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SYNTAX - Top 30 Enrolling Centers: IAustriaCzech
RepNorwayFranceGermanyHungaryItaly
CABG InvestigatorPCI InvestigatorPaul SimonDietmar GlogarJan
TosovskyMichael AschermannPer Nielsen HostrupLeif ThuesenGerard
FournialDidier CarrieArnaud FargeMarie-Claude MoriceJean-Paul
BessouJacques BerlandPatrick SoulaJean MarcoFriedrich MohrGerhard
SchulerBruno ReichartPeter BoekstegersHermann ReichenspurnerThomas
MeinertzLajos PappIvan G. HorvathFerenc TarrIstvan PredaPaolo
FerrazziGiulio GuagliumiAndrea dArminiEzio BramucciLucia
TorraccaAntonio Colombo
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SYNTAX - Top 30 Enrolling Centers:
IIItalyLatviaNetherlandsPolandSwedenUKUS
CABG InvestigatorPCI InvestigatorMattia GlauberSergio
BertiRomans LacisAndrejs ErglisPieter KappeteinPatrick
SerruysJacques SchonbergerJacques KoolenAndrejs BochenekJanus
DrzewieckiElisabeth StahleStefan JamesStephen WestabyAdrian
BanningGeoff BergKeith G. OldroydSteven LiveseyKeith D. Dawkins
Jatin DesaiMartyn ThomasTomasz SpytAnthony H. GershlickAndrew
ForsythAdam De BelderGraham VennSimon RedwoodWilliam KillingerTift
MannMichael MackDavid L. Brown
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SYNTAXHeart team meeting - surgeon(s) and interventional
cardiologist(s) assess each patient
Operative risk(EuroSCORE & Parsonnet score)
Coronary lesion complexity (SYNTAX score)Sianos et al,
EuroIntervention 2005;1:219-227Valgimigli et al, Am J Cardiol
2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459BARI
classification of coronary segmentsLeaman score, Circ
1981;63:285-299Lesions classification ACC/AHA , Circ
2001;103:3019-3041 Bifurcation classification, CCI
2000;49:274-283CTO classification, J Am Coll Cardiol
1997;30:649-656Dominance
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Limited Exclusion CriteriaPrevious interventions (PCI or
CABG)Acute MI with CPK>2xConcomitant cardiac surgerySYNTAX
Trial- Eligible PatientsDe novo disease
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+SYNTAX Trial Design
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+SYNTAX Trial Design
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+SYNTAX Trial Design
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Withdrawn 47 Lost to FU 1312 mo Follow up N=1740 (96.7%)Total
randomized N=1800TAXUS* 891 (98.7%)7 5TAXUS* 903 (50.2%)CABG 897
(49.8%)CABG 849 (94.6%)40 8Randomised Patient Flow (ITT)
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Patient Characteristics (l)Randomised Cohort
CABG N=897TAXUS* N=903P valueAge, mean SD (y)65.0 9.865.2
9.70.55Male, %78.976.40.20BMI, mean SD27.9 4.528.1 4.80.37Diabetes,
%28.528.20.89Hypertension, %77.074.00.14Hyperlipidemia,
%77.278.70.44Current smoker, %22.018.50.06Prior MI,
%33.831.90.39Unstable angina, %28.028.90.67Additive EuroSCORE, mean
SD 3.8 2.73.8 2.60.78Total Parsonnet score , mean SD 8.4 6.88.5
7.00.76
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Patient Characteristics (lI)Randomised Cohort
Patient-basedCABG N=897TAXUS* N=903P valueTotal SYNTAX Score29.1
11.428.4 11.50.19Diffuse disease or small vessels, %
10.711.30.69No. lesions, mean SD 4.4 1.84.3 1.80.443VD only,
%66.365.40.70Left main, any, %33.734.60.70 Left Main only3.13.80.46
Left Main + 1 vessel5.15.40.78 Left Main + 2 vessel12.011.50.72
Left Main + 3 vessel13.513.90.78Total occlusion,
%22.224.20.33Bifurcation, %73.372.40.67Trifurcation,
%10.610.70.92
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Baseline Characteristics in DES PatientsSYNTAX Trial Versus 2
Large, Multicenter MVD Registries*Creatinine >220mol/liter for
NY State, >200mol/liter for the SYNTAX trial
ARTS II N=607NY State N=9963SYNTAX N=903Age, meanSD (y)63 1065.4
11.965.2 9.7Male, %7767.276.4BMI, meanSD27.5 4.1-28.1 4.8Diabetes,
%2632.728.2Hypertension, %67-74.0Hyperlipidemia, %74-78.7Current
smoker, %19-18.5Prior MI, %3433.731.9History of CHF, %-10.14.0Renal
Failure*-1.41.1Left Main, %excludedexcluded35%3 Vessel Disease,
%54%25%91%
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Procedural CharacteristicsPCI Randomised Cohort
Patient-basedTAXUS* N=903Staged Procedure, %14.1Vessels treated,
% LAD36.3 Circumflex32.5 RCA29.2 LM11.2Bi/trifurcation,
%64.4Lesions treated/pt, mean SD 3.6 1.6No. stents implanted, mean
SD 4.6 2.3Total length implanted, mm SD 86.1 47.9Range, mm8 324Long
stenting (>100 mm), %33.2
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Procedural CharacteristicsCABG Randomised Cohort
Procedure-related CABG N=897Off-pump surgery, %15.0Graft
revascularization, % Complete arterial revascularisation18.9 At
least one arterial graft97.3 Double LIMA/RIMA27.6 LIMA+venous78.1
Arterial graft to LAD95.6 Radial Artery14.1 Venous graft
only2.6Grafts per patient, mean SD 2.8 0.7Distal anastomosis/pt,
mean SD 3.2 0.9
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Procedural CharacteristicsRandomised Cohort *Allocation to
procedureFor PCI patients, includes time for staged procedurePer
protocol: Complete revascularisation is defined as the treatment of
any lesion with more than 50% diameter stenosis in vessels 1.5 mm
diameter as estimated on the diagnostic angiogram during the local
Heart Team conference. Completeness of revascularization was
assessed post procedure by the operator (Surgeon or Interventional
Cardiologist)
CABG N=897TAXUS* N=903P valueTime to procedure*, d, mean SD 17.4
28.06.9 13.0
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ITT; Fisher Exact TestP=0.37SYNTAX - All-cause mortality to 12
Months 4.3%3.5%
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SYNTAX - Cerebrovascular Events to 12 Months 0.6%2.2%P=0.003ITT;
Fisher Exact Test
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SYNTAX - Myocardial Infarction to 12 Months 3.2%4.8% P=0.11ITT;
Fisher Exact Test
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SYNTAX - Death/CVA/MI to 12 MonthsP=0.987.7% 7.6% ITT; Fisher
Exact Test
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SYNTAX - Symptomatic Graft Occlusion & Stent Thrombosis at
12 Months3.33.4P=0.89CABGTAXUSPatients (%)n=27n=28TAXUS*
(N=903)CABG (N=897)ITT population
Chart1
3.43.3
CABG
TAXUS
Sheet1
MACCE
CABG3.4
TAXUS3.3
- SYNTAX - Repeat Revascularisation to 12 Months5.9% 13.7% P
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SYNTAX - MACCE to 12 MonthsP=0.001512.1% 17.8% ITT; Fisher Exact
Test
- SYNTAX - 12 Month Clinical Event RatesPatients (%)CABG
(N=897)TAXUS* (N=903)ITT, Kaplan-Meier Rates; Fisher Exact TestAll
DeathCVAMIDeath/MI/CVARevascularisationP=0.37P=0.003P=0.11P=0.98P
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Primary Endpoint: 12 Month MACCE Non-inferiority
analysis05%10%15%Pre-specified Margin = 6.6%Difference in
MACCE20%+95% CI = 8.3%5.5%
Chart1
18.3
2
0
Sheet1
0
5.51
2
Sheet1
8.3
0
Sheet2
Sheet3
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Stent Number and Length Higher in the SYNTAX TrialPatients
(%)Total Number of Stents Implanted per Patient Multivessel
disease: 96.2%* 3-vessel disease:90.8%Avg. stents per patient:4.6
2.3 Avg. stented length:86.1 mm*3VD+LM/3VD+LM/2VD+LM/1VD
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Average Number of Stents Implanted per
Patient4.62.3SYNTAXTrialSYNTAXAverage number of stents implantedin
SYNTAX is higher than any othercontemporary DES versus CABG
study
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Average Total Stented Length86.147.9SYNTAXTrialAverage total
stent length (mm)SYNTAX
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Linear Increase in MACCE by Number of Stentsin the SYNTAX
Trial12m MACCE in TAXUS Arm12345678+Number of Stents Implanted
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SYNTAX - Outcome according to Diabetic StatusDiabetes (Medical
Treatment)N=452Non-DiabeticN=1348Death/CVA/MIMACCEDeath/CVA/MIMACCEP=0.96P=0.0025P=0.08P=0.97
Diagramm1
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10.3
14.2
10.1
26.0
Tabelle1
Datenreihe 1Datenreihe 2
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untere rechte Ecke des Bereichs.
Diagramm1
6.86.8
11.815.1
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Datenreihe 2
6.8
11.8
6.8
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6.86.8
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untere rechte Ecke des Bereichs.
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SYNTAX - Left Main Subgroup MACCE Ratesat 12 MonthsPatients
(%)All LM N=705
Chart1
13.715.8
LM onlyLM only
LM+1VDLM+1VD
LM+2VDLM+2VD
LM+3VDLM+3VD
3VD (all)3VD (all)
CABG
PCI
Sheet1
allLM onlyLM+1VDLM+2VDLM+3VD3VD (all)
CABG13.7
PCI15.8
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SYNTAX - Left Main and Three Vessel Disease Subgroup MACCE Rates
at 12 MonthsCABGTAXUS*Patients (%)All LM N=705LM+1VD N=138LM
Isolated N=91LM+2VD N=218LM+3VDN=2583VD ( w/o LM)N=1095
Chart1
13.715.8
8.57.1
13.27.5
14.419.8
15.419.3
11.519.2
CABG
PCI
Sheet1
allLM onlyLM+1VDLM+2VDLM+3VD3VD (all)
CABG13.78.513.214.415.411.5
PCI15.87.17.519.819.319.2
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Contemporary studies of DES versus CABG1-Year Mortality in CABG
ArmMultivesselLeft MainYang 2008 (n=390)ARTS I (n=602)Lee, 2007
(n=103)Javaid2008 (n=505)SYNTAXTrial(n=897)Sanmartin2007
(n=245)Palmerini2006 (n=154)Lee2006 (n=123)Chieffo2006
(n=142)Patients (%)Multivessel and/or Left Main
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Contemporary studies of DES versus CABG1-Year TVR (PCI or CABG)
in CABG ArmMultivesselLeft MainLee2007 (n=103)Sanmartin2007
(n=245)Palmerini2006 (n=154)Lee2006 (n=123)Chieffo2006
(n=142)Patients (%)ARTS I (n=602)Yang 2008
(n=390)SYNTAXTrial(n=897)Multivessel and/or Left Main
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Contemporary studies of DES versus CABG1-Year Stroke Rates in
CABG ArmMultivesselLeft MainLee2007 (n=103)Javaid2008
(n=505)Sanmartin2007 (n=245)Chieffo2006 (n=142)Patients (%)ARTS I
(n=602)Yang 2008 (n=390)SYNTAXTrial(n=897)Multivessel and/or Left
Main
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Contemporary studies of DES versus CABG1-Year MAC(C)E* Rates in
CABG ArmMultivesselLeft MainLee 2007 (n=103)Javaid2008
(n=505)*definitions varyacross studiesSanmartin2007 (n=245)Lee2006
(n=123)Patients (%)ARTS I (n=602)Yang 2008
(n=390)SYNTAXTrial(n=897)Multivessel and/or Left Main
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Average Stent Number and Length in ARRIVE Registry(N=7,492
patients)Patients (%)Total Number of Stents Implanted per Patient
Multivessel disease: 36.9% 3-vessel stenting:1.2%Avg. stents per
patient:1.6 0.9 Avg. stented length:18.6 mm
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Average Stent Number and Length in OLYMPIA Registry(N=22,345
patients)Patients (%)Total Number of Stents Implanted per Patient
Multivessel disease: 56.5% 3-vessel stenting:1.3%Avg. stents per
patient:1.5 0.8 Avg. stented length:29.9 mm
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Stent Number and Length Higher in the SYNTAX TrialPatients
(%)Total Number of Stents Implanted per Patient Multivessel
disease: 96.2%* 3-vessel disease:90.8%Avg. stents per patient:4.6
2.3 Avg. stented length:86.1 mm*3VD+LM/3VD+LM/2VD+LM/1VD
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Average Number of Stents Implanted per
Patient4.62.3SYNTAXTrialSYNTAXAverage number of stents implantedin
SYNTAX is higher than any othercontemporary DES versus CABG
study
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Average Total Stented Length86.147.9SYNTAXTrialAverage total
stent length (mm)SYNTAX
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Linear Increase in MACCE by Number of Stentsin the SYNTAX
Trial12m MACCE in TAXUS Arm12345678+Number of Stents Implanted
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1-Year Mortality and Revascularisation Ratesin TAXUS Stent
Studies Patients (%)MortalityRevascularisationTAXUSSRMetaARRIVE
Simple UseARRIVE MV StentingSYNTAXTrialTAXUSSRMetaARRIVE Simple
UseARRIVE MV StentingSYNTAXTrialTarget vessel onlyAny Repeat
Revascularization
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Contemporary studies of DES versus CABG1-Year Revascularisation
in DES ArmMultivesselLeft MainYang 2008 (n=441)ARTS II
(n=607)Hannan 2008 (n=9963)DELFT2008 (n=358)Sanmartin2007
(n=96)Palmerini2006 (n=157)Lee2006 (n=50)Chieffo2006
(n=107)Patients (%)42% 3VD91% 3VD54% 3VD35% LM25%
3VD(TVR)(TVR)(TLR)(TVR)All Revasc.All
RevascularizationSYNTAXTrial(n=903)Multivessel and/or Left
Main(All)
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Contemporary studies of DES versus CABG1-Year Mortality in DES
ArmMultivesselLeft MainYang 2008 (n=441)ARTS II (n=607)Lee, 2007
(n=102)Hannan2008 (n=9963)Javaid2008 (n=95)(cardiac)DELFT2008
(n=358)Sanmartin2007 (n=96)Palmerini2006 (n=157)Lee2006
(n=50)Chieffo2006 (n=107)Patients (%)SYNTAXTrial(n=903)Multivessel
and/or Left Main
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Contemporary studies of DES versus CABG1-Year Stroke Rates in
DES ArmMultivesselLeft MainYang 2008 (n=441)ARTS II (n=607)Lee2007
(n=102)Javaid2008 (n=95)Sanmartin2007 (n=96)Chieffo2006
(n=107)Patients (%)SYNTAXTrial(n=903)Multivessel and/or Left
Main
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Contemporary studies of DES versus CABG1-Year MAC(C)E* Rates in
DES ArmMultivesselLeft MainYang 2008 (n=441)ARTS II (n=607)Lee 2007
(n=102)Javaid2008 (n=95)DELFT2008 (n=358)*definitions varyacross
studiesSanmartin2007 (n=96)Lee2006 (n=50)SYNTAX TrialPatients
(%)3VDLM
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Atherosclerosis: A progressive processDisease progressionPHASE
I: Initiation PHASE II: ProgressionPHASE III: Complication
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Atherosclerotic progression:Glagovs remodeling
hypothesisNormalvesselProgressionGlagov S, et al. N Engl J Med.
1987;316:1371-1375.
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What types of lesions cause MI?Falk E, et al. Circulation.
1995;92:657-671.10080604020014%18%68%All 4
studies50%-70%70%1006040200Ambrose 1988Little 1988Nobuyoshi
1991Giroud 1992Coronary stenosis (%)Coronary stenosis severity
prior to MI80
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Atherosclerosis: The first sign of CHD is often sudden death or
MI062% (552/895 men)Men45% (305/674 women)Women
Patients who experienced an MI (%)Murabito JM, et al.
Circulation. 1993;88:2548-2555.20304050607010
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Breakdown of Current CAD TreatmentCDC MMWR 2007;56:113-118Eur
Heart J 2005;26:1011-1022 J Am Coll Cardiol 2002;39:1096-1103
USEuropeCABG is the current gold-standard of care in patients with
left main & multivessel disease
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Isolated LM includes portion of ostial LAD and CX. A lesion
would have to be 3x RVD away from another lesion to count as a
separate lesion. So if lesion originates in LM and extends to both
LAD and CX that would be a LM isolated. Only when the RVD criteria
is met further down vessel, or obviously RCA, does it count as
+1/2/3.
******In this trial the Local Heart team (surgeon &
interventional cardiologist) assessed each patient in regards
to:
Patients operative risk ( the EuroSCORE & Parsonnet score)
and Coronary lesion complexity ( a newly developed SYNTAX
score)
The goal of the SYNTAX score is provide a tool to assist
physicians in their revascularization strategies for patients with
high risk lesions**********Exhibit 6**Exhibit 6*NY State:3 Diseased
Vessels, with or without proximal LAD = 7683 total / out of 17400
patients = 44% 3VD overallStent: 2481 / 9963 patients = 25%CABG:
5202 / 7437 = 69.9%**Exhibits 10, 12**Exhibits 18, 19**Exhibit
9**All cause death to 12 months was 4.3 for TAXUS patients and 3.5
for CABG patients (p=0.37)**Cerebrovascular Events to 12 months was
0.6 for TAXUS patients and 2.2 for CABG patients
(p=0.003)**Myocardial Infarction to 12 months was 4.8 for TAXUS
patients and 3.2 for CABG patients (p=0.11)**The composite of
Death, Cerebrovascular events and myocardial infarction to 12
months was 7.6 for TAXUS patients and 7.7 for CABG patients
(p=0.98)**Symptomatic Graft Occlusion and Stent Thromobosis was not
statistically different between CABG and TAXUS at 12 months**Repeat
Revascularization to 12 months was 13.7 for TAXUS patients and 5.9
for CABG patients (p=0.0001).**MACCE to 12 months was 17.8 for
TAXUS patients and 12.1 for CABG patients (p=0.0015). This was
primarily driven by the higher rates of repeat revascularization in
the PCR cohort.*No 95% CI around a binary rate**Non-inferiority
comparison was not met for the primary endpoint, further
comparisons for the LM and 3VD subgroups are observational only and
hypothesis generating
*Source: BSC Internal Data on File
(SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc, Exhibit 7 &
12)
3 vessel disease = 3VD, LM+3VD, LM+2VD = 90.8%Multivessel
disease = everything but LM isolated = 96.2%*******The LM and 3VD
subgroup MACE rates were analyzed by number of vessels treated as
depicted on this slide.**The LM and 3VD subgroup MACE rates were
analyzed by number of vessels treated as depicted on this
slide.*Multivessel: - Yang 2008: J. H. Yang et al., The Annals of
Thoracic Surgery 85, 65 (2008). - ARTS I: P. W. Serruys et al.,
EuroIntervention 1, 147 (2005). - Lee, 2007: M. S. Lee et al., Int
J Cardiol 123, 34 (2007). - Javaid, 2008: A. Javaid et al.,
Circulation 116, I200 (2007). - rates are for 3VD. Paper also lists
rates in 2VD
Left main- Sanmartin, 2007: M. Sanmartin et al., Am J Cardiol
100, 970 (2007)- Palmerini, 2006: T. Palmerini et al., Am J Cardiol
98, 54 (2006).- 430 days median follow-up- Lee, 2006: M. S. Lee et
al., J Am Coll Cardiol 47, 864 (2006).- Chieffo, 2006: A. Chieffo
et al., Circulation 113, 2542 (2006).
Lee, 2006, 1 year- Seung 2008, MAIN COMPARE (396 DES, 3906 CABG
wave 2), 3 years. (give 1 year interim)*Multivessel: - Yang 2008:
J. H. Yang et al., The Annals of Thoracic Surgery 85, 65 (2008). -
ARTS I: P. W. Serruys et al., EuroIntervention 1, 147 (2005). -
Lee, 2007: M. S. Lee et al., Int J Cardiol 123, 34 (2007). - not
sure if rate is all revascularization (any vessel) or TVR; paper
doesnt specify. - Javaid, 2008: A. Javaid et al., Circulation 116,
I200 (2007). - does not list revasc (TVF only) not in table
Left main- Sanmartin, 2007: M. Sanmartin et al., Am J Cardiol
100, 970 (2007)- Palmerini, 2006: T. Palmerini et al., Am J Cardiol
98, 54 (2006).- rate of 25.5% is TLR.- 430 days median follow-up-
Lee, 2006: M. S. Lee et al., J Am Coll Cardiol 47, 864 (2006).-
Chieffo, 2006: A. Chieffo et al., Circulation 113, 2542 (2006).
*Multivessel: - Yang 2008: J. H. Yang et al., The Annals of
Thoracic Surgery 85, 65 (2008). - ARTS I: P. W. Serruys et al.,
EuroIntervention 1, 147 (2005). - Lee, 2007: M. S. Lee et al., Int
J Cardiol 123, 34 (2007). - Javaid, 2008: A. Javaid et al.,
Circulation 116, I200 (2007). - rates are for 3VD. Paper also lists
rates in 2VD
Left main- Sanmartin, 2007: M. Sanmartin et al., Am J Cardiol
100, 970 (2007)- Palmerini, 2006: T. Palmerini et al., Am J Cardiol
98, 54 (2006).- stroke rates not given; 430 days median follow-up-
Lee, 2006: M. S. Lee et al., J Am Coll Cardiol 47, 864 (2006).-
stroke rates not given- Chieffo, 2006: A. Chieffo et al.,
Circulation 113, 2542 (2006).
*Multivessel: - Yang 2008: J. H. Yang et al., The Annals of
Thoracic Surgery 85, 65 (2008).- MACCE = all cause death, AMI, CVA,
revasc. by PCI or CABG - ARTS I: P. W. Serruys et al.,
EuroIntervention 1, 147 (2005). - Lee, 2007, 1 year- MACCE = all
cause death, nonfatal MI, CVA, revasc. by PCI or CABG - Lee, 2007:
M. S. Lee et al., Int J Cardiol 123, 34 (2007).- MACE = death, MI,
repeat revasc. - Javaid, 2008: A. Javaid et al., Circulation 116,
I200 (2007). - rates are for 3VD. Paper also lists rates in 2VD-
MACCE = MACE + cerebrovascular event (paper does not define
MACE)
Left main- Sanmartin, 2007: M. Sanmartin et al., Am J Cardiol
100, 970 (2007)- MACCE = death, Q-MI, stroke, repeat
revascularization- Lee, 2006: M. S. Lee et al., J Am Coll Cardiol
47, 864 (2006).- MACCE = death, MI, CVA, TVR***Source: BSC Internal
Data on File (SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc,
Exhibit 7 & 12)
3 vessel disease = 3VD, LM+3VD, LM+2VD = 90.8%Multivessel
disease = everything but LM isolated =
96.2%*********Atherosclerosis, the process underlying most CVD, has
3 distinct stages: Initiation - during which lipids are deposited
on the vessel wall Progression - during which inflammation
increases, plaque formation builds up in the intima, and fibrous
caps are formed, increasing the potential for atheroma Clinical
disease - when complications result from stenosis or unstable
plaque rupture, leading to myocardial infarction (MI), stroke, or
death.1
1. Libby P. Current concepts of the pathogenesis of the acute
coronary syndromes. Circulation. 2001;104:365-372.
*The new model of atherosclerosis was based on histological
analysis of coronary artery sections reported by Glagov et al in
1987.1 The work they described showed that the early stages of
disease were marked by plaque accumulation in the vessel wall, with
subsequent enlargement of the EEM but no change in lumen size. In
Glagovs original hypothesis, plaque development is extraluminal
until the lesion occupies 40% of the area within the EEM. Only then
does the lumen begin to shrink.
1. Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis
GJ. Compensatory enlargement of human atherosclerotic coronary
arteries. N Engl J Med. 1987;316; 22:1371-1375.
*Several investigators have examined the question of which types
of lesions cause MI. This slide shows collated data from a number
of studies.1 The proportion of patients with MI caused by either
>70%, 50%-70%, or