Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03119012 |
| Other study ID # |
CHOICEII16453143 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 19, 2017 |
| Est. completion date |
February 9, 2018 |
Study information
| Verified date |
April 2024 |
| Source |
Samsung Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus
extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing
percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)
Description:
After the development of second generation drug-eluting stent (DES), clinical outcomes
including in-stent restenosis have been dramatically improved in patients with coronary
artery disease undergoing percutaneous coronary intervention (PCI) compared with bare metal
stent or first generation DES era. However, interventional cardiologist still concern about
late adverse cardiac events including stent thrombosis (ST) in patients who received
implantation of permanent metallic stent. Bioresorbable scaffold (BRS) have been developed to
provide mechanical support and drug-delivery function similar to those of DES for
approximately 1 year, followed by complete bioresorption over several years. It has the
advantages of reducing the risk of late ST and maintaining of normal vascular function
because these novel devices are expected to leave no permanent materials within the vessel.
Although there was no significant difference from previous randomized controlled studies for
evaluating the clinical outcomes at 1-year between BRS and DES, recently documented ARSORB II
trial, which compared 3-year outcomes between BRS and DES, show that patients treated with
BRS had a higher risk of device-oriented composite endpoint mainly driven by target vessel
myocardial infarction (MI) compared to those with DES. In addition, in several case reports,
the late ST after discontinuation of dual anti-platelet therapy (DAPT) was reported in
patients who underwent BRS implantation. Therefore, the efficacy of extended DAPT and needs
for optimal DAPT duration in patients treated with BRS have been emerged. In the DAPT study,
randomized controlled trial including approximately 10,000 patients, DAPT beyond 1 year after
placement of a DES, as compared with aspirin therapy alone, significantly reduced the risks
of major adverse cardiovascular and cerebrovascular events (MACCE) and ST. However, extend
use of DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are
often delayed due to extended DAPT, which may affect the patient's quality of life. In
addition, there was no significant difference in all-cause mortality between extended DAPT
and aspirin monotherapy in the DAPT study because of increased bleeding risk in extended DAPT
group. Therefore, to determine the optimal or minimal necessary duration of DAPT is very
important. The other important issue is that which antiplatelet agent is more appropriate
after DAPT. In CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events)
trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with
aspirin and the incidence of gastrointestinal bleeding was significantly lower with
clopidogrel than with aspirin. Moreover, clopidogrel monotherapy was associated with a
reduced risk of ischemic events without increased bleeding risk compared with aspirin
monotherapy in patients receiving DES after 12-month DAPT. However, current guidelines still
recommend aspirin monotherapy after 6-12 months of DAPT in patients treated with DES, there
were no data for evaluating the optimal duration of DAPT and preferred choice of monotherapy
in patients treated with BRS. Through results of previous studies, the authors postulated
that P2Y12 antagonist monotherapy, which might have superior ability to prevent ischemic
event compared to aspirin monotherapy, had similar risk of ischemic events with lower risk of
bleeding complication compared with extended DAPT in patients who received BRS implantation
with 12-month DAPT. Therefore, in the SMART-CHOICE II trial, we will test noninferiority of
P2Y12 antagonist monotherapy compared with aspirin plus P2Y12 antagonist after 12-month of
DAPT in patients treated with BRS.
Stratification: presence of diabetes mellitus, clinical presentation (acute coronary
syndrome), type of P2Y12 inhibitor (clopidogrel or ticagrelor), and investigational center.
