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June 25, 2020

Medicare Advantage Database Analysis Finds No Evidence of Increased Long-Term Mortality After Paclitaxel Device Treatment

June 25, 2020—An analysis of Medicare Advantage patients who underwent femoropopliteal artery revascularization from April 2015 through December 2017 found no evidence of increased long-term mortality in those treated with paclitaxel-based devices, according to new data presented by Eric A. Secemsky, MD, MSc, during a VIVA Late-Breaking Trials Livestream.

The findings add to previous data Secemsky et al published in February 2019 and March 2019 from a series of Medicare database studies initiated to explore the safety of paclitaxel-coated balloons and stents versus bare/non-drug counterparts after a mortality signal was identified in a meta-analysis published by Katsanos et al in December 2018.

“This prespecified analysis designed with feedback from the FDA examined data from the Optum Database and included 16,796 Medicare Advantage beneficiaries," explained Dr. Secemsky in comments to Endovascular Today. Data from Medicare Advantage, a private plan alternative representing 36% of all Medicare beneficiaries, had not been included in the previous Medicare studies, which were also shorter in follow-up duration. The primary outcome measure was all-cause mortality through December 31, 2019.

The presented data included outcomes from 3,600 patients treated with drug-coated balloons, 827 with drug-eluting stents, 6,529 with bare-metal stents, and 5,840 with percutaneous transluminal angioplasty. The cumulative incidence of all-cause mortality for the weighted total population was 45.8% for patients treated with a drug-coated device versus 43.2% with a bare/non-drug device (adjusted HR 1.03; 95% CI = 0.96-1.10; P = 0.39), and results were said to be comparable for patients treated with balloons alone (44.1% for drug vs 42% for nondrug; adjusted HR 1.00; 95% CI = 0.92-1.08; P = 0.96) or stents (46.9% for drug vs 44.8% for nondrug; adjusted HR 1.02; 95% CI = 0.88-1.18; P = 0.78).

"With more than 2.65 years [median] follow-up and longest follow-up extending to 4.75 years, there was no evidence of harm associated with drug-coated devices compared with non–drug-coated devices," said Dr. Secemsky. Of note, the mortality signal reported by Katsanos et al was observed beginning at the 2-year follow-up point.

Prespecified subgroup analyses included device type (balloons versus stents), disease severity, whether the patient was treated at an outpatient or inpatient facility, sex, age, and comorbidity burden. "Importantly, no differences were observed in key subgroups, including female patients, non-CLI [critical limb ischemia], younger age, outpatient procedures, and patients with few comorbidities," Dr. Secemsky noted.

"These data build on prior real-world data analyses that have yet to replicate the findings of harm associated with paclitaxel-coated devices that was observed in the original meta-analysis of randomized trials,” concluded Dr. Secemsky to Endovascular Today.

Dr. Secemsky is Director of Vascular Intervention at Beth Israel Deaconess Medical Center and Director of Vascular Research at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, and Assistant Professor of Medicine at Harvard Medical School. The analysis presented was funded by and performed in conjunction with Medtronic.

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