3 years follow-up result of CREDIT Ⅱ study— an evidence-based clinical research for EXCROSSAL

CREDIT II was a multicenter, prospective, randomized, blinded clinical trial comparing the new generation BP-DES EXCROSSAL versus EXCEL stent in patients with up to two de novo coronary lesions. This study is the first one in China adopting EDC system, which ensures the reliability of the data collected and compliance with the requirements of GCP regulations. It is also the first study adopting the latest 2012 global MI definition in data analysis that guarantees the conformity with clinical practice.

The result showed that the primary endpoint (late lumen loss at 9 month) was similar between the two groups (non-inferiority p<0.0001); No significant difference was found in the 9-month angiographic results.

Indicated by the result of 3-year follow up, incidence of TLF and PoCE of the new generation BP-DES group was significantly lower than that of the EXCEL group. There were only two cases of definite/probable stent thrombosis, which indicates that the safety of the new generation BP-DES was significantly improved (1.0% vs. 2.9%).

As is known to all, the first generation BP-DES EXCEL was a high starting point for the biodegradable polymer drug eluting stent, and proved by the follow-up result, the new generation BP-DES EXCROSSAL is non-inferior to EXCEL. In addition, it is expected that the ongoing research would prove further benefits brought by EXCROSSAL.