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ShorT and OPtimal duration of Dual AntiPlatelet Therapy-3 study (STOPDAPT-3)

ShorT and OPtimal duration of Dual AntiPlatelet Therapy-3 study (STOPDAPT-3)

6002

The selection criteria for this study were patients scheduled for PCI who had acute coronary syndrome (ACS) or ARC criteria for high-risk bleeding (HBR). The mean age of the patients was 72 years, 23% were women, 75% had ACS, 43% had ST-elevation myocardial infarction, and 55% matched with criteria of ARC-HBR. At discharge, 13% were on oral anticoagulation, 94% on statins, including 48% on high-intensity statins, and 88% on PPI.

Between January 29, 2021, and April 5, 2023, a total of 6002 patients from 72 PCI centers nationwide were enrolled in the study and 3001 were assigned to the No-aspirin group and 3001 to the DAPT group. 1 patient in the No-aspirin group and 5 patients in the DAPT group were excluded because of overlap with other clinical studies or because they were not undergoing PCI. Until the 1-month primary analysis, 16 patients in the No-aspirin group and 14 patients in the DAPT group withdrew their consent, and a total of 5966 patients (2984 in the No-aspirin group and 2982 in the DAPT group) were included in the 1-month primary analysis. After 1 month, 4 patients in the No-aspirin group withdrew their consent, and the 1-year secondary analysis included 2980 patients in the No-aspirin (clopidogrel alone) group and 2982 patients in the DAPT (aspirin alone) group, for a total of 5962 patients. 1-year follow-up rate was 99.3% in both groups.

The major adverse events in the 5962 patients in the study at 1-year follow-up in both groups were as follows. 349 deaths (cardiovascular death: 248, non-cardiovascular death: 101), 143 myocardial infarctions, 33 stent thrombosis (Definite), 107 strokes, 372 major bleeds (BARC 3/5 criteria), 298 coronary revascularizations

<1-month primary analysis> No-aspirin group was not superior to DAPT group for bleeding events (4.47% vs. 4.71%, HR 0.95 [95%CI 0.75-1.20], P=0.66), and also non-inferior to DAPT group for cardiovascular events (4.12% vs. 3.69%, HR 1.12 [95%CI 0.87-1.45], PNI=0.01). Subacute stent thrombosis, one of the secondary endpoints, was significantly increased in the No-aspirin group (0.58% vs. 0.17% HR 3.40 [95%CI 1.26-9.23], P=0.02). <1-year secondary analysis> In a comparison of monotherapy beyond 1 month, the event rates of aspirin monotherapy was similar with clopidogrel monotherapy in both cardiovascular events (4.5/100 patient-years vs. 4.5/100 patient-years, HR 1.00 [95%CI 0.77-1.30], P=0.97) and bleeding events (2.0/100 person-years vs. 1.9/100 person-years, HR 1.02 [95%CI 0.69-1.52], P=0.92).

<1-month main analysis> Low-dose prasugrel monotherapy without aspirin from the time of PCI did not significantly reduce bleeding events compared with conventional DAPT therapy and showed a non-inferiority for cardiovascular events but associated with a signal of excess in coronary events. <1-year secondary analysis> From 1 month to 1 year after PCI, aspirin monotherapy was associated with similar outcome compared with clopidogrel monotherapy in both cardiovascular events and bleeding events.

Nov. 13, 2024

Nov. 23, 2023

https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.066720

No

No plan

https://jrct.mhlw.go.jp/latest-detail/jRCTs052200114

Ono Koh

Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine

54, Shogoin-kawara-cho, Sakyo-ku, Kyoto

kohono@kuhp.kyoto-u.ac.jp

Nishikawa Ryusuke

Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine

54, Shogoin-kawara-cho, Sakyo-ku, Kyoto

+81-75-751-4255

rn6072@kuhp.kyoto-u.ac.jp

Complete

Jan. 19, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

# Patients who are planned to have PCI with exclusive use of EES (XienceTM series).
# Patients with ARC-HBR or ACS
# Patients who could take DAPT with aspirin and P2Y12 inhibitors for 1-month

# Patients who withdraw consent (Included in the safety analysis set)

Both

Ischemic heart disease, stable angina, myocardial infarction

Intervention group:
After allocation immediately prior to PCI with Xience, antiplatelet therapy with prasugrel alone without aspirin for 1 month, followed by treatment with clopidogrel alone for up to 1-year post-PCI (aspirin-free group)

Control group:
One month of dual antiplatelet therapy with aspirin and prasugrel (DAPT) after allocation immediately prior to PCI with Xience, followed by treatment with aspirin alone for up to 1-year post-PCI (1-month DAPT group)

Ischemic heart disease, stable angina, myocardial infarction

No DAPT after PCI with DES

The primary analysis of the study will be on the primary and secondary endpoints 1 month after stent implantation. Secondary analyses will be performed on the primary and major secondary endpoints and death at 2 months after stenting. Exploratory Analysis will be performed on the primary and secondary endpoints at 1-year post-stenting.

The following two endpoints will be the primary and secondary endpoints of this study, respectively They will be evaluated at 1, 2, and 12 months after enrollment.

1. Major bleeding endpoint (BARC 3 or 5 bleeding) at 1-month (Superiority)
2. Cardiovascular composite endpoint: cardiovascular death, myocardial infarction (MI),
ischemic stroke or definite stent thrombosis (ST) at 1-month (Non-inferiority)

The following will be the major secondary endpoints of this study. Patients will be evaluated at 1 month, 2 months, and 12 months after enrollment.
# Cardiovascular death/ MI/ ischemic stroke/ definite ST/ Major bleeding (BARC 3 or 5)

The following will be the secondary endpoints of this study.
Patients will be evaluated at 1 month and 12 months after enrollment.
Death will be evaluated at 1, 2 and 12 months.
# Death
# Cardiovascular death
# MI
# Stroke
# Ischemic stroke
# Hemorrhagic stroke
# ST (ARC definition)
# TLF
# TVF
# Any TLR
# Clinically-driven TLR
# Non-TLR
# CABG
# Any TVR
# Any coronary revascularization
# Bleeding complications
BARC 2
BARC 3
BARC 4
BARC 5
BARC 2/3/5
TIMI major
TIMI minor
TIMI major/minor
GUSTO severe
GUSTO moderate
GUSTO moderate/severe
# Intracranial bleeding
# Gastrointestinal bleeding
# Gastrointestinal complaints

The number of deaths will be analyzed from the perspective of the safety assessment of this study, including cases in which consent was withdrawn.

+81-75-753-4680

Dec. 09, 2020

none