A new clinical trial investigated the treatment of restenosis in a drug-eluting stent (DES).
Berlin/ Erlangen (Germany). A new clinical trial has confirmed the superiority of the drug-eluting balloon SeQuent® Please for the treatment of restenosis after implantation of an uncoated stent (BMS). The clinical trial led by Dr. Harald Rittger of Universitätsklinikum Erlangen (Erlangen, Germany), investigated the treatment of restenosis in a drug-eluting stent (DES). This study was published online February 29, 2012, ahead of print in the “Journal of the American College of Cardiology”.
For the multicenter PEPCAD-DES trial 110 patients with DES restenosis were randomized to angioplasty with either a paclitaxel-coated balloon (SeQuent® Please, B. Braun, Melsungen, Germany; n = 72) or an uncoated balloon (n = 38). 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.
At 6-month angiographic follow-up late lumen loss at the target lesion, the primary endpoint, was 0.43 mm with the paclitaxel-coated balloon compared with 1.03 mm for the uncoated balloon. At 6 months, the incidence of MACE (cardiac death, target-vessel MI, and TLR), was 16.7 % and significantly lower in the drug-eluting balloon group compared with 50 % in the uncoated-balloon group. There were no cases of definite stent thrombosis.
Dr. Rittger and colleagues concluded that “although use of DES for DES restenosis is a common treatment strategy, the use of a drug-eluting balloon should be considered as an effective treatment strategy for DES restenosis.” Different to previous trials for treatment of BMS restenosis 53.6% of the treated lesions were at least the second restenotic lesion, identifying a high-risk patient population. These findings were first presented in November 2011 at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA.
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). It 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 BMS restenosis. It is expected, that this recommendation can now be extended for the treatment of DES restenosis. “SeQuent Please is a very exciting development for the cardiological community. 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 Vice President of B. Braun Vascular Systems Gerd Wacker.