1. The document compares clinical outcomes of Indian and imported drug-eluting stents (DES) implanted in over 5,000 patients in India. 2. One-year data from an ongoing registry shows no significant differences in rates of death, stent thrombosis or revascularization between the two groups after adjusting for variables through propensity score matching. 3. Specifically, Indian DES had a combined endpoint rate of 4.5% versus 4.12% for imported DES (p=0.630), suggesting Indian stents perform comparably to imported ones in real-world use in India.

1. Real World Clinical Performance of Indian
Stents Vs Imported Stents
Dr B K S Sastry
Hyderabad

2. Background
On 13th February 2017, National
Pharmaceutical and Pricing Authority had
notified the upper price ceiling of the coronary
stents and equated all coronary drug eluting
stents (DES) both Imported as well as
Indigenously manufactured Indian stents.
• How can it be done??

3. Background
• Multiple, multi center and multi national RCTs
support the Imported DES.
• Limited Registry data support Biomime and
Yukon Choice stents
• No such data for other Indian DES

4. Different Indian DES
Stent
Brand
Platform Drug Polymer Manufacturer Appr
oved
by
Abluminus Cobalt
Chromium
73 Microns
Sirolimus Biodegradable Envision CE
Biomime Cobalt
Chromium
65 Microns
Sirolimus Biodegradable Meril CE
Premier Cobalt
Chromium
Sirolimus Biodegradable Relisys DCGI
Pristine Cobalt
Chromium
Everolimus Biodegradable Relisys DCGI
Release R Cobalt
Chromium
62 microns
Sirolimus Biodegradable Relisys DCGI
Yukon
Choice
Cobalt
Chromium
Sirolimus Biodegradable Translumina CE

5. Different Imported DESStent Brand Platform Polymer Drug Manufacturer Approved
by
Biomatrix SS 112 Bioabsorbable Biolimus Biosensors CE
Endeavour
Sprint
CC <100 Biodurable Zotarolimus Medtronic FDA
Endeavour
Resolute
CC 91 mic Biodurable Zotarolimus Medtronic FDA
Onyx Resolute CC 81 mic Biodurable Zotarolimus Medtronic FDA
Promus
Element
Pl C 81 mic Biodurable Everolimus Boston
Scientific
FDA
Promus
Premier
Pl C 81 mic Biodurable Everolimus Boston
Scientific
CE
Synergy
Pl C 74 mic Bioabsorbable Everolimus Boston
Scientific
CE
Xience V
CC 81 mic Biodurable Everolimus Abbott FDA
Xience Prime
CC 81 mic Biodurable Everolimus Abbott FDA
Xience
Xpedition
CC 81 mic Biodurable Everolimus Abbott FDA

6. Registry
• Ongoing registry maintained in CARE
Hospitals, Hyderabad since 2013.
• Approved by Institutional Ethics Committee.
• All Comer registry for all coronary
interventions.
• Patients enrolled after signing Informed
consent.
• Follow up data for one year is presented.

7. Objective
To compare one year Adverse Clinical
outcomes including All Cause Death, Stent
thrombosis and Target Vessel Revascularization
between different stents.

8. Bias and Confounding Variables
 Observational Study in 2 centers but more than 20
Cardiologists.
 Stent selection based on patient’s affordability and
physician discretion.
 In general, Indian Stents were implanted in
Patients with low affordability
Very Sick patients with ACS or STEMI, with
borderline affordability. “Stop Loss”

9. Methods
 Collected information included
 Demographics
 Details of the Intervention procedure
 In hospital course
 Post Discharge Follow up.
 Follow up during review visit or by telephone
 For the purpose of Analysis we had excluded patients
who received Taxus, BVS and combination of different
stents.

10. End Points
 Deaths : Not Adjudicated.
Scanty Details for some patients
All Deaths except one due to were counted as cardiac
 SAT: Only patients who presented with
angiographic evidence were counted
as SAT.
Some of the out of the hospital deaths
could have been due to SAT
 TVF: All Target vessel revascualrizations
Irrespective of stent status were counted TVF

11. Basic Data
Total Patients 5436
Patients with DES 3545
Imported DES 1561
Missing patients 22
Available patients 1539
Percentage Follow up 98.5%
Indian DES 1875
Missing patients 19
Available patients 1856
Percentage Follow up[ 99%

12. Total Patients
Patients with DES
Patients with
Taxus, Absorb and
Different brands
Indian Stents Imported Stents
Missing patients
After propensity score
matching
5436
3545
Total followed patients
109
1875 1561
19 22
15391856
1310
Numerical Distribution of patients

13. Patients’ Baseline Characteristics
Parameter Imported Stents (1539) Indian Stents
(1856)
p Value
Mean Age 57.91 55.56 <0.001
Gender F: M 293:1246 (19%) 421:1435 (22.6) <0.05
LVEF Mean EF 55.45% 53.86 <0.001
Primary 313 (20.3%) 498 (26.8%) <0.001
ACS 873 (56.8%) 1229 (66%) <0.001
Stable Angina 246 (16%) 203 (11%) <0.001
Diabetes 717 (46.6%) 778 (41.7%) <0.01
Hypertension 881 (57.2%) 1049 (56.5%) NS
Tobacco 203 (13.1%) 373 (20%) <0.001
1 vessel disease 769 (50%) 992 (53.4%) <0.05
2 vessel disease 524 (34%) 651 (35%) NS
3 vessel disease 246 (16%) 213 (11.5%) <0.001
LAD 841 (54.6%) 991 (53.3%) NS
Circ. Support 145 (9.4%) 175 (9.4%) NS
Resp. Support 47 (3.0%) 65 (3.5%) NS
Dialysis Support 18 (1.1%) 22 (1.1%) NS

14. Proportion of Different Indian Stents
Stent Brand Number Percentage
ABLUMINUS 89 4.8%
BIOMIME 91 4.9%
PREMIER 8 0.4%
PRISTINE 24 1.2%
RELEASE R 1419 80%
YUKON CHOICE 225 12%

15. Distribution of Indian Stents Before
matching
1419
225
91
89
24 8
Release R (76%)
Yukon Choice (12%)
Biomime (4.9%)
Abluminus (4.8%)
Pristine (1.2%)
Premier (0.4%)

16. Proportion of Different Imported Stents before
matching
Stent Type Number Percentage
BIOMATRIX 135 8.7%
Endeavour family 115 7.4%
ENDEAVOR RESOLUTE 81
ENDEAVOR SPRINT 33
ONYX RESOLUTE 1
Promus family 1034 67%
PROMUS ELEMENT 946
PROMUS PREMIER 55
SYNERGY 33
Xience family 255 16.5%
XIENCE PRIME 112
XIENCE V 6
XIENCE XPEDITION 137

17. Distribution of Imported Stents
before Matching
135
115
1034
255
Biomatrix (8.7%)
Endeavour family (7.4%)
Promus family (67%)
Xience family (16.5%)

18. End Points for Individual Indian Stents
Stent Brand
No. of
Events
Event
rate (%)
In
hospital
Death
Post
discharge
death
SAT* TVR
ABLUMINUS (89) 2 2.24% 1 1
BIOMIME (91) 5 5.49% 4 1 1
PREMIER (8) 0 -
PRISTINE (24) 0 -
RELEASE R (1419) 68 4.79% 32 22 11 9
YUKON CHOICE (225) 8 3.55% 2 5 1
Total 83 4.47% 39 28 13 10

19. Stent Type
No. of
Events
Event
Rate (%)
In Hospital
Death
Post discharge
Death SAT* TVR
BIOMATRIX (135) 5 3.70% 3 2 1
Endeavour family 115 6 5.21%
ENDEAVOR RESOLUTE (41) 3 7.31% 2 1
ENDEAVOR SPRINT (73) 3 4.10% 1 2
ONYX RESOLUTE (1) - -
Promus family 1034 38 3.67%
PROMUS ELEMENT (946) 34 3.59% 8 11 8 10
PROMUS PREMIER (55) 3 5.45% 3
SYNERGY (33) 1 3.03% 1
Xience family 225 8 3.13%
XIENCE PRIME (112) 2 1.78% 1 1
XIENCE V (6) - -
XIENCE XPEDITION (137) 6 4.37% 5 1
Total 57 3.7% 17 20 11 13
Individual End points for Imported Stents Before Matching

20. Combined End Point as Percentage
Indian Stents Before Matching
Abluminus Biomime Release R
Yukon
Choice
Premier Prestine
Events 2.4 5.49 4.79 3.5 0 0
89
225
0 0
0
1
2
3
4
5
6
Eventsaspercentage
1419
24
91
8

21. Combined end point for Different
Stents Before Matching
2.40%
5.49%
4.79%
3.50%
3.70%
5.21%
3.67%
3.13%
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%

22. Individual End Points with Indian Vs
Imported Stents before Matching
Total
MACE
In Hospital
Death
Post
Discharge
Death
SAT TVR
Imported Stents 57 17 20 11 13
Indian Stents 83 39 28 13 10
3.7%
1.1% 1.3%
0.7%
0.8%
4.4%
2.1%
1.5%
0.7%
0.5%
0
10
20
30
40
50
60
70
80
90
NumberofEvents
*
* P <0.05

23. Covariates Used for Propensity Score
Matching
• Age, Gender.
• Primary or Elective,
• ACS or Stable CAD
• Diabetes, Hypertension, Tobacco usage
• Number of vessels diseased.
• LAD or other vessel.
• LV function.
• Need for Respiratory or Circulatory or renal
Support.

24. Density Plots of Propensity Score before and After Matching
method = "nearest", distance = "logit", caliper = 0.01
Software R

25. After Propensity Score Matching
Parameter Imported Stents
(1310)
Indian Stents
(1310)
p Value
Mean Age 57 56.9 0.664
Gender F: M 282:1028 (21.5%) 271:1039 (20.7%) 0.632
LVEF Mean EF 55% 55 0.802
Primary 294 (22.4%) 270 (20.6%) 0.274
ACS 800 (61.1%) 798 (60.9%) 0.968
Stable Angina 170 (13.3%) 166 (12.7%) 0.861
Diabetes 600 (45.8%) 577 (44%) 0.388
Hypertension 750 (57.3%) 749 (57.2%) 1.0
Tobacco 196 (15%) 198 (15.1%) 0.956
1 vessel disease 682 (52.1%) 664 (50.7%) 0.506
2 vessel disease 452 (34.5%) 479 (36.6%) 0.289
3 vessel disease 176 (13.4%) 167 (12.7%) 0.643
LAD 718 (54.8%) 708 (50.4%) 0.724
Circ. Support 129 (9.85%) 126 (9.62%) 0.895
Resp. Support 44 (3.36%) 39 (2.98%) 0.655
Dialysis Support 18 (1.37%) 13 (0.99%) 0.470

26. Post Matching Analysis
• No of Matched Indian Stents 1310 of 1856
• No of matched Imported Stents 1310 of 1539
• No of Events from Indian Stents 59
• No. of Events from Imported Stents `54
P Value 0.630 using McNamar test

27. Distribution of Indian Stents Post
Matching
Stent Brand Number Percentage
Abluminus 64 4.8
Biomime 63 4.8
Premier 6 0.4
Pristine 15 1.1
Release R 987 75.3
Yukon Choice 175 13.3

28. Distribution of Indian Stents After
Matching
64
63
6 15
987
175
Abluminus (4.8%)
Biomime (4.8%)
Premier (0.4%)
Pristine (1.1%)
Release R (75.3%)
Yukon Choice (13.3%)

29. Distribution of Imported Stents Post Matching
Stent Type Number Percentage
BIOMATRIX 109 109 8.3%
Endeavour family 99 7.5%
ENDEAVOR RESOLUTE 32
ENDEAVOR SPRINT 66
ONYX RESOLUTE 1
Promus family 884 67.4%
PROMUS ELEMENT 806
PROMUS PREMIER 47
SYNERGY 31
Xience family 218 16.6%
XIENCE PRIME 94
XIENCE V 6
XIENCE XPEDITION 118

30. Distribution of Stents after Matching
109
99
884
218
Sales
Biomatrix (8.3%)
Endeavour Family(7.5%)
Promus Family (67.4%)
Xience Family (16.6%)

31. Stent Brand
No. of
Events
Event
rate
(%)
In
hospital
Death
Post
discharge
death
SAT* TVR
ABLUMINUS (64) 1 1.5% 1
BIOMIME (63) 3 5.0% 2 1 1
PREMIER (6) 0 -
PRISTINE (15) 0 -
RELEASE R (987) 50 5.06% 25 15 10 5
YUKON CHOICE (175) 5 2.9% 4 1
Total 59 4.5% 27 20 12 6
Individual End Points After Matching in Indian Stents

32. Combined End Point as Percentage
Indian Stents After Matching
Abluminus Biomime Release R
Yukon
Choice
Premier Prestine
Events 1.50% 5.00% 5.06% 2.90% 0 0
64
63 987
175
6 15
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%

33. Individual End points for Imported Stents After matching
Stent Type
No. of
Events
Event
Rate (%)
In Hospital
Death
Post discharge
Death SAT* TVR
BIOMATRIX (109) 5 4.58% 3 2 1
Endeavour family 99 6 6.06%
ENDEAVOR RESOLUTE (32) 3 7.31% 2 1
ENDEAVOR SPRINT (66) 3 4.10% 1 2
ONYX RESOLUTE (1) - -
Promus family 884 36 4.07%
PROMUS ELEMENT (806) 34 3.59% 8 8 8 9
PROMUS PREMIER (41) 3 5.45% 3
SYNERGY (31) 1- 3.03% 1
Xience family 218 7 3.21%
XIENCE PRIME (94) 2 1.78% 1 1
XIENCE V (6) - -
XIENCE XPEDITION (118) 5 4.37% 4 1
Total 54 4.12% 16 17 11 12

34. Combined end point for Different
Stents after Matching
1.50%
5.00% 5.06%
2.90%
4.58%
6.06%
4.07% 3.21%
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%
7.00%

35. Individual End Points with Indian Vs
Imported Stents After Matching
Total
MACE
In Hospital
Deaths
Post
Discharge
Deaths
SAT TVR
Imported Stents 54 16 17 11 12
Indian Stents 59 27 20 12 6
3.8%
1.2% 0.85%
0.83 0.91%
4.5%
2.6%
1.5%
0.91%
0.45%
0
10
20
30
40
50
60
70
NumberofEvents

36. Indian Stents
1856
Imported
Stents
1539
Odds ratio P Value Lower CI Upper CI
Total Events 83 57 1.21 0.263 0.862 1.717
Total Deaths 67 37 1.52 0.043 1.011 2.284
In Hospital
Deaths
39 17 1.92 0.02 1.082 3.410
Post
Discharge
Deaths
28 20 1.16 0.60 0.652 2.073
Total SAT 13 11 0.979 0.960 0.437 2.193
SAT and
Survived
6 9 0.55 0.259 0.195 1.552
SAT and Died 7 2 2.909 0.183 0.603 14.02
TVR 10 13 0.635 0.283 0.278 1.454
Comparison of 1 year Outcomes before matching

37. Indian Stents
1310
Imported
Stents
1310
Odds ratio P Value Lower CI Upper CI
Total Events 59 54 1.097 0.630 0.752 1.599
Total Deaths 47 33 1.44 0.113 0.916 2.262
In Hospital
Deaths
27 16 1.702 0.94 0.912 3.173
Post
Discharge
Deaths
20 17 1.178 0.619 0.614 2.261
Total SAT 12 11 1.091 0.834 0.480 2.482
SAT and
Survived
6 9 0.665 0.440 0.236 1.874
SAT and Died 6 2 3.009 0.1777 0.606 14.93
TVR 6 12 0.497 0.164 0.186 1.330
Comparison of one year events after matching

38. Comparison of one year events after matching

39. Indian
Stents
1653
Imported
Stents
1293
Odds
Ratio
P Value Lower CI Upper CI
Total Events 79
/1574
53 / 1240 1.174 0.376 0.822 1.676
Total Deaths 65 /
1588
32 /1261 1.613 0.029 1.0496 2.478
In hospital
deaths
38 /
1615
15 / 1278 2.004 0.023 1.097 3.660
Post
discharge
Deaths
27 /
1626
17 / 1276 1.246 0.480 0.676 2.296
SAT 12 /
1641
11 / 1282 0.852 0.702 0.374 1.937
TVR 8 /
1645
12 / 1281 0.519 0.152 0.211 1.273
Events in patients with ACS before matching

40. Indian
Stents
1144
Imported
Stents
1140
Odds
Ratio
P Value Lower CI Upper CI
Total Events 55 54 1.101 0.936 0.691 1.492
Total Deaths 46 31 1.498 0.086 0.943 2.381
In hospital
deaths
26 15 1.744 0.088 0.918 3.310
Post
discharge
Deaths
20 16 1.250 0.509 0.6444 2.424
SAT 11 11 0.996 0.993 0.430 2.307
TVR 4 12 0.329 0.0554 0.1061 1.025
One year Events in Patients with ACS after Matching

41. One year Events in Patients with ACS after Matching

42. Indian
Stents
203
Imported
Stents
246
Odds
ratio
P
Value
Lower CI Upper CI
Total Events 4 / 199 4 / 242 1.216 0.784 0.300 4.924
Total Deaths 1 / 202 3 / 243 0.401 0.430 0.414 3.884
In hospital
deaths
1 / 202 2 / 244 0.604 0.681 0.0544 6.709
Post
discharge
Deaths
0 / 203 1 /245
SAT 1 / 202 0 / 246
TVR 2 /201 1 / 245 2.437 0.468 0.219 27.08
Events in Stable patients before matching

43. Indian
Stents
166
Imported
Stents
170
Odds
ratio
P
Value
Lower CI Upper CI
Total Events 4 2 2.074 0.403 0.374 11.479
Total Deaths 1 2 0.509 0.593 0.045 5.668
In hospital
deaths
1 1 1.024 0.986 0.0635 16.51
Post
discharge
Deaths
0 1
SAT 1 0
TVR 2 0
Events in Stable patients After matching

44. Sub Group Analysis of End Points After Matching

45. Sub Group Analysis of End Points after matching

46. Sub Group Analysis after matching

47. Release R Comparator Odds
Ratio
P Value Lower CI Upper CI
Biomatrix 68/1351 5/130 1.308 0.569 0.518 3.30
Endeavour
family
68/1351 6/109 0.914 0.837 0.388 2.154
Promus
family
68/1351 38/996 1.319 0.180 0.879 1.978
Xience family 68/1351 8/247 1.554 0.246 0.737 3.273
Biomime 68/1351 5/86 0.865 0.762 0.340 2.203
Abluminus 68/1351 2/87 2.18 0.280 0.527 9.083
Yukon 68/1351 8/217 1.365 0.413 0.647 2.880
Comparison of Events between
Different Stent Groups

48. Comparison of Events between Release R and
Different Stent Groups

49. Indian Imported Odds
Ratio
P Value Lower CI Upper CI
Men 52/1383 42/1204 1.077 0.722 0.712 1.630
Women 31/ 390 15/278 1.473 0.232 0.780 2.780
Low age 10/314 4/193 1.536 0.473 0.475 4.967
Middle
Age
39/ 866 20/657 1.479 0.161 0.854 2.560
Older Age 34/510 33/575 1.161 0.551 0.709 1.902
STEMI 61/1168 44/829 0.984 0.936 0.661 1.464
ACS 18/406 9/411 2.024 0.088 0.899 4.559
Stable AP 4/199 4/242 1.216 0.784 0.300 4.924
Primary 36/463 25/288 0.895 0.684 0.526 1.523
Elective 47/1311 32/1194 1.337 0.211 0.847 2.110
Diabetic 39/739 39/678 0.917 0.711 0.581 1.447
Non
Diabetic
44/1034 18/804 1.900 0.023 1.090 3.314
Sub Group Analysis of End Points before matching

50. Indian Imported Odds
Ratio
P Value Lower CI Upper CI
Hypertension 47/1002 39/842 1.01 0.954 0.655 1.563
Non
Hypertension
36/771 18/640 1.660 0.084 0.933 2.951
Tobacco usage 14/359 4/199 1.94 0.248 0.630 5.973
No tobacco 69/1409 53/1283 1.185 0.362 0.822 1.709
1 vessel
disease
43/949 18/751 1.890 0.025 1.081 3.304
2 Vessel
disease
21/630 24/500 0.694 0.231 0.382 1.262
3 Vessel
disease
19/194 15/231 1.508 0.252 0.746 3.047
Good LVEF 37/888 21/832 1.650 0.070 0.958 2.843
Mild LV Dys 12/358 12/283 0.790 0.571 0.349 1.786
Mod. LV Dys 22/435 18/302 0.848 0.615 0.447 1.609
Severe LV Dys 12/92 6/ 65 1.413 0.510 0.504 3.958
Sub Group Analysis of End Points before matching

51. Indian Imported Odds
Ratio
P Value Lower Ci Upper CI
LAD 49/942 40/801 1.041 0.851 0.678 1.598
Non LAD 34/831 17/681 1.639 0.101 0.907 2.959
Circulatory
Support
41/134 26/121 1.423 0.207 0.822 2.466
No Circ
Support
42/1639 31/1363 1.126 0.618 0.704 1.802
Resp
Support
21/44 18/29 0.768 0.511 0.350 1.685
No Resp
Support
62/1729 39/1453 1.336 0.162 0.889 2.006
Dialysis 10/12 9/9 0.833 0774 0.239 2.903
No Dialysis 73/1761 48/1473 1.272 0.203 0.878 1.843
Sub Group Analysis of End Points before matching

52. Indian
1310
Imported Odds
Ratio
P Value Lower CI Upper CI
Men 42/997 39/985 1.064 0.784 0.682 1.659
Women 17/254 14/266 1.271 0.517 0.614 2.633
Low age 4/179 4/183 1.022 0.975 0.251 4.150
Middle
Age
27/648 20/611 0.801 0.508 0.415 1.544
Older Age 28/424 29/457 1.040 0.884 0.609 1.778
STEMI 40/758 43/757 0.929 0.744 0.597 1.445
ACS 15/331 9/331 1.666 0.233 0.719 3.861
Stable AP 4/162 2/168 2.074 0.403 0.374 11.479
Primary 21/253 25/269 0.893 0.714 0.487 1.635
Elective 40/1042 29/987 1.306 0.280 0.803 2.123
Diabetic 32/573 36/564 0.874 0.593 0.535 1.428
Non
Diabetic
29/722 18/692 1.544 0.153 0.849 2.806
Sub Group Analysis of End Points After Matching

53. Indian Imported Odds
Ratio
P Value Lower CI Upper CI
Hypertension 30/719 37/713 0.804 0.385 0.491 1.315
Non
Hypertension
29/532 17/543 1.741 0.074 0.945 3.206
Tobacco usage 7/191 4/192 1.759 0.373 0.506 6.107
No tobacco 52/1060 50/1064 1.043 0.832 0.701 1.553
1 vessel
disease
27/637 18/664 1.563 0.148 0.852 2.866
2 Vessel
disease
16/463 23/429 0.644 0.186 0.336 1.236
3 Vessel
disease
16/151 13/163 1.328 0.466 0.618 2.854
Good LVEF 26/686 19/675 1.421 0.258 0.772 2.616
Mild LV Dys 10/248 11/249 0.912 0.837 0.380 2.187
Mod. LV Dys 14/267 18/276 0.804 0.551 0.392 1.649
Severe LV Dys 9/51 6/56 1.647 0.374 0.548 4.950
Sub Group Analysis of End Points after matching

54. Indian Imported Odds
Ratio
P Value Lower Ci Upper CI
LAD 36/672 37/681 0.986 0.953 0.615 1.579
Non LAD 23/579 17/575 1.343 0.363 0.710 2.541
Circulatory
Support
34/92 25/104 1.537 0.151 0.854 2.767
No Circ
Support
25/1159 29/1152 0.856 0.575 0.498 1.472
Resp
Support
12/27 18/26 0.642 0.338 0.259 1.590
No Resp
Support
47/1224 36/1230 1.312 0.227 0.843 2.039
Dialysis 7/6 9/9 1.667 0.832 0.279 4.871
No Dialysis 52/1245 45/1247 1.157 0.481 0.770 1.738
Sub Group Analysis after matching

55. Conclusion
One year adverse events are in general low and
comparable with published results.
There is no statistically significant difference in
the combined adverse end point at the end of
one year between Indian made stents and
Imported Stents.
Higher death rate and lower TVR are due to
higher proportion of ACS and STEMI patients.

56. Finally …..
Indian stents are comparable to Imported
stents and Cardiologists need not hesitate to use
an Indian stent.