Trends in antithrombotic therapy and clinical outcomes for percutaneous coronary intervention in Japan following the 2020 JCS guideline focused update: findings from the SAKURA PCI2 Antithrombotic Registry.

In April 2020, the Japanese Circulation Society updated guidelines recommending shortened dual antiplatelet therapy (DAPT) for patients at Japanese Version of the High Bleeding Risk (J-HBR), but the impact remains unclear. We conducted a prospective multicenter registry (SAKURA PCI2 Antithrombotic Registry) starting June 2020 (n = 1136), enrolling patients who underwent percutaneous coronary intervention (PCI). Planned DAPT duration, defined as short if less than 3 months, was based on patient background post-PCI and physicians' discretion. Planned short DAPT was used in 55.2% of patients, with a similar incidence of J-HBR (68.3% vs. 66.6%, p = 0.55) and a shorter actual DAPT duration (97 vs. 229 days, p < 0.001) compared with Planned non-short DAPT. Primary endpoints, major adverse cardiovascular and cerebrovascular events (MACCE) including all-cause death, non-fatal myocardial infarction, stent thrombosis, and stroke, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (BARC-3/5), occurred similarly across groups (MACCE: 6.5% vs. 7.3%, p = 0.66; BARC-3/5: 3.7% vs. 2.2%, p = 0.14). Independent predictors of MACCE included age ≥ 75, Clinical Frailty Scale ≥ 4, and hemoglobin < 11. Age ≥ 75, severe chronic kidney disease, hemoglobin < 11, and platelets < 100,000 were linked to BARC-3/5. Among BARC 3/5 patients, 41.2% experienced bleeding after switching to single antiplatelet therapy. Planned short DAPT was implemented in 55.2% of patients, showing comparable thrombotic and bleeding outcomes to non-short DAPT.
Competing Interests: Declarations. Conflict of interest: Yasuo Okumura received research grants unrelated to this study from Johnson & Johnson KK and Biosense Webster, Inc., scholarship funds from Nippon Boehringer Ingelheim, remuneration from Daiichi-Sankyo, AstraZeneca, Bayer Healthcare, Bristol-Myers Squibb, and Johnson & Johnson KK, and belongs to the endowed departments of Boston Scientific Japan, Biotronik Japan, Abbott Medical Japan, Japan Lifeline, and Medtronic Japan. The authors declare that they have no conflict of interest. IRB information: The study protocol was approved by the Ethics Committee of Nihon University Itabashi Hospital (RK200310-3).
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