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ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study (STOPDAPT-2)

ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study (STOPDAPT-2)

3045

Age was 68 years, 21-23% female, 37% were patients with acute coronary syndromes, and 19% had ST-elevation myocardial infarction. As for medications at discharge, prasugrel was prescribed as the P2Y12 inhibitor in 39% of patients, statins in 87%, and PPIs in 79%.

Between December 25, 2015 and December 8, 2017, a total of 3045 patients from 90 PCI centers in Japan were enrolled and randomly assigned. 1523 patients were assigned to the 1-month DAPT group and 1522 to the 12-month DAPT group. 23 patients in the 1-month DAPT group and 13 in the 12-month DAPT group withdrew consent before the 1-year analysis. A total of 3009 patients (1500 patients in the 1-month DAPT group and 1509 patients in the 12-month DAPT group) were analytical population for the 1-year primary analysis. After 1 year, 2 patients in the 1-month DAPT group and 2 patients in the 12-month DAPT group withdrew consent, and at 5 years, a total of 3005 patients (1498 in the 1-month DAPT group and 1507 in the 12-month DAPT group) were included in the secondary analysis. The 5-year follow-up rate was 97.3% for the 1-month DAPT group and 97.9% for the 12-month DAPT group.

Major adverse events in both groups of 3005 patients in the study at 5-year follow-up were as follows, 297 deaths (cardiovascular death: 111, non-cardiovascular death: 186), 119 myocardial infarctions, 14 stent thrombosis (Definite), 94 strokes, 134 major bleeds (TIMI major/minor criteria), 480 coronary revascularizations, 186 new cancer diagnoses

Clopidogrel group compared with aspirin group was noninferior, but not superior for the primary endpoint (11.75% and 13.57%; HR 0.85 [95%CI: 0.70-1.05], P noninferiority<0.001, P superiority=0.13), while it was superior for the cardiovascular outcomes (8.61% and 11.05%, HR 0.77 [95%CI: 0.61-0.97], P=0.03), and not superior for major bleeding (4.44% and 4.92%; HR 0.89 [95%CI: 0.64-1.25], P=0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%; HR 0.77 [95%CI: 0.59-1.01], P=0.06) without difference in major bleeding (3.99% and 3.32%; HR 1.23 [95%CI: 0.84-1.81], P=0.31).

For the patients receiving coronary stenting with DES, clopidogrel monotherapy following 1-month DAPT, compared with conventional aspirin monotherapy following 12-month DAPT, significantly reduced cardiovascular events at 5 years and was non-inferior in the primary endpoint, making it a promising new alternative to conventional therapy.

Dec. 18, 2023

June. 25, 2019

https://jamanetwork.com/journals/jama/fullarticle/2736563

Yes

SIDNEY-2 collaboration A IPD meta-analysis of 6 studies including this study comparing P2Y12 inhibitor monotherapy with DAPT. Publication was made from BMJ. https://www.bmj.com/content/373/bmj.n1332.long SIDNEY-3 collaboration IPD meta-analysis of the same group as SIDNEY-2, plus YC1348 (STOPDAPT-2 ACS).

https://jrct.mhlw.go.jp/latest-detail/jRCTs052180194

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

Obayashi Yuki

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

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

+81-75-751-4255

y_obayashi@kuhp.kyoto-u.ac.jp

Complete

Dec. 25, 2015

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients who have undergone PCI with the everolimus-eluting cobalt-chromium stent (CoCr-EES, XienceTM) and have not experienced major complications (death, MI, stroke, or major bleeding) during hospital stay for treatment
2) Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist

1) Patients requiring oral anticoagulants
2) Patients with medical history of intracranial hemorrhage
3) Patients who have experienced serious complications (MI, stroke, and major bleeding) during hospital stay post-PCI
4) Patients with DES other than Xience implanted in PCI performed at the time of enrollment.
5) Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment (including implantation cases in clinical trial)
6) Patients confirmed to have no tolerability to clopidogrel before enrollment
7) Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor antagonists (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment

Both

Ischemic heart disease, stable angina, myocardial infarction

Intervention:
After PCI with Xience, dual antiplatelet therapy (DAPT) will be performed for one month. Following that, clopidogrel monotherapy will be continued up to 5 years after index PCI (1-month DAPT group)

Control:
After PCI with Xience, dual antiplatelet therapy (DAPT) will be performed for twelve months. Following that, aspirin monotherapy will be continued up to 5 years after index PCI (12-month DAPT group)

Ischemic heart disease, stable angina, myocardial infarction

Short DAPT followed by clopidogrel monotherapy

The primary endpoint of primary analysis in current study is the composite of cardiovascular death, myocardial infarction (MI), stroke (ischemic and hemorrhagic), stent thrombosis (Definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 12 months. Non inferiority of 1-month DAPT group will be verified compared with 12-month DAPT group.

The primary endpoint of secondary analysis is the composite of cardiovascular death, MI, stroke (ischemic or hemorrhagic), stent thrombosis (definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 60 months. Superiority of 1-month DAPT group will be verified compared with 12-month group.

Death
Death from cardiac cause
Death from cardiovascular cause
Death from non-cardiovascular cause
MI
Large MI (CKMB>=10 times of upper limit of normal [ULN])
Small MI (CKMB<10 times of ULN)
MI without CKMB elevation
MI without measurement of CKMB
Stroke (ischemic/hemorrhagic)
Ischemic stroke
Hemorrhagic stroke
Stent thrombosis (definite, probable, definite/probable in ARC definition)
Bleeding (TIMI criteria, BARC criteria, and GUSTO criteria)
Intracranial bleeding
Gastrointestinal bleeding
MACE (composite of death from cardiac cause. MI and clinically-driven TLR)
Death / MI
Cardiovascular death/ MI
Any coronary revascularization
Any TLR
Clinically-driven TLR
Non-TLR
TLF
TVF
CABG
Newly diagnosed cancer (60 months only)

+81-75-753-4680

Feb. 18, 2019

Only in Japan