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DR ALEX CHASE
REGIONAL HEART CENTRE
MORRISTON
SWANSEA
SLIDE MATERIAL: PERSONAL COMMUNICATION WITH AUTHORS
ABBOTT, BOSTON SCIENTIFIC, CORDIS, MEDTRONIC
TCT WEBSITE: www.tcdmd.com
12 registries of DES use in 12 months
DR ALEX CHASE
REGIONAL HEART CENTRE
MORRISTON
SWANSEA
• do they work? • are they safe?
Swedish Coronary Angiography and Angioplasty Registry
Adjusted Death 2003-04
N= 19 771
R.R. 1.32 95% CI (1.11 to 1.57)
R.R. 1.09 95% CI (0.96 to 1.25)
NEJM TCT 07 N= 35262
Adjusted Death 2003-05 2005 2006
% DES / month
2003- 21% DES
0 1 2 3 4
0.00
0.05
0.10
0.15
0.20
0.25
2005 landmark
Time (years)
Cum
ulat
ive
risk
of d
eath
or M
I
BMSDES
BMS 5584 5061 4949 2611 0 0 0 0 0DES 6336 5963 5809 2573 0 0 0 0 0
RR: 0.69 (0.59, 0.81)
RR: 0.93 (0.76, 1.13)
R.R. 0.93 95% CI (0.76 to 1.13)
2005- 53.1% DES
0 1 2 3 4
0.00
0.05
0.10
0.15
0.20
0.25
2003 landmark
Time (years)
Cum
ulat
ive
risk
of d
eath
or M
I
BMSDES
BMS 6448 6037 5918 5820 5713 5612 5520 2934 7DES 1799 1685 1644 1607 1568 1539 1496 535 0
RR: 1.06 (0.86, 1.32)
RR: 1.31 (1.12, 1.53)
R.R. 1.31 95% CI (1.12 to 1.53)
TCT 07 no difference in death or MI or both DES ‘on’ or ‘off’ all reproduced in single stent cohort
tctmd.com
2-year Multiple Italy (13)
2002-2005 Real-world registry
evaluating outcomes of DES and BMS
10,629 3,064 / 7,565 REAL
1-year
Multiple
U.S. 2004 -2006 (3 waves)
STEMI excluded
Evaluation of DES used on and off-label and
over time
3,323 (all DES) 1506 on / 1817 off EVENT
3 year Multiple
Sweden (26)
2003-04 Real-world registry
evaluating outcomes of DES and BMS
19,771 6033 / 13738 SCAAR
2-year Multiple Denmark (Multiple)
2002-05 Real-world registry
evaluating outcomes of DES and BMS
12,395 3,548 / 8,247 Western Denmark
2-year Multiple U.S. (MA) 2003-05
Propensity-matched analysis of DES vs.
BMS outcomes
17,726 11,516 / 6,210 Massachusetts
Evaluation of DES and BMS in an unrestricted
patient population
Landmark analysis comparing DES and
BMS
Case-matched propensity analysis of
DES vs. BMS
Real-world registry evaluating outcomes of
DES and BMS
Long-term evaluation of DES vs. BMS mortality
in ST & NSTAMI patients
Evaluation of DES and BMS used in all comers
in off-label
Real-world registry evaluating outcomes of
DES and BMS
Study Description
3,223 1460 / 1763
7,355 5,996 / 1,359
7,502 3751 / 3751
14,218 6,384 / 7,834
11,118 5719 / 5399
1,354 483 / 871
7,221 3,160 / 4,061
Number of Pts DES / BMS
Multiple
Multiple
Multiple
Multiple
Multiple
Single
Single
Number of Sites
1-year U.S.
BMS 2001-02 DES 2004
NHLBI Dynamic Registry
2-year U.S. (Southeast) STENT
2-3-year Canada
Dec 03-Mar 05 Ontario
2-year U.S. (NY) NY State Registry
2-year U.S. (NJ)
did not report TVR MIDAS
2-3-year U.S. (PA) *(1)* 35% STEMI
GHOST
3-year Korea *(1)*
did not report TVR ASAN
Years of Follow Up Country Registry
do they work?
revasc
are they safe?
mortality
DES
BMS
are they safe?
MI
thrombosis
DES
BMS
summary & any other business
• several studies (SCAAR, NHLBI, GHOST & EVENT demonstrated the safety and efficacy of DES off label (NHLBI : Greatest benefit TVR on label ( HR 0.44, 95% CI 0.28 ) vs off (HR 0.57, 95% CI 0.39 to 0.83) indications)
GHOST: > 12 months dual anti-platelet was an advantage on sub-analysis
• several studies (MIDAS, ONTARIO, STENT & NY,
ASAN & MASSACHUSETTS) demonstrated mortality benefit of DES vs BMS including STEMI and NSTEMI
TCT 2007
Bifurcations Bad Krozingen
M. Ferenc, H.J. Buettner, H.-P. Bestehorn, M. Gick, T. Comberg, K. Werner, J. Allgeier, J. Minners, R.-P. Kienzle F.-J. Neumann
Heart Center Bad Krozingen / Germany
ClinicalTrials.gov Identifier: NCT00288535 Cordis, Johnson & Johnson Company
“The opposite of simple is not complicated, but wrong”
“keep it simple stupid” “Avoid second stent at all costs”
Systematic versus provisional T-stenting in the treatment of de novo coronary bifurcation lesions using
sirolimus-eluting stents
hypothesis
In the treatment of coronary bifurcation lesions with sirolimus-eluting stents (CYPHER) systematic T-stenting of both main
and the side branch reduces the restenosis in the side branch compared with provisional T-stenting
TCTMD.com
matched for lesion characteristics
Medina A. Rev Esp Cardiol. 2006 Feb;59(2):183
1
3 2
angiographic endpoints @ 9 months
clinical endpoints @ 1 year
conclusions
Compared with provisional T-stenting, systematic T-stenting does not reduce in-segment percent diameter stenosis of the side branch. Provisional T-stenting yields a similar angiographic and clinical outcome as the more consumptive systematic T-stenting.
Endeavor IV & Spirit III
Taxus Endeavor
colbalt alloy steel
zotarolimus
x 500 x 500
paclitaxel
• matched lesion characteristics • matched post-procedural QCA • 82.3% to 98.1% FU
Endeavor IV- design & demographics
*TVF = cardiac death, MI, or ischemia-driven TVR
*
8 month QCA
12 month clinical
1o endpoint TVF @ 9 months
• non Q MI@ 30 days Endeavor 0.5%(4) vs Taxus 2.2%(17) • diabetics risk TVF 9 months 7.7%(18) vs 8.4%(19) RR 0.91, p=0.99
Endeavor IV- the mesage
-
Endeavor IV - authors’ conclusions
SPIRIT III - design & demographics
• PI: Gregg Stone, MD, 65 US sites • RCT: Prospective, single blind • Primary end point: In-segment Late Loss at 8M • Stent Size: 2.5 – 3.5mm mm; Stent lengths: 8, 18, 28 mm • Angiographic and IVUS Follow-Up on 564 and 240 pts, respectively • Clinical follow-up at 30, 180, 270d and 1, 2, 3, 4 and 5 years • 6 Months clopidogrel for all arms • $$$ Abbott
2 : 1
Up to two de novo lesions,
maximum of one lesion per
epicardial vessel
Main US RCT 2.5 – 3.75 mm
LL ≤ 28 mm N = 1,002
XIENCE V N = 669
TAXUS® Control N = 333
Stone ACC 2007
1002 pts
everolimus
paclitaxel
% e
vent
@ 1
2 m
onth
s
SPIRIT III – the message Xience Taxus
lunch