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PIONEER Global Trial Strategy of BuMA Supreme™ Released on CIT2016

Date:2016-04-25

 

The 14th China Interventional Therapeutics Conference (CIT2016) was held in Beijing, China between 17th and 20th of March 2016. On 18th of March, SINOMED has hosted its annual satellite symposium where various KOLs touched upon the recent clinical trial updates and provided further progress on the SINOMED TMVR. Next to this event, a PIONEER workshop was organized (Chairman: Prof. Junbo Ge and Prof. Patrick Serruys) for the Chinese and overseas investigators to share their preliminary experience and expectations on the BuMA Supreme DES.

Luncheon Satellite Symposium

This year, the satellite symposium primarily focused on three topics: latest progress of the PIONEER Global Trial of BuMA Supreme (2nd generation DES of SINOMED), results from PANDA III (post-market RCT trial of BuMA, 1stgeneration DES of SINOMED), and research achievements of SINOMED Trans-catheter Mitral Valve Replacement System (TMVR). The session was chaired by Prof. Patrick Serruys and Prof. Martin Leon and accompanied by Prof. Junbo Ge, Prof. Alexandra Lansky, Prof. Yong Huo and Prof. Bo Xu.

Prof. Alexandra Lansky from Yale University demonstrated the outstanding pre-clinical results of BuMA Supreme and introduced the PIONEER Global Clinical Strategy, including PIONEER FIM Trial in Europe, PIONEER II RCT Trial in China and PIONEER III IDE Pivotal Trial in US, Europe and Japan. Currently, the PIONEER III IDE trial is under full preparation.

Among the global trials, the progress of PIONEER FIM enrolment in Europe was presented by Prof. Patrick Serruys (Chairman). With totally 168 patients enrolled in 14 sites participating centers of Netherlands, Belgium, Portugal and Spain, the trial has successfully reached the 9 month QCA follow-up stage with great anticipation of the final data by Q4 2016. With the excellent flexibility/crossability in various types of lesions and the proven faster endothelium healing performance due to timed drug release in 1 month and the unique electro-grafting (eG™) nanometric base layer design, the result of PIONEER FIM is anticipated to be safe and effective, contributing to a promising PIONEER Global Trial.

Prof. Junbo Ge (PI) from Zhongshan Hospital, Shanghai, shared the latest progress of PIONEER II, a prospective trial program designed to compare BuMA Supreme with BuMA assigning to total 1319 patients in 40 centers of China, to evaluate the efficacy and safety of BuMA Supreme™ in patients with de novo coronary lesions, including RCT and OPC-arm. Till 10th of March 2016, 42 patients in 17sites have been enrolled. The recruitment phase will be completed by Q4 2016.

Next to the ongoing studies of BuMA Supreme™, Prof. Bo Xu from Fuwai Hospital, Beijing, illustrated a systematic overview of PANDA III, a Prospective Randomized Trial of BuMA comparing with Excel (JW Medical) SES (2350 patients in China). The results indicated the non-inferiority of BuMA SES comparing to the Excel SES for the primary endpoint (TLF at 1 year). BuMA (with eG base layer) SES was associated with a significantly lower incidence of definite or probable stent thrombosis compared with Excel SES: 0.5% vs. 1.3% P = 0.047 on an Intention-to-Treat (ITT) basis; 0.4% vs. 1.3% (P = 0.001) on a Per-Treatment-Evaluable (PTE)* basis.

Furthermore, Prof. Yong Huo, former president of Chinese Society of Cardiology, provided the latest animal study results of SINOMED Trans-catheter Mitral Valve Replacement System (TMVR). The chronic animal testing has been initiated and the FIM study in Europe will be conducted by Q1 2017 through the transapical (TA) approach.

PIONEER Workshop


On 18thof March, a PIONEER workshop was organized for the PIONEER Asia-EU community with attendance of various experts in the field. The top 2 enrollers of PIONEER FIM Trial in Europe, Dr. Giovanni Amoroso (OLVG hospital, Amsterdam, NL) and Dr. Adel Aminian (CHU Chaleroi, Belgium) were invited as speakers in this session chaired by Prof. Patrick Serruys and Prof. Junbo Ge. During this meeting, various BuMA Supremecases were discussed from the PIONEER trial series in Europe and China. Dr. Amoroso introduced a PIONEER case through a slender setting and Dr. Aminian shared a case including some captured baseline OCT images. Investigators from China, including Dr. Jianying Ma (Zhongshan hospital, Shanghai) and Dr. Guoxin Tong (Hangzhou First People’s Hospital), also shared their practical experience in using BuMA Supreme™ for PIONEER II. This fruitful meeting ended with an interesting discussion regarding DAPT and potential future trials for BuMA Supreme. This meeting aimed to create an academic platform for exchanging knowledge between Europe and Asia. 

For more details about PIONEER Global Trial of BuMA Supreme (2nd generation DES of SINOMED), please refer to: BuMA Supreme Platform and Pre-Clinical Results