Date：2015-3-24
The 13th China Interventional Therapeutics Conference (CIT) has taken place in Beijing National Conference & Exhibition Center between 19th and 22th March. On 21th March, SINOMED hosted its Luncheon Symposium where the topics mainly focused on the late breaking results of BuMA and BuMA Supreme. Next to prof. Patrick W. Serruys, prof. Renu Virmani, prof. Junbo Ge and Dr. Jianping Li, SINOMED has invited Key Opinion Leaders (prof. Yong Huo, prof. Huay Cheem Tan, prof. Robaayah Zambahari, prof. Rosli Mohd Ali and prof. Teguh Santoso) from China and south-east Asia to co-chair the session.
During this session, Dr. Jianping Li from Peking University First Hospital shared a systematic overview on endothelium functional healing. A new concept named ‘the window of opportunity hypothesis’ was introduced and discussed in this session. With this presentation, Dr. Jianping Li aimed to clarify the process of endothelium restoration and provide the benefit of BuMA from a perspective of vascular restoration. This concept entails that complete functional endothelial healing is required to prevent late stent thrombosis in the long-term. In order to achieve this, functional endothelium healing need to be achieved within a certain period.
Furthermore, Dr. Jianping Li provided an overview on all BuMA Series clinical trials. PANDA III is a post-market RCT trial where the enrollment has completed in September 2014. The primary endpoint of this trial is 1 year TLD including cardiac death, target vessel MI and clinical driven TLR. One year result is anticipated to confirm the concept ‘the window of opportunity’.
Prof. Renu Virmani and prof. Patrick W. Serruys provided latest information on BuMA Supreme. BuMA Supreme is the 2nd generation DES of SINOMED where a platform alteration is made (from 316L to CoCr). Prof. Serruys provided insights and updates on the FIM trial called PIONEER in Europe. This FIM trial is a multi center trial including 13 sites in the Netherlands, Belgium, Spain and Portugal. The first patient enrolment will take place by end of March 2015.
Simultaneously, SINOMED has initiated PIONEER II trial in China for CFDA approval. During this session, Prof. Junbo Ge (PI) from Zhongshan hospital in Shanghai, China presented the trial design. This is a FIM RCT trial of BuMA Supreme comparing with BuMA (1st generation) in China including circa 40 centers and 1500 patients. The primary endpoint of this trial is 9 month late loss and OPC target lesion failure at 1 year.
BuMA (1st generation) has been implanted in China (130.000) with superior clinical results. It is considered by Chinese cardiologists as the safest coronary stent presently available on the market, both in terms of success rate of implantation and in terms of long terms acceptance and safety for patients.