From the Journals

Paclitaxel drug-coated balloons appear safe for PAD treatment



Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

Dr. Peter A. Schneider is a vascular surgeon at Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu

Dr. Peter A. Schneider

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

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