michael maeng, anne kaltoft, lisette okkels jensen, hans-henrik tilsted, per thayssen,
DESCRIPTION
Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus -Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease. Michael Maeng, Anne Kaltoft, Lisette Okkels Jensen, Hans-Henrik Tilsted, Per Thayssen, Klaus Rasmussen, Evald Høj Christiansen, - PowerPoint PPT PresentationTRANSCRIPT
Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-
Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease
Michael Maeng, Anne Kaltoft, Lisette Okkels Jensen, Hans-Henrik Tilsted, Per Thayssen,
Klaus Rasmussen, Evald Høj Christiansen, Morten Madsen, Søren Paaske Johnsen,
Henrik Toft Sørensen, Jens Flensted Lassen, Leif Thuesen
Western Denmark Heart Registry
Conflicts of interests for Leif Thuesen, M.D.Cordis, Johnson & Johnson:
Research grants, speaker’s fees.
Medtronic:
Advisory board, research grants, speaker’s fees.
Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-
Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease
Background (1)
• More angiographic late lumen loss• Greater angiographic restenosis• Similar target lesion revascularization rate
• Limitations; short term (9 months) follow-up and a selected patient population
The randomized 436-patient ENDEAVOR III trial compared the zotarolimus-eluting Endeavor stent with the sirolimus-eluting Cypher stent
Background (2)
Based on the phosphorylcholine coating and larger late lumen loss, the Endeavor stent stent might be associated with less stent thrombosis but more restenosis than other drug-eluting stents
Purpose
To compare the effectiveness and safety of the Endeavor versus the Cypher stent in a large registry reflecting every-day clinical practice
Endpoints
Safety MortalityMyocardial infarction >28 daysStent thrombosis
Effectiveness Clinically driven TLRClinically significant in-segment restenosis
Western Denmark Heart Registry
Covers the 3.0 million inhabitants in Western Denmark
Collects detailed patient and procedure data on all coronary interventions including CABG
Three high-volume interventional centers cover the entire region
Material and Methods (I)
Patients All patients treated with Endeavor or Cypher stent from August 2005 to October 2007Patients: 6,122Lesions: 8,185
Follow-up
From 40 to 823 days after index PCI
Material and Methods (II)
Patients treated during the study period
All PCI-treated patients10,992Study population (Cypher/Endeavor) 6,122Other DES 1,050BMS 2,125POBA, other intervention 1,695
Material and Methods (III)
MI and deathAscertained from national databases
Target lesion revascularization (TLR)Definite stent thrombosisIn-segment restenosis
Obtained from the WDHR by review of all cases of target vessel revascularization occurring during the study period
Registry Study
RegistryInclusion period
August 05 - October 07PCI centres
n=3Patientsn=6,122
Follow-up 40 - 823 days
SORT-OUT III
RCTInclusion period
January 06 - August 07PCI centres
n=5Patientsn=2,334
Follow-up270 days
SO III patients in registry
n=1,868 (30.5%)
Statistics
A Cox’s proportional hazards regression model controlling for age, gender, indication for PCI, diabetes, stent length, number of stents, number of lesions treated, and procedure time was used to compute hazard ratios as estimates of relative risks for each endpoint
Selected Patient Characteristics
Cypher Endeavor pNo of patients 3,840 2,282Age (yrs) 64.7 66.7 <0.001Male (%) 74.7 72.1 <0.05 BMI (kg/m2) 27.3 27.2 nsDiabetes (%) 15.8 15.0 nsHypertension (%) 49.4 54.1 <0.001Lipid-lowering therapy (%) 62.6 65.7 <0.05Previous CABG (%) 8.8 9.4 nsPrevious PCI (%) 32.2 33.7 nsPrevious MI (%) 35.0 36.7 ns
PCI Indication
Cypher Endeavor pStable angina (%) 41.9 40.5Unstable angina (%) 30.2 33.4STEMI (%) 24.6 22.4Other (%) 3.3 3.7
<0.05
Selected Procedure Characteristics
Cypher Endeavor pNo of lesions 5,095 3,090No of lesions/patient 1.3 1.4 nsLesion length (mm) 16.2 15.7 <0.05Stent length (mm) 20.2 19.9 <0.001Ref. vessel diameter 3.2 3.2 <0.001Lesion type <0.001Type A 21.6 21.3Type B 50.2 47.0Type C 28.2 31.7Procedure time (min) 26.6 28.6 <0.001
All Cause Mortality
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
All
caus
e m
orta
lity
(%)
EndeavorCypher
All Cause Mortality
Adjusted RR (95% CI) = 1.34 (1.04 – 1.71)
p=0.02A
ll ca
use
mor
talit
y (%
)
EndeavorCypher
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Cardiac Mortality
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Car
diac
mor
talit
y (%
)
EndeavorCypher
Cardiac MortalityAdjusted RR (95% CI) = 1.83 (0.99 – 3.41)
p=0.06
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Car
diac
mor
talit
y (%
)
EndeavorCypher
Myocardial Infarction > 28 days
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Late
myo
card
ial i
nfar
ctio
n (%
)
EndeavorCypher
Adjusted RR (95% CI) = 1.01 (0.88 – 1.16)
p=0.87
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Late
myo
card
ial i
nfar
ctio
n (%
)
Myocardial Infarction > 28 days
EndeavorCypher
Definite Stent Thrombosis (patient)
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Def
inite
ste
nt th
rom
bosi
s (%
)
EndeavorCypher
Definite Stent Thrombosis (patient)Adjusted RR (95% CI) = 2.06 (0.77 – 5.51)
p=0.15D
efin
ite s
tent
thro
mbo
sis
(%)
EndeavorCypher
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
Definite Stent Thrombosis (lesion)
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
Def
inite
ste
nt th
rom
bosi
s (%
)
EndeavorCypher
Definite Stent Thrombosis (lesion)Adjusted RR (95% CI) = 1.78 (1.06 – 3.00)
P<0.05
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
Def
inite
ste
nt th
rom
bosi
s (%
)
EndeavorCypher
Target Lesion Revascularization (patient)
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
TLR
(%)
EndeavorCypher
Target Lesion Revascularization (patient)Adjusted RR (95% CI) = 2.25 (1.42 – 3.56)
p=0.0005
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
TLR
(%)
EndeavorCypher
Target Lesion Revascularization (lesion)
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
TLR
(%)
EndeavorCypher
Target Lesion Revascularization (lesion)Adjusted RR (95% CI) = 2.39 (1.82 – 3.13)
P<0.0001
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
TLR
(%)
EndeavorCypher
In-segment Restenosis (patient)
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
In-s
egm
ent r
este
nosi
s (%
)
EndeavorCypher
In-segment Restenosis (patient)Adjusted RR (95% CI) = 2.25 (1.33 – 3.81), p=0.003
Cypher (n) 3840 3232 2479 1542 555 103Endeavor (n) 2282 1725 967 456 92 0
In-s
egm
ent r
este
nosi
s (%
)
EndeavorCypher
In-segment Restenosis (lesion)
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
In-s
egm
ent r
este
nosi
s (%
)
EndeavorCypher
In-segment Restenosis (lesion)Adjusted RR (95% CI) = 2.44 (1.76 – 3.37)
P<0.0001
Cypher (n) 5095 4320 3347 2081 751 143Endeavor (n) 3090 2338 1339 637 122 0
In-s
egm
ent r
este
nosi
s (%
)
EndeavorCypher
Limitations
In the present registry, the Cypher and Endeavor stent groups were not comparable. We adjusted for the most important predictors.It is unlikely that we made a complete compensation for selection bias at patient or operator level.
Conclusions
Within the current follow-up period, none of the safety endpoints indicated better safety profile of the Endeavor stent vs. the Cypher stent
The Endeavor stent seemed to be less effective than the Cypher stent concerning risk of clinical significant restenosis and target lesion revascularization