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

• 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

Supraflex SES – Composition

Thin strut

Co-Cr Stent Platform

SirolimusBiodegradable

Polymers

Supraflex Strut Thickness Comparison

140 13296 81 81 8087

6091

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

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

FLEX Registry Study Design

Retrospective, Multicenter, Single-arm, All-comers, Observational Registry

Supraflex SESPatients = 995Lesions = 1242

6M

Clinical endpoints

INH

Clinical Follow-Up98.5%

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

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%)

Lesion characteristics

Target Coronary Artery

LAD46.7%

RCA29.3%

LCX23.0%

LM0.9%

SVG0.1%

ACC/AHA Lesion Classification

A6.1%

B115.9%

B220.8%

C57.2%

Procedural Characteristics

VariablesPatients = 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%)

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%)

Kaplan-Meier MACE-free survival curve

through 12 months

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)

Histogram of neointimal thickness

Cumulative frequency curve of percentage

of covered struts

Cumulative frequency of patients (%)

Str

ut

co

vera

ge (

%)

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

SESEXCEL II

SES

Yukon

SESStudy

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)

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.

Study design