LB-5
Update From the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices (SAFE-PAD) Study
Presenter
Eric Secemsky, MD, MSc, FSCAI, Beth Israel Deaconess Medical Center, Newton, MA
Eric Secemsky, MD, MSc, FSCAI1, Yang Song, MSc2, Marc L Schermerhorn, MD2 and Robert W. Yeh, M.D., FSCAI2, (1)Beth Israel Deaconess Medical Center, Newton, MA, (2)Beth Israel Deaconess Medical Center, Boston, MA
Keywords: Drug-coated Balloon (DCB), Drug-eluting Stent (DES), Peripheral Artery Disease (PAD) and Peripheral Vascular Disease (PVD)
Background:
Paclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials. The SAFE-PAD Study (NCT04496544) was created with the FDA to provide a longitudinal safety assessment of these devices, with follow-up data now surpassing 6 years.
Methods:
SAFE-PAD included Medicare beneficiaries ≥66 years treated with a drug-coated (DCD) or non-drug-coated device (NDCD) from 4/1/2015-12/31/2018. Non-inferiority (NI) between devices was evaluated for mortality through 7/21/2021. The impact of uncontrolled confounding was evaluated using multiple sensitivity tests, including an instrumental variable (IV) analysis. Of pre-specified subgroups, a cohort at the lowest risk of mortality was defined as those aged 66-70 with no critical limb ischemia and ≤2 comorbidities.
Results:
Of 168,553 patients, 70,584 (41.9%) were treated with a DCD. Median follow-up was 3.52 yrs (IQR 1.56-4.70 yrs; longest 6.31 yrs). The weighted cumulative incidence of mortality at 6.3 yrs was 63.6% with NDCDs and 62.5% with DCDs (HR 0.98; 95% CI 0.96, 0.99; NI p<0.0001) (
Figure). Multiple sensitivity testing including the IV analysis were supportive of the primary finding. Findings were consistent among all subgroups. In particular, there was no difference in risk among those at lowest risk of mortality (n=4,212; weighted HR 0.98; 95%CI 0.87, 1.10).
Conclusions
:
In this report from SAFE-PAD, there remained no evidence of harm associated with DCDs. The findings were robust in sensitivity analyses and consistent across all subgroups, in particular those at lowest risk of mortality.
