Drug-Coated Balloon: Mortality Unrelated to Paclitaxel

Jan 25, 2019
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Authors:
Schneider PA, Laird JR, Doros G, et al.
Citation:
Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis. J Am Coll Cardiol 2019;Jan 25:[Epub ahead of print].
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the correlation between paclitaxel exposure with a drug-coated balloon (DCB) and mortality?

Methods:

The investigators analyzed data from four independently-adjudicated prospective studies of DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA; n = 143). Extensive analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations with long-term mortality. Time to survival by paclitaxel dose tertile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. Endpoint analyses by treatment were adjusted for study as random effect.

Results:

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs. 11.2%, p = 0.399). No deaths were adjudicated by an independent clinical events committee as device-related. A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0 µg, 10,007.5 µg, and 19,978.2 µg. There was no statistically significant difference in all-cause mortality between the three groups through 5 years (p = 0.700).

Conclusions:

The authors concluded that there is no correlation between any level of paclitaxel exposure and mortality.

Perspective:

This study reports that there was no difference in up to 5-year mortality rates between patients treated with DCB and patients treated with PTA. Furthermore, among individual DCB patients, the dose of paclitaxel received during the index procedure did not correlate with mortality risk. These data are at odds with another recent meta-analysis of paclitaxel-based balloons and stents (Katsanos K, et al., J Am Heart Assoc 2018;7:e011245), which reported increased long-term mortality with paclitaxel coated balloon angioplasty. Some data included in this report have not yet undergone peer review, sharing the same shortcomings as the other meta-analysis with contradictory findings. Additional independent analysis is indicated to better understand the impact of other factors on long-term outcomes in this complex patient population and to explore any potential detrimental effects of paclitaxel.

Keywords: Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Paclitaxel, Percutaneous Coronary Intervention, Secondary Prevention, Stents, Survival Analysis, Vascular Diseases


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