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