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1 Year Results in All-Comer European Patient Population

Published in

THE LANCET 1

February 28,2019

"The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population." - Text from The Lancet
CI-TLR 61% 12m

Supraflex is
61% better than Xience

<

Supraflex

Log-rank p=0.021
1.2%

Xience

3.1%
Clinically-indicated Target Lesion Revascularization (%) at 12 months
Per Protocol Analysis
T

Thin strut sirolimus-eluting stent in
All comer population vs
Everolimus-eluting stent

San Diego - USA

Prof. Patrick Serruys presented Talent trial results in late-breaking session at TCT 2018

R

Randomized Controlled Trial in

All Comer population 1435 patients with 1:1 randomisation

supra
vs

Xience
Family


*Supraflex is trademark of Sahajanand Medical Technologies Pvt. Ltd. or its addiliates.
**XIENCE is trademark of the Abbott Group of Companies.
1

Any ischemic coronary syndrome (STEMI, NSTEMI, UAP, SAP)

Any type of lesions (left main, SVG, CTO, Bifurcation, ISR, etc.)

2
3

Unrestricted use of DES (number, length)

STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-elevation Myocardial Infarction), UAP (Unstable Angina Pectoris), SAP (Stable Angina Pectoris), SVG (Saphenous Vein Graft), CTO (Chronic Total Occlusion), ISR (In-stent Restenosis)

S

Steering Committee

Prof. Patrick Serruys

Chairman

Prof. Upendra Kaul

Co-Chairman

Dr. R. J. De Winter

Principal Investigator

Prof. Azfar Zaman

Principal Investigator
P

Primary End Point

Intention-To-Treat (ITT) analysis

DOCE/TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR)


Per Protocol Analysis
61 %

Supraflex is
61% better than Xience


Intention-To-Treat (ITT) analysis
11 %

Supraflex is
11% better than Xience


Intention-To-Treat (ITT) analysis
11 %

Supraflex is
11% better than Xience


Intention-To-Treat (ITT) analysis
33 %

Supraflex is
33% better than Xience


Per Protocol Analysis
20 %

Supraflex is
20% better than Xience

B

Baseline Characteristics

Characteristic Supraflex
(n=720)		 Xience
(n=715)		 Percentage diffrence
(95% CI)
Age (years) 65.0±10.3 64.7±10.1 0.3 (-0.8 to 1.3)
Male 75.80% 76.50% -0.7 (-5.1 to 3.7%)
BMI(kg/m2) 28.3±4.8 28.3±4.6 0.0 (-0.5 to 0.5%)
Risk factors
Current Smoker 24.50% 24.10% 0.4% (-4.0 to 4.9%)
Diabetes mellitus 21.80% 24.90% -3.1% (-7.5 to 1.3%)
Insulin dependent 6.70% 9.40% -2.7% (-5.5% ,0.1%)
Hypertension 65.30% 66.10% -0.8% (-5.7% ,4.1%)
Hypercholesterolemia 61.80% 60.20% 1.6% (-3.4 to 6.7%)
Family history of CAD 46.30% 45.20% 1.2% (-4.1 to 6.5%)
History of
Previous MI 18.90% 17.90% 1.0% (-3.0 to 5.0%)
PVD 7.10% 9.00% -1.9%(-4.7 to 0.9%)
Previous PCI 24.30% 21.40% 2.9% (-1.4 to 7.2%)
Previous CABG 4.60% 7.70% -3.1% (-5.6 to -0.6%)
Heart Failure 4.70% 6.90% -2.1% (-4.5 to 0.3%)
Renal Insufficiency 2.80% 2.00% 0.8% (-0.8 to 2.4%)
Indication
Stable angina 40.40% 43.40 3.0% (-2.1 to 8.1%)
ACS 59.60% 56.60%
UAP 16.10% 13.80% 2.3% (-1.4 to 6.0%)
NSTEMI 26.90% 26.40% 0.5% (-4.1 to 5.1%)
STEMI 16.50% 16.40% 0.2% (-3.7 to 4.0%)
L

Lesion Characteristics

Parameter Supraflex
(n=1046 lesions)		 Xience
(n=1030 lesions)		 p-value
Vessel location: 0.070
LAD 44.70% 41.90%
LCX 21.00% 23.00%
RCA 32.30% 31.80%
Left main 1.40% 1.60%
Bypass graft 0.50% 1.70%
Number of lesions treated per patient 1.45±0.77 1.44±0.74 0.760
Total stented length per patients (mm) 37.2±27.4 37.2±27.0 0.961
TIMI flow pre 0.122
Flow 0 13.70% 10.90%
Flow 1 3.80% 4.10%
Flow 2 6.30% 8.20%
Flow 3 72.50% 72.20%
Restenotic lesion 4.20% 4.10% 0.883
Small vessel (≤ 2.75mm) 40.20% 40.20% 0.999
Long vessel (> 18mm) 49.70% 49.60% 0.964
Bifurcation Involved 16.00% 15.20% 0.650
P

Procedural Characteristics

Parameter Supraflex
(n=1046 lesions)		 Xience
(n=1030 lesions)		 p-value
Pre-dilatation 77.20% 75.90% 0.509
Max Pressure (atm) 13.6±4.3 13.5±4.1 0.677
Max ballon diameter (mm) 2.52±0.43 2.46±0.43 0.006
Stent characteristics (per lesion)
Number of stents used 1.2±0.5 1.2±0.5 0.592
Total stent length (mm) 25.7±14.5 26.0±14.5 0.623
Overlapping stents 21.10% 19.50% 0.361
Stent length (mm) 21.3±8.3 21.8±8.8 0.120
Nominal Stent diameter (mm) 3.0±0.5 3.0±0.5 0.186
Post ballon dilatation 52.00% 52.20% 0.918
Max pressure (atm) 17.1±4.3 17.5±3.9 0.096
Max ballon diameter (mm) 3.30±0.58 3.29±0.60 0.804
C

Conclusions

  • The Supraflex biodegradable polymer SES (sirolimus eluting stent) was non-inferior to the Xience durable polymer EES (everolimus-eluting stent) for DOCE at 12 months in an all-comer population with a lower rate of CI-TLR in the per-protocol analysis
  • In Per-Protocol analysis (only study stent used, no crossover to any other stent) Supraflex shows significant 61% relative reduction in CI-TLR as compared to Xience stent
  • No difference in Definite and Probable Stent Thrombosis between Supraflex and Xience
Maximum Study PK Study Recoil Study Manipal Flex Study OCT Study Taxco Study Talent Flex Registry Supraflex Cruz Registry S-CORE Registry S-FLEX UK Registry
foot

  1. Zaman, Azfar et al. The Lancet, Volume 393, Issue 10175, 987-997
 *Supraflex is trademark of Sahajanand Medical Technologies Ltd. or its addiliates.  
**XIENCE is trademark of the Abbott Group of Companies.
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