Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal PAD Reassessed

CTA femoral artery
Findings from this study argue against a causative link between paclitaxel-coated balloon angioplasty and mortality.

No mortality differences were found between patients treated with paclitaxel drug-coated balloons (DCB) and those treated with uncoated balloon angioplasty (PTA), according to a study published in JACC: Cardiovascular Interventions. Moreover, the lack of clustering of causes of death or dose-response relationships argues against there being a causal relationship between paclitaxel and mortality.

A recent systematic review and meta-analysis identified increased long-term mortality among patients treated with DCB and stents. The current analysis sought to assess femoropopliteal DCB safety outcomes using patient-level data from a subset of participants in 3 randomized controlled trials from the Lutonix clinical program (LEVANT 1, LEVANT 2, and LEVANT Japan). A total of 2845 (91.9%) participants were treated with DCB and 250 (8.1%) were treated with uncoated PTA. Analyses were performed on an intent-to-treat basis. Cox proportional hazards modeling was used to calculate hazard ratios (HR).

Although LEVANT 2 had increased 5-year survival rates for PTA as compared with DCB (87.7 ± 2.7% vs 80.8 ± 2.3%), the difference was not significant (P =.084). Two-year HR after DCB in LEVANT 1 was 0.99 (95% CI, 0.25-3.95), compared with 1.40 (95% CI, 0.62-3.14) in LEVANT 2, and 0.32 (95% CI, 0.05-1.92) in LEVANT Japan.

The HR for all-cause mortality in LEVANT 2 increased from 1.13 (9 compared with PTA 5% CI, 0.35-3.68, P =.834) at 1 year to 1.60 (95% CI, 0.94-2.72, P =.084) at 5 years. In the LEVANT 2 combined randomized and continued access DCB cohorts, the 5-year HR was 1.48 (95% CI, 0.88-2.50, P =.139) compared with PTA. The differences in survival rates diminished as the data were aggregated: the aggregated analysis dataset of all 3 trials showed a 5-year HR of 1.01 (95% CI, 0.68-1.52, P =.95).

Causes of death and adverse events were balanced and without clustering between PTA and DCB, and patients undergoing paclitaxel or non-paclitaxel reinterventions had higher rates of survival compared with patients who did not undergo interventions. No dose-response relationship was found when adjustments were made for key mortality predictors.

Study limitations included the small sample size (which was underpowered for mortality), use of only select medications and covariates, uneven loss to follow-up between arms, and limited generalizability.

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Study investigators concluded, “The association between DCB and late mortality does not imply causality and mortality differences may be better explained by the differences in post-randomization medical treatment in the two cohorts, DCB and PTA. The identification of factors predictive of mortality after treatment may be due to chance alone; alternatively, the observed associations may arise from associations between the identified predictor and other, unmeasured covariates. The beneficial effect of reinterventions suggests a survival advantage related to more frequent patient-physician encounters. Further analysis of existing datasets from clinical trials and real-world registries may elucidate these findings.”

Disclosure: This clinical trial was supported by BD Peripheral Interventions, Tempe, AZ. Please see the original reference for a full list of authors’ disclosures.


Ouriel K, Adelman MA, Rosenfield K, et al. Safety of paclitaxel-coated balloon angioplasty for femoropopliteal peripheral artery disease [published online September 29, 2019]. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2019.08.025