Intracoronary beta brachytherapy as a treatment option for high-risk refractory in-stent restenosis: Compassionate use
Introduction
While the initial results of human trials evaluating the efficacy of drug-eluting stents are highly promising, economic and technical considerations may render the delivery and deployment of these devices infeasible in a variety of clinical scenarios. In contemporary interventional practice, physicians are increasingly faced with patients with more complicated clinical histories and more difficult coronary lesions, and the optimal strategy for dealing with these problematic patients remains controversial. Vascular brachytherapy (VBT) has clearly been shown in multiple clinical trials to decrease restenosis rates for in-stent restenosis (ISR) [1], [2]. However, patients enrolled in these randomized clinical trials represent a select group, and the efficacy of VBT in patients with ISR who were excluded from these controlled trials due to more complex coronary anatomy requires further investigation. In general, patients who were not eligible for randomization include those with saphenous vein graft (SVG) lesions, long lesions (>35 mm), and patients with a history of more than three prior interventions. This study sought to define the angiographic and clinical profile and outcomes of these high-risk patients with ISR who were excluded from the randomized clinical trials and who received VBT using strontium-90 (Sr-90) using the Novoste Beta-Cath System through a compassionate use protocol (CUP).
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Patient population
The study was designed as a single-center, prospective, open-label registry trial evaluating the use of VBT on complex in-stent restenotic lesions. Between September 4, 1998, and December 6, 2000, 32 patients were referred to our center for VBT, but were excluded from the randomized trials due to disease complexity. At the time, VBT for ISR using the Novoste Beta-Cath System was not approved by the Food and Drug Administration (FDA) for the treatment of ISR, and thus VBT was administered as
Baseline demographics
Baseline characteristics of this patient population are shown in Table 1. The majority of the patients were middle-aged males with multiple cardiac risk factors. There was a large percentage of diabetics (42%, n=14), and 59% had previous coronary bypass surgery (n=19).
Procedural success
Procedural success, defined as <30% residual stenosis upon completion of the PCI and delivery of the prescribed radiation treatment, was achieved in 31 (94%) of the patients. A total of 34 lesions were treated. The lesion
Discussion
The number of percutaneous interventions utilizing intracoronary stenting has increased exponentially over the past decade. As a result, ISR remains a problematic issue in contemporary interventional practice despite advances in medical therapy and percutaneous interventions [6], [7], [8], [9], [10]. The results with drug-eluting stents are promising, but its efficacy for ISR has not been clearly established [10], [11], [12], [13]. VBT is the only therapeutic modality for ISR that has been
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2006, Strahlentherapie und Onkologie