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August 7, 2020

EffPac Trial Confirms Benefit and Safety of Paclitaxel-Coated Balloon Catheter to Treat Intermittent Claudication

August 7, 2020—Jena University Hospital in Jena, Germany, announced the publication of results from the EffPac trial comparing balloon angioplasty with a paclitaxel-coated balloon (Luminor, iVascular) versus an uncoated balloon to treat vascular occlusion in the femoropopliteal region.

The trial showed superior efficacy with the drug-coated devices, and a complete review of the study cohort 2 years after the intervention showed no increased mortality associated with the drug coating.

The prospective, multicenter, randomized controlled EffPac trial enrolled 171 patients at 11 centers across Germany. The success of the treatment was measured by a patient’s ability to walk and ultrasound examinations of the vascular permeability in two follow-up examinations.

The trial was initiated and led by radiologists at Jena University Hospital in cooperation with the university’s Center for Clinical Studies. Professor Ulf Teichgräber, MD, Director of the Institute for Diagnostic and Interventional Radiology at Jena University Hospital, is the study’s Principal Investigator.

The findings, “Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy Over Conventional Balloon: 2-Year Results of the Randomized EffPac Trial,” were published by Prof. Teichgräber et al in Radiology (2020;295:478-487).

“Compared to the control group, in the group treated with drug-coated balloon catheters, there was better vascular permeability and less tissue formation at the former constriction 2 years after the procedure,” commented Prof. Teichgräber in the university’s announcement.

On behalf of the Federal Institute for Drugs and Medical Devices in Germany, the study investigators re-evaluated the complete cohort with respect to morbidity and mortality. This study was conducted in response to the meta-analysis of angioplasty studies published in Journal of the American Heart Association by Katsanos et al in December 2018 that warned of long-term increased mortality associated with paclitaxel-coated devices. As noted in the Jena press release, the Katsanos findings elicited controversial discussions among experts because subsequent analyses of patient-level data could not confirm the increased long-term risk.

A possible source of error in determining mortality rates is not considering patients who have not completed the entire follow-up program. Within the trials considered in the Katsanos meta-analysis, these patients counted up to a quarter of the participants. The data from those patients are not included in the study results, as if they had not participated at all. However, for mortality assessment, these patients have to be included, stated the Jena University announcement.

The subsequent review of the EffPac trial included findings on 167 patients, which represents approximately the entire study cohort, thus preventing a misjudgment in comparing the groups. The review yielded no difference in survival after 2 years between the groups treated with a paclitaxel-coated balloon or an uncoated balloon.

On July 21, these findings were published online by Prof. Teichgräber et al as a research letter in Radiology, “Two-Year Review on Mortality and Morbidity After Femoropopliteal Drug-Coated Balloon Angioplasty in the Randomized EffPac Trial.”

Prof. Teichgräber concluded in the Jena University Hospital announcement, “The mortality risk by drug-coated balloons turned out to be even lower than that shown in the original 2-year results recently published. We could confirm angioplasty with paclitaxel-coated balloons to be a long-term successful and safe treatment option for intermittent claudication.”

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