In a historical comparative study, the CREDO-Kyoto Registry Cohort-3 had a higher risk of bleeding compared to Cohort-2, which is at least partially explained by differences in P2Y12 receptor blockers, as reported by Dr. Masahiro Natsuaki of Saga University and his colleagues in the May issue of Circulation Journal.
Outcomes Related to Bleeding after PCI Over the Past 20 Years in Japan: The CREDO-Kyoto Registry Cohort-2 and Cohort-3 Studies
From the CREDO-Kyoto Registry, 25,419 patients (Cohort-2: 12,161; Cohort-3: 13,258) undergoing first-time PCI were included in the study.
Compared to Cohort-2 patients, Cohort-3 patients were older, had more heart failure, prior stroke, peripheral vascular disease, chronic kidney disease, atrial fibrillation, anemia, thrombocytopenia, malignancy, higher risk of ARC bleeding, and fewer patients were current smokers. Procedural characteristics showed that the proximal left anterior descending artery, left main coronary artery, and bifurcation lesions were treated more frequently in Cohort-3 than in Cohort-2, and chronic total occlusion was treated less frequently than in Cohort-2. The prevalence of DES use was much higher in Cohort-3 than in Cohort-2, and the majority of DES cases in Cohort-3 used new generation DES. Minimum stent size was significantly smaller in Cohort-3 than in Cohort-2. For treatment with P2Y12 receptor blockers, Cohort-2 and Cohort-3 patients received reduced doses of ticlopidine (200 mg/day) and global doses of clopidogrel (75 mg/day) in 87.7% and 94.8% of patients, respectively.
The 3-year cumulative incidence of GUSTO moderate/severe bleeding was significantly higher in Cohort-3 than in Cohort-2 (12.1% vs. 9.0%; p<0.0001). After adjusting for 17 demographic factors and 9 control factors potentially associated with bleeding events other than type of P2Y12 receptor blocker, the higher risk of Cohort-3 relative to Cohort-2 bleeding risk was still significant (HR 1.52 [95% CI 1.37-1.68] p<0.0001). The Cohort-3 trial was not associated with a lower adjusted risk of myocardial infarction/ischemic stroke compared to the Cohort-2 trial (HR 0.96 [95% CI 0.87-1.06] p = 0.44).
Dr. Natsuaki et al. summarized, “The cumulative 3-year incidence of major bleeding was significantly higher in Cohort-3 than in Cohort-2, with or without ARC-HBR. On the other hand, the cumulative 3-year incidence of major ischemic outcome measures was similar between Cohort-3 and Cohort-2 with and without ARC-HBR.”
Natsuaki M. et al, Circ J. 2022; 86: 748–759
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