Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter.

OBJECTIVE: An unmet need is represented in angioplasty catheters that permit the predilation stage of treating complex coronary anatomy oftentimes not amenable to conventional device therapies. BACKGROUND: Lesion preparation with balloon angioplasty prior to stent placement remains the most common method of percutaneous coronary revascularization. METHODS: Clinical and angiographic outcomes were evaluated following a treatment strategy of coronary artery disease that included predilation with a low-profile, 1.25-mm angioplasty catheter prior to stent placement. The study primary end point of procedural success was defined as successful device delivery and lesion treatment, including the absence of clinically significant perforation, arrhythmia, flow-limiting dissection, or reduction in baseline Thrombolysis In Myocardial Infarction (TIMI) grade with final achievement of TIMI 3 flow. RESULTS: Among 51 patients (54 lesions), predilation using a 1.25 mm angioplasty catheter was associated with procedural and device-related success rates of 100%. In-hospital target lesion failure occurred in one patient (2.0%) related to postprocedural myocardial infarction. Patient and angiographic characteristics included diabetes, 43.1%; lesion length ≥ 20 mm, 20.4%; bifurcation lesion, 31.5%; lesion classification B2/C, 74.1%; and baseline TIMI 0/1 flow, 13.0%. No subsequent in-hospital adverse events occurred. CONCLUSIONS: Percutaneous coronary revascularization involving a predilation strategy with a low profile, 1.25-mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective initial treatment for complex coronary anatomy.