Safety as regards stent thrombosis

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Safety as regards stent thrombosis

Cairo University

The use of DES or BMS in pts

undergoing primary PCI had been an

unanswered question in the past few years.

Stent thrombosis, a major safety

concern, remains elusive and problematic

event.


‣ Evidence from RCTs

Safety as regards stent thrombosis

‣ 8 randomized trials DES vs BMS

‣ 2,786 patients with STEMI

‣ Follow-up 12.0-24.22 months

‣ Primary efficacy endpoint: TLR

‣ Primary safety endpoint: Stent thrombosis

Kastrati A et al: Euro Heart J 2007; 28:2706-2713


Mean

DUAL

Patients age Type therapy F-U

Study (no.) (yr) of DES (mo) (mo)

BASKET-AMI 216 62.2 PES 6 18.0

SES

Di Lorenzo 270 64.0 PES 6 12.0

SES

HAAMU-STENT 164 63.0 PES 12 16.7

MISSION 310 59.2 SES 12 12.0

PASSION 619 60.8 PES 6 12.0

SESAMI 320 61.6 SES 12 12.3

STRATEGY 175 62.6 SES 3 24.2

TYPHOON 712 59.3 SES 6 12.1

Kastrati A et al: Eur Heart J 28:2706, 2007

CP1299198-1

DES

BMS

P =0.006 P


DES

BMS

All P = NS

8.0%

9.0%

65% 6.5%

4.3%

4.6%

2.3% 2.2%

1.8%

STRATEGY 8 mo

(n = 175)

TYPHOON 12 mo

(n = 700)

SESAMI 12 mo

(n = 320)

PASSION 12 mo

(n = 619)

• Evidence from RCTs

Safety as regards stent t thrombosis

s


10

DES

BMS\

Cumu lative incid dence (%)

8

6 p = 0.511

4

2

0

0 200 400 600 800 1000 1200

Kereiakes DJ. ACC 2010

Days

10

DES

BMS

Cumu lative incid dence (%)

8

6 p

4

2

p = 0.296

0

0 200 400 600 800 1000 1200

Kereiakes DJ. ACC 2010

Days


Group Rate of MACE (%)

Number DES BMS

All 626 11.5 18.2

Age < 63 315 9.4 19.4

Age 63 311 13.7 17.1

Male 458 11.8 16.1

Female 168 10.6 24.1

Diabetes mellitus 65 13.8 22.2

No diabetes mellitus 561 11.3 17.7

Ref D > 3.1 mm 317 9.6 15.6

Ref D 31mm 3.1 299 12.0 20.8

Visible thrombus 458 11.6 15.9

No visible thrombus 168 11.1 24.1

Stent length > 18 mm 309 12.9 17.8

Stent length 18 mm 310 9.5 17.9

LAD 258 14.8 20.6

CX/RCA 368 9.4 16.4

Kereiakes DJ. ACC 2010

DES

better

Odds Ratio (95% CI)

0 0.5 1.0 0.5 2.0

BMS

better

Group Rate of MACE (%)

Number DES BMS

All 626 11.5 18.2

Age < 63 315 9.4 19.4

Age 63 311 13.7 17.1

Male 458 11.8 16.1

Female 168 10.6 24.1

Diabetes mellitus 65 13.8 22.2

No diabetes mellitus 561 11.3 17.77

Ref D > 3.1 mm 317 9.6 15.6

Ref D 3.1 mm 299 12.0 20.8

Visible thrombus 458 11.6 15.9

No visible thrombus 168 11.1 24.1

Stent length > 18 mm 309 12.9 17.8

Stent length 18 mm 310 9.5 17.9

LAD 258 14.8 20.6

CX/RCA 368 9.4 16.4

Kereiakes DJ. ACC 2010

DES

better

Odds Ratio (95% CI)

0 0.5 1.0 0.5 2.0

BMS

better


Group Rate of MACE (%)

Number DES BMS

All 626 11.5 18.2

Age < 63 315 94 9.4 19.4

Age 63 311 13.7 17.1

Male 458 11.8 16.1

Female 168 10.6 24.1

Diabetes mellitus 65 13.8 22.2

No diabetes mellitus 561 11.3 17.7

Ref D > 3.1 mm 317 9.6 15.6

Ref D 3.1 mm 299 12.0 20.8

Visible thrombus 458 11.6 15.9

No visible thrombus 168 11.1 24.1

Stent length > 18 mm 309 12.9 17.8

Stent length 18 mm 310 95 9.5 17.9

LAD 258 14.8 20.6

CX/RCA 368 9.4 16.4

Kereiakes DJ. ACC 2010

Odds Ratio (95% CI)

DES

0 05 0.5 10 1.0 05 0.5 20 2.0

better

BMS

better

Group Rate of MACE (%)

Number DES BMS

All 626 11.5 18.2

Age < 63 315 9.4 19.4

Age 63 311 13.7 17.1

Male 458 11.8 16.11

Female 168 10.6 24.1

Diabetes mellitus 65 13.8 22.2

No diabetes mellitus 561 11.3 17.77

Ref D > 3.1 mm 317 9.6 15.6

Ref D 3.1 mm 299 12.0 20.8

Visible thrombus 458 11.6 15.9

No visible thrombus 168 11.1 24.1

Stent length > 18 mm 309 12.9 17.8

Stent length 18 mm 310 9.5 17.9

LAD 258 14.8 20.6

CX/RCA 368 9.4 16.4

Odds Ratio (95% CI)

Kereiakes DJ. ACC 2010 DES 0 0.5 1.0 0.5 2.0

better

BMS

better


The safety and efficacy of CYPHER ® in AMI is

supported by comprehensive clinical evidence

De Luca meta-analysis:

Involving 9 clinical i l ti trials with 2769 patients

t

randomised to CYPHER or BMS.

The safety and efficacy of CYPHER was

compared with BMS.

The outcome in patients with STEMI was

examined.

De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.

CYPHER ® shows a trend towards reduced Re-MI vs.

BMS in AMI

Re-MI occurrence with CYPHER Select ® Plus vs. BMS: 3.0% vs. 4.3% (p = 0.06),

at 1 year

Study name

STRATEGY

TYPHOON

SESAMI

MISSION

Diaz et al

Di Lorenzo

Outco

me

Re-MI

Re-MI

Re-MI

Re-MI

Re-MI

Re-MI

BASKET AMI

Re-MI

Pasceri et al

MULTISTRATE

GY

Re-MI

Time

point

12

months

12

months

12

months

12

months

12

months

12

months

12

months

12

months

Statistics for each study

MH odds

ratio

Lower

limit

Upper

limit

Events/total

CYPHE

R ®

BMS

0.88 0.30 2.53 7/87 8/88

0.80 0.21 3.01 4/355 5/357

1.00 0.20 5.03 3/160 3/160

0.60 0.25 1.42 9/158 14/152

0.90 0.05 14.72 1/60 1/54

0.55 0.16 1.95 4/90 7/90

048 0.48 009 0.09 270 2.70 2/75 4/74

0.33 0.01 8.49 0/32 1/33

Re-MI 8 months 070 0.70 033 0.33 148 1.48 12/372 17/372

0.68 0.46 1.02 43/1389 60/1380

MH odds ratio and 95% CI

0.1 0.2 0.5 1 2 5 10

Favours CYPHER Select ® Plus Favours BMS

p (overall effect) = 0.06

Heterogeneity (I 2 ) = 0.0%

RR = 0.70 (95% CI 0.48 to 1.02) Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.


CYPHER ® and BMS demonstrate similar incidence

of stent thrombosis in AMI

No difference in ST with CYPHER Select ® Plus vs. BMS at 12 months

Study name

STRATEGY

TYPHOON

SESAMI

MISSION

Diaz et al

Di Lorenzo

BASKET AMI

MULTISTRATE

GY

Outco

me

ST

ST

ST

ST

ST

ST

ST

p (overall effect) = 0.60

Heterogeneity (I 2 ) = 0.0%

RR = 0.88 (95% CI 0.55 to 1.42)

Time

point

12

months

12

months

12

months

12

months

12

months

12

months

12

months

Statistics for each study

MH odds Lower Upper CYPHE

ratio limit limit R

®

Events/total

BMS

0.20 0.01 4.18 0/87 2/88

0.93 0.42 2.06 12/355 13/357

2.01 0.18 22.42 2/160 1/160

0.64 0.10 3.86 2/158 3/152

1.83 0.16 20.74 2/60 1/54

0.33 0.01 8.20 0/90 1/90

1.50 0.24 9.25 3/75 2/74

ST 8 months 0.81 0.33 1.99 9/372 11/372

0.88 0.54 1.43 30/1389 34/1380

MH odds ratio and 95% CI

0.1 0.2 0.5 1 2 5 10

Favours CYPHER Select ® Plus

Favours BMS

Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.

CYPHER ® shows superior efficacy vs.

BMS demonstrated by lower TVR rates

There was a 64% reduction in TVR with CYPHER Select ® Plus vs. BMS at 1 year

Study name

Outcom

e

Time

point

Statistics for each study

Events/total

STRATEGY

TVR

12

months

MH odds

ratio

Lower

limit

Upper

limit

CYPHER ®

BMS

0.32 0.13 0.78 8/87 21/88

MH odds ratio and 95% CI

TYPHOON

TVR

12

months

0.38 0.22 0.66 20/355 48/357

SESAMI

TVR

12

months

0.32 0.13 0.78 7/160 20/160

MISSION

TVR

12

months

0.26 0.09 0.72 5/158 17/152

Diaz et al

TVR

12

months

0.12 0.01 2.41 0/60 3/54

Di Lorenzo

TVR

12

months

020 0.20 006 0.06 074 0.74 3/90 13/90

BASKET AMI

TVR

12

months

0.52 0.16 1.62 5/75 9/74

Pasceri et al

TVR

12

months

0.30 0.06 1.61 2/32 6/33

0.1 0.2 0.5 1 2 5 10

MULTISTRAT

EGY

TVR 8 months 0.29 0.15 0.57 12/372 38/372

Favours CYPHER Select ® Plus

Favours BMS

p (overall effect) < 0.001

Heterogeneity (I 2 ) = 0.0%

RR = 0.36 (95% CI 0.27 to 0.47)

0.32 0.24 0.43 62/1389 175/1380

Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.


CYPHER ® demonstrates an advantage in longterm

mortality rates vs. BMS in AMI

A trend towards better mortality rates with CYPHER Select ® Plus vs.

BMS at 2–3 years

Study name

Outco

me

Time

point

Statistics for each study

Events/total

MH odds ratio and 95% CI

MH

odds

ratio

Lower Upper CYPHE

limit limit R ® BMS

BASKET AMI

Death

36

months

0.47 0.11 1.96 3/75 6/74

Pasceri et al

Death

36

months

319 3.19 013 0.13 81.25 1/32 0/33

STRATEGY

Di Lorenzo

Death

Death

24

months

24

months

0.82 0.34 2.02 10/87 12/88

0.1 0.2 0.5 1 2 5 10

0.42 0.12 1.41 4/90 9/90 Favours CYPHER Select ® Plus Favours BMS

p (overall effect) = 0.17

Heterogeneity (I 2 ) = 0.0%

RR = 0.68 (95% CI 0.39 to 1.19)

0.65 0.35 1.20 18/284 27/285

Adapted from De Luca, G., et al. J Thromb Thrombolysis 2009;28:200-10.

Safety and efficacy of CYPHER ® in AMI vs.

BMS is confirmed at 5 years

TVR to 5 years

STRATEGY confirms long-term

superior efficacy of

CYPHER Select ® Plus vs. BMS

No difference in safety risk vs.

BMS at 5-years follow-up in

STEMI patients

Penzo C. Oral presentation on the STRATEGY Study EuroPCR 2009.


‣ Rapid restoration of blood by 1ry PCI is the

most important factor determining the clinical

outcome after STEMI.

‣ DES use in pts with STEMI reduces the rate of

MACE when compared with BMS.

‣ The rate of stent t thrombosis is not significantly

ifi higher in pts with DES and is balanced by the

reduction in events associated with decrease

TLR.

‣ Avoid the use of DES in non complaint pts or

those likely to need surgery in less than one

year.

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