Lumen Gain After Endovascular Therapy in Calcified Superficial Femoral Artery Occlusive Disease Assessed by Intravascular Ultrasound (CODE Study).

To assess calcium patterns in superficial femoral artery (SFA) disease before and after balloon angioplasty ± stent implantation using fluoroscopy, angiography, and intravascular ultrasound (IVUS) imaging and then correlate calcification severity and midterm clinical outcomes. A multicenter investigation was carried out to retrospectively review 130 symptomatic patients (mean age 73.2±8.4 years; 86 men) with de novo SFA lesions who had successfully undergone endovascular therapy (EVT) at 7 centers between January and October 2015. The primary outcome was lumen gain measured as minimum lumen area (MLA) in post-EVT IVUS images according to calcification severity. The secondary outcomes included rates of stent malapposition, restenosis, and clinically-driven target lesion revascularization (TLR). A total of 102 (78.5%) cases had calcification in the lesions over a mean length of 64.3±72.8 mm. Of these, 70 cases were classified as having bilateral calcification according to fluoroscopy and angiography; 50 (49%) lesions had ≥180° calcification according to IVUS. The lumen gain in calcified lesions was significantly smaller than in the 28 noncalcified lesions (14.1±4.4 vs 17.8±5.2 mm IVUS evaluation of calcification in SFA lesions predicted lumen gain after EVT. Severe calcification in a ≥180° arc prevented successful dilation of the lesion with either plain balloon angioplasty or a nitinol stent. Accurate assessment of calcification patterns by IVUS is useful in maximizing the efficacy of endovascular therapy.