The European Society of Cardiology publishes new guidelines with a recommendation for the drug-coated balloon
The use of the drug-coated balloon for the treatment of in-stent restenosis has now been upgraded.
Barcelona (Spain). At the meeting of the European Society of Cardiology the new guidelines for myocardial revascularization have been published on August, 31st. The use of the drug-coated balloon for the treatment of in-stent restenosis has now been upgraded within the new guideline to the highest clinical evidence class I/ level A. Class I means that a procedure is indicated and with evidence level A clinical data are available from multiple clinical trials. The literature in the new guideline references six clinical studies, all of them utilizing the Paccocath (TM) coating used with the drug-coated balloon SeQuent Please from B. Braun Melsungen AG. As further mentioned "... one cannot assume a class effect for all drug-coated balloons". SeQuent Please is the only product on the market with completed randomized clinical trials for the treatment of in-stent restenosis. For this reason the recommendation in the ESC guideline can only be applied to the drug-coated balloon SeQuent Please from B. Braun.
In-stent restenoses is a severe complication of percutaneous treatment of patients with coronary artery disease. Stenosed arteries can be treated with the implantation of stents keeping the vessel open. However, about 10 % of the stented lesions will require a further re-intervention. This can be done by implantation of a second stent. When using the drug-coated balloon (DCB) the implantation of a second metal layer can be avoided. Further advantages of the DCB are a shorter period of the concomitand drug therapy and lower costs. Clinical trials have demonstrated that the DCB is at least as clinically effective as conventional stenting. The new ESC guideline can be applied both to the treatment of in-stent restenosis following the prior implantation of an uncoated stent as well as a drug-eluting stent. The use of the DCB SeQuent Please is a further step for improving the safety and efficacy in the treatment of coronary artery disease. B. Braun is considered as the innovator and the global market leader for this advanced therapeutic procedure.