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Over the past 16 years coronary angioplasty has become an established therapy for coronary artery disease. Advances in technology and growing operator experience have improved initial success rates, lowered the complications associated with coronary angioplasty and expanded the indications of percutaneous revascularization to include large numbers of patients with complex lesions. The mechanisms of coronary angioplasty include plaque fracture, intimal atherosclerotic flaps, localized medial dissection and stretching of plaque-free segments. The problems and limitations of coronary angioplasty are: unfavourable lesion morphology which may preclude complete revascularization or increase the risk of major complications, "high-risk" patients requiring pharmacological or mechanical support, acute coronary occlusion, and restenosis, the 2 latter problems being related to the very mechanisms of coronary angioplasty. Recently, new interventional devices have been introduced: intracoronary stents, directional coronary atherectomy, rotational atherectomy, transluminal extraction atherectomy, excimer laser coronary angioplasty. A multidevice lesion-specific approach integrated with balloon angioplasty may optimize procedural results in a growing number of patients with complex coronary lesions. However, restenosis occurring within 6 months after successful angioplasty remains the "Achilles' heel" of coronary interventional procedures and erodes the potential advantages angioplasty holds over coronary bypass surgery. These 2 forms of myocardial revascularization are currently compared for the treatment of multivessel disease in randomized trials.

ObjectivesThis study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging.BackgroundNovel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis).MethodsThis first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries.ResultsAcute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 ± 0.48 mm and the percent neointimal hyperplasia volume was 27.9 ± 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium–defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55).ConclusionsThis first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.

We report the case of a 58-year-old woman who underwent outpatient coronary angiography with 5F catheters for atypical chest pain. Superselective angiography of a right superior septal artery mimicked a coronary arteriovenous fistula. Appropriate placement of the catheter in the ostium of the right coronary artery excluded the suspected anomaly.