dr alex chase regional heart centre morriston swansea slide material:personal communication with...
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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 2003-052005 2006
% DES / month
2003- 21% DES
0 1 2 3 4
0.0
00
.05
0.1
00
.15
0.2
00
.25
2005 landmark
Time (years)
Cu
mu
lativ
e r
isk
of d
ea
th o
r 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. 0.9395% CI (0.76 to 1.13)
2005- 53.1% DES
0 1 2 3 4
0.0
00
.05
0.1
00
.15
0.2
00
.25
2003 landmark
Time (years)
Cu
mu
lativ
e r
isk
of d
ea
th o
r 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. 1.3195% CI (1.12 to 1.53)
TCT 07no difference in death or MI or both DES ‘on’ or ‘off’all reproduced in single stent cohort
tctmd.com
2-yearMultipleItaly (13)
2002-2005
Real-world registry evaluating outcomes of
DES and BMS
10,629
3,064 / 7,565REAL
1-yearMultipleU.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 offEVENT
3 yearMultipleSweden (26)
2003-04
Real-world registry evaluating outcomes of
DES and BMS
19,771
6033 / 13738SCAAR
2-yearMultipleDenmark (Multiple)
2002-05
Real-world registry evaluating outcomes of
DES and BMS
12,395
3,548 / 8,247Western Denmark
2-yearMultipleU.S. (MA)
2003-05
Propensity-matched analysis of DES vs.
BMS outcomes
17,726
11,516 / 6,210Massachusetts
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-yearU.S. (Southeast)STENT
2-3-yearCanada
Dec 03-Mar 05Ontario
2-yearU.S. (NY)NY State Registry
2-yearU.S. (NJ)
did not report TVRMIDAS
2-3-yearU.S. (PA) *(1)*
35% STEMI
GHOST
3-yearKorea *(1)*
did not report TVRASAN
Years of Follow UpCountryRegistry
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, The opposite of simple is not complicated, but wrong”but wrong”
““keep it simple stupid”keep it simple stupid”““Avoid second stent at all costs”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
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.
TaxusEndeavor
colbalt alloy steel
zotarolimus
x 500x 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 endpointTVF @ 9 months
•non Q MI@ 30 days Endeavor 0.5%(4) vs Taxus 2.2%(17)•diabetics risk TVF 9 months7.7%(18) vs 8.4%(19)RR 0.91, p=0.99
Endeavor IV- the mesage
-
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 RCT2.5 – 3.75 mm
LL ≤ 28 mmN = 1,002
XIENCE VN = 669
TAXUS® Control N = 333
Stone ACC 2007
1002 pts
everolimus
paclitaxel