Abstract
Background: Intravascular ultrasound (IVUS) during peripheral artery intervention is being increasingly used, however there is limited real-world procedural and outcomes data. Methods: We examined 4847 patients from the XLPAD Registry (NCT01904851) from 2006-2021 that underwent femoropopliteal (FP) endovascular intervention. The primary outcome was the incidence of major adverse limb events (MALE), which includes death, clinically driven revascularization, amputation, myocardial infarction (MI), and stroke. Comparative analyses were done between patients with IVUS and no IVUS interventions. Results: 322 (6.6%) patients underwent an IVUS guided FP intervention and 4525 without. Mean age 67, predominantly men (83% IVUS-group vs. 71% non-IVUS, p<0.0001) and Caucasian (71% vs. 69%, p=NS). IVUS patients had worse risk profiles, with more smokers (59% vs. 47 %, p<0.0001), heart failure (20% vs. 14%, p=0.006) and prior-MI (31% vs. 22%, p<0.0001), and similar proportion of hypertensives, diabetics, dyslipidemics, or those with chronic kidney disease. IVUS patients had more multivessel intervention (2.4 vs. 1.9 lesions, p<0.0001), SFA being the most common artery, followed by the popliteal artery in both groups. Balloon angioplasty was more common in the non-IVUS group (68% vs. 75%, p=0.005), whereas drug coated balloons (19% vs. 12%, p=0.005), drug-eluting stents (15 vs. 9%, p=0.001) and vascular mimetic stents (13 vs. 4%, p<0.0001) were more frequent in the IVUS patients. Fluoroscopy time was longer in IVUS patients (35 min vs 30 min., p=0.005) with similar rates of procedural (90% vs. 93, p=NS) and technical success (94% vs. 95%, p=NS). There were no differences in peri-procedural complications, or 12-month MALE (21% vs. 20%, p=NS). Only death from any cause was significantly higher in the non-IVUS group (0.7 vs 3.0%, p=0.017). Conclusion: IVUS use is under 7% of all FP interventions in the XLPAD registry with IVUS guidance is used in patients with more adverse clinical risk profile, however with no difference in technical, procedural success and 12-month MALE events.
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