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Comparison of the Major Clinical Outcomes for the Use of Endeavor® and Resolute Integrity® Zotarolimus-Eluting Stents During a Three-Year Follow-up Cover

Comparison of the Major Clinical Outcomes for the Use of Endeavor® and Resolute Integrity® Zotarolimus-Eluting Stents During a Three-Year Follow-up

Open Access
|Feb 2020

Figures & Tables

Figure 1

Flow chart.

Table 1

Baseline angiographic characteristics and post-PCI medications.

VariablesTotal study populationPropensity-matched patients
E-ZES (n = 272)I-ZES (n = 495)pE-ZES (n = 193)I-ZES (n = 193)p
Men, n (%)192 (70.6)346 (69.9)0.842136 (70.5)134 (69.4)0.824
Age (years)62.7 ± 10.564.0 ± 11.20.13163.2 ± 10.863.1 ± 11.70.882
LVEF (%)51.0 ± 10.855.1 ± 8.6<0.00153.2 ± 9.854.1 ± 10.10.390
Stable angina, n (%)60 (22.1)133 (26.9)0.14245 (23.3)58 (30.1)0.135
Unstable angina, n (%)101 (37.1)168 (33.9)0.37579 (40.9)63 (32.6)0.091
ST segment elevation MI, n (%)51 (18.8)56 (11.3)0.00430 (15.5)32 (16.6)0.782
Non-ST segment elevation MI, n (%)38 (14.0)103 (20.8)0.01925 (13.0)29 (15.0)0.557
Hypertension, n (%)161 (66.5)326 (65.9)0.848128 (66.3)133 (68.9)0.587
Diabetes mellitus, n (%)78 (28.7)188 (38.0)0.01055 (28.5)67 (34.7)0.189
Dyslipidemia, n (%)111 (40.8)92 (18.6)<0.00159 (30.6)60 (31.1)0.912
Previous cerebrovascular accidents, n (%)12 (4.4)36 (7.3)0.11810 (5.2)12 (6.2)0.827
Previous MI, n (%)1 (0.4)1 (0.2)0.6671 (0.5)0 (0.0)0.317
Previous PCI, n (%)9 (3.3)0 (0.0)<0.0010 (0.0)0 (0.0)
Peripheral vascular disease, n (%)6 (2.2)25 (5.1)0.0563 (1.6)4 (2.1)0.703
Chronic kidney disease, n (%)9 (3.3)34 (6.9)0.0408 (4.1)8 (4.1)1.000
Routine angiographic follow-up190 (69.9)176 (35.6)<0.001116 (60.1)111 (57.5)0.605
CK-MB (mg/dL), initial31.8 ± 89.031.5 ± 80.00.96928.6 ± 87.542.7 ± 100.50.159
Troponin T (ng/dL), initial0.43 ± 1.410.55 ± 1.690.4000.40 ± 1.480.74 ± 2.170.130
High sensitivity CRP (mg/dL)10.9 ± 23.17.7 ± 11.10.0157.2 ± 15.39.3 ± 14.80.185
Total cholesterol (mg/L)169.5 ± 37.9171.7 ± 45.80.529168.0 ± 36.5169.4 ± 47.00.747
Triglyceride (mg/L)136.9 ± 75.5147.9 ± 125.00.307130.2 ± 68.5144.6 ± 95.00.168
HDL cholesterol (mg/L)45.6 ± 12.244.2 ± 11.00.19046.1 ± 12.443.8 ± 11.10.126
LDL cholesterol (mg/L)111.5 ± 34.2108.3 ± 38.00.391110.8 ± 34.2106.9 ± 39.80.408
Serum creatinine (mg/L)0.97 ± 0.561.06 ± 1.360.3210.99 ± 0.650.99 ± 1.350.992
Serum glucose (mg/dL)117.5 ± 43.2124.6 ± 52.90.073116.4 ± 45.0122.2 ± 46.60.245
Hemoglobin A1C (%)6.4 ± 1.36.6 ± 1.30.1086.4 ± 1.36.5 ± 1.30.462
Angiographic characteristics
Targeted vessel
    Left anterior descending, n (%)155 (57.0)310 (62.6)0.126111 (57.5)113 (58.5)0.837
    Left circumflex, n (%)63 (23.2)181 (36.6)<0.00146 (23.8)53(27.5)0.415
    Right coronary artery, n (%)111 (40.8)172 (34.7)0.09676 (39.4)74 (38.3)0.835
    Left main, n (%)9 (3.3)14 (2.8)0.7096 (3.1)6 (3.1)1.000
    Ramus, n (%)2 (0.7)8 (1.6)0.3041 (0.5)3 (1.6)0.623
    Multi-vessel disease (≥2 vessels)60 (22.1)156 (31.5)0.00542 (21.8)48 (24.9)0.470
ACC/AHA Lesion type
    Type B1, n (%)16 (5.9)30 (6.1)0.92112 (6.2)8 (4.1)0.492
    Type B2, n (%)46 (16.9)124 (25.1)0.00932 (16.6)45 (23.3)0.098
    Type C, n (%)210 (77.2)340 (68.7)0.012149 (77.2)139 (72.0)0.242
Extent of coronary artery disease, n (%)
    1-vessel212 (77.9)337 (68.1)0.004151 (78.2)143 (74.1)0.339
    2-vessel52 (19.1)123 (24.8)0.07037 (19.2)43 (22.3)0.451
    3-vessel8 (2.9)35 (7.1)0.0175 (2.6)7 (3.6)0.771
Treated CTO11 (4.0)37 (7.5)0.0616 (3.1)14 (7.3)0.106
Ostial lesion (≤5mm), n (%)54 (19.9)100 (20.2)0.98935 (18.1)40 (20.7)0.520
Diffuse long lesion (>30mm), n (%)123 (45.2)211 (42.6)0.48883 (43.5)87 (45.1)0.759
Small vessel disease (≤2.25), n (%)15 (5.5)77 (15.6)<0.00113 (6.7)19 (9.8)0.356
Bifurcation, n (%)83 (30.5)171 (34.5)0.25660 (31.1)65 (33.7)0.587
Heavy Calcification36 (13.2)80 (16.2)0.27926 (13.5)30 (15.5)0.563
Mean total stent length (mm)23.7 ± 5.822.2 ± 6.60.00323.3 ± 5.723.7 ± 7.10.532
Mean stent diameter (mm)3.09 ± 0.452.98 ± 0.460.0023.08 ± 0.453.06 ± 0.470.639
Number of stents/patient1.31 ± 0.581.74 ± 1.05<0.0011.40 ± 0.721.48 ± 0.720.235
Total procedure time (minutes)38.5 ± 29.544.7 ± 29.50.00536.9 ± 25.441.8 ± 27.00.070
Post-PCI medications
Aspirin, n (%)253 (93.0)461 (93.1)0.951182 (94.3)180 (93.3)0.673
Clopidogrel, n (%)249 (91.5)447 (90.3)0.570182 (94.3)177 (91.7)0.318
Cilostazol, n (%)59 (21.7)91 (18.4)0.26945 (23.3)37 (19.2)0.384
Beta blockers, n (%)146 (53.7)234 (47.3)0.090102 (52.8)99 (51.3)0.760
Calcium channel blockers, n (%)96 (35.3)187 (37.8)0.49563 (32.6)70 (36.3)0.453
ACEIs, n (%)97 (35.7)136 (27.5)0.01868 (35.2)65 (33.7)0.748
ARBs, n (%)107 (39.3)203 (41.0)0.65277 (39.9)76 (39.4)0.917
Diuretics, n (%)70 (25.7)90 (18.2)0.01445 (23.3)44 (22.8)0.904
Lipid lowering agents, n (%)233 (85.7)435 (87.9)0.381171 (88.6)173 (89.6)0.744

[i] Values are mean ± SD or n (%). The p values for continuous data obtained from analysis of variance. The p values for categorical data obtained from chi-square test.

E, Endeavor®; I, Resolute Integrity®; ZES, zotarolimus-eluting stent; LVEF, left ventricular ejection fraction; MI, myocardial infarction; CK-MB, creatine kinase myocardial band; CRP, C-reactive protein; HDL, high-density lipoprotein; LDL, low-density lipoprotein; ACC/AHA, American college of cardiology/American heart association; CTO, chronic total occlusive lesion. PCI, percutaneous coronary intervention; ACEIs, angiotensin converting enzyme inhibitors; ARBs, angiotensin receptor blockers.

Table 2

Clinical outcomes at 30 days, 1 year, and 3 years.

OutcomesTotal study populationPropensity-matched patients
Total (n = 767)E-ZES (n = 272)I-ZES (n = 495)pE-ZES (n = 193)I-ZES (n = 193)p
30 days
   MACEs11 (1.4)4 (1.5)7 (1.4)0.9504 (2.1)1 (0.5)0.177
    All-cause death, n (%)7 (0.9)2 (0.7)5 (1.0)0.7022 (1.0)0 (0.0)0.156
      Cardiac death, n (%)6 (0.8)2 (0.7)4 (0.8)0.9132 (1.0)0 (0.0)0.156
    Non-fatal MI, n (%)6 (0.8)3 (1.1)3 (0.6)0.6723 (1.6)1 (0.5)0.623
    Any revascularization, n (%)6 (0.8)2 (0.7)4 (0.8)0.9132 (1.0)1 (0.5)0.562
      TLR, n (%)5 (0.7)2 (0.7)3 (0.6)0.8322 (1.0)1 (0.5)0.562
      TVR, n (%)6 (0.8)2 (0.7)4 (0.8)0.9132 (1.0)1 (0.5)0.562
      Non-TVR, n (%)1 (0.1)1 (0.4)0 (0.0)0.3551 (0.5)0 (0.0)0.317
    ST (definite or probable), n (%)
      Acute, n (%)2 (0.3)1 (0.4)1 (0.2)0.6671 (0.5)1 (0.5)1.000
      Subacute, n (%)4 (0.5)2 (0.7)2 (0.4)0.5422 (1.0)1 (0.5)0.562
      Total, n (%)6 (0.8)3 (1.1)3 (0.6)0.6723 (1.6)2 (1.0)0.653
1-year
  MACEs, n (%)61 (8.0)29 (10.7)32 (6.5)0.04013 (6.7)13 (6.7)1.000
    All-cause death, n (%)22 (2.9)10 (3.7)12 (2.4)0.3208 (4.1)7 (3.6)0.792
      Cardiac death, n (%)16 (2.1)7 (2.6)9 (1.8)0.5985 (2.6)5 (2.6)1.000
    Non-fatal MI, n (%)9 (1.2)5 (1.8)4 (0.8)0.2924 (2.1)1 (0.5)0.177
    Any revascularization, n (%)45 (5.9)21 (7.7)24 (4.8)0.1057 (3.6)8 (4.1)0.792
      TLR, n (%)30 (3.9)17 (6.3)13 (2.6)0.0136 (3.1)5 (2.6)0.760
      TVR, n (%)38 (5.0)20 (7.4)18 (3.6)0.0237 (3.6)7 (3.6)1.000
      Non-TVR, n (%)9 (1.2)5 (1.8)4 (0.8)0.2922 (1.0)0 (0.0)0.156
  ST (definite or probable), n (%)
      Late (31–365 days)1 (0.1)1 (0.4)0 (0.0)0.1771 (0.5)0 (0.0)0.317
      Total (1–365 days)7 (0.9)4 (1.5)3 (0.6)0.2534 (2.1)2 (1.0)0.685
3-year
  MACEs, n (%)90 (11.7)42 (15.4)48 (9.7)0.01825 (13.0)20 (10.4)0.428
    All-cause death, n (%)31 (1.0)17 (6.3)14 (2.8)0.02115 (7.8)7 (3.6)0.079
      Cardiac death, n (%)19 (2.5)10 (3.7)9 (1.8)0.1138 (4.1)5 (2.6)0.574
    Non-fatal MI, n (%)20 (2.6)11 (4.0)9 (1.8)0.09510 (5.2)4 (2.1)0.172
    Any revascularization, n (%)59 (7.7)25 (9.2)34 (6.9)0.24810 (5.2)12 (6.2)0.661
      TLR, n (%)38 (5.0)19 (7.0)19 (3.8)0.0557 (3.6)7 (3.6)1.000
      TVR, n (%)54 (7.0)24 (8.8)30 (6.1)0.15210 (5.2)12 (6.2)0.661
      Non-TVR, n (%)11 (1.4)5 (1.8)6 (1.2)0.5322 (1.0)1 (0.5)0.562
  ST (definite or probable), n (%)
      Very late (366–1095 days)1 (0.1)1 (0.4)0 (0.0)0.1771 (0.5)0 (0.0)0.317
      Total (1–1095 days)8 (1.0)5 (1.8)3 (0.6)0.1405 (2.6)2 (1.0)0.449

[i] Values are numbers and percentages. The p values for categorical data obtained from chi-square test.

E, Endeavor®; I, Resolute Integrity®; ZES, zotarolimus-eluting stent; MACEs, major adverse cardiac events; MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization.

Figure 2

Kaplan-Meier curved analysis for MACE-free survival (A, B), and stent thrombosis (C, D) at 3 years.

Table 3

Three-Year Clinical Outcomes by Kaplan–Meier Curved Analysis and Cox-proportional Hazard Ratio Model Analysis.

OutcomesCumulative Events at 3 years (%)Hazard Ratio (95% CI)p
E-ZESI-ZESLog Rank
Total study population
  MACEs42 (15.6)48 (10.5)0.0360.644 (0.425–0.975)0.038
    All-cause death17 (6.2)14 (2.9)0.0340.474 (0.233–0.962)0.039
      Cardiac death10 (3.7)9 (1.8)0.1370.511 (0.207–1.259)0.144
    Non-fatal MI11 (4.1)9 (2.1)0.1100.494 (0.204–1.195)0.118
    Any revascularization25 (9.5)34 (7.4)0.2840.755 (0.450–1.266)0.286
      TLR19 (7.1)19 (4.2)0.0650.554 (0.293–1.048)0.069
      TVR24 (9.0)30 (6.7)0.2040.707 (0.413–1.211)0.207
      Non-TVR5 (1.9)6 (1.3)0.4950.663 (0.202–2.174)0.498
      Stent thrombosis5 (1.8)3 (0.6)0.1080.328 (0.078–1.373)0.127
Propensity-matched patients
   MACEs25 (13.1)20 (11.0)0.5530.837 (0.464–1.508)0.553
    All-cause death15 (7.8)7 (3.6)0.1040.482 (0.196–1.183)0.111
      Cardiac death8 (4.2)5 (2.6)0.4320.641 (0.210–1.961)0.436
    Non-fatal MI10 (5.3)4 (2.3)0.1400.428 (0.134–1.367)0.152
    Any revascularization10 (5.4)12 (6.5)0.6221.235 (0.533–2.862)0.623
      TLR7 (3.7)7 (3.9)0.9911.006 (0.353–2.869)0.991
      TVR10 (5.3)12 (6.6)0.5981.253 (0.541–2.904)0.599
      Non-TVR2 (1.1)1 (0.6)0.5780.512 (0.046–5.653)0.585
    Stent thrombosis5 (2.6)2 (1.0)0.2540.398 (0.077–2.052)0.271
Multivariate analysis*
  MACEs42 (15.6)48 (10.5)0.0360.943 (0.559–1.563)0.820
    All-cause death17 (6.2)14 (2.9)0.0340.433 (0.175–1.070)0.070
      Cardiac death10 (3.7)9 (1.8)0.1370.597 (0.191–1.863)0.374
    Non-fatal MI11 (4.1)9 (2.1)0.1100.481 (0.164–1.408)0.182
    Any revascularization25 (9.5)34 (7.4)0.2841.374 (0.721–2.614)0.334
      TLR19 (7.1)19 (4.2)0.0651.138 (0.515–2.512)0.749
      TVR24 (9.0)30 (6.7)0.2041.322 (0.677–2.584)0.414
      Non-TVR2 (1.1)1 (0.6)0.5780.697 (0.163–2.984)0.627
    Stent thrombosis5 (2.6)2 (1.0)0.2540.536 (0.103–2.788)0.459

[i] * Adjusted by age, men, LVEF, STEMI, NSTEMI, diabetes, dyslipidemia, previous history of PCI, CKD, routine angiographic follow-up, serum level of hs-CRP, LCx (targeted vessel), multi-vessel disease, ACC/AHA type B2/C lesion, 1-vessel disease, 3-vessel disease, small vessel disease, mean total stent length, mean stent diameter, number of stents/patient, total procedure time, ACEIs, diuretics.

E, Endeavor®; I, Resolute Integrity®; ZES, zotarolimus-eluting stent; CI, confidence interval; MACEs, major adverse cardiac events; MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization; CKD, chronic kidney disease; hs-CRP, high-sensitivity C-reactive protein; LCx, left circumflex artery; ACC/AHA, American College of Cardiology/American Heart Association; PCI, percutaneous coronary intervention; ACEIs, angiotensin converting enzyme inhibitors.

Table 4

Outcome incidence rates according to time to event.

MACEsAll-cause deathCardiac deathNon-fatal MIAny revascularizationTLRTVRNon-TVRStent thrombosis
E-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZESE-ZESI-ZES
Total study population (n = 767)
E-ZES (n = 272),
I-ZES (n = 495)
Number of events, n (%)424817141091192534191924305653
Number of events/patients0.150.100.060.030.040.020.040.020.090.070.070.040.090.060.020.0010.020.01
Time to event (days), n (%)
1–73 (7)3 (6)1 (6)2 (14)1 (10)2 (22)2 (18)1 (11)2 (8)02 (11)02 (8)01 (20)03 (60)1 (33)
8–301 (2)4 (8)1 (6)3 (21)1 (10)2 (22)1 (9)2 (22)04 (12)03 (16)04 (13)0002 (67)
31–1809 (21)11 (23)4 (24)4 (29)3 (30)2 (22)2 (18)1 (11)7 (28)8 (24)5 (26)5 (26)7 (29)7 (23)01 (17)1 (20)0
181–36516 (38)14 (29)4 (24)3 (21)2 (20)3 (33)0012 (48)12 (35)10 (53)5 (26)11 (46)7 (23)4 (80)3 (50)00
366–5485 (12)5 (10)3 (18)1 (7)1 (10)02 (18)2 (22)2 (8)3 (9)2 (11)2 (11)2 (8)3 (10)001 (20)0
549–7303 (7)7 (15)1 (6)1 (7)001 (9)1 (11)05 (15)02 (11)05 (17)02 (33)00
731–9133 (7)2 (4)2 (12)02 (20)03 (27)2 (22)1 (4)1 (3)01 (5)1 (4)3 (10)0000
914–10952 (5)2 (4)0000001 (4)1 (3)01 (5)1 (4)1 (3)0000
Propensity-matched patients (n = 386)
E-ZES (n = 193),
I-ZES (n = 193)
Number of events, n (%)25201578510410127710122152
Number of events/patients0.130.100.080.040.040.030.050.020.050.060.040.040.050.060.010.010.030.01
Time to event (days), n (%)
1–73 (12)01 (7)01 (13)02 (20)02 (20)02 (29)02 (20)01 (50)03 (60)1 (33)
8–301 (4)1 (5)1 (7)01 (13)01 (10)1 (25)01 (8)01 (16)01 (8)0001 (67)
31–1805 (20)7 (35)4 (27)4 (57)3 (38)2 (40)1 (10)03 (30)4 (33)2 (29)1 (26)3 (30)3 (25)001 (20)0
181–3654 (16)5 (25)2 (13)3 (43)03 (60)002 (20)3 (25)2 (29)3 (26)2 (20)3 (25)1 (50)000
366–5484 (16)3 (15)2 (13)01 (13)02 (20)1 (25)1 (10)2 (17)1 (14)1 (11)1 (10)2 (17)001 (20)0
549–7303 (12)3 (15)2 (13)0001 (10)1 (25)02 (17)0002 (17)01 (100)00
731–9133 (12)02 (13)02 (25)03 (30)1 (25)1 (10)001 (5)1 (10)1 (8)0000
914–10952 (8)1 (5)1 (7)000001 (10)0001 (10)0000

[i] E, Endeavor®; I, Resolute Integrity®; ZES, zotarolimus-eluting stent; MACEs, major adverse cardiac events; MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization.

Figure 3

Subgroup analyses for MACEs.

DOI: https://doi.org/10.5334/gh.374 | Journal eISSN: 2211-8179
Language: English
Submitted on: Dec 20, 2019
Accepted on: Dec 20, 2019
Published on: Feb 6, 2020
Published by: Ubiquity Press
In partnership with: Paradigm Publishing Services
Publication frequency: 1 issue per year

© 2020 Yong Hoon Kim, Ae-Young Her, Seung-Woon Rha, Byoung Geol Choi, Se Yeon Choi, Jae Kyeong Byun, Yoonjee Park, Dong Oh Kang, Won Young Jang, Woohyeun Kim, Cheol Ung Choi, Chang Gyu Park, Hong Seog Seo, published by Ubiquity Press
This work is licensed under the Creative Commons Attribution 4.0 License.