pooled analysis of trials comparing titanium nitride oxide coated stents with paclitaxel eluting...
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Pooled Analysis of Trials Pooled Analysis of Trials Comparing Titanium Nitride Oxide Comparing Titanium Nitride Oxide
Coated Stents with Paclitaxel Coated Stents with Paclitaxel Eluting Stents in Patients Eluting Stents in Patients
Undergoing PCIUndergoing PCI
Otto M. HessOtto M. Hess
Swiss Cardiovascular CenterSwiss Cardiovascular Center
University Hospital, BernUniversity Hospital, Bern
otto.hess @ insel.chotto.hess @ insel.ch
Conflict of Interest Conflict of Interest StatementStatement
Travel SupportTravel SupportBiotronik AG, Baar
Surcotec SA, Geneva
Bioring SA, Geneva
Biosteel GmbH, Aachen
Hexacath SA, Paris
Speed & Good AG, Ruggell
Stent Technology AG, Zug
CardioLab SA, Oberbüren
LateLate LossLoss
Vascular healingVascular healingVascular healingVascular healingInflammationInflammationInflammationInflammation
Camenzind E. et al.Camenzind E. et al.Circulation 115: Circulation 115: 1440-55, 20071440-55, 2007
Camenzind E. et al.Camenzind E. et al.Circulation 115: Circulation 115: 1440-55, 20071440-55, 2007
Coverage of Overlapping Stents
Cypher 2.25 x 23, 2.5 x 28, Cypher 2.25 x 23, 2.5 x 28, 3 x 33, 3x23 mm3 x 33, 3x23 mm
BaselineBaseline
prepre
StentStentThrombosisThrombosis
DeathDeath
MIMI
TLRTLR
CardiacCardiacDeathDeath
MI or MI or DeathDeath
MagicMagicStentStent
Cobalt-Chromium StentCobalt-Chromium Stent Inflammatory GranulomaInflammatory Granuloma
TITANTITAN®®- Stent- StentTitanium-Nitride-Oxide CoatingTitanium-Nitride-Oxide Coating
TITAN-Coating TITAN-Coating (Titanium-Nitride-(Titanium-Nitride-
Oxide)Oxide)
Nitrogen, Oxygen and Titanium atoms areNitrogen, Oxygen and Titanium atoms are
bound by electronic forces.bound by electronic forces.
(L. Pauling: classification) (L. Pauling: classification)
Stent Stent geometrgeometr
yy
Helicoidal Helicoidal DesignDesign
MaterialMaterial 316 L stainless 316 L stainless steel +Titanox-steel +Titanox-
coatingcoatingStrut Strut
thicknesthicknesss
90 microns90 microns
Crimped Crimped profileprofile
~1mm~1mm
1
100
10’000
Titanium – The Material of Choice ?Titanium – The Material of Choice ?
Titan StentTitan Stent Titan StentTitan Stentsputteredsputtered
Bare metal Bare metal stentstent
High NOHigh NO No NONo NOHigh NOHigh NO
The SIRTAX II Registry
1607 pts undergoing PCI withTiNOX, SES or PES
542 pts received SES
558 pts received TiNOX
389 pts matched 389 pts matched
Propensity score matching
507 pts received PES
389 pts matched
Baseline characteristics before Baseline characteristics before propensity score matchingpropensity score matching
Baseline characteristics after Baseline characteristics after propensity score matchingpropensity score matching
Histogram of Propensity Scores• Kernel-Density and Threshold for Common Support
01
23
4
.2 .4 .6 .8 1 .2 .4 .6 .8 1
SES TiNOX
Density
kdensity propscore
Den
sity
Estimated propensity score
Graphs by type_code
MACE (death, MI or TVR)MACE (death, MI or TVR)0
510
1520
25C
umul
ativ
e In
cide
nce
(%)
319 290 278 269 265 262 187TiNOX319 297 287 275 268 260 182SES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
SES
TiNOX
p = 1.00
05
1015
2025
Cum
ulat
ive
Inci
denc
e (%
)
337 307 294 285 281 277 196TiNOX337 298 291 284 273 265 196PES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
PES
TiNOX
p = 0.78
Titan vs. Sirolimus Titan vs. Paclitaxel
DeathDeath0
510
15C
umul
ativ
e In
cide
nce
(%)
319 308 302 299 297 293 213TiNOX319 309 308 302 301 293 215SES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
SES
TiNOX
05
1015
Cum
ulat
ive
Inci
denc
e (%
)
337 326 320 317 315 310 223TiNOX337 322 320 318 311 305 222PES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
PES
TiNOX
p = 0.89 p = 0.79
Titan vs. Sirolimus Titan vs. Paclitaxel
Target Lesion RevascularizationTarget Lesion Revascularization0
510
15C
umul
ativ
e In
cide
nce
(%)
319 307 302 299 299 296 218TiNOX319 314 309 305 301 297 214SES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
SES
TiNOX 05
1015
Cum
ulat
ive
Inci
denc
e (%
)
337 324 319 316 316 313 228TiNOX337 323 320 318 314 310 229PES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
PES
TiNOX
p = 0.88 p = 1.00
Titan vs. Sirolimus Titan vs. Paclitaxel
Target Vessel RevascularizationTarget Vessel Revascularization
Titan vs. Sirolimus Titan vs. Paclitaxel
05
1015
Cum
ulat
ive
Inci
denc
e (%
)
319 303 298 293 292 289 212TiNOX319 312 302 296 290 286 203SES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
SES
TiNOX
05
1015
Cum
ulat
ive
Inci
denc
e (%
)337 320 315 310 309 306 222TiNOX337 314 309 305 299 295 219PES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
PES
TiNOX
p = 0.90 p = 0.41
05
1015
Cum
ulat
ive
Inci
denc
e (%
)
319 316 314 311 310 307 227TiNOX319 313 313 312 309 304 223SES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
SES
TiNOX
05
1015
Cum
ulat
ive
Inci
denc
e (%
)
337 334 331 328 327 324 238TiNOX337 330 330 328 326 322 234PES
Number at risk
0 6 12 18 24 30 36Months of Follow-up
PES
TiNOX
Myocardial InfarctionMyocardial Infarction
p = 0.21 p = 0.24
Titan vs. Sirolimus Titan vs. Paclitaxel
Clinical outcome in the propensity-Clinical outcome in the propensity-score-matched groupsscore-matched groups
ConclusionsConclusions1. Titanium-coated stents show a similar safety
and efficiency as DES of the first generation over 3 years suggesting no benefit of first generation drug eluting stents over Titanium-coated stents
2. Stent thrombosis rates are low for all 3 stent types but are lowest for Titanium-coated stents. However, dual antiplatelet therapy was carried out only for 3 months in Titanium-coated and 12 months in drug-eluting stents
3. Thus, bio-active stents are a true alternative to DES of the first generation specifically in patients with an increased bleeding risk and in elderly.
Forever youngForever young