ISAR-DESIRE 3 study demonstrates the safety and effectiveness of the drug-eluting balloon as an alternative to drug-eluting stents in the treatment of in-stent restenosis.
Miami, FL. The so far largest randomized clinical trial with a drug-eluting balloon has been presented at the TCT conference on October, 26th, in Miami, Florida by Dr. Robert Byrne from the German Heart Centre in Munich, Germany. A total of 402 patients have been enrolled in the ISAR-DESIRE 3 trial.
Several clinical trials have previously demonstrated the superiority of the drug-eluting balloon SeQuent® Please for the treatment of restenosis after implantation of an uncoated stent (BMS). Recently a clinical trial led by Dr. Harald Rittger of Universitätsklinikum Erlangen (Erlangen, Germany), investigated the treatment of restenosis in a drug-eluting stent (DES). The drug-eluting balloon was significantly more effective in reducing late lumen loss and early clinical events, particularly target lesion revascularization (TLR), compared with conventional balloon angioplasty.
In ISAR-DESIRE 3 patients suffering from in-stent restenosis (ISR) after implantation of a drug-eluting stent and have been randomized into one of the three study arms. The treatment was accomplished either using the drug-eluting balloon SeQuent Please from B. Braun (DEB) or with an uncoated balloon (POBA) or with use of a drug-eluting stent (DES). Primary endpoint was in-segment diameter stenosis at the 6-8 month angiographic follow-up. At the 6-8 month follow-up the binary restenosis rate was 26.5 % with the paclitaxel-coated balloon compared with 56.7 % for the uncoated balloon and 24.0 % for then DES. The incidence of the secondary endpoint death and myocardial infarction at 12 months was 4.4 % in the drug-eluting balloon group and thus lower than 6.8 % for the uncoated-balloon and 6.9 % for the DES. As Dr. Byrne commented, "by obviating the need for additional stent implantation treatment with a drug-eluting balloon should be the treatment of choice in patients with "limus"-DES restenosis".
ISAR-DESIRE 3 confirms the positive clinical results from the prior studies and is consistent with the results from ISR I/II, PEPCAD II, the Habara trial and PEPCAD-DES. SeQuent Please has demonstrated the superiority to both POBA and DES for both treatment of restenosis from BMS and from DES in large randomized clinical trials. The drug-eluting balloon SeQuent Please recently got a recommendation from the European Society of Cardiology, from the German Society of Cardiology and the British NICE institute for the treatment of in-stent restenosis.
“With the current clinical evidence, SeQuent Please can be considered as a reasonable alternative to drug-eluting stents for selected patients with coronary artery disease; it is the most advanced solution for the treatment of patients with ISR and it represents currently the most promising therapeutic alternative to reduce the number of unnecessary stent implantations” said the Director Group Product Management Vascular Systems Dr. Sergej Kammerzell.