, the minimal lumen diameter was larger and the percentage diameter stenosis was smaller in the DCA group than in the BA group. The late loss and loss index were equivalent in both groups. Compared with conventional BA, DCA in protected left main coronary artery stenosis is associated with a higher angiographic success rate and provides a wider luminal diameter with reduced incidence of restenosis.

Impact of cilostazol on intimal proliferation after directional coronary atherectomy.

Cilostazol, a novel platelet aggregation inhibitor, inhibits intimal proliferation in animal models. We randomly assigned 41 patients with lesions suitable for directional coronary atherectomy to the cilostazol group (200 mg/day) or the aspirin (250 mg/day) group. Medication was started before directional coronary atherectomy and was continued to a 6-month follow-up. Serial quantitative coronary angiography and intravascular ultrasound study were performed. Baseline characteristics were not different between the two groups. However, the minimal lumen diameter at follow-up was larger (2.33 +/- 0.60 mm vs 1.81 +/- 0.68 mm, p = 0.016) and the percent diameter stenosis (24.5% +/- 16.6% vs 40.9% +/- 21.0%, p = 0.010) was smaller in the cilostazol group. The change in vessel area was not different, but the percent plaque area at follow-up was smaller in the cilostazol group (55.7% +/- 11.2% vs 64.5% +/- 14.5%, p = 0.044). The restenosis rate was significantly lower in the cilostazol group (0% vs 26%, p = 0.020). We conclude that cilostazol appears to have an inhibitory effect on intimal proliferation after directional coronary atherectomy and may reduce restenosis.

[Adult T-cell leukemia/lymphoma, histologically presenting Ki-1 positive anaplastic large cell lymphoma].

A 48-year-old woman was admitted with neck tumors and cutaneous nodules. On the histological basis of the skin nodule biopsy, a metastatic anaplastic carcinoma was suspected. Immunohistochemical studies showed the presence of Ki-1 antigen, IL-2 receptor antigen, leukocyte common antigen (LCA), CD3 and CD4 on the tumor cells compatible with Ki-1 positive anaplastic large-cell lymphoma. This case was, however, finally diagnosed as adult T cell lymphoma (ATL) of a helper/inducer phenotype. She was born in Kagoshima. The serum anti-ATL associated antigen (ATLA) was positive. Southern blot analysis on the DNA extracted from the skin tumor cells showed a monoclonal integration of HTLV-1 proviral DNA. The results suggested that Ki-1 positive lymphomas may include a subset of ATL with a large-cell histology.