omparison of Coronary Artery Bypass Surgery Withercutaneous Coronary Intervention With Drug-Elutingtents for Unprotected Left Main Coronary Artery Diseaseichael S. Lee, MD, Nikhil Kapoor, MD, Faizi Jamal, MD, Lawrence Czer, MD, Joseph Aragon, MD,
ames Forrester, MD, Saibal Kar, MD, Suhail Dohad, MD, Robert Kass, MD, Neal Eigler, MD,lfredo Trento, MD, Prediman K. Shah, MD, Raj R. Makkar, MDos Angeles, California
OBJECTIVES This study evaluated the clinical outcomes of consecutive, selected patients treated withcoronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI)with drug-eluting stents (DES) for unprotected left main coronary artery (ULMCA) disease.
BACKGROUND Although recent data suggest that PCI with DES provides better clinical outcomes comparedto bare-metal stenting for ULMCA disease, there is a paucity of data comparing PCI withDES to CABG.
METHODS Since April 2003, when DES first became available at our institution, 123 patients underwentCABG, and 50 patients underwent PCI with DES for ULMCA disease.
RESULTS High-risk patients (Parsonnet score �15) comprised 46% of the CABG group and 64% ofthe PCI group (p � 0.04). The 30-day major adverse cardiac and cerebrovascular event(MACCE) rate for CABG and PCI was 17% and 2% (p � 0.01), respectively. The meanfollow-up was 6.7 � 6.2 months in the CABG group and 5.6 � 3.9 months in the PCI group(p � 0.26). The estimated MACCE-free survival at six months and one year was 83% and75% in the CABG group versus 89% and 83% in the PCI group (p � 0.20). By multivariableCox regression, Parsonnet score, diabetes, and CABG were independent predictors ofMACCE.
ublished by Elsevier Inc. doi:10.1016/j.jacc.2005.09.072
the American College of Cardiology Foundation
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ULMCA) disease treated medically have a three-yearortality rate of approximately 50% (3,4). Based on the
esults of several trials that consistently demonstrated aurvival benefit in patients treated with coronary arteryypass graft (CABG) surgery over medical therapy (5–7),he current standard of care for treatment of ULMCAtenosis is CABG.
See page 878
On the other hand, the high rate of early restenosis, acutehrombotic occlusion, and mortality associated with percu-aneous coronary intervention (PCI) in earlier clinical stud-es has led the American College of Cardiology and Amer-can Heart Association to discourage PCI for ULMCA (8).ince these guidelines were established, newer technology
From Cedars-Sinai Medical Center, University of California, Los Angeles Schoolf Medicine, Los Angeles, California.
iManuscript received June 16, 2005; revised manuscript received August 10, 2005,
ccepted September 8, 2005.
nd percutaneous techniques for revascularization have beeneveloped.Re-evaluation of the optimal treatment for ULMCA may
e important, especially in light of recent observational datauggesting that ULMCA PCI with sirolimus-eluting stentsCypher, Cordis, Johnson & Johnson Corp., Miami, Flor-da) and paclitaxel-eluting stents (Taxus, Boston Scientificorp., Natick, Massachusetts) may be safe and effective inecreasing in-stent restenosis when compared to bare-metaltents (9–11). However, the efficacy of PCI with drug-luting stents (DES) on short- and intermediate-termlinical outcomes on ULMCA disease compared to CABGs unknown. We report on the short- and intermediate-termafety and efficacy of 173 consecutive patients withLMCA disease who underwent either PCI with DES orABG in a single institution.
ETHODS
tudy population. Since April 2003, when DES firstecame available at our institution, 195 consecutive patientsith ULMCA disease underwent revascularization.wenty-two patients underwent concomitant valve surgery
nd were excluded from comparative analysis. The remain-
ng 173 patients constitute our study population of 50
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865JACC Vol. 47, No. 4, 2006 Lee et al.February 21, 2006:864–70 CABG Versus DES for Left Main Artery Stenosis
atients who underwent PCI with DES and 123 patientsho underwent CABG for ULMCA disease.The primary clinical end points were freedom from major
dverse cardiac and cerebrovascular events (MACCE) at 30-ay and intermediate-term follow-up. We included patientsith ULMCA stenoses or documented myocardial ischemia
nd �50% diameter stenosis of the ULMCA on angiography.he left main coronary artery was defined as unprotected if
here were no CABGs to the left anterior descending arterynd left circumflex artery. Patients were jointly evaluated byardiac surgery and interventional cardiology consultants. Thenal decision of the method of revascularization was madefter comprehensive review of all relevant factors. To beelected for PCI, a patient had to have one of the followingharacteristics: very high risk for CABG, limited life expect-ncy, patient refusal to undergo CABG with a preference forCI, or patient deemed unsuitable for CABG by the cardiacurgeon. This study was approved by the Cedars-Sinai Medicalenter Institutional Review Board.CI. Percutaneous coronary intervention was performed us-
ng the standard percutaneous transfemoral approach, exceptor two patients who underwent PCI via the transradialpproach due to extensive peripheral vascular disease. Lesionsn the ostium or body of the ULMCA without distal bifurca-ion involvement were usually treated with a single stent.everal techniques were used for the treatment of distalifurcation disease. Stenting across the left circumflex artery,imultaneous kissing stenting, T stenting, and the crushechnique have been previously described (12,13). The choicef a sirolimus-eluting stent or paclitaxel-eluting stent andntithrombotic agent was made by the operator. High-ressure stent deployment was performed using an initialnflation of 16 atm. Intravascular ultrasound was used toonfirm optimal stent deployment. Post-dilation with addi-ional balloons was performed for optimal stent apposition.lycoprotein IIb/IIIa antagonists and intra-aortic balloon
ump were used if clinically indicated. All patients receivedspirin (325 mg/day) indefinitely and a loading dose of 300g of clopidogrel. Clopidogrel was continued for at least sixonths. Cardiac enzymes were not measured routinely
nless there was a clinical suspicion of ischemia, andherefore was not a designated outcome of the study.ypass surgery. Standard bypass techniques included a left
nternal mammary artery for revascularization of the leftnterior descending coronary artery whenever possible and
Abbreviations and AcronymsARTS � Arterial Revascularization Therapies StudyCABG � coronary artery bypass graftDES � drug-eluting stentMACCE � major adverse cardiac and cerebrovascular
eventPCI � percutaneous coronary interventionULMCA � unprotected left main coronary artery
old potassium cardioplegia. Cardiac enzymes were not g
easured routinely unless there was a clinical suspicion ofschemia.
efinitions. Percutaneous coronary intervention proce-ural success was defined as Thrombosis In Myocardialnfarction (TIMI) flow grade 3 with a final residual stenosisf �30% without death, myocardial infarction, or emer-ency CABG before hospital discharge. Death was defineds any post-procedure death. A myocardial infarction wasefined as ischemic symptoms associated with cardiac en-yme elevation �3 times the upper limit of the normalalue. Target vessel revascularization was defined as a repeatevascularization to treat a luminal stenosis within the stentr within 5-mm distal and proximal segments adjacent tohe stent, including the ostium of the left anterior descend-ng artery and/or left circumflex artery. A cerebrovascularvent was defined as stroke, transient ischemic attack,eversible ischemic neurologic deficit, or coma.
The Parsonnet score was used to stratify the risk of deatht 30 days in patients undergoing cardiac surgery (14,15). Aarsonnet score �15 identified patients at high risk forurgical mortality.tatistics. Continuous variables are presented as mean �D and were compared by Student t test (when the groupistributions were symmetrical and mounded) or Mann-
hitney U test (when the group distributions werekewed). The Satterthwaite adjustment was applied to the test when there was evidence against equality of variance.he chi-square test (when all expected cell counts were �5)r Fisher exact test (when any expected cell count was �5)as used to determine the significance of differences in
ategorical variables. Survival curves were generated by theaplan-Meier method, and the differences were assessed by
he log-rank test. Survival analyses were performed for therst 423 days of follow-up so that the comparison of CABGnd PCI would be over the same time period. A multi-ariable Cox proportional hazard model was created withhe use of baseline clinical and angiographic characteristicsnd procedure-related variables in order to identify inde-endent predictors of MACCE. All statistical tests werewo-tailed, and a significance level of 0.05 was usedhroughout. Statistical analyses were performed using SPSSersion 10.0 (SPSS Inc., Chicago, Illinois).
ESULTS
aseline characteristics. Baseline clinical and demo-raphic characteristics are listed in Table 1. Compared tohe CABG group, the PCI group had less men (50% vs.6%, p � 0.01), more patients with chronic renal insuffi-iency (16% vs. 5%, p � 0.02), and more patients withnstable angina as the presenting symptom (46% vs. 25%,� 0.01). The average Parsonnet score was 13.7 � 9.7 in
he CABG group and 18.3 � 10.9 in the PCI group (p �.01). High-risk patients (Parsonnet score �15) wereresent in 46% of the CABG group and 64% of the PCI
roup (p � 0.04).
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866 Lee et al. JACC Vol. 47, No. 4, 2006CABG Versus DES for Left Main Artery Stenosis February 21, 2006:864–70
Nine patients (18%) who underwent PCI were turnedown for CABG after surgical consultation. All patientsith isolated ostial or mid-body disease received one stent.
total of 60% in the PCI group had distal bifurcationisease.rocedural outcomes. Procedural characteristics are pre-
ented in Table 2. The procedural success rate was 98% in
bntravascular ultrasound; LAD � left anterior descending artery; LCX � leftircumflex artery; other abbreviations as in Table 1.
he PCI group. Intra-aortic balloon pump was used in 32atients (64%), and the TandemHeart percutaneous leftentricular assist device (CardiacAssist Inc., Pittsburgh,ennsylvania) was used in 3 patients (6%). Forty-twoatients (84%) underwent PCI with sirolimus-eluting stentsnd eight patients (16%) with paclitaxel-eluting stents. Onverage, 2.5 � 1.4 stents were implanted with a total stentength of 43.2 � 28.4.
In the CABG group, 3.0 � 0.8 grafts per patient weresed, with 96% of patients receiving an internal mammaryrtery conduit to the left anterior descending artery.0-day outcomes. The 30-day clinical outcomes are sum-arized in Table 3. The cerebrovascular event rate was
igher in the CABG group (8% vs. 0%, p � 0.03), but thereas no statistically significant difference in mortality (5% vs.%, p � 0.34). In the CABG group, there were sixn-hospital deaths (four from cardiac reasons, one from atroke, and one from a pneumothorax). The one death inhe PCI group occurred in a patient with a Parsonnet scoref 41 who was turned down by cardiac surgery because theatient was considered a high-risk candidate for CABG.his patient underwent peripheral vascular surgery two days
fter her PCI and died suddenly eight days after surgery.ne CABG patient underwent emergent PCI on the
econd post-operative day for an ST-segment elevationyocardial infarction secondary to the occlusion of a saphe-
ous vein graft that was anastomosed to the posteriorescending artery. No patient required urgent target vesselevascularization in the PCI group. No statistically signifi-ant differences in myocardial infarction were observed
epeat surgery for bleeding (%) 7 NAn-hospital length of stay
(days � SD)7.6 � 4.9 3.9 � 4.5 �0.01
One patient with a Parsonnet score of 41 had severe peripheral vascular disease andeft ventricular dysfunction and was turned down by the surgeon for CABG. Theatient underwent PCI with a percutaneous left ventricular assist device for hemo-ynamic support. The patient underwent peripheral vascular surgery 2 days after PCInd died suddenly 10 days after PCI. †Only post-hospitalization and/or clinicalyocardial infarction as cardiac enzymes were not drawn serially after revascularization.MACCE � major adverse cardiac and cerebrovascular event; VF � ventricular
brillation; VT � ventricular tachycardia; other abbreviations as in Table 1.
etween the two groups (2% vs. 0%, p � 0.9). The overall
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867JACC Vol. 47, No. 4, 2006 Lee et al.February 21, 2006:864–70 CABG Versus DES for Left Main Artery Stenosis
ACCE rate was higher in the CABG group (17% vs. 2%,� 0.01).There were also other significant post-operative compli-
ations in the CABG group. Eight patients (7%) requiredepeat operation for bleeding (1 for cardiac tamponade), 6atients (5%) developed pneumonia, 5 patients (4%) re-uired permanent pacemaker implantation, 8 patients (7%)eveloped pleural effusions requiring thoracocentesis, 2atients (2%) developed renal failure requiring hemodialysis,nd 11 patients (9%) developed ventricular tachycardia/entricular fibrillation.
One patient in the PCI group developed a cardiac tam-onade requiring emergent pericardiocentesis secondary to aire perforation. No patient required permanent pacemaker
mplantation, developed acute renal failure requiring hemodi-lysis, or had vascular complications like major hematoma,seudoaneurysm, or need for vascular repair at the accessite.
Patients treated with CABG had significantly longerospitalization compared with patients treated with PCI
igure 1. Major adverse cardiac and cerebrovascular events (including dezation) (MACCE)-free survival (A). Freedom from death (the second deaParsonnet score of 23 who was a “do not resuscitate/do not intubate” pati
ransfusion) (B). Freedom from target vessel revascularization (all three patiad focal in-stent restenosis at the ostium of the left circumflex artery, aescending artery) (C). Freedom from death, myocardial infarction, and c
7.6 � 4.9 days vs. 3.9 � 4.5 days, p � 0.01). v
ntermediate follow-up. The mean follow-up was 6.7 �.2 months in the CABG group and 5.6 � 3.9 months inhe PCI group (p � 0.26). The estimated MACCE-freeurvival at six months and one year was 83% and 75% in theABG group versus 89% and 83% in the PCI group
p � 0.20) (Fig. 1A). The estimated freedom from death atix months and one year was 87% and 85% in the CABGroup versus 96% and 96% in the PCI groups (p � 0.18). Inhe CABG group, there were seven deaths at intermediateollow-up (two from cardiac reasons, one from a stroke, onerom an abdominal aortic aneurysm rupture, one fromespiratory failure secondary to pneumonia, one from renalailure, and one from suicide). The second death in the PCIroup was in a patient with a Parsonnet score of 23 who was“do not resuscitate/do not intubate” patient who died aftereveloping acute pulmonary edema following an outpatientlood transfusion (Fig. 1B). Angiographic follow-up in theCI group was available in 21 patients (42%). The esti-ated freedom from target vessel revascularization at sixonths and one year was 99% and 95% in the CABG group
yocardial infarction, cerebrovascular events, and target vessel revascular-the percutaneous coronary intervention [PCI] group was in a patient withho died after developing acute pulmonary edema after an outpatient bloodho underwent repeat PCI had distal bifurcation involvement; two patientse patient had focal in-stent restenosis at the ostium of the left anteriorvascular events (D). CABG � coronary artery bypass graft.
ath, mth inent wents w
ersus 93% and 87% in the PCI group (p � 0.22) (Fig. 1C).
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868 Lee et al. JACC Vol. 47, No. 4, 2006CABG Versus DES for Left Main Artery Stenosis February 21, 2006:864–70
ll three patients who underwent repeat PCI (two patientsnderwent balloon angioplasty and one patient underwentepeat PCI with DES) had distal bifurcation involvement.wo of these three patients returned with re-restenosis andnderwent CABG. Two additional patients in the PCIroup underwent repeat PCI for de novo lesions in the distaleft anterior descending artery. The estimated freedom fromeath, myocardial infarction, and cerebrovascular events atix months and one year was 83% and 79% in the CABGroup versus 96% and 96% in the PCI group (hazard ratio,.4 [95% confidence interval, 1.0 to 18.6]; p � 0.03) (Fig.D).redictors of intermediate MACCE. The following vari-bles were entered into a stepwise multivariable Coxroportional hazard model for MACCE-free survival:ge, gender, diabetes mellitus, Parsonnet score, ejectionraction, chronic renal insufficiency, myocardial infarc-ion, and CABG. The significant univariate predictorsere Parsonnet score, diabetes mellitus, and myocardial
nfarction (Table 4). In the final Cox model, the significantredictors of the hazard of MACCE were Parsonnet score,iabetes mellitus, and CABG.
ISCUSSION
he most important finding of our study is that in a pilotxperience with ULMCA, treatment with PCI with DESesulted in outcomes equivalent to CABG. Patients in theCI group were of comparable pre-operative risk using
raditional cardiac surgery criteria.Our study adds to the existing database comparing PCI
o CABG in angiographic subsets of coronary artery disease.n several studies comparing PCI with bare-metal stents toABG in multivessel coronary artery disease, no mortalityenefit was demonstrable, although there was a lowerequirement for target vessel revascularization with CABG16–18). On the other hand, the Arterial Revascularizationherapies Study II (ARTS II) (19), a nonrandomized
omparison of CABG and PCI with DES in patients withultivessel coronary artery disease, did not demonstrate an
ncreased need for repeat revascularization in the PCI arm.t present, therefore, it is not known whether the improvedutcomes in PCI with DES will be extended to patientsith ULMCA disease. Our observational study suggests
I � confidence interval; other abbreviations as in Table 1.
hat, in the ULMCA subset, PCI may provide a comparable (
r lower rate of death, myocardial infarction, and cerebro-ascular events compared to CABG, when patients aressigned to treatment by consensus of interventionalist andardiac surgeon. On the other hand, we do not haveong-term follow-up data, although long-term data (up toour years) in other angiographic subsets suggest thatirolimus-eluting stents have a low rate of in-stent restenosis20). The ongoing prospective Synergy Between PCI andaxus and Cardiac Surgery (SYNTAX) and Revasculariza-
ion Comparing Surgery Versus Percutaneous Coronaryntervention for Unprotected Left Main Artery Stenosisandomized Evaluation (REVASCULARIZE) trials will
dd more data for analysis of this issue, especially inifurcation disease.Our CABG 30-day (4.9%) and 6-month (11.4%) mor-
ality rates are consistent with the published data for CABGor ULMCA disease. The Society of Thoracic Surgeryeported an in-hospital mortality of 3.9% in patients witheft main disease (21). The Cleveland Clinic Foundationeported 2.3% in-hospital mortality and 11.3% one-yearortality (22). In patients who were considered to be low
urgical risk, with age �65 years and New York Heartssociation heart failure class �2, the one-year mortalityas 5.7%. d’Allonnes et al. (23) reported an early post-perative mortality of 4.7% in 106 patients with ULMCAtenosis who underwent CABG.
Although our patients were selected for either PCI orABG based on consensus of clinical judgment of the
ardiologist and surgeon, the surgical risk of the patientroups was comparable. Overall, patients with high Parson-et scores constituted 51% of the patient population (64% inhe PCI group and 46% in the CABG group). Included inhe 50 PCI patients were patients with multivessel coronaryrtery disease, cardiogenic shock, orthotopic heart trans-lant, orthotopic lung transplant, and three patients onercutaneous left ventricular assistance. There was a rela-ively low 30-day mortality rate (2%) in the PCI groupespite the majority of patients being at high surgical riskor mortality and no deaths in the PCI group with low-riskarsonnet scores.Intra-aortic balloon pumps were used in 64% of our
atients who underwent PCI of ULMCA with DESompared to 4.9% in Park et al. (9), 21.2% in Chieffo et al.10), and 15% in Valgimigli et al. (11). Three other patientsnderwent ULMCA PCI with the TandemHeart percuta-eous left ventricular device. Hemodynamic support withhe intra-aortic balloon pump and the percutaneous leftentricular assist device was frequently used because wehose to be very cautious in this early experience with PCIf ULMCA. With more experience, we currently do not usentra-aortic balloon pumps in low-risk patients with normaleft ventricular function.
A total of 14% of patients received glycoprotein IIb/IIIantagonists in our study compared to 7.8% in Park et al. (9),8% in Valgimigli et al. (11), and 28.5% in Chieffo et al.
10). The impact of glycoprotein IIb/IIIa antagonists on
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869JACC Vol. 47, No. 4, 2006 Lee et al.February 21, 2006:864–70 CABG Versus DES for Left Main Artery Stenosis
atients undergoing ULMCA PCI has not been studied inrandomized clinical trial and is thus unknown.One previously reported limitation of PCI in ULMCA
hat involves the distal bifurcation is the high incidence ofestenosis at the ostium of the left circumflex artery (9–11).atients in our study with distal bifurcation disease also hadgreater need for target vessel revascularization. All three of
he cases of target vessel revascularization were in patientsith distal bifurcation disease involving the ULMCA com-ared to no patients with ostial and mid-body lesions.athology studies of bifurcation lesions suggest that arterialranch points are predisposed to the development of ath-rosclerotic plaque, thrombus, and inflammation due to lowhear and low flow velocities (24–26). Although the idealCI strategy for dealing with distal bifurcation lesions is stillndefined, our preliminary experience suggests that in thisondition, it may be difficult to match the clinical outcomesf a left internal mammary to the left anterior descendingrtery graft, which has a patency rate of more than 90% at0 years and improves survival and freedom from furtherardiovascular events (27,28).
The optimal treatment of restenosis after PCI of ULMCAith DES is unknown. The percentage of patients whonderwent CABG as their mode of revascularization rangedrom 0% to 50% (9–11). In our study, two of three patientsho underwent repeat PCI (one patient underwent balloon
ngioplasty and the other patient underwent repeat PCIith DES) returned with re-restenosis and subsequentlynderwent CABG. Because the outcomes of repeat PCI forestenosis of ULMCA are not well defined, it is reasonableo recommend CABG as the primary treatment modalityor patients with restenosis after PCI with DES.otential clinical implications of data. Our data suggest
hat PCI in ULMCA disease is safe when patients arellocated by clinical judgment. Because PCI showed trendsoward benefit in a number of outcome variables, it isossible that a large sample size might have revealed othertatistically significant outcome variables. On the otherand, there may be an incidence of very late complicationsssociated with DES that will be defined with longer-termollow-up. A randomized trial certainly seems indicated. Its important to recognize, however, that randomization, asith all trials comparing CABG to PCI, eliminates clinical
udgment in patient selection and carries a potential foreing misleading as a predictor of outcomes in actual clinicalractice.tudy limitations. The nonrandomized nature of the study
imits any direct comparisons of the two methods ofevascularization. We included all patients with ULMCAisease, resulting in a heterogeneous population of patients.lthough trial strategies often seek to determine if oneption is superior to another, our trial cannot be interpretedn this manner. Rather, it demonstrates that comparableesults can be obtained in clinical practice when consensusudgment is utilized. Another potential limitation is that
lmost all of the PCI of the ULMCA was performed by one
rimary operator. Thus, the results obtained in this studyay not be applicable to the broad population of interven-
ional cardiologists. The majority of the patients receivedypher stents (Cordis, Johnson & Johnson Corp.) (42 outf 50 patients). Therefore, the limited experience withaxus stents may preclude extrapolating these data to allES. Periprocedural cardiac enzyme levels were not serially
rawn after PCI or CABG. The reported myocardialnfarction rate in both revascularization strategies is only theost-hospitalization and/or clinical myocardial infarctionate and not the usually reported myocardial infarction raten clinical trials. Absence of these data could be important,ecause creatine kinase-MB was considered to be a majorredictor of clinical outcome in the CABG arm of theRTS I trial, which compared PCI with bare metal stents
o CABG in multivessel coronary artery disease (19). Ourrial did not include any asymptomatic patients, so potentialutcomes in this subset remain undefined. Our follow-upas somewhat less rigorous in the CABG group, because
symptomatic patients in this group were not subjected tooutine follow-up angiography, and the length of follow-ups currently not quite equal in the two groups. Although wencourage follow-up angiography at three to six months,here was a low incidence of angiographic follow-up (42%)ue to patients refusing repeat angiography. Currently, it isur policy not to offer ULMCA PCI to patients unless theygree to follow-up angiography. Finally, we did not conductuantitative analysis of symptom or functional improvementn both groups.
onclusions. In this observational study, PCI with DESas found to be a viable alternative to CABG, with no
ncrease in short- and intermediate-term MACCE in pa-ients with ULMCA disease compared with CABG, whenlinical judgment was used for patient allocation. Theseesults suggest a potential need for a large, multicenter,andomized study with long-term follow-up to provide aasis for re-evaluation of treatment guidelines for ULMCAisease.
eprint requests and correspondence: Dr. Raj R. Makkar,ardiovascular Intervention Center, Cedars-Sinai Medical Cen-
er, 8631 West Third Street, Room 415E, Los Angeles, California0048. E-mail: [email protected].
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