Drug-eluting balloon found safe and effective for de novo lesions in Valentines Trial II


Eight-month results of the Valentines Trial II global registry have shown that the Dior drug-eluting balloon is a safe and effective treatment for cases of de novo coronary lesions. The follow-up data were presented at Cardiovascular Research Technologies (CRT2012) in Washington, USA, by Antonio Serra, Barcelona, Spain.

“Drug-eluting balloons are emerging as a potential alternative to combat restenosis. The drug-eluting balloon technology demonstrated safety and efficacy in randomised clinical trials for patients with in-stent restenosis. The question now is whether drug-eluting balloon as adjunct therapy to angioplasty can be a viable alternative to stenting in patients with de novo lesions in native coronary arteries,” Serra, from Hospital de la Santa Creu i Sant Pau, noted.


The international, multicentre short-term Valentines-registry was conducted to assess the efficacy of the paclitaxel-eluting balloon Dior (Eurocor) for de novo lesions at 6–9 months follow-up. One hundred and three patients suffering from de novo lesions were enrolled by 38 investigators in 16 countries from 14 February to 31 March 2011. A follow-up rate of 99 % was reached with a 50.5% on-site clinical monitoring rate, said Serra, one of the principal investigators in the study. The other principal investigators are Fazila Malik (Dhaka, Bangladesh) and Alfredo Rodriguez (Buenos Aires, Argentina).


The primary endpoints of the Valentines II Trials were death, myocardial infarction, target lesion revascularisation, target vessel revascularisation, and vessel thrombosis (both early and late occurrences).


The treatment with Dior resulted in a very low overall target lesion revascularisation rate of 2.9% and a target vessel revascularisation rate of 6.9%, Serra told delegates. “The overall major adverse cardiac event rate of 8.7% was remarkable low,” he said.


The preliminary late lumen loss upon angiographic follow-up of a small subset of patients was 0.30±0.36mm and 0.33±0.37mm for the in-drug-eluting balloon segment and traditional in-segment analyses, respectively. A subgroup analysis of the patients suffering from diabetes (28.2%) showed that Dior is effective in this population with a target lesion revascularisation rate of 6.9% and a target vessel revascularisation rate of 13.8% at 6–9 months follow-up post treatment. The non-diabetic group of patients showed a target lesion revascularisation rate of 1.4% and a target vessel revascularisation rate of 4.1%.


“The results of the Valentines Trial II data confirm the excellent results we obtained already in the Spanish Multicenter Registry which investigated safety and efficacy of Dior drug-eluting balloon treatment for de novo lesions in small vessels. With the now available results for Valentines Trial II we could prove that this is also true for de novo lesions in vessel with diameter of ≥2.5mm,” Serra stated. “Further investigation with the use of the Dior drug-eluting balloon system is required to establish the role of this technology for de novo lesions.”