Clinical Outcomes after PCI in Japanese Patients: PENDULUM Registry 30-month Follow-up

The 30-month follow-up of the PENDULUM registry showed that MACCE (all-cause mortality, nonfatal MI, nonfatal stroke, and stent thrombosis) increased after 12 months in patients undergoing PCI with DES in Japanese practice, but the increase in BARC 3/5 severe bleeding slowed after 12 months, according to Dr. Kazushige Kadota, Kurashiki Central Hospital, and colleagues reported in the August issue of Circulation Journal.

Dr. Kadota and colleagues examined the risk of MACCE and severe bleeding in 5,796 of 6,422 patients who underwent PCI with DES enrolled in the PENDULUM registry from 67 Japanese centers between December 2015 to June 2017, and the risk of MACCE and severe bleeding was examined in 5,796 patients after 30 months of follow-up.

The rate of continuation of DAPT decreased to 59.3% at 12 months and 26.4% at 30 months; the rate of MACCE increased linearly through 30 months, reaching 9.5% (95% CI 8.8-10.2). For severe bleeding, there was an inflection point at 12 months and 4.4% (95% CI 3.9-5.0) at 30 months.

Although the rates of 30-month MACCE and bleeding events were higher in HPR patients compared to non-HPR patients (11.4% vs. 8.0%, respectively: unadjusted HR 1.45 [95%CI 1.23-1.72] p<0.001; 5.3% vs. 3.9%: unadjusted HR 1.35 [95%CI 1.06-1.73] p=0.016), after adjustment, PRU values measured immediately after PCI were not an independent risk factor for MACCE or severe bleeding at 30 months.

Dr. Kadota and colleagues concluded, "In Japanese real-world patients, MACCE remained constant and increased 12 months after PCI, but the increase in severe bleeding events slowed. HPR was not an independent risk factor for these events at 30 months post-PCI".

Kadota K, et al. Circ J. 2022; 86: 1339-1349

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