Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World

Paclitaxel- and Sirolimus-coated Balloons in Peripheral Artery Disease Treatment: Current Perspectives and Concerns

“…A multivariable Cox regression analysis showed paclitaxel DES was not associated with increased long-term mortality for over 11 years follow-up. Moreover, DCB was associated with decreased mortality for the first year past application and not correlated with long-term mortality in the years thereafter.Recently, a study from Germany has reported the long-term mortality after paclitaxel DCB versus standard PTA for femoropopliteal lesions in real-world clinical setting 43. A total 1,574 patients who underwent DCB (n=1065) or plain old balloon angioplasty (POBA; n=514) treatments were included.…”

“…[41][42][43][44] Secemsky et al have reported a large Medicareand Medicaid-based analysis of the relationship between paclitaxel device usage and mortality 41. The authors compared mortality in 5,989 PAD patients treated with paclitaxel devices versus 10,571 PAD patients who received standard PTA (median follow-up duration was 389 days).…”

Retrospective Real-World Studies of Paclitaxel and Mortality

“…Although claims-based observational data experience uncontrolled residual confounding and selection bias, the size and completeness of vital status-based analyses are valuable.In this issue of JACC: Cardiovascular Interventions, it is into this statistical cauldron that Bohme et al(8) present their single-center, retrospective real-world analysis of DCB and plain old balloon angioplasty (POBA)-associated mortality in 1,579 patients followed for a mean follow-up of 52 months. After propensity score matching, they concluded that DCB use conferred a survival benefit.…”

Drug‐eluting stent, drug eluting balloon controversy in peripheral artery disease; what is the verdict?

“…The same research group also published their real-world data on paclitaxel-coated balloons recently and demonstrated a long-term mortality benefit after DCB angioplasty compared to uncoated balloon angioplasty of femoropopliteal lesions. 3 Authors also explored the relationship between paclitaxel dose and the mortality risk. The patients treated with Zilver PTX were divided into 3 groups according to the paclitaxel dosage (<1,500 μg, 1,500-2,500 μg and >2,500 μg) and found no mortality difference between the groups.…”

“…Of note, these mortality rates were remarkably higher than those in the meta‐analysis (14.7 and 8.1% at 5 years), which was attributed to the exclusion of higher‐risk patients from the RCTs, raising further concerns on the applicability of the results of the meta‐analysis to the real‐world. The same research group also published their real‐world data on paclitaxel‐coated balloons recently and demonstrated a long‐term mortality benefit after DCB angioplasty compared to uncoated balloon angioplasty of femoropopliteal lesions 3 …”