Clinical Outcomes in 995 Unselected Real-world Patients Treated With an Ultra-thin Biodegradable Polymer-coated Sirolimus-eluting Stent: 12 Months Results from the FLEX Registry

1. Clinical Outcomes in 995 Unselected Real-world Patients Treated
With an Ultra-thin Biodegradable Polymer-coated
Sirolimus-eluting Stent:
12 Months Results from the FLEX Registry
Dr. Atul D. Abhyankar (MD, DM, FSCAI, FISE, FACC)
Shree B.D. Mehta Mahavir Heart Institute,
Surat, India

2. • The objective of this registry was to evaluate clinical outcomes
of an ultra-thin (60µm) biodegradable polymer-coated
Supraflex (Sahajanand Medical Technologies Pvt. Ltd., Surat,
India) sirolimus-eluting stent (SES) for the treatment of
coronary artery disease across a wide range of 995
unselected patients treated in routine clinical practice,
including those with high-risk characteristics and complex
lesions.
• The vascular response to Supraflex SES was also evaluated
in the present registry through optical coherence tomography
(OCT) analysis.
Objective

3. Supraflex SES – Composition
Thin strut
Co-Cr Stent Platform
Sirolimus
Biodegradable
Polymers

4. Supraflex Strut Thickness Comparison
140 132
96 81 81 8087
60
91
316L-SS 316L-SS 316L-SSL605 MP35N L605 L605Pt-Cr 316L-SS
Stainless Steel stent Cobalt Chrome stent Platinum Chromium stent
Cypher Taxus
Express
Taxus
Liberte
Endevor
Resoulte
Integrity
Xience V
Xience
Prime
Yukon
Choice
PC
Promus
Element
Supralimus Supraflex
Coating Thickness
12.6 µm 19.6 µm 14.0 µm 6.0 µm 8.0 µm 8.0 µm 4-5 µm 5-6 µm

5. Supraflex SES v/s Rest (SEM images)
Taxus Liberte
Endeavor
Size: 2.5x8 mm
Magnification:
150X
Size: 3.0x9 mm
Magnification:
200X
Size: 2.5x12 mm
Magnification:
150X
Xience V
Supraflex
Size: 2.5x8 mm
Magnification:
200X - 400X

6. FLEX Registry Study Design
Retrospective, Multicenter, Single-arm, All-comers, Observational Registry
Supraflex SES
Patients = 995
Lesions = 1242
6M
Clinical endpoints
INH
Clinical Follow-Up
98.5%
30D 12M
OCT Follow-Up
(In a subset of 47 patients
Primary
Endpoint
MACE intended as cardiac death, MI, TLR and non-TL TVR
during 12 months follow-up period

7. Baseline Demographics
Variables Patients=995
Demographic
Age, (mean ± SD, years) 61.6±10.8
Male, n (%) 796 (80.0%)
Coexisting condition
Diabetes mellitus, n (%) 231 (23.2%)
Hypertension, n (%) 441 (44.3%)
Acute coronary syndrome, n (%) 398 (40%)
Cardiac risk factor
Current smoker, n (%) 71 (7.1%)
Family history of CAD, n (%) 79 (7.9%)
Previous stroke, n (%) 3 (0.3%)
Previous MI, n (%) 109 (11.0%)
Previous CABG, n (%) 15 (1.5%)
Previous PCI, n (%) 87 (8.7%)

8. Lesion characteristics
Target Coronary Artery
LAD
46.7%
RCA
29.3%
LCX
23.0%
LM
0.9%
SVG
0.1%
ACC/AHA Lesion Classification
A
6.1%
B1
15.9%
B2
20.8%
C
57.2%

9. Procedural Characteristics
Variables
Patients = 995 /
Lesions = 1242
Total no. of stents, n 1398
No. of stents per patient, (mean ± SD, mm) 1.4±0.7
No. of stents per lesion, (mean ± SD, mm) 1.1±0.4
Average stent length, (mean ± SD, mm) 26.6±9.3
Average stent diameter, (mean ± SD, mm) 3.1±0.4
Total occlusion, n (%) 185 (14.9%)
Chronic total occlusion, n (%) 113 (9.1%)

10. Cumulative rates of MACE
Variables 30 days 6 months 12 months
No. of patients, n 995 986 980
Death, n (%) 7 (0.7%) 10 (1.0%) 22 (2.2%)
Cardiac death, n (%) 7 (0.7%) 9 (0.9%) 18 (1.8%)
Non-cardiac death, n (%) 0 (0%) 1 (0.1%) 4 (0.4%)
MI, n (%) 4 (0.4%) 15 (1.5%) 16 (1.6%)
TLR, n (%) 0 (0%) 5 (0.5%) 7 (0.7%)
Non-TL TVR, n (%) 0 (0%) 0 (0%) 2 (0.2%)
Overall stent thrombosis, n (%) 0 (0%) 11 (1.1%) 11 (1.1%)
Definite stent thrombosis, n (%) 0 (0%) 3 (0.3%) 3 (0.3%)
Probable stent thrombosis, n (%) 0 (0%) 8 (0.8%) 8 (0.8%)
Possible stent thrombosis, n (%) 0 (0%) 0 (0%) 0 (0%)
MACE, n (%) 11 (1.1%) 22 (2.2%) 36 (3.7%)

11. Kaplan-Meier MACE-free survival curve
through 12 months

12. OCT analysis at 6 months (±1 month) follow-up
OCT analysis
Total number of patients, n 47
Total number of lesions, n 47
Total analysed cross-sections, n 1227
Total analysed struts, n 9309
Mean number of struts per cross-section, n ± SD 7.58±0.87
Percentage of covered struts (IQR) 98.1 (92.1-100)
Mean neointimal thickness, μm± SD 0.13±0.06
Percentage of malapposed struts (IQR) 0.00 (0.00-4.1)
Percentage presence of both
malapposed or uncovered struts
2.40 (0.00-10.1)

13. Histogram of neointimal thickness

14. Cumulative frequency curve of percentage
of covered struts
Cumulative frequency of patients (%)
Strutcoverage(%)

15. Comparative Strut Coverage of Other Stents
98.1%
97.9%
97.2%
96.0%
93.5%
91.0%
92.0%
93.0%
94.0%
95.0%
96.0%
97.0%
98.0%
99.0%
FLEX Registry DIRECT [1] ORCA-1 [2] CENTURY [3] CREDIT-1 [4]
(n=47)
(n=20)
(n=15)
(n=30)
(n=12)
Supraflex
SES
Ultimaster
SES
Svelte
SES
EXCEL II
SES
Yukon
SES
Study
Stent
6 months 6 months6 months 4 months3 monthsOCT at
References:
Ref 1: EuroIntervention 2013;9:46-53
Ref 2: JACC Cardiovasc Interv. 2009 May;2(5):437-44.
Ref 3: EuroIntervention 2014;10-online publish-ahead-of-print August 2014
Ref 4: Catheterization and Cardiovascular Interventions 85:744–751 (2015)

16. Conclusions
• The FLEX Registry evaluated clinical outcomes in real-world
and more complex cohorts and thereby provides evidence to
the clinicians for safe and routine extended use of the
Supraflex SES to a broader percutaneous coronary
intervention population.
• Also, the Supraflex SES showed high percentage of stent strut
coverage and good stent apposition during OCT follow-up.

17. Study design