The EffPac trial was initiated and led by radiologists at Jena University Hospital to compare balloon angioplasty with drug-coated and uncoated balloons in vascular occlusion in the femoropopliteal region. In the result of the multicenter study, the drug-coated devices proved to be superior. Additionally, the complete review of the study cohort two years after the intervention also showed no increased mortality by the drug coating.
Balloon angioplasty is the treatment option for the advanced stage of intermittent claudication - if medication and targeted training can no longer alleviate the pain and impairments caused by constricted leg arteries. Under X-ray control, a catheter is guided inside the leg artery to the constriction and then carefully expanded with a balloon. This minimally invasive procedure is called angioplasty.
In cooperation with the Center for Clinical Studies, radiologists at Jena University Hospital, Germany, initiated an investigation to evaluate the efficiency of drug-coated balloon catheters (Luminor® by iVascular, Barcelona, Spain) versus uncoated ones. The coating substance paclitaxel is intended to prevent the dilated vascular site from re-constricting due to scarring. The success of the treatment was measured by the patient's ability to walk and by ultrasound examinations of the vascular permeability in two follow-up examinations. This prospective, multicenter, randomized controlled trial enrolled a total of 171 participants at 11 centers throughout Germany. "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 two years after the procedure," Prof. Dr. Ulf Teichgräber summarizes the result. He is director of the Institute for Diagnostic and Interventional Radiology at Jena University Hospital and principal investigator.
On behalf of the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, the study authors now once again checked the complete cohort with respect to morbidity and mortality. The occasion was a meta-analysis of angioplasty studies published last year that warned of long-term increased mortality associated with paclitaxel-coated devices. This warning triggered controversial discussions amongst experts, since subsequent analyzes at patient data level 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 meta-analysis, these patients counted up to a quarter of the subjects. Their data are not included in the study result as if they had not participated at all. However, for mortality assessment, they have to be included. This happened for the first time in the EffPac trial: In the subsequent review 167 patients were recorded, which represents almost the entire study cohort, thus preventing a misjudgment in comparing the groups.
The review yielded no difference in the survival after two years between the groups treated with an uncoated balloon or with a paclitaxel-coated balloon. Ulf Teichgräber: “The mortality risk by drug-coated balloons turned out to be even lower than that shown in the original two-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.”
Prof. Dr. Ulf Teichgräber
Institute for Diagnostic and Interventional Radiology, Jena University Hospital
Tel: +49 3641 9324831
Teichgräber et al. Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial. Radiology. 2020 May; 295(2):478-487. doi: 10.1148/radiol.2020191619
Teichgräber et al. Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac Trial. Radiology. 2020 Jul 21; 201370. doi: 10.1148/radiol.2020201370
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