Objectives To provide an accurate adjustment for mortality in a benchmark, developing a risk prediction model from its own dataset is mandatory. We aimed to develop and validate a risk model predicting in-hospital mortality in a broad spectrum of Japanese patients after percutaneous coronary intervention (PCI).
Design A retrospective cohort study was conducted.
Setting The Japanese-PCI (J-PCI) registry includes a nationally representative retrospective sample of patients who underwent PCI and covers approximately 88% of all PCIs in Japan.
Participants Overall, 669 181 patients who underwent PCI between January 2014 and December 2016 in 1018 institutes.
Main outcome measures In-hospital death.
Results The study population (n=669 181; mean (SD) age, 70.1(11.0) years; women, 24.0%) was divided into two groups: 50% of the sample was used for model derivation (n=334 591), while the remaining 50% was used for model validation (n=334 590). Using the derivation cohort, both ‘full’ and ‘preprocedure’ risk models were developed using logistic regression analysis. Using the validation cohort, the developed risk models were internally validated. The in-hospital mortality rate was 0.7%. The preprocedure model included age, sex, clinical presentation, previous PCI, previous coronary artery bypass grafting, hypertension, dyslipidaemia, smoking, renal dysfunction, dialysis, peripheral vascular disease, previous heart failure and cardiogenic shock. Angiographic information, such as the number of diseased vessel and location of the target lesion, was also included in the full model. Both models performed well in the entire validation cohort (C-indexes: 0.929 and 0.926 for full and preprocedure models, respectively) and among prespecified subgroups with good calibration, although both models underestimated the risk of mortality in high-risk patients with the elective procedure.
Conclusions These simple models from a nationwide J-PCI registry, which is easily applicable in clinical practice and readily available directly at the patients’ presentation, are valid tools for preprocedural risk stratification of patients undergoing PCI in contemporary Japanese practice.
- risk model
- percutaneous coronary intervention
- In-hospital mortality
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Contributors TI and SK had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: TI and SK. Acquisition, analysis or interpretation of data: TI, SK, KY, HI, TA, SU, KK, HK, HM and MN. Drafting of the manuscript: TI and SK. Critical revision of the manuscript for important intellectual content: SK, KY, HI, TA, SU, KK, HK, HM and MN. Statistical analysis: TI, HK and HM. Obtained funding: MN. Administrative, technical or material support: SK, TA and MN. Study supervision: SK, HK, HM and MN.
Funding This study was funded by the Grant-in-Aid from Scientific Research from Japan Agency for Medical Research and Development (Grant No. 17ek0210097h000) and the Japan Society for the Promotion of Science (Grant No. 16KK0186 and 16H05215). The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics.
Competing interests TI has a research grant from Boston Scientific. SK reports investigator-initiated grant funding from Bayer and Daiichi Sankyo, and personal fees from Bayer and Bristol‐Myers Squibb. HI receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo and MSD. TA receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo and Bristol‐Myers Squibb. MN receives remuneration for lecture from Daiichi Sankyo, Sanofi, Bayer, Nippon Boehringer Ingelheim, Bristol‐Myers Squibb, Terumo, Japan Lifeline, Abbott, Boston Scientific, Medtronic and Nipro, and investigator‐initiated grant funding from Sanofi and Daiichi Sankyo.
Ethics approval The study protocol of the J-PCI registry was approved by the Institutional Review Board Committee at the Network for Promotion of Clinical Studies (a specified non-profit organisation affiliated with Osaka University Graduate School of Medicine, Osaka, Japan) and complied with the principles contained within the Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement In addition to data in this manuscript, all data in the J-PCI registry are available to investigators from >1000 sites participating in the J-PCI registry. The dataset is stored in servers of the National Clinical Database (NCD). Local investigators can submit proposal for data use for research purposes.
Collaborators Member of CVIT Scientific Committee: Kazushige Kadota (Kurashiki Central Hospital), Nobuo Shiode (Akane Foundation Tsuchiya General Hospital), Nobuhiro Tanaka (Tokyo Medical University), Tetsuya Amano (Aichi Medical University), Shiro Uemura (Kawasaki Medical School), Takashi Akasaka (Wakayama Medical University), Yoshihiro Morino (Iwate Medical University), Kenshi Fujii (Sakurabashi Watanabe Hospital), Hiroshi Hikichi (Saga University).
Patient consent for publication Not required.
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