The use of paclitaxel drug-coated devices (DCDs) in patients undergoing lower-extremity revascularization (LER) is associated with reduced need for unplanned repeated LER procedures and is not associated with risk of mortality or major adverse events, a post hoc analysis of trial data shows.
Published online Monday and in the Nov. 2 issue of the Journal of the American College of Cardiology, the study noted that paclitaxel DCDs were developed to improve LER patency in patients with peripheral artery disease (PAD), and their use has been recommended in SCAI guidelines. However previous studies, including a 2018 meta-analysis of trial data, reported an increase in mortality associated with DCDs.
Led by Connie N. Hess, MD, MHS, from the University of Colorado School of Medicine, and CPC Clinical Research, Aurora, Colorado, the new study analyzed data from 4,316 patients taking part in the VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) clinical trial.
“After adjusting for differences in baseline characteristics, no association between long-term mortality in patients treated with DCDs versus those treated with non-DCDs was observed, including in subgroups by device type,” said the authors – adding that DCD use was also not associated with major adverse limb events (MALE) but was associated with early and long-term reduction in unplanned index limb revascularization (UILR).
Using data from VOYAGER PAD, Hess and colleagues set out to assess whether use of paclitaxel DCDs is associated with mortality and limb outcomes.
The team noted that the primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For the new pre-specified DCD analyses, the primary safety and effectiveness outcomes were mortality and UILR, while MALE were a secondary outcome.
Of 4,316 patients, 1,342 (31.1%) received DCDs, with an average follow-up of 31 months.
An analysis found that DCDs were not associated with mortality (hazard ratio [HR]: 0.95; 95% confidence interval [CI]: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92).
Furthermore, the team noted that irrespective of DCD use, a consistent benefit of rivaroxaban for composite cardiovascular and limb events (P-interaction = 0.88) and safety of rivaroxaban with respect to bleeding (P-interaction = 0.57) were seen in the data.
Hess and colleagues concluded that there was “significant and persistent benefit” associated with DCDs, with long-term reduction in repeat LER and no association with mortality or MALE.
They noted that, the new analysis of VOYAGER PAD data addresses many of the limitations of previous studies in the field and provides safety and effectiveness data to help guide use of DCDs in PAD. However, they added that further randomized trials are needed to more completely evaluate the long-term safety and efficacy of DCD-based LER in well-characterized cohorts of patients with PAD.
The DCD debate
Writing in an accompanying editorial, Thomas Zeller, MD, and Tanja Böhme, MD, from the University Heart Center Freiburg–Bad Krozingen, Germany, noted that DCDs, including paclitaxel-coated drug-eluting stents and drug-coated balloons (DCBs), have been shown to result in superior technical and clinical outcomes and reduce health care costs compared with uncoated devices in the treatment of femoropopliteal artery disease. The editorialists added that the current post hoc analysis of effectiveness outcomes from VOYAGER PAD has confirmed the superior effectiveness of DCD.
Zeller and Böhme said that the finding is also supported by a recent interim analysis of the SWEDEPAD (Swedish Drug-Elution Trial in Peripheral Arterial Disease) study, which adds to the ongoing debate over use of DCD.
However, they commented that despite the large sample size of the VOYAGER PAD study, “it is very difficult to evaluate the interaction effect when the underlying effects are small.”
“Due to the low event rate and multiple confounders, it will be hard to confirm or finally exclude this mortality risk even in a dedicated RCT,” they noted.
Hess CN, Patel MR, Bauersachs RM, et al. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol 2021;78:1768-1778.
Zeller T, Böhme T. Antiproliferative Device Coatings: Efficacy Without Adverse Drug Effect?. J Am Coll Cardiol 2021;78:1779-1781.
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