long term clinical outcomes following drug-eluting and bare metal stenting in massachusetts
DESCRIPTION
Long Term Clinical Outcomes Following Drug-Eluting and Bare Metal Stenting in Massachusetts. Laura Mauri, MD, MSc; Treacy Silverstein, B.Sc.; Ann Lovett, R.N., M.A.; Frederic S. Resnic, M.D., M.Sc.; and Sharon-Lise T. Normand, Ph.D. Brigham and Women’s Hospital, Harvard Medical School, - PowerPoint PPT PresentationTRANSCRIPT
Long Term Clinical Outcomes Following Long Term Clinical Outcomes Following Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusetts
Laura Mauri, MD, MSc; Treacy Silverstein, B.Sc.; Laura Mauri, MD, MSc; Treacy Silverstein, B.Sc.; Ann Lovett, R.N., M.A.; Frederic S. Resnic, M.D., M.Sc.; Ann Lovett, R.N., M.A.; Frederic S. Resnic, M.D., M.Sc.; and Sharon-Lise T. Normand, Ph.D. and Sharon-Lise T. Normand, Ph.D.
Brigham and Women’s Hospital, Harvard Medical School, Brigham and Women’s Hospital, Harvard Medical School, Harvard School of Public HealthHarvard School of Public HealthBoston, MassachusettsBoston, Massachusetts
Study funding from Massachusetts Department of Public HealthStudy funding from Massachusetts Department of Public Health
November 4, 2007November 4, 2007American Heart Association Scientific SessionsAmerican Heart Association Scientific Sessions
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsBackgroundBackground
The data reported for available DES in the US The data reported for available DES in the US indicate that these devices are important indicate that these devices are important advancements by reducing the need for advancements by reducing the need for revascularizationrevascularization
Long term clinical outcomes remain uncertain Long term clinical outcomes remain uncertain following DES use compared to BMS use in the following DES use compared to BMS use in the general populationgeneral population
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusetts BackgroundBackground
Randomized trials of DES have been limited in Randomized trials of DES have been limited in power to detect rare events and in power to detect rare events and in generalizability to a broad range of practice generalizability to a broad range of practice patterns and patient populationspatterns and patient populations
Observational studies have been limited by Observational studies have been limited by possible residual selection bias and incomplete possible residual selection bias and incomplete follow-upfollow-up
Studies comparing DES and BMS use have been Studies comparing DES and BMS use have been performed in populations with restricted DES useperformed in populations with restricted DES use
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusetts ObjectivesObjectives
– To evaluate whether the use of DES is To evaluate whether the use of DES is associated with increased rates of death or MI associated with increased rates of death or MI compared with BMS in general use compared with BMS in general use representative of current US practicerepresentative of current US practice
– To confirm whether the use of DES is To confirm whether the use of DES is associated with reduction in revascularization associated with reduction in revascularization compared with BMS in general use compared with BMS in general use representative of current US practicerepresentative of current US practice
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusetts Methods: Data source Methods: Data source Mass-DACMass-DAC
All PCI in Massachusetts (>25000 stent procedures per All PCI in Massachusetts (>25000 stent procedures per year)year)Massachusetts Dept. of Public Health mandatory reportingMassachusetts Dept. of Public Health mandatory reportingClinical and procedural factors collected prospectively Clinical and procedural factors collected prospectively using ACC NCDR instrumentusing ACC NCDR instrumentMortality from hospital record, Mass. vital statistics and Mortality from hospital record, Mass. vital statistics and Social Security websiteSocial Security websiteMyocardial infarction and revascularization from Mass-Myocardial infarction and revascularization from Mass-DAC PCI and CABG data merged with hospital discharge DAC PCI and CABG data merged with hospital discharge datadataIndex procedures performed April 2003 – September 2004Index procedures performed April 2003 – September 2004Non-Massachusetts residents excludedNon-Massachusetts residents excluded
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusetts Methods: Propensity Score Matched AnalysisMethods: Propensity Score Matched Analysis
Patients assigned to DES or BMS groups based Patients assigned to DES or BMS groups based on treatment at index procedure on treatment at index procedure Propensity score matching Propensity score matching – Logistic regression to predict DES treatment Logistic regression to predict DES treatment
by patient, procedural, hospital variablesby patient, procedural, hospital variables– Caliper matching of DES to BMS patients Caliper matching of DES to BMS patients
Primary outcomes: Matched risk differences for Primary outcomes: Matched risk differences for mortality, myocardial infarction and mortality, myocardial infarction and revascularization rates at 2 yearsrevascularization rates at 2 yearsPaired t-test, 2-sided alpha 0.05Paired t-test, 2-sided alpha 0.05
Drug-Eluting and Bare Metal Stenting in Massachusetts
7
N=21,019 PCI Patients in N=21,019 PCI Patients in MassachusettsMassachusetts
April 1, 2003- September 30, 2004April 1, 2003- September 30, 2004Complete 2 year follow-upComplete 2 year follow-up
N=21,019 PCI Patients in N=21,019 PCI Patients in MassachusettsMassachusetts
April 1, 2003- September 30, 2004April 1, 2003- September 30, 2004Complete 2 year follow-upComplete 2 year follow-up
1,538 non-residents excluded1,538 non-residents excluded1,538 non-residents excluded1,538 non-residents excluded
564 adminstrative files not 564 adminstrative files not linkablelinkable
564 adminstrative files not 564 adminstrative files not linkablelinkable
N=18,917 N=18,917 PCI PatientsPCI Patients
N=18,917 N=18,917 PCI PatientsPCI Patients
N=11,516N=11,516DES Only PatientsDES Only Patients
N=11,516N=11,516DES Only PatientsDES Only Patients
N=6,210 N=6,210 BMS Only PatientsBMS Only Patients
N=6,210 N=6,210 BMS Only PatientsBMS Only Patients
1,191 patients with both 1,191 patients with both stent types excludedstent types excluded
1,191 patients with both 1,191 patients with both stent types excludedstent types excluded
0 50 100 150 200 250 300 350 400 450 500 550
02
00
60
01
00
01
40
0
Days from Market Introduction (April 1, 2003)
No
. o
f P
atie
nts
Bare Metal Stents (6,210 Patients)
0 50 100 150 200 250 300 350 400 450 500 550
02
00
60
01
00
01
40
0
Days from Market Introduction (April 1, 2003)
No
. o
f P
atie
nts
Drug Eluting Stents (11,516 Patients)
35% BMS
65% DES
72% sirolimus, 28% paclitaxel eluting stents
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsPatient Characteristics before MatchPatient Characteristics before Match
DESDES(n = 11516)(n = 11516)
BMSBMS(n =6210)(n =6210)
p p valuevalue
Age – yrsAge – yrs 64.4 ±12.364.4 ±12.3 65.3 ±13.065.3 ±13.0 <0.001<0.001
Female (%)Female (%) 32.0 32.0 32.2 32.2 0.850.85
Diabetes Mellitus (%)Diabetes Mellitus (%) 28.928.9 27.427.4 0.040.04
Insulin Dependent DiabetesInsulin Dependent Diabetes 9.79.7 8.88.8 0.070.07
Hyperlipidemia (%)Hyperlipidemia (%) 77.177.1 71.971.9 <0.001<0.001
Hypertension (%)Hypertension (%) 76.176.1 72.672.6 <0.001<0.001
Current Smoker (%)Current Smoker (%) 19.619.6 23.223.2 <0.001<0.001
Prior PCI (%)Prior PCI (%) 22.522.5 20.720.7 0.0040.004
Prior MI (%)Prior MI (%) 26.926.9 28.728.7 0.010.01
Prior CABG (%)Prior CABG (%) 13.013.0 16.116.1 <0.001<0.001
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsPatient Characteristics before MatchPatient Characteristics before Match
DESDES(n = 11516)(n = 11516)
BMSBMS(n =6210)(n =6210)
p p valuevalue
Congestive Heart Failure Congestive Heart Failure (%)(%) 9.89.8 12.212.2 <0.001<0.001
Chronic Lung Disease Chronic Lung Disease (%)(%) 10.810.8 12.212.2 0.0030.003
History of Neoplasm History of Neoplasm (%)(%) 2.12.1 3.23.2 <0.001<0.001
History of GI Bleeding History of GI Bleeding (%)(%) 1.61.6 2.42.4 <0.001<0.001
Chronic Renal Insufficiency (%)Chronic Renal Insufficiency (%) 6.26.2 7.07.0 0.030.03
Dialysis (%)Dialysis (%) 1.51.5 1.71.7 0.100.10
Clopidogrel Pretreatment (%)Clopidogrel Pretreatment (%) 34.834.8 33.733.7 0.130.13
GpIIbIIIa Inhibitor Pretreatment GpIIbIIIa Inhibitor Pretreatment (%)(%)
16.216.2 23.523.5 <0.001<0.001
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsProcedure Indications before MatchProcedure Indications before Match
DESDES(n = 11516)(n = 11516)
BMSBMS(n =6210)(n =6210)
p p valuevalue
Procedure statusProcedure status <0.001<0.001
Urgent Urgent (%)(%) 39.739.7 36.336.3
Emergency/Salvage Emergency/Salvage (%)(%) 13.813.8 28.928.9
IndicationIndication
Non-ST elevation MI Non-ST elevation MI (%)(%) 20.820.8 21.721.7 0.140.14
ST elevation MI ST elevation MI (%)(%) 13.513.5 29.229.2 <0.001<0.001
Treatment for restenosisTreatment for restenosis 7.17.1 3.93.9 <0.001<0.001
Atheroablative therapyAtheroablative therapy 5.35.3 4.44.4 0.0120.012
ThrombectomyThrombectomy 3.13.1 7.77.7 <0.001<0.001
BrachytherapyBrachytherapy 0.40.4 0.40.4 0.810.81
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsProcedural Characteristics before MatchProcedural Characteristics before Match
DESDES(n = 11516)(n = 11516)
BMSBMS(n =6210)(n =6210)
p p valuevalue
Number of vessels treatedNumber of vessels treated 1.19 ± 0.431.19 ± 0.43 1.13 ± 0.361.13 ± 0.36 <0.001<0.001
Number of lesions treatedNumber of lesions treated 1.44 ± 0.721.44 ± 0.72 1.36 ± 0.671.36 ± 0.67 <0.001<0.001
Left anterior descending Left anterior descending (%)(%) 45.645.6 38.738.7 <0.001<0.001
Circumflex Circumflex (%)(%) 32.532.5 29.929.9 <0.001<0.001
Right coronary Right coronary (%)(%) 38.338.3 42.542.5 <0.001<0.001
Left main Left main (%)(%) 1.81.8 1.91.9 0.650.65
Saphenous vein graft Saphenous vein graft (%)(%) 4.44.4 9.19.1 <0.001<0.001
Arterial graft Arterial graft (%)(%) 0.40.4 0.40.4 0.480.48
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts, Massachusetts, Unadjusted 2-Year OutcomesUnadjusted 2-Year Outcomes
BMSBMS(n=768/6210)(n=768/6210)
DESDES(n=769/11516)(n=769/11516)
12.4%12.4%
6.7%6.7%
Mortality
P < 0.0001
Revascularization
DESDES(n=2297/11516)(n=2297/11516)
BMSBMS(n=1488/6210)(n=1488/6210)
P < 0.0001
24.0%24.0%
20.0%20.0%
MI
DESDES(n=1049/11516)(n=1049/11516)
BMSBMS(n=754/6210)(n=754/6210)
P < 0.0001
12.1%12.1%
9.1%9.1%
Standardized Difference (%)
-40 -35 -30 -25 -20 -15 -10 -5 0 5 10 15
Pilot ProgramEF < 30%
EF MeasuredThrombolytics Given
Thrombolytics ContraindicatedVein SVG
Artery SVGClopidogril Given
Clopidogril ContrainidacatedIIB/IIIA Given
IIB/IIIA ContraindicatedBrachytherapy
AngiojetAdjunct. Atheroblative
RestenosisHigh Risk Lesion
RCA TrtdLeftMain Trtd
LCX Trtd>4 Treated Lesions4 Treated Leasions3 Treated Lesions2 Treated Lesions
LM DiseaseDiseased vessels 2
Diseased vessels < 2Hx Neoplasms
Hx GI BleedHx CAD
Renal FailureDialysis
Chronic Lung DiseaseCerebrovascular Disease
Peripheral Vascular DiseasePrevious PCI
Previous CABGPrevious MI
CHFCCS 3 or 4CCS 1 or 2NYHA III/IV
NYHA I/IINegative FunctionPositive Function
ACS < 6 hrsACS > 24 hrsACS 6-24 hrs
UrgentEmergent/Salvage
Former SmokerCurrent Smoker
No InsuranceHMO
Commercial InsuranceHypertensionHypercholest.
DiabetesOther Race
HispanicAfrican American
FemaleYrs > 65
Larger for BMS Cohort Larger for DES Cohort
Pre-Stent Differences: DES - BMS
Pre-Matching (17,726 Patients)Post-Matching (5441 Pairs)
n=5441 DES n=5441 BMS
Propensity matched pairs63 variables
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsPatient Characteristics after MatchPatient Characteristics after Match
DESDES(n = 5441)(n = 5441)
BMSBMS(n =5441)(n =5441) % SD% SD
Age – yrsAge – yrs 66.266.2 65.365.3 0.070.07
Female (%)Female (%) 33.333.3 32.332.3 2.272.27
Diabetes Mellitus (%)Diabetes Mellitus (%) 27.327.3 28.128.1 -1.85-1.85
Hyperlipidemia (%)Hyperlipidemia (%) 69.869.8 73.373.3 -7.71-7.71
Hypertension (%)Hypertension (%) 72.472.4 73.873.8 -3.23-3.23
Current Smoker (%)Current Smoker (%) 23.723.7 22.222.2 3.413.41
Prior PCI (%)Prior PCI (%) 20.620.6 21.121.1 -1.40-1.40
Prior MI (%)Prior MI (%) 30.930.9 28.428.4 5.515.51
Prior CABG (%)Prior CABG (%) 16.416.4 15.315.3 3.173.17
*%SD = Percent Standardized DifferenceValues <10% reflect well-matched characteristics
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsPatient Characteristics after MatchPatient Characteristics after Match
DESDES(n = 5441)(n = 5441)
BMSBMS(n =5441)(n =5441) %SD%SD
Congestive Heart Failure (NYHA 3-4)Congestive Heart Failure (NYHA 3-4) 8.58.5 6.86.8 6.296.29
Chronic Lung Disease Chronic Lung Disease (%)(%) 14.014.0 12.312.3 5.065.06
History of Neoplasm History of Neoplasm (%)(%) 3.83.8 2.92.9 5.025.02
History of GI Bleeding History of GI Bleeding (%)(%) 2.52.5 2.12.1 2.962.96
Chronic Renal Insufficiency (%)Chronic Renal Insufficiency (%) 7.67.6 6.96.9 2.762.76
Dialysis (%)Dialysis (%) 1.81.8 1.71.7 1.131.13
Clopidogrel Preadminstered (%)Clopidogrel Preadminstered (%) 35.935.9 34.134.1 3.743.74
GpIIbIIIa Inhibitor Preadminstered GpIIbIIIa Inhibitor Preadminstered (%)(%)
25.025.0 21.921.9 7.427.42
*%SD = Percent Standardized DifferenceValues <10% reflect well-matched characteristics
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsProcedure Characteristics after MatchProcedure Characteristics after Match
DESDES(n = 5441)(n = 5441)
BMSBMS(n =5441)(n =5441) %SD%SD
Procedure statusProcedure status
Urgent Urgent (%)(%) 37.137.1 38.238.2 -2.28-2.28
Emergency/Salvage Emergency/Salvage (%)(%) 27.927.9 23.423.4 10.2810.28
IndicationIndication
Non-ST elevation MI Non-ST elevation MI (%)(%) 24.524.5 22.922.9 3.633.63
ST elevation MI ST elevation MI (%)(%) 26.626.6 23.423.4 6.306.30
Treatment for restenosisTreatment for restenosis 3.03.0 4.34.3 -6.89-6.89
Atheroablative therapyAtheroablative therapy 5.15.1 4.74.7 1.88
ThrombectomyThrombectomy 6.36.3 5.65.6 2.79
BrachytherapyBrachytherapy 0.50.5 0.40.4 0.45
*%SD = Percent Standardized DifferenceValues <10% reflect well-matched characteristics
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsProcedural Characteristics after MatchProcedural Characteristics after Match
DESDES(n = 5441)(n = 5441)
BMSBMS(n =5441)(n =5441) %SD%SD
Multilesion treatmentMultilesion treatment
2 lesions2 lesions 21.921.9 22.622.6 -1.63-1.63
3 lesions3 lesions 4.64.6 5.45.4 -3.89-3.89
4 lesions4 lesions 1.21.2 1.21.2 0.170.17
Target vesselTarget vessel
Left circumflexLeft circumflex 29.729.7 31.031.0 -2.80-2.80
Right coronary Right coronary 43.543.5 40.940.9 5.365.36
Left mainLeft main 2.22.2 2.02.0 1.531.53
Saphenous vein graftSaphenous vein graft 8.88.8 7.57.5 4.644.64
Arterial graftArterial graft 0.30.3 0.40.4 -1.25-1.25
*%SD = Percent Standardized DifferenceValues <10% reflect well-matched characteristics
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts, Primary ResultsMassachusetts, Primary ResultsPropensity Matched 2-Year OutcomesPropensity Matched 2-Year Outcomes
BMSBMS(n=647/5441)(n=647/5441)
DESDES(n=514/5441)(n=514/5441)
11.9%11.9%9.4
%9.4%
Mortality
P < 0.0001
Revascularization
DESDES(n=1095/5441)(n=1095/5441)
BMSBMS(n=1303/5441)(n=1303/5441)
P < 0.0001
23.9%23.9%
20.1%20.1%
MI
DESDES(n=590/5441)(n=590/5441)
BMSBMS(n=643/5441)(n=643/5441)
P = 0.11
11.8%11.8%10.8
%10.8%
= -3.8% [-5.4,-2.3] = -1.0% [-2.2,+0.2] = -2.4% [-3.6,-1.3]
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20%
30%
00%
180 365 730
(At risk) Days(At risk) Days 00 180180 365365 730730
DESDES 5,4415,441 5,3385,338 5,2195,219 5,1235,123
BMSBMS 5,4415,441 5,2795,279 5,1055,105 4,9954,995
DES n=5,441BMS n=5,441
Time after Initial Procedure (days)
11.9%
9.4%
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts 2-Year Outcome in Matched Patients2-Year Outcome in Matched Patients
Mortality
(At risk) Days(At risk) Days 00 180180 365365 730730
DESDES 5,4415,441 5,1035,103 4,8964,896 4,7294,729
BMSBMS 5,4415,441 5,0295,029 4,7474,747 4,5694,569
DES n=5,441BMS n=5,441
Time after Initial Procedure (days)
12.3%
11.2%
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts 2-Year Outcome in Matched Patients2-Year Outcome in Matched Patients
MI
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10%
20%
30%
00%
180 365 730
(At risk) Days(At risk) Days 00 180180 365365 730730
DESDES 5,4415,441 4,9404,940 4,5814,581 4,3094,309
BMSBMS 5,4415,441 4,9094,909 4,3034,303 3,9923,992
DES n=5,441BMS n=5,441
Time after Initial Procedure (days)
25.1%20.9%
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts 2-Year Outcome in Matched Patients2-Year Outcome in Matched Patients
Revascularization
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10%
20%
30%
00%
180 365 730
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts Matched Risk Differences at 2 yearsMatched Risk Differences at 2 years
Myocardial InfarctionMyocardial InfarctionDES 10.8%BMS 11.3%
MortalityMortalityDES 9.4%BMS 11.9%
RevascularizationRevascularizationDES 20.1%BMS 23.9%
Favors
DES
Favors
BMS
Risk Difference (95% CI)Risk Difference (95% CI)
-5% 0 5%
= -2.4% [-3.6,-1.3] p<0.0001
= -1.0% [-2.2,+0.2] p=0.11
= -3.8% [-5.4,-2.3] p<0.0001
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts Sensitivity analysesSensitivity analyses
Effect of differential rates of use of DES vs BMS over Effect of differential rates of use of DES vs BMS over timetime
2 day mortality difference2 day mortality difference
Standardized Difference (%)
-40 -35 -30 -25 -20 -15 -10 -5 0 5 10 15
Days X Pilot(Market Days)̂ 2
Market DaysPilot Program
EF < 30%EF Measured
Thrombolytics GivenThrombolytics Contraindicated
Vein SVGArtery SVG
Clopidogril GivenClopidogril Contrainidacated
IIB/IIIA GivenIIB/IIIA Contraindicated
BrachytherapyAngiojet
Adjunct. AtheroblativeRestenosis
High Risk LesionRCA Trtd
LeftMain TrtdLCX Trtd
>4 Treated Lesions4 Treated Leasions3 Treated Lesions2 Treated Lesions
LM DiseaseDiseased vessels 2
Diseased vessels < 2Hx Neoplasms
Hx GI BleedHx CAD
Renal FailureDialysis
Chronic Lung DiseaseCerebrovascular Disease
Peripheral Vascular DiseasePrevious PCI
Previous CABGPrevious MI
CHFCCS 3 or 4CCS 1 or 2NYHA III/IV
NYHA I/IINegative FunctionPositive Function
ACS < 6 hrsACS > 24 hrsACS 6-24 hrs
UrgentEmergent/Salvage
Former SmokerCurrent Smoker
No InsuranceHMO
Commercial InsuranceHypertensionHypercholest.
DiabetesOther Race
HispanicAfrican American
FemaleYrs > 65
Larger for BMS Cohort Larger for DES Cohort
Pre-Stent Differences: DES - BMS
Pre-Matching (17,731 Patients)Post-Matching (3752 Pairs)
n=3752 DES n=3752 BMS
Propensity matched pairsadjusted for time on market
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts Sensitivity Analysis Sensitivity Analysis 2-Year Outcomes adjusted for time on market2-Year Outcomes adjusted for time on market
BMSBMS(n=439/3752)(n=439/3752)
DESDES(n=318/3752)(n=318/3752)
11.7%11.7%
8.5%8.5%
Mortality
P < 0.0001
Revascularization
DESDES(n=784/3752)(n=784/3752)
BMSBMS(n=858/3752)(n=858/3752)
P = 0.040
22.9%22.9%20.9%20.9%
MI
DESDES(n=370/3752)(n=370/3752)
BMSBMS(n=422/3752)(n=422/3752)
P = 0.052
11.8%11.8%10.8
%10.8%
= -1.9% [-3.9,-0.1] = -1.4% [-2.8,0.0] = -3.2% [-4.6,-1.8]
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts Sensitivity analysesSensitivity analyses
Adjustment for time on market is consistent with results Adjustment for time on market is consistent with results of the primary analysisof the primary analysis
– larger observed difference favoring DES for mortalitylarger observed difference favoring DES for mortality
2 day mortality difference after propensity match is small2 day mortality difference after propensity match is small
• 2 day mortality 0.4% vs 0.8% (DES vs BMS) = -0.4% at 2d vs = -2.4% at 2 y
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in Massachusetts Massachusetts Comparison Comparison with PCI Practice Patterns and Other Studieswith PCI Practice Patterns and Other Studies
Adult Adult populationpopulation
DES DES patientspatients
BMS BMS patientspatients
DESDES(%)(%)
StudyStudydurationduration
SwedenSweden11 9 million9 million 60336033 1373813738 3030 1/03-12/041/03-12/04
Western Western DenmarkDenmark22 3 million3 million 35483548 88478847 2929 1/02-6/051/02-6/05
OntarioOntario33 9 million9 million 51065106 82478247 3838 12/03-3/0512/03-3/05
MassachusettsMassachusetts 6 million6 million 1151611516 62106210 6565 4/03-9/044/03-9/04
Distinguishing features: high rate of PCI/population, high rate of DES/procedure, study sample chosen to start with introduction of DES and to end when all patients had complete 2 year follow up.
1. Lagerqvist B et al. 1. Lagerqvist B et al. N Engl J MedN Engl J Med 2007;356:1009-19. 2. 2007;356:1009-19. 2. Jensen, LO et al. JACC 2007;50(5):463-70. 3. Tu J et al. NEJM 2007;357:1393-42.
From the Massachusetts state dataset of From the Massachusetts state dataset of 21,024 PCI unique 21,024 PCI unique patient procedures in Massachusetts from April 2003- patient procedures in Massachusetts from April 2003- September 2004 with complete 2y follow-up, propensity September 2004 with complete 2y follow-up, propensity matched analysis of 10,882 patients demonstrated:matched analysis of 10,882 patients demonstrated:
No increase in rates of death, or myocardial infarction No increase in rates of death, or myocardial infarction associated with DES as compared to BMS use at 2 years.associated with DES as compared to BMS use at 2 years.
– A significantly lower mortality rate was observed for DES at 2 years, A significantly lower mortality rate was observed for DES at 2 years, and will be monitored as follow up proceeds to 3-5 yearsand will be monitored as follow up proceeds to 3-5 years
A lower rate of revascularization in patients treated with A lower rate of revascularization in patients treated with DES compared with BMS.DES compared with BMS.
Drug-Eluting and Bare Metal Stenting in Drug-Eluting and Bare Metal Stenting in MassachusettsMassachusettsConclusionsConclusions