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TITLE: A New Strategy for Discontinuation of Dual Antiplatelet Therapy: REal Safety and
Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent
implantation (RESET) Trial
AUTHORS: Byeong-Keuk Kim, MD, Myeong-Ki Hong, MD, Dong-Ho Shin, MD, MPH,
Chung-Mo Nam, PhD, Jung-Sun Kim, MD, Young-Guk Ko, MD, Donghoon Choi, MD, TaeSoo Kang, MD, Byoung-Eun Park, MD, Woong-Chol Kang, MD,║ Seung-Hwan Lee, MD,
Jung-Han Yoon, MD, Bum-Kee Hong, MD,# Hyuck-Moon Kwon, MD, Yangsoo Jang, MD,
for the RESET Investigators
APPENDIX
This appendix has been provided by the authors to give readers additional information about
their work.
Contents
Page
I. Participating institutes, investigators, and trial personnel list
3
II. Supplementary introduction
7
III. Supplementary methods
7
A.
Inclusion and exclusion criteria
7
B. Randomization and study procedures
10
C.
10
Quantitative coronary angiographic analysis
1
D Study endpoints
11
E.
12
Definitions of clinical disease and procedural findings
F. Statistical analysis
13
IV. Supplementary discussion
13
V. Supplementary references
16
2
I. Participating institutes, investigators, and trial personnel list
Participating institutes and investigators;
1.
Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul,
Korea; Myeong-Ki Hong, MD
2.
Wonju Christian Hospital, Yonsei University Wonju College of Medicine, Wonju,
Korea; Seung-Hwan Lee, MD
3.
Kangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea;
Hyuck Moon Kwon, MD
4.
National Health Insurance Corporation Ilsan Hospital, Goyang, Korea; Dong-Woon
Cheon, MD
5.
Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea; Byung-Ok
Kim, MD
6.
Dankook University College of Medicine, Cheonan, Korea; Byoung-Eun Park, MD
7.
Kyunghee University College of Medicine, Seoul, Korea; Myeong-Kon Kim, MD
8.
Gil Hospital, Gachon University College of Medicine, Incheon, Korea; Woong-Cheol
Kang, MD
9.
Seoul Eulji University College of Medicine, Seoul, Korea; Jae-Woong Choi, MD
10. Kangnam Sacred Heart Hospital, Seoul, Korea; Jung-Rae Cho, MD
11. CHA University Medical Center, Seongnam, Korea; Sang-Wook Lim, MD
12. Daejeon Eulji University College of Medicine, Daejeon, Korea; Sahng Lee, MD
13. Pusan National University Hospital, Pusan, Korea; Guk-Jin Juhn, MD
14. Pusan Paik Hospital, Inje University College of Medicine, Pusan, Korea; Tae-Hyun,
Yang, MD
3
15. Changwon Fatima Hospital, Changwon, Korea; Bong-Ryong Choi, MD
16. Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea;
Wook-Bum Pyun, MD
17. Myongji Hospital, Kwandong University College of Medicine, Goyang, Korea; YunHyeong Cho, MD
18. Kwangju Christian Hospital, Kwangju, Korea; Seung-Wook Lee, MD
19. St. Carollo Hospital, Sooncheon, Korea; Jang-Hyun Cho, MD
20. Jeonnju Presbyterian Medical Center; Jeonju, Korea; Jae-Young Ryu, MD
21. Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea; Sung-Yoon
Lee, MD
22. Dongsan Hospital, Keimyung University College of Medicine, Daegu, Korea; SungHo Hu, MD
23. Ulsan University College of Medicine, Ulsan, Korea; Sang-Gon Lee, MD
24. Wonkwang University College of Medicine, Iksan, Korea; Kyung-Ho Yun, MD
25. Kwangju Veterans Hospital, Kwangju, Korea; Won-Yu Kang, MD
26. Chuncheon Sacred Heart Hospital, Chuncheon, Korea; Duk-Heong Yoon, MD
Principal investigator;
Professor Myeong-Ki Hong, MD, PhD
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of
Medicine, Seoul, Korea
Steering committee;
4
1. Myeong-Ki Hong, MD, Severance Cardiovascular Hospital, Yonsei University
College of Medicine, Seoul, Korea
2. Yangsoo Jang, MD, Severance Cardiovascular Hospital, Yonsei University College
of Medicine, Seoul, Korea
3. Joo-Young Yang, MD, National Health Insurance Corporation Ilsan Hospital,
Goyang, Korea
4. Hyuck-Moon Kwon, MD, Kangnam Severance Hospital, Yonsei University College
of Medicine, Seoul, Korea
5. Jung-Han Yoon, MD, Wonju Christian Hospital, Yonsei University Wonju College
of Medicine, Wonju, Korea
6. Dong-Woon Jeon, MD, National Health Insurance Corporation Ilsan Hospital,
Goyang, Korea
7. Seung-Whan Lee, MD, Wonju Christian Hospital, Yonsei University Wonju College
of Medicine, Wonju, Korea
8. Byung-Ok Kim, MD, Sanggye Paik Hospital, Inje University College of Medicine,
Seoul, Korea
9. Bum-Kee Hong, MD, Kangnam Severance Hospital, Yonsei University College of
Medicine, Seoul, Korea
Coordinating center;
Cardiovascular Research Center, Seoul Korea
Data safety monitoring board (DSMB);
5
1. Chul-Min Ahn, MD, Korea University College of Medicine, Seoul, Korea
2. Hyuck-Jai Chang, MD, Severance Cardiovascular Hospital, Yonsei University
College of Medicine, Seoul, Korea
3. Seong-Hoon Choi, MD, Hallym University College of Medicine, Seoul, Korea
4. Deok-Kyu Cho, MD, Kwandong University College of Medicine, Goyang, Korea
Clinical event committee (CEC);
1. Eui-Young Choi, MD, Kangnam Severance Hospital, Yonsei University College of
Medicine, Seoul, Korea
2. Ji-Young Shim, MD, Severance Cardiovascular Hospital, Yonsei University College
of Medicine, Seoul, Korea
3. Se-Jung Yoon, MD, NHIC Ilsan Hospital, Koyang, Korea
4. Jang Young Kim, MD, Wonju Christian Hospital, Yonsei University Wonju College
of Medicine, Wonju, Korea
Data management and biostatistical analysis;
1. Jung Mo Nam, PhD, Department of Preventive Medicine and Biostatistics, Yonsei
University College of Medicine, Seoul, Korea
2. Dong-Ho Shin, MD, MPH, Severance Cardiovascular Hospital, Yonsei University
College of Medicine, Seoul, Korea
6
II. Supplementary introduction
Stent thrombosis including late fatal complications is a major limitation of drug-eluting stents
(DES).1,2 Therefore, prolonged dual antiplatelet therapy (DAPT) is highly recommended to
prevent stent thrombosis in the clinical practice. However, prolonged use of clopidogrel is
associated with increase in bleeding complications, higher drug cost and poor patient
compliance.3-5 In addition, as the use of DESs have steadily increased, the dilemma of either
temporarily discontinuing clopidogrel prematurely for unexpected non-cardiac operations or
invasive procedures, or maintaining clopidogrel and performing these procedures with
increased bleeding risk to prevent stent thrombosis is encountered more frequently.3,6 Under
these circumstances, DESs that have early re-endothelialization over the struts within a short
period after implantation as well as effective anti-restenotic properties could enable a shorter
duration of DAPT.3,7-9 Imaging studies have reported that the zotarolimus-eluting stent
(Endeavor, E-ZES; Medtronic, Inc., Santa Rosa, CA) showed a higher rate of neointimal
coverage at 8 months than paclitaxel-or sirolimus-eluting stents and showed similar pattern of
neointimal coverage as compared to bare-metal stents.10-12
III. Supplementary methods
A. Inclusion and exclusion criteria
General inclusion criteria
1.
Coronary artery disease including stable angina, unstable angina and acute myocardial
infarction
2.
Age 20 years or older
7
3.
Patients with typical chest pain and objective evidences of myocardial ischemia on the
electrocardiogram or positive functional studies consistent with reversible myocardial
ischemia
4.
Patients with signed informed consent
Angiographic inclusion criteria
1.
Significant coronary artery stenosis (>50% by visual estimate) which is considered for
coronary revascularization with stent implantation
2.
Reference vessel diameter of 2.5 to 4.0 mm by the visual estimation of operator
assessment
3.
Lesion success (30% or less residual stenosis by visual assessment over the entire stent
length, with Thrombolysis in Myocardial Infarction (TIMI)-3 flow and no more than
type B peri-stent dissection in National Heart, Lung, and Blood Institute (NHLBI)
criteria)
4.
Lesion and stent length for short-lesion subgroup:
1) Length of single stent per single lesion ≤24 mm and,
2) Summation of total length of all inserted drug-eluting stent (DES) in 3 vessels ≤60
mm
5.
Lesion and stent length for subgroup of acute coronary syndrome and diabetes mellitus:
1) Length of single stent per single lesion ≤24 mm and,
2) Summation of total length of all inserted DESs in the 3 vessels ≤60 mm
6.
Lesion and stent length for long-lesion subgroup:
8
1) Length of single stent per single lesion ≥28 mm and,
2) Summation of total length of all inserted DESs in 3 vessels ≤90 mm
3) Overlapping stent is allowed
General exclusion criteria
1.
Contraindication to anti-platelet agents & bleeding history within prior 3 months
2.
Known hypersensitivity or contraindication to any of the following medications: heparin,
aspirin, clopidogrel, and -limus related drugs
3.
Prior history of the following presentations:
1)
Cerebral vascular accidents (not including transient ischemic attack)
2)
Peripheral artery occlusive diseases
3)
Thrombo-embolic disease
4)
Stent thrombosis
4.
Severe hepatic dysfunction (≥3 times normal reference values)
5.
Significant renal dysfunction (Serum creatinine >2.0 mg/dl)
6.
Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding
diathesis
7.
Cardiogenic shock
8.
Left ventricular ejection fraction <40%
9.
Pregnant women or women with potential childbearing
10. Life expectancy <3 year
11. Acute ST-elevation myocardial infarction within 48 hours after onset of symptoms
9
Angiographic exclusion criteria
1.
Left main disease requiring percutaneous coronary intervention
2.
Bifurcation lesion treated with a two-stent technique
3.
Target lesions with in-stent restenosis at the stented segment of DES or bare-metal stent
4.
Lesions with chronic total occlusion
5.
History of percutaneous coronary intervention with DESs
6.
Overlapped DESs (overlapping stenting was only allowed in the long-lesion subgroup)
B. Randomization and study procedures
There are no data about different impact of E-ZES+3-month DAPT among clinically
or angiographically specific subgroups that it may be safe in low-risk patients, but may be
harmful in high-risk patients. Therefore, this study included 4 subgroups to evaluate the
benefit or risk of E-ZES+3-month DAPT individually among clinically or angiographically
different subgroups. Before procedure, all patients received at least 75 mg of aspirin. A
loading dose of 300 mg of clopidogrel was administered at least 12 hours before
percutaneous coronary intervention. However, if the administration of a loading dose of
clopidogrel was not administered 12 hours in advance, a 600 mg loading dose of clopidogrel
was also allowed in the catheterization laboratory prior to percutaneous coronary intervention.
Unfractionated heparin was administered to maintain the activated clotting time >250
seconds. The use of the glycoprotein IIb/IIIa inhibitors was left to the operator’s discretion.
Balloon angioplasty and stent implantation were performed according to standard techniques.
Direct stenting and adjuvant post-dilation were allowed. Use of cilostazol was not allowed.
10
C. Quantitative coronary angiography analysis
Quantitative coronary angiography analysis was performed using an off-line
quantitative coronary angiographic system (CASS system, Pie Medical Instruments,
Maastricht, The Netherlands) before and after stent implantation by the individuals who were
blinded to a patient’s treatment assignment in an independent core laboratory at
Cardiovascular Research Center, Seoul, Korea. Using the guiding catheter for magnificationcalibration, the diameters of the reference vessel (the average of the proximal and distal
reference lumen diameters), the minimal luminal diameter, and the percent diameter stenosis
(%) were measured before and after stenting from diastolic frames in a single, matched view
showing the smallest minimal luminal diameter. All quantitative angiographic measurements
were obtained within the stented segment (in-stent) and over the entire segment including the
stent and its 5-mm proximal and distal margins (in-segment).
D. Study endpoints
Secondary endpoints included the individual components of the primary endpoint
and the composite of death from all cause, myocardial infarction or stent thrombosis. All
deaths are considered cardiovascular deaths unless a definite non-cardiovascular cause can be
established. Myocardial infarction is defined as the presence of clinical symptoms,
electrocardiographic change or abnormal imaging findings of myocardial infarction
combined with an increase in creatine kinase myocardial band fraction to greater than three
times the upper limit of the normal range or troponin-T/troponin-I more than the 99th
percentile of the upper normal limit, unrelated to an interventional procedure.13,14 Definite,
probable, and possible stent thrombosis is defined according to the recommendations of the
ARC.13,15 The timing of stent thrombosis is classified as acute (within 24 hours), subacute (1day to 1 month), and late (from day 31-260) post-index procedure. Target-vessel
11
revascularization is defined as a repeat percutaneous intervention or bypass surgery of the
target vessel according to each physician with following findings; ischemic symptoms or
positive stress test and angiographic minimal lumen diameter stenosis ≥50% by quantitative
coronary angiographic analysis; or angiographic diameter stenosis ≥70% by quantitative
coronary angiographic analysis without either ischemic symptoms or positive stress test.
According to the thrombolysis in myocardial infarction (TIMI) criteria,16 major bleeding was
defined as overt clinical bleeding (or documented intracranial or retroperitoneal hemorrhage)
associated with a drop in hemoglobin of greater than 5 g/dl or in hematocrit of greater than 15%
(absolute); and minor bleeding was defined as overt clinical bleeding associated with a fall in
hemoglobin of 3 g/dl to less than or equal to 5 g/dl or in hematocrit of 9% to less than or
equal to 15% (absolute). Analyses of all angiographic data were performed in the
angiographic core laboratory of Cardiovascular Research Center (Seoul, Korea).
E. Definitions of clinical disease and procedural findings
Diabetes mellitus included the patients treated with medications such as oral
hypoglycemic agents or insulin after diagnosed with diabetes mellitus, regardless of duration
or types of disease.17 Acute coronary syndrome was defined as a clinical syndrome
constituted with unstable angina, non-ST-elevation, or ST-elevation myocardial infarction,
diagnosed with the clinical presentations, electrocardiogram, or cardiac enzymes.18,19
Cerebrovascular accidents were defined as a sudden onset of vertigo, numbness, aphasia, or
dysarthria resulting from vascular lesions of the brain, including hemorrhage, embolism,
thrombosis, or rupturing aneurysm. Procedure success was defined as the achievement of a
final in-stent diameter stenosis of 30% or less by online quantitative coronary angiographic
analysis or visual assessment over the entire stent length, with TIMI–3 flow and no more than
12
an NHLBI type B peri-stent dissection with or without any adjunctive devices,20 and without
the occurrence of cardiac death, target vessel myocardial infarction or repeat
revascularization of the target lesion during the health care facility stay.
F. Statistical analysis
All data are presented as percentages or as mean ± standard deviation. Comparisons
of baseline data were performed using the chi-square test or Fisher’s exact test (categorical
variables) and Student’s t-test (continuous variables) as appropriate. We estimated the
cumulative event rate using the Kaplan-Meier method and calculated the absolute differences
and 95% confidence intervals (CI). The log-rank test was used to assess the significance of
differences between incidences. All comparisons were performed according to the intentionto-treat allocations. All p-values are 2-sided except ones for the non-inferiority test, and
results with a p-value <0.05 were considered statistically significant. Statistical analyses were
performed using the Statistical Analysis System software (SAS; 9.1.3., SAS Institute, NC)
and R version 2.12.2 (R Development Core Team, Vienna, Austria).
IV. Supplementary discussion
Chronic DAPT regimens are associated with a very high (56.5-60.7%) prevalence of
superficial bleeding episodes in patients with coronary artery disease and ischemic stroke.21
Prolonged DAPT requirements can be problematic in cross-discipline patient care
especially in managing requests for discontinuation of clopidogrel due to unexpected minor
and major non-cardiac operations or invasive procedures.3,6 One prospective study reported
that premature discontinuation of DAPT was observed in 14.4% of 1622 candidate patients
during the first year after DES implantation.22
Therefore, balanced DES which can offer both safety and efficacy are desirable,
13
especially for those who may need to stop DAPT early after DES implantation. These
selected patients may include those at risk for bleeding complications; at risk of poor
compliance with medication, especially in the elderly population; with a high probability of
unexpected non-cardiac surgery or invasive procedures; or a low risk of stent thrombosis.
The E-ZES comprises a cobalt alloy thin-strut stent with a biocompatible
phosphorylcholine polymer. The drug in the E-ZES is fully eluted within approximately 2
weeks, which is significantly shorter than earlier generation DES. Data from 6 prospective
trials involving 2,132 patients treated with E-ZES reported 0.8% rate of ARC-defined definite
or probable stent thrombosis; with 0.3% early (<30 days), and 0.3% late stent thrombosis; 0.2%
very late stent thrombosis.23 The presence of neointima over stent struts may play a protective
role to prevent stent thrombosis in the early period after DES implantation.
In our study, DAPT duration did not affect the rate of ARC-definite and probable
stent thrombosis, with 0.2 to 0.3% at 1 year. Furthermore, during the period from 3 to 12
months post procedure, no additional stent thrombosis events were observed in the E-ZES+3month DAPT group with use of aspirin alone. There were 3 stent thrombosis events in the
standard therapy group even with sustained DAPT. Therefore, this randomized study supports
the use of DAPT for 3 months following E-ZES implantation, without an increased risk of
stent thrombosis, and is consistent with the findings from a previous registry study.24
Resolute ZES has a similar stent platform and drug, but it has a different polymer,
which changes the elution kinetics and extends drug elution.25 From the clinical studies, in
spite of the absence of head-to-head comparison between E-ZES and Resolute ZES within 12
months, the clinically indicated target-vessel revascularization rates of E-ZES and Resolute
ZES have been reported to be up to 5.6%26 or 6.2%27 and 3.3%28 or 4.9%29 within 12 months,
respectively.
E-ZES+3-month DAPT showed the consistent outcomes across the diverse
14
subgroups, even in the patients with diabetes mellitus or acute coronary syndrome.
However, Gwon HC et al. recently reported that the duration of DAPT could affect the
clinical outcomes in the patients with diabetes mellitus.30 The differences between the
two studies might be related with different DES types, DAPT duration and analysis
methods.30 .
15
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