PVI With Paclitaxel-Coated Devices Safe, With No Increased Mortality, NCDR Study Shows

Use of paclitaxel-coated devices (PCD) during peripheral vascular intervention (PVI) procedures may be safe, with no increased mortality up to two years, compared with PVI without PCD, according to a study published Dec. 13 in the American Heart Journal.

Elizabeth Hope Weissler, MD, et al., analyzed use of PCD during PVI procedures with data from ACC's PVI Registry, operated in collaboration with the SVS Vascular Quality Initiative. The researchers linked registry data with claims data from the Center for Medicare and Medicaid Services (CMS) to examine outcomes.

The overall study cohort consisted of 5,460 patients who underwent 6,302 PVI procedures. After excluding patients younger than age 65 or for whom CMS data was unavailable, an analytic cohort of 1,493 patients who underwent 1,666 PVI procedures was used to analyze outcomes. The patients in the analytic cohort were older, had more comorbidities, and were more likely to be treated at a public hospital and to undergo intervention for critical limb ischemia.

In the overall cohort, 56.4% (3,554) of PVI procedures used PCD. The proportion of PCD-PVI procedures was slightly lower in the analytic cohort at 53.5% (888). Primary outcome results showed that the use of PCD was associated with lower unadjusted mortality at six months (6.9% vs. 9.8%), one year (11.5% vs. 17.1%) and two years (17.2% vs. 24.7%), compared to without PCD.

For secondary outcomes, among patients receiving PCD, unadjusted hospital readmissions were lower at six months (31% vs. 40%) and one year (40.9% vs. 51.4%). In addition, there were fewer unadjusted second surgical or endovascular interventions, as well as fewer major and minor amputations, in patients who underwent PVI with PCD. After adjustment, there were no significant differences in outcomes.

According to the researchers, the study provides real-world data suggesting that PVI with PCD use is safe and that mortality is no greater up to two years among patients undergoing PVI with vs. without PCD. The findings suggest that "interventionalists are consciously choosing certain patients in which PCD PVI would be beneficial and that PCD PVI can safely be used in those patients and instances," they conclude.

Keywords: Patient Readmission, Centers for Medicare and Medicaid Services, U.S., Medicare, Medicaid, Paclitaxel, Amputation, Comorbidity, Registries, National Cardiovascular Data Registries, Ischemia, PVI Registry

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