ACC LBCT 2018 Six-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE): a randomized, open- label, multicenter trial Hyeon-Cheol Gwon, On the behalf of SMART-DATE trial investigators
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ACC LBCT 2018
Six-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary
intervention in patients with acute coronary syndromes (SMART-DATE): a randomized, open-
label, multicenter trial
Hyeon-Cheol Gwon,
On the behalf of SMART-DATE trial investigators
ACC LBCT 2018ACC LBCT 2018
Disclosure Statement of Financial Interest
• CONSULTING FEES/HONORARIA:
• Medtronic Asia Pacific
• RESEARCH/RESEARCH GRANTS:
• Abbott Korea
• Boston Scientific Korea
• Medtronic Korea
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
ACC LBCT 2018
• Patients with acute coronary syndrome (ACS) carry a higher risk of
recurrent ischemic events than those with stable ischemic heart
disease.
• Current guidelines recommend dual antiplatelet therapy (DAPT) for
12 months or longer in these patients, unless there are no excessive
risk of bleeding. These recommendations, however, were not based
on randomized controlled trials dedicated to the optimal duration of
DAPT in ACS population.
Background
ACC LBCT 2018
To test the efficacy of the reduced 6-month duration of DAPT after
second-generation DES implantation in patients with ACS.
Primary objective of study
Working hypothesis
The reduced 6-month duration of DAPT is non-inferior to the conventional
12-month or longer duration of DAPT to prevent major adverse cardiac and
cerebrovascular events (MACCE), defined as a composite of all-cause
mortality, myocardial infarction (MI), and cerebrovascular event at 18 months
after index procedure.
ACC LBCT 2018
• Key inclusion criteria
ACS patients with target lesion(s) in native coronary artery, amenable for
PCI with DES implantation
• Key exclusion criteria
Recent major bleeding, bleeding diathesis, DES implantation within 12
months, life expectancy <1 year, planned elective surgery within 12 months
Patient selection criteria
* The specific definitions of ACS1) ST-segment elevation MI: elevation of ST-segment ≥ 0.1 mV in 2 or more contiguous ECG leads or new LBBB with elevated biomarkers of myocardial necrosis2) Non-ST-segment elevation MI: elevated biomarkers of myocardial necrosis (troponin or CK-MB ≥ upper reference limit) with one of the following:
(a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia(b) Identification of a culprit lesion at coronary angiography
3) Unstable angina: an accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T-wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial.
ACC LBCT 2018
• Primary endpoint
• Major adverse cardiac and cerebrovascular events (MACCE) at 18 months
after the index procedure ( A composite of all-cause mortality, myocardial
infarction, and cerebrovascular events)
• Secondary endpoints
• The individual components of the primary end point
• Definite/probable stent thrombosis (ST)
• Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding
Study endpoints
* Definitions follow the ARC recommendations, if not described.
ACC LBCT 2018
• Primary Endpoint: 18-month MACCE
• Estimated event rates for 18 months: 4.5%
• Non-inferiority margin: 2.0%
• Sampling ratio of 1:1
• Follow-up loss for 18 months: 2%
• Study power: 80%
• An one-sided α error: 5%.
• 2,700 patients would be required
Sample size calculation
ACC LBCT 2018
Study design
2,700 patients with ACS receiving PCI
DAPT-6 group
P2Y12 inhibitors for 6 months
DAPT-12 group
P2Y12 inhibitors for ≥ 12 months
Primary endpoint: 18-month MACCE
a composite of all-cause mortality, MI, and cerebrovascular events
EESEES ZESZES BESBES
Loading aspirin and P2Y12 inhibitors
Randomization stratified by
centers, diabetes, STEMI
type of P2Y12 inhibitors• PCI=percutaneous coronary
A prospective, multicenter, randomized, and open-label trial
Lee JM, Am Heart J 2016 ClinicalTrials.gov NCT01701453
ACC LBCT 2018
Participating centers
31 centers in South Korea
Cheju Halla General Hospital
Chonnam National university hospital
Chung-Ang University Hospital
Chungnam National University Hospital
Daegu Catholic University Medical Center
Daejeon Eulji Medical Center
Dankook University Hospital
Dong-A University Hospital
Gwangju Veterans Hospital
Gyeongsang National University Hospital
Hanil General Hospital
Inje University Haeundae Paik Hospital
Inje University Ilsan Paik Hospital
Inje University Sanggye Paik Hospital
Kangbuk Samsung Hospital
Konkuk University Chungju Hospital
Konyang University Hospital
Korean University Guro Hospital
Kyimyung University Dongsan Medical Center
Kyungpook national university hospital
Myeongji Hospital
Pusan National University Hospital
Sam Hospital
Samsung Changwon Hospital
Samsung Medical Center
Sejong Hospital
Seoul National University Boramae Medical Center
Seoul National University Bundang Hospital
St. Carollo Hospital
VHS Medical Center
Yeungnam University Medical Center
ACC LBCT 2018
Trial coordination
Steering Committee
31 study investigators
DSMB
Data Safety
Monitoring Board
Trial Center
Academic Clinical Research
Organization CEAC
Clinical Event Adjudication
Committee
Grant Support
Abbott Vascular Korea, Medtronic
Korea, Biosensors Korea, Dong-A ST
The sponsors were not involved with the protocol development or the studyprocess, including site selection, management, and data collection and analysis.
P.I. Hyeon-Cheol Gwon
ACC LBCT 2018
Study flow
2,712 patients randomized
DAPT-6 group6-month DAPT (N=1,357)
DAPT-12 group
≥12-month DAPT (N= 1,355)
N=41 lost to follow-up N=26 lost to follow-up
18 months FU rate 97.5%
Intention-to-treat (ITT)
analysis
N=15 P2Y12 inhibitor <120 daysN=333 P2Y12 inhibitor >240 days
N=9 Aspirin <300 days
N=43 P2Y12 inhibitor <300 daysN=15 Aspirin <300 days