Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease

Mehdi H Shishehbor; Dierk Scheinert; Ashit Jain; Marianne Brodmann; Gunnar Tepe; Kenji Ando; Prakash Krishnan; Osamu Iida; John R Laird; Peter A Schneider; Krishna J Rocha-Singh; Thomas Zeller

doi:10.1016/j.jacc.2022.10.016

Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease

J Am Coll Cardiol. 2023 Jan 24;81(3):237-249. doi: 10.1016/j.jacc.2022.10.016. Epub 2022 Nov 1.

Authors

Affiliations

¹ University Hospitals Health System, Harrington Heart & Vascular Institute, Cleveland, Ohio, USA. Electronic address: shishem@gmail.com.
² University Hospital Leipzig, Leipzig, Germany.
³ Mission Cardiovascular Research Institute, Fremont, California, USA.
⁴ Medical University, Graz, Austria.
⁵ RoMed Clinic, Rosenheim, Germany.
⁶ Kitakyushu, Fukuoka, Japan.
⁷ Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁸ Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
⁹ Adventist Heart and Vascular Institute, St Helena, California, USA.
¹⁰ Kaiser Permanente, Moanalua Medical Center and Clinic, Honolulu, Hawaii, USA (current address: University of California San Francisco, San Francisco, California, USA).
¹¹ Department of Cardiology, Prairie Heart Institute at St. John's Hospital, Springfield, Illinois, USA.
¹² Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

PMID: 36332764
DOI: 10.1016/j.jacc.2022.10.016

Abstract

Background: Endovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS).

Objectives: The purpose of this study was to compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials.

Methods: Patient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE).

Results: The primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months.

Conclusions: In a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis vs BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments.

Keywords: angioplasty; bare-metal stent; drug-coated balloon; paclitaxel; peripheral arterial disease.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Angioplasty, Balloon*
Coated Materials, Biocompatible
Femoral Artery / surgery
Humans
Paclitaxel / pharmacology
Peripheral Arterial Disease* / etiology
Peripheral Arterial Disease* / surgery
Popliteal Artery / surgery
Prospective Studies
Stents
Treatment Outcome
Vascular Patency

Substances

Paclitaxel
Coated Materials, Biocompatible