A first trial in the clinical application of photodynamic therapy for the prevention of restenosis after coronary-stent placement.
BACKGROUND AND OBJECTIVES: The aim of this clinical study was to evaluate the safety of local delivery of a photosensitizer followed by photodynamic therapy (PDT), to determine its effectiveness in reducing in-stent restenosis. STUDY DESIGN/PATIENTS AND METHODS: Porfimer sodium was administered via a local delivery catheter to five coronary-stent implanted lesions followed by irradiation with a pulse laser. Coronary angiography (CAG) was performed at the baseline, after the procedure and at a 6-month follow-up. RESULTS: By the 18-month clinical follow-up, no adverse events such as photodermatosis, or myocardial ischemia had occurred. At the follow-up, no coronary embolization, dissection, or aneurysmal dilatation was observed in the CAG. In-stent diameter stenosis, late loss, and loss index were 19.16+/-8.20%, 0.37+/-0.18 mm, and 0.19+/-0.12, respectively. No in-stent restenosis was observed. CONCLUSIONS: This study suggests that PDT, with local delivery of Porfimer sodium, is safe and may be a feasible technique in preventing in-stent restenosis.