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
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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
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%)
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)
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.