Acute and long-term outcomes of cutting balloon angioplasty followed by gamma brachytherapy for in-stent restenosis.

In-stent restenosis lesions were divided into 2 groups according to the use of cutting balloon (n = 76) or conventional balloon angioplasty (n = 407) before gamma-brachytherapy. Cutting balloon angioplasty, compared with conventional balloon angioplasty, in patients undergoing gamma-brachytherapy for in-stent restenosis is associated with less requirement for new stents (11% vs 22%, p = 0.02) but similar target vessel revascularization (35.1% vs 29.8%, p = 0.4) at follow-up.

Pilot trial of oral rapamycin for recalcitrant restenosis.

BACKGROUND: Sirolimus-coated stents are a promising new therapy for restenosis. We treated a select group of patients at especially high risk for restenosis with oral sirolimus. METHODS AND RESULTS: Patients were treated with an oral sirolimus-loading dose of 6 mg after coronary angioplasty, followed by 2 mg/d for 4 weeks. Serum electrolytes, lipid profile, renal panel, and complete blood cell count were measured at 1, 3, and 5 weeks after drug initiation. Oral sirolimus was prescribed to 22 patients who had a total of 28 lesions and were at high risk for restenosis. Of the 22 study patients, 11 (50%) discontinued oral sirolimus early because of side effects or laboratory abnormalities. Hypertriglyceridemia and leukopenia were the most frequent adverse events, occurring in 3 patients each. All adverse drug effects were reversible after discontinuation. Follow-up was obtained in 100% of patients at a mean of 9.9+/-1.8 months, ranging from 6.5 to 11.8 months. Target lesion revascularization (TLR) occurred in 15 of 28 lesions (53.6%) and 13 of 22 patients (59.1%). There was no difference in TLR for patients receiving a complete course of sirolimus (n=8; 72.7%) compared with patients who terminated treatment prematurely (n=5; 45.5%; P=NS). Clinically driven repeat cardiac catheterization was obtained in 15 (68.2%) patients; restenosis (>50% diameter stenosis at follow-up) was present in 13 (86.7%). CONCLUSIONS: Oral sirolimus does not appear to provide benefit to patients with recalcitrant restenosis. Adverse drug effects are frequent, underscoring the importance of local drug delivery to achieve high tissue concentrations without systemic adverse drug effects.

Restenosis after Angioplasty.

Angiographic restenosis occurs in 30% to 50% of patients after percutaneous transluminal coronary angioplasty (PTCA) with 20% to 30% target vessel revascularization at one year, and is associated with increased morbidity, mortality and health care costs. Intracoronary stents are the first line of therapy against restenosis after angioplasty. Depending on lesion morphology and location, stents can reduce restenosis and target lesion revascularization (TLR) by 20% to 30%. Obstructive coronary lesions in vessels with a diameter larger than 3.0 mm should be stented. The benefit of stenting in vessels smaller than 3.0 mm is controversial, with the BESMART (Bestent in Small Arteries) and ISAR-SMART (Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries) studies demonstrating conflicting results. Chronically occluded and subtotal vessels should be stented after PTCA. Obstructive lesions in saphenous vein grafts should be stented. It is preferable to stent ostial lesions after PTCA. Restenosis can occur in 15% to 25% of patients within 6 months of stent placement. Initial approach to focal in-stent restenosis is to repeat PTCA. Patients with diffuse restenosis may require debulking prior to PTCA to improve acute results. "Stenting within-stent" has not proven beneficial unless there is diffuse in-stent restenosis, neointimal prolapse or vessel dissection during PTCA. There are no pharmacologic therapies approved by the Food and Drug Administration available to treat restenosis at present. Brachytherapy, gamma or beta, is an effective adjunctive therapy that can reduce recurrent in-stent restenosis by 40% to 70%. Patients at high risk for recurrent in-stent restenosis (proliferative or total occlusion pattern) can be considered for brachytherapy to treat the first episode of in-stent restenosis. Patients with focal in-stent restenosis should be treated with brachytherapy after multiple recurrences of in-stent restenosis. Emerging therapies for treatment of restenosis include antiproliferative-coated stents and photoangioplasty.