Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Western.

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Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Western Denmark Heart Registry 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 1

Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Conflicts of interests for Leif Thuesen, M.D. Cordis, Johnson & Johnson: Research grants, speaker’s fees. Medtronic: Advisory board, research grants, speaker’s fees. 2

Background (1) The randomized 436-patient ENDEAVOR III trial compared the zotarolimus-eluting Endeavor stent with the sirolimus-eluting Cypher stent 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 3

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 4

Purpose To compare the effectiveness and safety of the Endeavor versus the Cypher stent in a large registry reflecting every-day clinical practice 5

Endpoints Safety Mortality Effectiveness Clinically driven TLR Myocardial infarction >28 days Stent thrombosis Effectiveness Clinically driven TLR Clinically 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 7

Material and Methods (I) Patients All patients treated with Endeavor or Cypher stent from August 2005 to October 2007 Patients: 6,122 Lesions: 8,185 Follow-up From 40 to 823 days after index PCI Ascertained from 8

Material and Methods (II) Patients treated during the study period All PCI-treated patients 10,992 Study population (Cypher/Endeavor) 6,122 Other DES 1,050 BMS 2,125 POBA, other intervention 1,695 Ascertained from 9

Material and Methods (III) MI and death Ascertained from national databases Target lesion revascularization (TLR) Definite stent thrombosis In-segment restenosis Obtained from the WDHR by review of all cases of target vessel revascularization occurring during the study period Ascertained from 10

SO III patients in registry Registry Study SORT-OUT III Registry Inclusion period August 05 - October 07 PCI centres n=3 Patients n=6,122 Follow-up 40 - 823 days RCT Inclusion period January 06 - August 07 PCI centres n=5 Patients n=2,334 Follow-up 270 days Ascertained from SO III patients in registry n=1,868 (30.5%) 11 11

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 12

Selected Patient Characteristics Cypher Endeavor p No of patients 3,840 2,282 Age (yrs) 64.7 66.7 <0.001 Male (%) 74.7 72.1 <0.05 BMI (kg/m2) 27.3 27.2 ns Diabetes (%) 15.8 15.0 Hypertension (%) 49.4 54.1 Lipid-lowering therapy (%) 62.6 65.7 Previous CABG (%) 8.8 9.4 Previous PCI (%) 32.2 33.7 Previous MI (%) 35.0 36.7

PCI Indication Cypher Endeavor p Stable angina (%) 41.9 40.5 Unstable angina (%) 30.2 33.4 STEMI (%) 24.6 22.4 Other (%) 3.3 3.7 <0.05

Selected Procedure Characteristics Cypher Endeavor p No of lesions 5,095 3,090 No of lesions/patient 1.3 1.4 ns Lesion length (mm) 16.2 15.7 <0.05 Stent length (mm) 20.2 19.9 <0.001 Ref. vessel diameter 3.2 Lesion type Type A 21.6 21.3 Type B 50.2 47.0 Type C 28.2 31.7 Procedure time (min) 26.6 28.6

All Cause Mortality All cause mortality (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 16

All Cause Mortality Adjusted RR (95% CI) = 1.34 (1.04 – 1.71) p=0.02 Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 17

Cardiac Mortality Cardiac mortality (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 18

Cardiac Mortality Adjusted RR (95% CI) = 1.83 (0.99 – 3.41) p=0.06 Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 19

Myocardial Infarction > 28 days Late myocardial infarction (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 20

Myocardial Infarction > 28 days Adjusted RR (95% CI) = 1.01 (0.88 – 1.16) p=0.87 Late myocardial infarction (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 21

Definite Stent Thrombosis (patient) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 22

Definite Stent Thrombosis (patient) Adjusted RR (95% CI) = 2.06 (0.77 – 5.51) p=0.15 Definite stent thrombosis (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 23

Definite Stent Thrombosis (lesion) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 24

Definite Stent Thrombosis (lesion) Adjusted RR (95% CI) = 1.78 (1.06 – 3.00) P<0.05 Definite stent thrombosis (%) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 25

Target Lesion Revascularization (patient) TLR (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 26

Target Lesion Revascularization (patient) Adjusted RR (95% CI) = 2.25 (1.42 – 3.56) p=0.0005 TLR (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 27

Target Lesion Revascularization (lesion) TLR (%) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 28

Target Lesion Revascularization (lesion) Adjusted RR (95% CI) = 2.39 (1.82 – 3.13) P<0.0001 TLR (%) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 29

In-segment Restenosis (patient) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 30

In-segment Restenosis (patient) Adjusted RR (95% CI) = 2.25 (1.33 – 3.81), p=0.003 In-segment restenosis (%) Endeavor Cypher Cypher (n) 3840 3232 2479 1542 555 103 Endeavor (n) 2282 1725 967 456 92 0 31

In-segment Restenosis (lesion) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 32

In-segment Restenosis (lesion) Adjusted RR (95% CI) = 2.44 (1.76 – 3.37) P<0.0001 In-segment restenosis (%) Endeavor Cypher Cypher (n) 5095 4320 3347 2081 751 143 Endeavor (n) 3090 2338 1339 637 122 0 33

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