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Eurocors Valentines Trial II published in EuroIntervention

Date: 2013/11/19

The Valentines Trial II: results of the worldwide multicenter enrollment trial, evaluating the real world usage of the second generation DIOR® paclitaxel drug-coated balloon for treatment of de novo coronary lesions.

Eurocor announced the publication of the Valentines Trial II in the Scientific Journal EuroIntervention (Volume 9, Number 5, Sep. 2013) with the title Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial. The registry was conducted with an objective to assess the efficacy of the second-generation Paclitaxel-coated balloon DIOR for de novo lesions at 6-9 months follow-up. 103 patients suffering from de novo lesions were enrolled by 38 Investigators from 16 countries starting between February 14th and March 31st 2011. Overall 109 lesions were treated. A follow-up rate of 99 % was reached with a 50.5% on-site Clinical Monitoring. Three Principal Investigators carried out the trial: Dr. Antonio Serra, (Barcelona, Spain), Dr. Alfredo Rodriguez (Buenos Aires, Argentina) and Prof. Dr. Fazila Malik (Dhaka, Bangladesh).

Dr. Antonino Laudani, COO at Eurocor GmbH says: “The results of the Valentines Trial II show, that the usage of DCB should be widely extended to de novo lesions, particullary for patients where DES is not an option.“

The authors are Ron Waksman, MD; Antonio Serra, MD, PhD; Joshua Loh, MBBS; Fazila Tun-Nesa Malik, MBBS; Rebecca Torguson, MPH; Stefanie Stahnke, PhD; Rembert Pogge von Strandmann, PhD; Alfredo E. Rodriguez, MD, PhD.

The Results: The follow-up results convincingly show that the DIOR DCB is a safe and effective treatment for cases of de novo lesions. The treatment with DIOR DCB resulted in a very low overall target lesion revascularization (TLR) rate of 2.9% and a target vessel revascularization (TVR) rate of 6.9%. Also, the overall major adverse cardiac event (MACE) rate of 8.7% was remarkably low. The preliminary late lumen loss (LLL) upon angiographic follow-up of a small subset of patients was 0.30 ± 0.36 mm and 0.33 ± 0.37 mm for the in-DCB segment and in-segment analyses, respectively. A subgroup analysis of the patients suffering from diabetes (28.2%) show that the DIOR DCB is effective in this population with a single digit TLR rate of 6.9% and a TVR rate of 13.8% at 6-9 months follow-up post treatment. The non-diabetic group of patients shows a TLR rate of 1.4% and a TVR rate of 4.1% at 6-9 months follow-up.

Conclusion
The results demonstrate that, in elective percutaneous coronary intervention, the adjunctive use of DCBs may be a feasible alternative to stenting in lesions that respond favorably to POBA. This may prove valuable in the subset of patients who are unsuitable for DES implantation.

Please see the publication: http://www.pcronline.com/eurointervention/64th_issue/98/

PR Eurocors Valentines Trial II published in EuroIntervention