Articles

6-month versus 12-month or longer dual antiplatelet

therapy after percutaneous coronary intervention in
patients with acute coronary syndrome (SMART-DATE):
a randomised, open-label, non-inferiority trial
Joo-Yong Hahn*, Young Bin Song*, Ju-Hyeon Oh, Deok-Kyu Cho, Jin Bae Lee, Joon-Hyung Doh, Sang-Hyun Kim, Jin-Ok Jeong, Jang-Ho Bae,
Byung-Ok Kim, Jang Hyun Cho, Il-Woo Suh, Doo-il Kim, Hoon-Ki Park, Jong-Seon Park, Woong Gil Choi, Wang Soo Lee, Jihoon Kim, Ki Hong Choi,
Taek Kyu Park, Joo Myung Lee, Jeong Hoon Yang, Jin-Ho Choi, Seung-Hyuk Choi, Hyeon-Cheol Gwon, for the SMART-DATE investigators†

Summary
Background Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least Published Online
12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available March 12, 2018
http://dx.doi.org/10.1016/
data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary S0140-6736(18)30493-8
intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the See Online/Comment
conventional 12-month or longer duration of DAPT in this population. http://dx.doi.org/10.1016/
S0140-6736(18)30612-3
Methods We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they *Contributed equally
had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, †All SMART-DATE investigators
and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system are listed at the end of the Article
by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT Division of Cardiology,
Department of Medicine,
group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The
Samsung Medical Center,
primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index Sungkyunkwan University
procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary School of Medicine, Seoul,
endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding South Korea (Prof J-Y Hahn MD,
Y B Song MD, J Kim MD,
Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure. The primary endpoint
K H Choi MD, T K Park MD,
was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453. J M Lee MD, J H Yang MD,
Prof J-H Choi MD,
Findings Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group Prof S-H Choi MD,
Prof H-C Gwon MD); Samsung
and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in
Changwon Hospital,
1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. Sungkyunkwan University
The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer School of Medicine, Changwon,
DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; South Korea (Prof J-H Oh MD);
Myongji Hospital, Goyang,
pnon-inferiority=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly
South Korea (D-K Cho MD);
between the 6-month DAPT group and the 12-month or longer DAPT group (35 [2·6%] patients vs 39 [2·9%]; hazard Daegu Catholic University
ratio [HR] 0·90 [95% CI 0·57–1·42]; p=0·90) and neither did stroke (11 [0·8%] patients vs 12 [0·9%]; 0·92 [0·41–2·08]; Medical Center, Daegu, South
p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer Korea (J B Lee MD); Inje
University Ilsan Paik Hospital,
DAPT group (24 [1·8%] patients vs ten [0·8%]; 2·41 [1·15–5·05]; p=0·02). 15 (1·1%) patients had stent thrombosis in the Goyang, South Korea
6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 [95% CI 0·68–3·35]; (Prof J-H Doh MD); Seoul
p=0·32). The rate of BARC type 2–5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) National University Boramae
in the 12-month or longer DAPT group (HR 0·69 [95% CI 0·45–1·05]; p=0·09). Results from the per-protocol analysis Medical Center, Seoul,
South Korea (Prof S-H Kim MD);
were similar to those from the intention-to-treat analysis. Chungnam National University
Hospital, Daejeon, South Korea
Interpretation The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin (Prof J-O Jeong MD); Konyang
prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing University Hospital, Daejon,
South Korea (Prof J-H Bae MD);
percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary Inje University Sanggye Paik
syndrome without excessive risk of bleeding should remain the standard of care. Hospital, Seoul, South Korea
(Prof B-O Kim MD); St Carollo
Funding Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST. General Hospital, Suncheon,
South Korea (J H Cho MD); SAM
Medical Center, Anyang,
Introduction Association (ACC/AHA)3 and European Society of South Korea (I-W Suh MD); Inje
Patients presenting with acute coronary syndrome have a Cardiology (ESC) guidelines4 recommend dual antiplatelet University Haeundae Paik
higher risk of recurrent ischaemic events than do those therapy (DAPT) of aspirin plus a P2Y12 inhibitor for Hospital, Busan, South Korea
(Prof D-i Kim MD); Seoul
with stable ischaemic heart disease.1,2 Therefore, standard 12 months or longer in patients with acute coronary Veterans Hospital, Seoul, South
American College of Cardiology/American Heart syndrome unless there are contraindications such as Korea (H-K Park); Yeungnam

www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8 1

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University Hospital, Daegu,

South Korea (Prof J-S Park MD);
Chungju Konkuk University
Medical Center, Chungju,
South Korea (W G Choi MD);
and Chung-Ang University
Hospital, Seoul, South Korea
(W S Lee MD)
Correspondence to:
Prof Hyeon-Cheol Gwon, Heart
Vascular Stroke Institute,
Samsung Medical Center,
Sungkyunkwan University
School of Medicine, Seoul 06351,
South Korea
hcgwon@naver.com
Research in context
Evidence before this study
Current guidelines recommend dual antiplatelet therapy
(DAPT) of aspirin plus a P2Y12 inhibitor for 12 months or
longer in patients with acute coronary syndrome. However, the
optimal duration of DAPT in patients with acute coronary
syndrome undergoing percutaneous coronary intervention
with drug-eluting stents (DES) remains controversial. We
searched PubMed for relevant articles published in English up to
Dec 21, 2017, with the search terms “acute coronary syndrome”,
“dual antiplatelet therapy”, “percutaneous coronary
intervention”, and “drug-eluting stents”. DAPT was beneficial in
reducing major cardiovascular events in the PCI-CURE study,
the only dedicated prospective trial that compared the efficacy
of DAPT versus aspirin monotherapy in patients with acute
coronary syndrome undergoing percutaneous coronary
intervention. However, the duration of DAPT in the clopidogrel
group varied from 3 months to 12 months and the duration of
DAPT in the control group was only 1 month without
preprocedural loading of clopidogrel. Several observational
studies have reported conflicting results about the safety of
6-month DAPT in patients with acute coronary syndrome. In a
recent network meta-analysis of six randomised trials
investigating DAPT duration, 6-month DAPT was not
associated with higher rates of myocardial infarction or stent
thrombosis compared with 1-year DAPT in patients with acute
coronary syndrome after DES implantation. However, most
enrolled patients in this analysis had a relatively low risk and
the proportion of patients with myocardial infarction was quite
low, at about 10%. Recently, the DAPT STEMI and REDUCE trials
also compared short duration versus 12-month DAPT in
patients with acute coronary syndrome undergoing
percutaneous coronary intervention. Based on preliminary
results presented at Transcatheter Cardiovascular Therapeutics
2017 (TCT 2017), the sample size of the two trials seemed
inadequate to make a definite conclusion.
Added value of this study
In this prospective, randomised, non-inferiority trial, 6-month
DAPT was non-inferior to 12-month or longer DAPT for the
primary composite endpoint of all-cause death, myocardial
infarction, or stroke at 18 months after the index procedure.
All-cause mortality did not differ significantly between the
two groups and the risk of bleeding was not significantly lower in
the 6-month DAPT group than in the 12-month or longer group.
However, the rate of myocardial infarction was significantly
higher in the 6-month DAPT group than in the 12-month or
longer group. In the posthoc landmark analysis, the composite
endpoint of all-cause death, myocardial infarction, or stroke
tended to occur more frequently in the 6-month DAPT group
than in the 12-month or longer DAPT group between 6 months
and 18 months after the index percutaneous coronary
intervention. Although the non-inferiority of 6-month DAPT
compared with 12-month or longer DAPT was met, the increased
risk of myocardial infarction with 6-month DAPT prevents us
from concluding that short-term DAPT is safe in patients with
acute coronary syndrome undergoing percutaneous coronary
intervention with current-generation DES.
Implications of all the available evidence
Patients presenting with acute coronary syndrome have a
higher risk of recurrent ischaemic events than do those with
stable ischaemic heart disease. Our results suggest that
12-month or longer DAPT should remain the standard of care
for patients with acute coronary syndrome undergoing
percutaneous coronary intervention, despite the improved
safety of current-generation DES. Until a large prospective trial
shows the safety of short-term DAPT in patients with acute
coronary syndrome undergoing percutaneous coronary
intervention, guidelines recommending prolonged DAPT in
patients with acute coronary syndrome without excessive risk
of bleeding should be upheld.

excessive risk of bleeding. However, the optimal duration
of DAPT in patients with acute coronary syndrome
undergoing percutaneous coronary intervention remains
controversial. Of several studies referenced in the
ACC/AHA and ESC guidelines, the PCI-CURE study,
a substudy of the CURE trial, has been cited as the
most important and direct evidence in support of pro­
longed DAPT in patients with acute coronary syndrome
undergoing percutaneous coronary intervention.5 How­
ever, the PCI-CURE study compared the efficacy of DAPT
versus aspirin monotherapy rather than the optimal
duration of DAPT in patients with acute coronary
syndrome undergoing percutaneous coronary inter­
vention. Moreover, since the PCI-CURE study was done
nearly 20 years ago, direct application of its results to
contemporary clinical practice is difficult.
Considering the improved safety and efficacy of
drug-eluting stents (DES)6,7 and advances in medical
treatment,8–10 re-exploration of the optimal or minimal
necessary duration of DAPT in patients with acute
coronary syndrome undergoing percutaneous coronary
intervention is challenging. Several observational studies
and posthoc analyses have reported conflicting results
about the safety of 6-month DAPT in patients with acute
coronary syndrome.11–13 In a recent network meta-analysis
of six randomised trials, 6-month DAPT was not associated
with higher rates of myocardial infarction or stent
thrombosis after DES implantation in patients with acute
coronary syndrome.14 However, most enrolled patients had
a relatively low risk and the proportion of patients with
myocardial infarction was low, at about 10%. Therefore, we
sought to investigate whether a reduced 6-month duration
of DAPT would be non-inferior to the conventional
12-month or longer duration of DAPT at 18 months after
current-generation DES implantation in patients with a
broad spectrum of acute coronary syndrome.

2 www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8


Methods
Study design and patients
The SMART-DATE study was a multicentre, prospective,
open-label, non-inferiority, randomised trial done at
31 sites in South Korea, and designed by the SMART-
DATE investigators. Initially, the institutional review
board of Samsung Medical Center (Seoul, South Korea)
was concerned with the short duration of DAPT in
patients with acute coronary syndrome, especially those
with ST-segment elevation myocardial infarction
(STEMI). We persuaded the institutional review board to
approve the study design by highlighting the absence of
relevant randomised con­trolled trials and available data
on DAPT duration and outcomes in patients with acute
coronary syndrome. After revision of the protocol and
informed consent form, the institutional review board of
Samsung Medical Center and the institutional review
board at each participating centre approved the trial
protocol. After approval, the institutional review board of
Samsung Medical Center requested the investigators to
report study status annually. This study was coordinated
by the Academic Clinical Research Organization of
Samsung Medical Center. An independent data and
safety monitor­ing board reviewed safety data from the
study and provided recommendations for adverse events
or serious adverse events, protocol deviation, and follow-
up case reports. The rationale and design of this study
have been previously published.15
Patients were eligible for inclusion if they had acute
coronary syndrome that included unstable angina, non-
ST-segment elevation myocardial infarction (NSTEMI),
and STEMI. The specific definition of acute coronary
syndrome is presented in the appendix. Patients had to
have at least one lesion in a native coronary vessel with
reference diameter of 2·25–4·25 mm and stenosis
of more than 50% by visual estimation amenable
for percutaneous coronary intervention with stents.
Major exclusion criteria were a known hypersensitivity
or contraindication to aspirin, clopidogrel, heparin,
biolimus, everolimus, zotarolimus, or contrast media;
active pathological bleeding, major bleeding within
the previous 3 months, or major surgery within the
previous 2 months; history of bleeding diathesis or
known coagulopathy; life expectancy less than 2 years; an
elective surgical procedure planned within less than
12 months; and active participation in another drug or
device investigational study. All patients provided written
informed consent.
Randomisation
Patients were randomly assigned (1:1) to either the
6-month DAPT group (aspirin plus a P2Y12 inhibitor
for 6 months and thereafter aspirin alone) or to the
12-month or longer DAPT group (aspirin plus a P2Y12
inhibitor for at least 12 months following standard
ACC/AHA3 and ESC guidelines4) at the time of the index
procedure. Randomisation was done via a web-based
www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8 3
Articles
system by computer-generated block randomisation,
and was stratified by the site of enrolment, clinical
presentation (unstable angina, NSTEMI, or STEMI),
and diabetes. During the study, prasugrel and ticagrelor
became available in South Korea, so randomisation was
also stratified by the type of P2Y12 inhibitor thereafter.
To minimise bias from different stent devices, patients
were also randomly assigned (1:1:1) to three types of
stent: the zotarolimus-eluting stent (Resolute Integrity,
Medtronic Vascular, Santa Rosa, CA, USA), everolimus-
eluting stent (Xience Prime, Abbott Vascular, Santa Clara,
CA, USA), or biolimus A9-eluting stent (BioMatrix Flex,
Biosensors Inc, Newport Beach, CA, USA). All lesions
had to be treated with the allocated stent. However, other
stents were allowed in case of device failure or in
situations in which the operators decided otherwise
when considering the best interests of the patient.
Procedures
Percutaneous coronary intervention was done according
to standard techniques. Unfractionated heparin or low-
molecular-weight heparin was used for anticoagulation
during the procedure. Thrombus aspiration, predilation
or postdilation, or use of glycoprotein IIb/IIIa inhibitors
were left to the operators’ discretion. The length and
diameter of the stent were not restricted. The use of
intravascular imaging or fractional flow reserve was also
done according to the operators’ discretion.
All patients received 300 mg of aspirin orally and a
300 mg or 600 mg clopidogrel loading dose orally at least
12 h before percutaneous coronary intervention, unless
they had previously received these antiplatelet medi­
cations. However, if administration of a loading dose was See Online for appendix
not possible 12 h in advance, a 600 mg loading dose of
clopidogrel was given as early as possible before the
intervention. After the procedure, aspirin (100 mg orally
once daily) was used indefinitely and clopidogrel (75 mg
orally once daily) was maintained according to the
randomisation scheme (6 months versus 12 months or
longer). As mentioned above, prasugrel and ticagrelor
became available in South Korea during the course of the
study. Therefore, after December, 2014, 60 mg prasugrel
orally followed by 10 mg daily or 180 mg ticagrelor orally
followed by 90 mg twice daily could be used instead of
clopidogrel.
After the procedure, all patients were recommended to
receive optimal pharmacological therapy, including
statins, beta blockers, or renin-angiotensin system
blockade, if indicated, following standard ACC/AHA3
and ESC4 guidelines. Clinical follow-up was done at
1, 6, 12, and 18 months after index percutaneous coronary
intervention. At follow-up, data from patients, including
clinical status, all interventions, outcome events, and
adverse events, were recorded. In particular, information
about the use of aspirin or a P2Y12 inhibitor was assessed
at each follow-up. Patients who prematurely discontinued
antiplatelet therapy secondary to significant active
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bleeding or for other procedures were monitored
carefully for cardiac events and, once stabilised, their
antiplatelet therapy was restarted as soon as possible.
An independent clinical event adjudication committee,
whose members were masked to the study group
assignments, assessed all clinical endpoints.
Outcomes
The primary endpoint was a composite of major adverse
cardiac and cerebrovascular events, defined as a composite
of all-cause mortality, myocardial infarction, or stroke at
18 months after the index procedure. Secondary end­points
were the individual components of the primary endpoint,
cardiac death, a composite of cardiac death or myocardial
infarction; definite or probable stent throm­ bosis as
defined by the Academic Research Consortium (ARC);
and Bleeding Academic Research Consortium (BARC)
type 2–5 bleeding at 18 months after the index procedure.
Major bleeding was defined as BARC type 3–5 bleeding.
Net adverse clinical and cerebral events were defined as
major adverse cardiac and cerebrovascular events plus
BARC type 2–5 bleeding.
All deaths were considered cardiac unless a definite
non-cardiac cause could be established. Myocardial
infarction was defined as elevated cardiac enzymes
(cardiac troponin or myocardial band fraction of creatine
kinase) above the upper reference limit with ischaemic
symptoms or electrocardiography findings indicative of
ischaemia that was not related to the index procedure.16
Stroke was defined as any non-convulsive focal or global
neurological deficit of abrupt onset lasting more than
24 h or leading to death, which was caused by ischaemia
or haemorrhage within the brain. Stent thrombosis
was defined as definite or probable stent thrombosis
according to the ARC classi­fication.16 BARC bleeding was
defined as previously reported.17
Statistical analysis
The sample size was calculated for a non-inferiority
comparison of 6-month DAPT versus 12-month or
longer DAPT for the primary endpoint of major adverse
cardiac and cerebrovascular events. Based on event rates
of patients with acute coronary syndrome in the
EXCELLENT trial previously conducted by our group,18
we estimated that the event rate of the primary endpoint
in both groups at 18 months after the index pro­
cedure would be 4·5%. A non-inferiority margin of
2·0% was chosen on the basis of the feasibility of study
recruitment as well as the non-inferiority margin of
major trials.19,20 With a sampling ratio of 1:1 allowing for
2% attrition in each group during 18 months, we
estimated that 2700 patients (1350 per group) would
result in at least 80% power at a one-sided type I error
of 5%. If the upper limit of the one-sided 95% CI of the
difference was lower than the prespecified non-
inferiority margin, 6-month DAPT would be considered
to be non-inferior to 12-month or longer DAPT.
4 www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8
The primary analysis was done according to an intention-
to-treat principle. The posthoc landmark analysis was done
with a landmark of P2Y12 inhibitor discontinuation at
6 months among patients who were event-free at 6 months.
We also did a prespecified per-protocol analysis among
patients who adhered to the study protocol (as a sensitivity
analysis). For the study endpoints, we censored patients
lost to follow-up and subsequently lost to assessment of
the primary endpoint when estimating Kaplan-Meier
event rates. Subgroup analyses were done to assess
the consistency of treatment effects of 6-month DAPT
compared with 12-month or longer DAPT on the major
adverse cardiac and cerebro­ vascular events. Predefined
subgroups were STEMI, diabetes, and type of P2Y12
inhibitor (clopidogrel, prasugrel, or ticagrelor). A
posthoc analysis was done for age, sex, acute myocardial
infarction, left ventricular ejection fraction, treated vessel,
and multivessel percutaneous coronary intervention. We
also did a posthoc subgroup analysis to assess the
consistency of treatment effects of 6-month DAPT
compared with 12-month or longer DAPT on myocardial
infarction.
Categorical variables were presented as counts and
percentages and compared by use of the χ² test or Fisher’s
exact test, as appropriate. Continuous variables were
presented as means (SD) and compared with the Student’s
t test. Cumulative event rates were estimated with the
Kaplan-Meier method and compared with log-rank tests.
Time from randomisation to occurrence of the first major
adverse cardiac and cerebrovascular events was used in the
survival analysis. For analyses of the primary and secondary
endpoints, hazard ratios (HRs) with 95% CIs were
estimated with the Cox proportional-hazards method. The
proportional hazards assumptions of the HR for 6-month
DAPT compared with 12-month or longer DAPT in the
Cox proportional hazards models were graphically
inspected in the “log minus log” plot and were also
confirmed with the Schoenfeld residual test. All Cox
proportional hazards models presented here met the
assumption of proportional hazards. All p values and
95% CIs were two-tailed except for those given for non-
inferiority testing of the primary endpoint. All analyses
were done with SAS, version 9.2.
Role of the funding source
The sponsors of the study had no role in study design,
data collection, site monitoring, data analysis, data
interpretation, or writing of the report. H-CG, J-YH, and
YBS had full access to all the data in the study and
had final responsibility for the decision to submit for
publication.
Results
Between Sept 5, 2012, and Dec 31, 2015, 2712 patients
were enrolled. Of these, 1357 patients were randomly
assigned to receive 6-month DAPT and 1355 were
randomly assigned to receive 12-month or longer DAPT
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(figure 1). Patients in the two groups were balanced with

regard to all baseline demographic and clinical 2712 patients enrolled
characteristics (table 1). Medications at discharge from
the index percutaneous coronary intervention procedure
were similar in both groups (appendix). Angiographic 1357 randomly assigned to receive 6-month 1355 randomly assigned to receive 12-month or
and procedural data were also similar in the two groups DAPT longer DAPT
(table 2).
The median age was 62 years (IQR 54–71) overall and
15 P2Y12 inhibitor <120 days 43 P2Y12 inhibitor <300 days
more than a fourth of the patient population had diabetes. 333 P2Y12 inhibitor >240 days 15 aspirin <300 days
More than a third of patients presented with acute 9 aspirin <300 days
STEMI. Nearly half of patients had multivessel disease,
and the left main or left anterior descending artery lesion 1000 included in per-protocol analysis 1297 included in per-protocol analysis
was treated in about 60% of patients (table 2). Everolimus-
eluting, zotarolimus-eluting, and biolimus-eluting stents
41 lost to follow-up 26 lost to follow-up
were implanted in a third of patients each, as per the
randomisation scheme (table 2).
The median duration of DAPT was 184 days 1357 included in intention-to-treat analysis 1355 included in intention-to-treat analysis
(IQR 177–236) or 6·1 months (IQR 5·9–7·9) in the
6-month DAPT group and 531 days (378–540) or Figure 1: Trial profile
17·7 months (12·6–18·0) in the 12-month or longer DAPT=dual antiplatelet therapy.
DAPT group. Adherence to the study protocol was
73·7% (1000 of 1357 patients) in the 6-month DAPT
6-month DAPT 12-month or longer
group and 95·7% (1297 of 1355 patients) in the 12-month group (n=1357) DAPT group (n=1355)
or longer DAPT group. Clopidogrel was used as a P2Y12
Clinical
inhibitor for DAPT in 1082 (79·7%) patients in the
Mean age, years 62·0 (11·5) 62·2 (11·9)
6-month DAPT group and in 1109 (81·8%) patients in the
12-month or longer DAPT group. Median age, years (IQR) 62 (54–71) 63 (53–71)

Follow-up for the primary endpoint was completed in Men 1016 (74·9%) 1028 (75·9%)

97·5% of all patients. At 18 months, the primary Women 341 (25·1%) 327 (24·1%)
endpoint of major adverse cardiac and cerebrovascular Mean BMI, kg/m² 24·3 (3·2) 24·5 (3·1)
events occurred in 63 patients in the 6-month DAPT Diabetes 365/1355 (26·9%) 379/1350 (28·1%)
group and in 56 patients in the 12-month DAPT group. Hypertension 669/1340 (49·9%) 654/1342 (48·7%)
Cumulative rates (Kaplan-Meier estimates) of major Dyslipidaemia 322/1329 (24·2%) 336/1332 (25·2%)
adverse cardiac and cerebrovascular events at 18 months Current smokers 506/1333 (38·0%) 536/1335 (40·1%)
were 4·7% for the 6-month DAPT group and 4·2% for Previous myocardial 30/1328 (2·3%) 23/1334 (1·7%)
infarction
the 12-month or longer DAPT group. The non-inferiority
of the 6-month DAPT to 12-month or longer DAPT was Previous revascularisation 65/1320 (4·9%) 52/1328 (3·9%)

met (absolute risk difference 0·5%; upper limit of Cerebrovascular disease 52/1330 (3·9%) 58/1332 (4·4%)

one-sided 95% CI 1·8%; pnon-inferiority=0·03 with a Chronic renal failure 13/1327 (1·0%) 6/1328 (0·5%)
predefined non-inferiority margin of 2·0%; table 3; Mean left ventricular 55·5% (11·0) 55·4% (10·5)
ejection fraction
figure 2A). Although all-cause mortality did not differ
Clinical presentation
significantly between the two groups at 18 months
ST-elevation myocardial 509 (37·5%) 514 (37·9%)
(2·6% vs 2·9%; HR 0·90 [95% CI 0·57–1·42]; p=0·90; infarction
figure 2B), myocardial infarction occurred more Non-ST-elevation 428 (31·5%) 425 (31·4%)
frequently in the 6-month DAPT group than in the myocardial infarction
12-month or longer DAPT group (1·8% vs 0·8%; HR 2·41 Unstable angina 420 (31·0%) 416 (30·7%)
[95% CI 1·15–5·05]; p=0·02; figure 2C). Both non-target
Data are n (%), n/N (%), mean (SD), or median (IQR). Data are given for the
vessel myocardial infarction and target vessel myocardial
intention-to-treat population. DAPT=dual antiplatelet therapy.
infarction occurred more frequently in the 6-month BMI=body-mass index.
DAPT group than in the 12-month or longer DAPT
group (table 3). However, the risk of stent thrombosis Table 1: Baseline characteristics of patients

and of stroke did not differ significantly between the

two groups (table 3). The rate of BARC type 2–5 bleeding
also did not differ significantly between the two groups
(figure 2D). Although no significant interaction between
the effects of DAPT duration and potency of P2Y12
inhibitors on bleeding complications was found
(appendix), patients receiving potent P2Y12 inhibitors
tended to have a higher bleeding risk than did those
receiving clopidogrel (HR 1·54 [95% CI 0·96–2·48];
p=0·08). The rate of net adverse clinical and cerebral
events was similar between the two groups (table 3).

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The posthoc landmark analysis showed that the risk of

6-month DAPT group 12-month or longer DAPT group
(n=1357) (n=1355) major adverse cardiac and cerebrovascular events between
6 months and 18 months seemed to be higher in the
Transradial approach 637/1354 (47·0%) 632/1354 (46·7%)
6-month DAPT group than in the 12-month or longer
Multivessel disease 591/1356 (43·6%) 631/1355 (46·6%)
DAPT group (HR 1·69 [95% CI 0·97–2·94]; p=0·07;
Location of lesion treated
figure 3A). Rates of all-cause death did not differ
Left main 29/1356 (2·1%) 17/1355 (1·3%)
significantly between the 6-month DAPT group and the
Left anterior descending 767/1356 (56·6%) 826/1355 (61·0%)
12-month or longer DAPT group (HR 1·08 [95% CI
Left circumflex 331/1356 (24·4%) 340/1355 (25·1%)
0·52–2·24]; p=0·84; figure 3B), but myocardial infarction
Right coronary artery 504/1356 (37·2%) 490/1355 (36·2%)
occurred more frequently in the 6-month DAPT group than
Calcified lesion 165/1355 (12·2%) 178/1353 (13·2%)
in the 12-month or longer DAPT group (5·06 [1·46–17·47];
Bifurcation lesion 124/1355 (9·2%) 123/1353 (9·1%) p=0·01; figure 3C). Moreover, the risk of cardiac death or
Thrombotic lesion 325/1355 (24·0%) 330/1353 (24·4%) myocardial infarction was significantly higher in the
Glycoprotein IIb/IIIa inhibitors 62/1349 (4·6%) 81/1350 (6·0%) 6-month DAPT group than in the 12-month or longer
Use of intravascular ultrasound 311/1355 (23·0%) 331/1353 (24·5%) DAPT group (HR 2·47 [95% CI 1·14–5·37]; p=0·02).
Treated lesions per patient 1·3 (0·6) 1·4 (0·7) BARC type 2–5 bleeding also did not differ significantly
Multi-lesion intervention 339/1356 (25·0%) 367/1355 (27·1%) between the 6-month DAPT group and the 12-month or
Multivessel intervention 263/1356 (19·4%) 281/1355 (20·7%) longer DAPT group (HR 0·57 [95% CI 0·29–1·12]; p=0·10;
Stents per patient 1·4 (0·8) 1·5 (0·8) figure 3D).
Stents per lesion 1·1 (0·3) 1·1 (0·3) Results from the per-protocol analysis were similar to
Stent length per lesion, mm 26·1 (10·1) 26·3 (10·3) those from the intention-to-treat analysis (appendix).
Type of drug-eluting stents Major adverse cardiac and cerebrovascular events occurred
No stent 9 (0·7%) 5 (0·4%) in 44 of 1000 patients in the 6-month DAPT group and in
Everolimus-eluting stents 476 (35·1%) 462 (34·1%) 52 of 1297 patients in the 12-month or longer DAPT
Zotarolimus-eluting stents 459 (33·8%) 459 (33·9%) group. Cumulative rates (Kaplan-Meier estimates) of
Biolimus-eluting stents 406 (29·9%) 419 (30·9%) major adverse cardiac and cerebrovascular events at
Other stents 7 (0·5%) 10 (0·7%) 18 months were 4·5% for the 6-month DAPT group and
Procedural success 1299/1355 (95·9%) 1280/1353 (94·6%) 4·1% for the 12-month or longer DAPT group. The non-
inferiority of 6-month DAPT to 12-month or longer DAPT
Data are n (%), n/N (%), or mean (SD), unless otherwise stated. Data are given for the intention-to-treat population.
DAPT=dual antiplatelet therapy.
was met (absolute risk differ­ence 0·4%; upper limit of
one-sided 95% CI 1·9%; pnon-inferiority=0·04). All-cause death
Table 2: Lesion and procedural characteristics of patients and stent thrombosis did not differ significantly between
the two groups. The rate of myocardial infarction was
numerically higher in the 6-month DAPT group than in
the 12-month or longer DAPT group, but this difference
6-month 12-month or HR (95% CI) p value
was not significant (1·6% vs 0·8%; HR 1·97 [95% CI
DAPT group longer DAPT 0·88–4·38]; p=0·10; appendix). However, the risk of BARC
(n=1357) group (n=1355) type 2–5 bleeding was significantly lower in the 6-month
Major adverse cardiac and cerebrovascular 63 (4·7%) 56 (4·2%) 1·13 (0·79–1·62) 0·51 DAPT group than in the 12-month or longer DAPT group
events (2·3% vs 3·8%; HR 0·60 [95% CI 0·36–0·99]; p=0·046;
Death 35 (2·6%) 39 (2·9%) 0·90 (0·57–1·42) 0·90 appendix).
Myocardial infarction 24 (1·8%) 10 (0·8%) 2·41 (1·15–5·05) 0·02 In subgroup analyses, the treatment effects of 6-month
Target vessel myocardial infarction 14 (1·1%) 7 (0·5%) 2·01 (0·81–4·97) 0·13 DAPT compared with 12-month or longer DAPT were
Non-target vessel myocardial infarction 10 (0·8%) 3 (0·2%) 3·35 (0·92–12·18) 0·07 consistent across various subgroups for the primary
Cerebrovascular accident (stroke) 11 (0·8%) 12 (0·9%) 0·92 (0·41–2·08) 0·84 endpoint of major adverse cardiac and cerebrovascular
Cardiac death 18 (1·4%) 24 (1·8%) 0·75 (0·41–1·38) 0·36 events, including in subgroups analysed according to
Cardiac death or myocardial infarction 39 (2·9%) 32 (2·4%) 1·22 (0·77–1·95) 0·40 the presence versus absence of ST-segment elevation
Stent thrombosis 15 (1·1%) 10 (0·7%) 1·50 (0·68–3·35) 0·32 and type of P2Y12 inhibitors (appendix). However, a
BARC type 2–5 bleeding 35 (2·7%) 51 (3·9%) 0·69 (0·45–1·05) 0·09 significant interaction between the treatment effect of
Major bleeding 6 (0·5%) 10 (0·8%) 0·60 (0·22–1·65) 0·33 the two DAPT regimens and treated lesion location on
Net adverse clinical and cerebral events* 96 (7·2%) 99 (7·4%) 0·97 (0·73–1·29) 0·84 major adverse cardiac and cerebrovascular events was
found (pinteraction=0·014; appendix). In a posthoc subgroup
Data are n (%), unless otherwise stated. Percentages are Kaplan-Meier estimates. We defined major adverse cardiac
analysis of the risk of myocardial infarction, a significant
and cerebrovascular events as a composite of all-cause mortality, myocardial infarction, and stroke. DAPT=dual
antiplatelet therapy. HR=hazard ratio. BARC=Bleeding Academic Research Consortium. *Net adverse clinical and interaction between the treatment effect of the two DAPT
cerebral events were defined as major adverse cardiac and cerebrovascular events plus BARC type 2–5 bleeding. regimens and clinical presentation was found
(pinteraction=0·025; appendix). Among patients presenting
Table 3: Clinical primary and secondary outcomes at 18 months
with acute myocardial infarction, the risk of myocardial

6 www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8

 Articles

A B
10 12-month or longer DAPT 10
6-month DAPT

8 8

All-cause death (%)

6 6
MACCE (%)

HR 1·13 (95% CI 0·79–1·62); p=0·51

4 4
HR 0·90 (95% CI 0·57–1·42); p=0·90

2 2

0 0
0 3 6 9 12 15 18 0 3 6 9 12 15 18
Number at risk
(number censored)
12-month or longer DAPT 1355 1312 1299 1290 1283 1278 1043 1355 1320 1309 1302 1296 1292 1056
(0) (14) (5) (6) (0) (0) (230) (0) (14) (6) (6) (0) (0) (233)
6-month DAPT 1357 1318 1296 1271 1264 1255 1032 1357 1325 1306 1290 1285 1281 1055
(0) (17) (14) (12) (1) (1) (216) (0) (17) (14) (13) (1) (1) (220)

C D
10 10

8 8
BARC type 2–5 bleeding (%)
Myocardial infarction (%)

6 6

HR 0·69 (95% CI 0·45–1·05); p=0·09

4 4

HR 2·41 (95% CI 1·15–5·05); p=0·02

2 2

0 0
0 3 6 9 12 15 18 0 3 6 9 12 15 18
Time after initial procedure (months) Time after initial procedure (months)
Number at risk
(number censored)
12-month or longer DAPT 1355 1315 1303 1295 1289 1284 1049 1355 1307 1285 1271 1260 1251 1023
(0) (34) (10) (7) (6) (4) (234) (0) (33) (8) (8) (3) (4) (224)
6-month DAPT 1357 1321 1300 1277 1270 1263 1039 1357 1314 1286 1263 1257 1252 1034
(0) (29) (19) (15) (4) (4) (222) (0) (31) (18) (15) (3) (4) (216)

Figure 2: Time-to-event Kaplan-Meier curves for selected endpoints in the intention-to-treat population
(A) Primary endpoint of major adverse cardiac and cerebrovascular events (MACCE). (B) All-cause death. (C) Myocardial infarction. (D) Bleeding Academic Research Consortium (BARC) type 2–5
bleeding. DAPT=dual antiplatelet therapy. HR=hazard ratio.

infarction was significantly higher in the 6-month DAPT than in the 12-month or longer group. In the posthoc
group than in the 12-month or longer DAPT group landmark analysis, major adverse cardiac and
(2·3% vs 0·5%; HR 4·27 [95% CI 1·61–11·32]; appendix). cerebrovascular events tended to occur more frequently
in the 6-month DAPT group than in the 12-month or
Discussion longer DAPT group, with a significant increase in
In this prospective, randomised trial, 6-month DAPT myocardial infarction between 6 months and 18 months
was shown to be non-inferior to 12-month or longer after the index percutaneous coronary intervention
DAPT for the primary endpoint of major adverse cardiac procedure. The risk of bleeding seemed to be lower in
and cerebrovascular events at 18 months after the index the 6-month DAPT group than in the 12-month or longer
procedure. However, the rate of myocardial infarction DAPT group, but the rate of major bleeding did not differ
was significantly higher in the 6-month DAPT group significantly between the two groups.

www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8 7

 Articles

A B
10 12-month or longer DAPT 10
6-month DAPT

8 8

All-cause death (%)

6 6
MACCE (%)

HR 0·83 (95% CI
4 0·51–1·35); 4
p=0·46 HR 0·80 (95% CI
HR 1·69 (95% CI
0·44–1·44);
0·97–2·94); HR 1·08 (95% CI
2 2 p=0·45
p=0·07 0·52–2·24);
p=0·84

0 0
0 3 6 9 12 15 18 0 3 6 9 12 15 18
Number at risk
(number
censored)
12-month or 1355 1312 1299 1290 1283 1278 1043 1355 1320 1309 1302 1296 1292 1056
longer DAPT (0) (14) (5) (6) (0) (0) (230) (0) (14) (6) (6) (0) (0) (233)
6-month DAPT 1357 1318 1296 1271 1264 1255 1032 1357 1325 1306 1290 1285 1281 1055
(0) (17) (14) (12) (1) (1) (216) (0) (17) (14) (13) (1) (1) (220)

C D
10 10

8 8
BARC type 2–5 bleeding (%)
Myocardial infarction (%)

6 6

4 4 HR 0·78 (95% CI
HR 1·28 (95% CI 0·45–1·37);
0·48–3·45); p=0·39 HR 0·57 (95% CI
HR 5·06 (95% CI
p=0·62 0·29–1·12);
2 1·46–17·47); 2
p=0·01 p=0·10

0 0
0 3 6 9 12 15 18 0 3 6 9 12 15 18
Time after initial procedure (months) Time after initial procedure (months)
Number at risk
(number
censored)
12-month or 1355 1315 1303 1295 1289 1284 1049 1355 1307 1285 1271 1260 1251 1023
longer DAPT (0) (34) (10) (7) (6) (4) (234) (0) (33) (8) (8) (3) (4) (224)
6-month DAPT 1357 1321 1300 1277 1270 1263 1039 1357 1314 1286 1263 1257 1252 1034
(0) (29) (19) (15) (4) (4) (222) (0) (31) (18) (15) (3) (4) (216)

Figure 3: Landmark analysis at 6 months after the index procedure

All graphs are Kaplan-Meier curves. (A) Primary endpoint of major adverse cardiac and cerebrovascular events (MACCE). (B) All-cause death. (C) Myocardial infarction.
(D) Bleeding Academic Research Consortium (BARC) type 2–5 bleeding. DAPT=dual antiplatelet therapy. HR=hazard ratio. The dashed line corresponds to the
6-month timepoint for the landmark analysis.

Despite advances in treatment for coronary heart disease coronary intervention,3,4 the available data are scant. In the
over several decades, patients with acute coronary PCI-CURE study, sustained DAPT was beneficial in
syndrome carry a higher risk of recurrent ischaemic reducing the risk of major cardiovascular events.5
events than do those with stable ischaemic heart disease.1,2 However, several important issues must be considered:
Benefits of prolonged DAPT might be more prominent in the average duration of follow-up after percutaneous
patients with acute coronary syndrome than in those with coronary intervention was only 8 months; the duration of
stable ischaemic heart disease. However, prolonged DAPT DAPT in the clopidogrel group varied from 3 months to
increases bleeding and has been associated with increased 12 months; and the duration of DAPT in the control group
mortality in several studies.21,22 Therefore, to improve was only 1 month without preprocedural loading of
outcomes for patients with acute coronary syndrome, clopidogrel. Therefore, the PCI-CURE study does not
defining the optimal or minimal necessary duration of support prolonged duration of DAPT for 12 months or
DAPT is of great importance. Although major guidelines longer, but supports DAPT per se in patients with acute
recommend DAPT for 12 months or longer in patients coronary syndrome undergoing percutaneous coronary
with acute coronary syndrome undergoing percutaneous intervention. In the PEGASUS-TIMI 54 trial,23 treatment

8 www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8


with ticagrelor significantly reduced the risk of
cardiovascular death, myocardial infarction, or stroke in
patients with previous myocardial infarction. However,
patients were a selected population who had myocardial
infarction more than 1 year previously and were at
high risk, making it difficult to directly apply the results of
the PEGASUS-TIMI 54 trial to patients with acute
coronary syndrome undergoing percutaneous coronary
intervention within 6 months. Therefore, we believe the
findings of the SMART-DATE study, which compared
6-month DAPT with 12-month or longer DAPT in patients
with acute coronary syndrome undergoing percutaneous
coronary intervention with current-generation DES, can
provide valuable insight into the optimal DAPT duration
in this population.
In the present study, the non-inferiority of 6-month
DAPT compared with 12-month or longer DAPT was met.
However, the non-inferiority margin of 2·0% seemed to
be wide considering that the actual rate of the primary
endpoint was 4·2% with 12-month or longer DAPT,
although the non-inferiority margin of major trials was
similar to or even wider than that of our study.19,20
Moreover, the upper limit of the one-sided 95% CI of the
difference in the rate of major adverse cardiac and
cerebrovascular events was 1·8%, which was very close to
the predefined non-inferiority margin. Notably, we found
a significant increase in myocardial infarction in the
6-month DAPT group, especially between 6 months and
18 months after the index percutaneous coronary
intervention procedure when actual treatment differed
between the two groups. Therefore, we cannot conclude
that short-term DAPT is safe in patients with acute
coronary syndrome undergoing percutaneous coronary
intervention with current-generation DES. Since we
observed no definite harm of prolonged DAPT in terms of
mortality or major bleeding in our study, 12-month or
longer DAPT should remain the standard of care for these
patients despite the improved safety of current DES.
The most plausible explanation for the observed
difference in myocardial infarction between the two
groups might be an increase in stent thrombosis after
cessation of a P2Y12 inhibitor in the 6-month DAPT
group. However, in the present study, the rate of stent
thrombosis did not differ significantly between the
two groups. Although the sample size of our study was
not adequate to detect a difference in events occurring at
a low rate, such as stent thrombosis, exclusive use of
second-generation DES with proven efficacy and safety
might explain the absence of a significant difference in
the rate of stent thrombosis between the two groups.
Patients with acute coronary syndrome were reported to
be at higher risk of stent thrombosis than those with
stable ischaemic heart disease after implantation of
the first-generation DES,1 but second-generation DES
significantly reduce rates of stent thrombosis and
myocardial infarction compared with first-generation
DES.6,7 Moreover, second-generation DES have shown
www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8 9
Articles
excellent outcomes with short duration of DAPT in
selected populations.24–26 Meanwhile, non-target vessel
myocardial infarction occurred four times more
frequently in the 6-month DAPT group than in the
12-month or longer DAPT group in the present study.
A previous study reported that major adverse cardio­
vascular events occurring during follow-up were equally
attributable to recurrence at the site of culprit lesions
and non-culprit lesions after percutaneous coronary
intervention.27 Three-vessel intravascular ultrasound
imaging showed that secondary remote plaque ruptures
and multiple plaque ruptures as well as culprit lesion
plaque rupture were all more common in patients with
myocardial infarction than in those with stable ischaemic
heart disease.28 Taken together, these results suggest that
prolonged DAPT might reduce the risk of myocardial
infarction by prevention of non-target vessel myocardial
infarction rather than by reduction of stent thrombosis
in patients with acute coronary syndrome.
In the SMART-DATE study, clopidogrel instead of
prasugrel or ticagrelor was predominantly used as a P2Y12
inhibitor for DAPT. Although we found no significant
interaction between the treatment effect of the two DAPT
regimens and type of P2Y12 inhibitor, predominant use of
clopidogrel might have biased our findings towards non-
inferiority of 6-month DAPT because prasugrel and
ticagrelor showed superior outcomes compared with
clopidogrel in patients with acute coronary syndrome
undergoing percutaneous coronary intervention. The
observed difference in myocardial infarction between the
two groups might have been greater with more frequent
use of prasugrel or ticagrelor. Nonetheless, clopidogrel is
still prescribed in a substantial proportion of patients with
acute coronary syndrome and our results are therefore
applicable to real-world clinical practice.29
The DAPT STEMI trial and the REDUCE trial also
compared short duration versus 12-month DAPT in
patients with acute coronary syndrome undergoing
percutaneous coronary intervention. Although the
results of these two trials have not been published, and
preliminary data were only presented in the late
breaking clinical trial session in the Transcatheter
Cardiovascular Therapeutics 2017 (TCT 2017) scientific
meeting, it is worthwhile to compare our findings
with preliminary results of the DAPT STEMI30
(NCT01459627) and REDUCE31 (NCT02118870) trials.
All three trials showed that short-duration DAPT
(6 months in the SMART-DATE and DAPT STEMI
trials, and 3 months in the REDUCE trial) was non-
inferior to conventional 12-month or longer DAPT in
patients with acute coronary syndrome undergoing
percutaneous coronary intervention. However, only the
SMART-DATE study showed a significant increase in
myocardial infarction, which might be due to the
difference in sample size (1100 patients in the DAPT
STEMI trial and 1500 patients in the REDUCE trial), the
risk of recurrent ischaemic events of enrolled patients,
 Articles
and the DAPT regimen in our study versus that of the
other two trials. A pooled analysis of the SMART-DATE,
DAPT STEMI, and REDUCE trials, using preliminary
data presented at TCT 2017, showed similar results to
those of our study (appendix). The primary endpoint did
not significantly differ between the short duration of
DAPT and the conventional 12-month or longer DAPT.
Notably, our primary endpoint was a composite of
all-cause death, myocardial infarction, or stroke,
whereas the primary endpoint of the DAPT STEMI and
REDUCE trials was a composite of death, myocardial
infarction, revascular­isation, stroke, or bleeding. There
was a non-significant increase in myocardial infarction
with short-duration DAPT compared with 12-month or
longer DAPT. All-cause mortality was similar between
the two treatment regimens and major bleeding tended
to occur less frequently with short-term DAPT than
with long-term DAPT.
Our study had several limitations. First, randomisation
was done at the index procedure, not at 6 months after the
index procedure. Theoretically, it might be desirable that
randomisation is done when treatment in each group
actually differs. However, randomisation at 6 months after
the index procedure could have caused selection bias as
a result of selective enrolment of patients with low risk
profiles in whom 6-month DAPT seemed to be adequate.
Second, our study was an open-label trial and not
placebo-controlled. However, clinical endpoints were
assessed by members of independent clinical event
adjudication committee, and statistical analyses were
done by independent statisticians. Third, a substantial
proportion of patients in the 6-month DAPT group
received a P2Y12 inhibitor after 6 months. However, we
also did a per-protocol analysis, which showed results
consistent with the intention-to-treat analysis. Fourth, we
did not have information about total patients screened for
enrolment and not all consecutive patients were
considered for study randomisation, which might have
resulted in selection bias for enrolment of patients with
relatively low risk. Lastly, our findings apply only to
patients with acute coronary syndrome undergoing
percutaneous coronary intervention with current-
generation DES. These results therefore cannot be
extrapolated to patients who do not undergo percutaneous
coronary intervention and only receive medical treatment.
Because of the increased risk of myocardial infarction
with 6-month DAPT and the wide non-inferiority margin,
we cannot conclude that short-term DAPT is safe in
patients with acute coronary syndrome undergoing
percutaneous coronary intervention with current DES. On
the basis of all the available evidence, prolonged DAPT in
patients with acute coronary syndrome without excessive
risk of bleeding should remain the standard of care.
Contributors
J-YH and YBS contributed equally to this work. All authors participated
in the study design, enrolment of patients, did invasive procedures, and
were involved in clinical follow-up. J-YH, YBS, J-HO, J-HD, JK, KHC,
10 www.thelancet.com March 12, 2018 http://dx.doi.org/10.1016/ S0140-6736(18)30493-8
JML, and H-CG participated in data analysis and data interpretation.
J-YH and YBS wrote the first draft, and S-HC and H-CG reviewed and
revised the manuscript. All authors approved the final version of the
manuscript.
SMART-DATE investigators
Joo-Yong Hahn, Samsung Medical Center; Young Bin Song, Samsung
Medical Center; Taek Kyu Park, Samsung Medical Center;
Joo Myung Lee, Samsung Medical Center; Jeong Hoon Yang, Samsung
Medical Center; Jin-Ho Choi, Samsung Medical Center;
Seung-Hyuk Choi, Samsung Medical Center; Hyeon-Cheol Gwon,
Samsung Medical Center; Jong-Young Lee, Kangbuk Samsung
Hospital; Woong Gil Choi, Konkuk University Chungju Hospital;
Jang-Ho Bae, Konyang University Hospital; Hun Sik Park, Kyoungpook
National University Hospital; Jin-Yong Hwang, Gyeongsang National
University Hospital; Seung-Ho Hur, Dongsan Medical Center;
Seung-Woon Rha, Korea University Guro Hospital; Deok-Kyu Cho,
Myongji Hospital; Sang Cheol Cho, Gwangju Veterans Hospital;
Won You Kang, Gwangju Veterans Hospital; Seong-Hoon Lim,
Dankook University Hospital; Jin Bae Lee, Daegu Catholic University
Medical Center; Moo Hyun Kim, Dong-A University Hospital;
Kwang Soo Cha, Pusan National University Hospital; Rak Kyung Choi,
Sejong General Hospital; In-Ho Chae, Seoul National University
Bundang Hospital; Woo Jin Jang, Samsung Changwon Hospital;
Yong Hawn Park, Samsung Changwon Hospital; Woo Jung Chun,
Samsung Changwon Hospital; Ju-Hyeon Oh, Samsung Changwon
Hospital; Sang-Hyun Kim, Seoul National University Boramae Medical
Center; Jang Hyun Cho, St. Carollo General Hospital; Il-Woo Suh, SAM
Medical Center; Jong-Seon Park, Yeungnam University Hospital;
Jae Woong Choi, Eulji Medical Center; Byung-Ok Kim, Inje University
Sanggye Paik Hospital; Joon-Hyung Doh, Inje University Ilsan Paik
Hospital; Doo-il Kim, Inje University Haeundae Paik Hospital;
Myung Ho Jeong, Chonnam National University Hospital;
Seung Ho Kang, Cheju Halla General Hospital; Wang Soo Lee,
Chung-Ang University Hospital; Hoon-Ki Park, Seoul Veterans
Hospital; Jin-Ok Jeong, Chungnam National University Hospital;
and Kyung-Ju Ahn, Hanil General Hospital.
Declaration of interests
H-CG has received research grants from Abbott Vascular, Boston
Scientific, and Medtronic; and speaker’s fees from Abbott Vascular,
Boston Scientific, and Medtronic. J-YH has received grants from Abbott
Vascular, Boston Scientific, and Biotronik; and speaker’s fees from
AstraZeneca, Daiichi Sankyo, and Sanofi-Aventis. All other authors
declare no competing interests.
Acknowledgments
This study was supported by Abbott Vascular Korea, Medtronic Vascular
Korea, Biosensors Inc, and Dong-A ST.
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