Great news|EuroPCR 2020 releases DEFINITION Ⅱ research

CBSMD丨Sep 07,2020

EuroPCR 2020 released the DEFINITION Ⅱ study by Professor Chen Shaoliang from Nanjing First Hospital, and the research paper was also published in the top academic journal "European Heart Journal."

On June 26, 2020, the "DEFINITION Ⅱ" study initiated by Professor Chen Shaoliang from the Department of Cardiology, Nanjing First Hospital was unveiled at EuroPCR 2020 (European Cardiovascular Intervention Conference-the world's top cardiovascular intervention conference) in Paris, France. , The research paper "Multicentre, Randomised Comparison of Two-Stent and Provisional Stenting Techniques in Patients with Complex Coronary Bifurcation Lesions: the DEFINITION II trial" was also published simultaneously in "European Heart Journal"! This study confirmed for the first time that in complex bifurcation lesions, double stent surgery is significantly better than provisional surgery. This is another glorious moment for Professor Chen Shaoliang's team following the publication of "Excellence Heart Center-Department of Cardiology, Nanjing First Hospital" on April 1, 2020 in European Heart Journal.

The DEFINITION II study is a prospective, international multi-center, randomized controlled trial initiated by Professor Chen Shaoliang. A total of 49 centers participated. The main purpose of the trial was to compare the eefficacy of the dual stent surgery and provisional surgery in patients with complex bifurcation lesions.. The primary endpoint of the study is the target lesion failure rate (TLF) 12 months after surgery, which mainly includes cardiogenic death, target vessel myocardial infarction, and clinically driven target lesion revascularization. The safety endpoint was stent thrombosis at 12 months postoperatively. The research proposal has been published in BMJ Open. The study was officially launched in December 2015, the last patient was enrolled in November 2018, and the 1-year clinical follow-up of all patients was completed at the end of November 2019.

A total of 660 patients with complex coronary bifurcation lesions defined by the DEFINITION criteria were selected in this study. The DEFINITION criteria was proposed by Professor Shaoliang Chen in 2014 and published in the JACC Intervention Journal. It can be defined by meeting 1 major criterion + 2 minor criteria. For complex bifurcation lesions, this standard distinguishes simple and complex bifurcation lesions and has strong clinical guiding significance. 660 patients with coronary heart disease with complicated bifurcation lesions were randomized 1:1 to receive dual stent surgery and provisional surgery. After being excluded due to randomness and informed consent, 328 patients were in the dual stent group and 325 patients in the provisional group. The age of the enrolled patients is about 63 years old, the proportion of ACS is 71%, the left main trunk end bifurcation is 29%, the length of the branch lesion is about 20mm, the proportion of DK crush in double stent surgery is 77.8%, and double stent surgery is used in the provisional group 22.5% of the patients, TAP operation accounted for 64.4% of them. At 12 months after surgery, the TLF rate of the dual stent group was 6.1%, which was significantly lower than the 11.4% of the provisional group (p=0.019). The difference in the composite endpoint was mainly due to the reduction of the target vessel MI for 12 months in the dual stent group (TVMI, 3.0% vs. 7.1%, p=0.025) and target lesion revascularization (TLR, 2.4% vs. 5.5%, p=0.049). There was no difference in clear stent thrombosis between the two groups (p=0.982).

The DEFINITION Ⅱ study confirmed the accuracy and reliability of the DEFINITION standard. For complex bifurcation lesions defined by the DEFINITION standard, the double-stent operation (mainly DK crush technology) is significantly better than the provisional operation in terms of reducing TLF. This result will It is of milestone significance to end the 20 years of controversy over the choice of bifurcation surgery in the industry. Following the inclusion of the DK crush technology invented by Professor Chen Shaoliang in the 2018 European Revascularization Guidelines, the DEFINITION standard and the research results of DEFINITION II will definitely change the European and American guidelines. These two major research achievements have successfully established the important position of Chinese cardiovascular doctors in the field of international cardiovascular research! With the development of national science and technology, the gap between China and the developed countries in Europe and the United States in the field of cardiovascular development has been narrowing, even in certain areas, we have achieved surpassing!

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