Publications

BACKGROUND: Intravascular ultrasound (IVUS) use in aortic endovascular interventions, including thoracic endovascular aneurysm repair (TEVAR) and endovascular aneurysm repair (EVAR), may have similar benefits to those seen in coronary and peripheral interventions, but limited utilization and outcome data exist.

METHODS: Centers for Medicare and Medicaid Services claims data were used to identify patients undergoing TEVAR and EVAR from 2016 to 2023. Utilization trends were stratified by region, urbanicity, distressed communities index, community versus academic center, Medicare versus dual enrollment status, indication, urgency, and presence of dissection with malperfusion. Inverse probability weighting was used to assess the impact of IVUS on a composite outcome of repeat aortic intervention or death. Cox regression was used to estimate weighted hazard ratios.

RESULTS: A total of 136 540 patients underwent TEVAR and EVAR, of which 9.8% (13 364) used IVUS. IVUS use increased slightly from 2016 to 2023, driven more by use in TEVAR compared with EVAR, and was higher in academic settings, with Medicare and Medicaid dual enrollment, in the West, with dissections, with malperfusion and for elective procedures. IVUS was associated with a lower risk of the primary outcome at 30-days (hazard ratio, 0.80 [95% CI, 0.73-0.89]; P<0.001) and 6-months (hazard ratio, 0.93 [95% CI, 0.87-0.99]; P=0.022) for all-comers. Subgroup analysis suggested lower risks of the primary outcome with IVUS use for aneurysm driven by the abdominal segment, malperfusion, thoracoabdominal dissection with malperfusion, thoracoabdominal repair, and chronic kidney disease.

CONCLUSIONS: IVUS use has increased slightly in TEVAR and EVAR with heterogeneity in use. IVUS implementation during TEVAR and EVAR was associated with improved early and mid-term outcomes, particularly in certain subsets.

Policymakers have intensified calls to expand work requirements in Medicaid across the United States, which could have implications for low-income adults who experience a high burden of cardiometabolic risk factors and disease. In this difference-in-differences analysis, we found that the implementation of Medicaid work requirements was associated with decreased health insurance coverage, no change in employment status, and a trend towards worse access to care. Our findings suggest that the expansion of work requirements could have major implications for the cardiovascular health of working-age adults in the US.

BACKGROUND: Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs.

OBJECTIVES: We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs.

METHODS: The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss).

RESULTS: A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, Pnoninferiority < 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for BP-SES and 0.327 ± 0.463 mm for control (least squares mean difference: -0.178; 90% CI: -0.2943 to -0.0632; Pnoninferiority < 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (Pnoninferiority = 0.01).

CONCLUSIONS: The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).