. Author manuscript; available in PMC: 2022 Mar 1.

Published in final edited form as: Prog Cardiovasc Dis. 2021 Feb 13;65:15–22. doi: 10.1016/j.pcad.2021.02.004

Table 3.

Studies of the Safety of Paclitaxel-Coated Devices using Real-World Data.

Studies of PCDs using Real-World Data	Time to Follow Up	Outcome
Secemsky et al. JAMA. 2019.⁵³ (Medicare)	Median 389 days, up to 600 days	No Increase in Mortality for PCDs - unadjusted cumulative incidence through 600 days: 32.5% PCD vs 34.3% non-PCD (P=0.007) - aHR 0.97, 95% CI 0.91–1.04 (p=0.43)
Secemsky et al. JACC. 2019.⁵⁴ (Medicare)	Median 2 years, up to 4.1 years	No Increase in Mortality for PCDs - unadjusted cumulative incidence through 4.1 years: 51.7% PES vs. 50.1% BMS (P=0.16) - aHR 0.98; 95%CI 0.93–1.03 (p=0.53)
Secemsky et al. EuroIntervention. 2020.⁵⁶ (Optum Claims)	Median 2.66 years, up to 4.75 years	No Increase in Mortality for PCDs - aHR for mortality of PCDs relative to non-PCDs: 1.03, 95% CI 0.96–1.10 (p=0.39)
Freisinger et al. ESC. 2019.⁵⁷ (BARMER)	Median 92 months, up to 11 years	No Increase in Mortality for PCDs - HR at 5 years for PES vs non-PCD: 1.01, 95% CI 0.83–12.3 (p=0.91) - HR at 5 years for PCB vs non-PCD: 0.97, 95% CI 0.89–1.06 (p=0.492)
Behrendt et al. Eur. J. Vasc. Surg. 2020.⁵⁸ (BARMER)	5 years	No Increase in Mortality for PCDs - aHR for survival in PCD vs non-PCD in patients with IC: 0.87, 95% CI 0.76–0.99 - aHR for survival in PCD vs non-PCD in patients with CLTI: 0.83, 95% CI 0.77–0.90
Bohme et al. JACC CI.2020.⁶³	Median 51 months	No Increase in Mortality for PCDs - Mortality rate 27.5% after PTA vs 16.9% after PCB (p<0.001)
Bohme et al. Catheter Cardiovasc. Interv. 2020.⁶⁴	3–7 years, mean of 52 months	No Increase in Mortality for PCDs - Unadjusted mortality incidence for PES vs BMS: 22.6 vs 32.3% (p<0.033) - Adjusted mortality incidence for PES vs BMS: 24.1% vs 32.5% (p=0.264)
Hess et al. TCT Connect. 2020.⁶¹	Median of 31 months	No Increase in Mortality for PCDs - adjusted HR 0.95, 95% CI 0.83–1.09 (p=0.49)
Weissler et al. 2021.⁶⁵ (ACC PVI Registry)	2 years	No Increase in Mortality for PCDs - aRR for all-cause mortality in PCD vs non-PCD: 0.98, 95% CI 0.77–1.24 (p=0.844)
Bertges et al. 2020.⁶⁶ (VQI)	1 year	No Increase in Mortality for PCDs - aHR for mortality in PCDs compred with non-PCDs: 0.82, 95% CI 0.68–0.98 (p=0.03)