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

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, 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

matched for lesion characteristics

Medina A. Rev Esp Cardiol. 2006 Feb;59(2):183

1

32

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

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

-

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 RCT2.5 – 3.75 mm

LL ≤ 28 mmN = 1,002

XIENCE VN = 669

TAXUS® Control N = 333

Stone ACC 2007

1002 pts

everolimus

paclitaxel

% e

ven

t @

12

mo

nth

s

SPIRIT III – the messageXience

Taxus

lunch