paclitaxel eluting stent versus conventional stent in st-segment elevation myocardial infarction...

Paclitaxel Eluting Stent Versus Conventional Stent Paclitaxel Eluting Stent Versus Conventional Stent in ST-segment Elevation Myocardial Infarction in ST-segment Elevation Myocardial Infarction

(PASSION) Trial(PASSION) Trial

Paclitaxel Eluting Stent Versus Conventional Stent Paclitaxel Eluting Stent Versus Conventional Stent in ST-segment Elevation Myocardial Infarction in ST-segment Elevation Myocardial Infarction

(PASSION) Trial(PASSION) Trial

Presented atPresented atThe American College of Cardiology The American College of Cardiology

Scientific Sessions 2006Scientific Sessions 2006

Presented by Dr. Maurits T. DirksenPresented by Dr. Maurits T. Dirksen

PASSION TrialPASSION TrialPASSION TrialPASSION Trial

www. Clinical trial results.org

PASSION Trial: BackgroundPASSION Trial: BackgroundPASSION Trial: BackgroundPASSION Trial: Background

• This is the first large-scale randomized study with paclitaxel-eluting This is the first large-scale randomized study with paclitaxel-eluting stents compared with bare metal stents conducted exclusively in stents compared with bare metal stents conducted exclusively in the ST-elevation MI population the ST-elevation MI population

• The objective of the trial was to evaluate treatment with paclitaxel-The objective of the trial was to evaluate treatment with paclitaxel-eluting stents compared with bare metal stents among patients eluting stents compared with bare metal stents among patients undergoing primary PCI for ST-elevation myocardial infarctionundergoing primary PCI for ST-elevation myocardial infarction

• This is the first large-scale randomized study with paclitaxel-eluting This is the first large-scale randomized study with paclitaxel-eluting stents compared with bare metal stents conducted exclusively in stents compared with bare metal stents conducted exclusively in the ST-elevation MI population the ST-elevation MI population

• The objective of the trial was to evaluate treatment with paclitaxel-The objective of the trial was to evaluate treatment with paclitaxel-eluting stents compared with bare metal stents among patients eluting stents compared with bare metal stents among patients undergoing primary PCI for ST-elevation myocardial infarctionundergoing primary PCI for ST-elevation myocardial infarction

Presented at ACC 2006Presented at ACC 2006


PASSION Trial: Study DesignPASSION Trial: Study DesignPASSION Trial: Study DesignPASSION Trial: Study Design


Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 mm of stent edges) revascularization (TLR) at one yearmm of stent edges) revascularization (TLR) at one year

Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 mm of stent edges) revascularization (TLR) at one yearmm of stent edges) revascularization (TLR) at one year

Paclitaxel-eluting stentTaxus Express2 or Liberte Stent

n=309

Paclitaxel-eluting stentTaxus Express2 or Liberte Stent

n=309

Bare metal stentBare Express stent

n=310

Bare metal stentBare Express stent

n=310

619 patients619 patients with ST-elevation myocardial infarction with chest pain for > 20 minutes with ST-elevation myocardial infarction with chest pain for > 20 minutes and ST-elevation in and ST-elevation in ≥2 contiguous leads; infarct related artery with a de novo lesion ≥2 contiguous leads; infarct related artery with a de novo lesion

Randomized.24% female, mean age 61 years, mean follow-up 1 year

Use of GP IIb/IIIa inhibitors abciximab or tirofiban at discretion of physicianTime to balloon was 3.1 hours; LAD artery was the culprit in 50% of patients, 45% had multi-vessel disease.

Angiographic success was 96% in both groups; an average of 1.3 stents were used in both arms.

619 patients619 patients with ST-elevation myocardial infarction with chest pain for > 20 minutes with ST-elevation myocardial infarction with chest pain for > 20 minutes and ST-elevation in and ST-elevation in ≥2 contiguous leads; infarct related artery with a de novo lesion ≥2 contiguous leads; infarct related artery with a de novo lesion

Randomized.24% female, mean age 61 years, mean follow-up 1 year

Use of GP IIb/IIIa inhibitors abciximab or tirofiban at discretion of physicianTime to balloon was 3.1 hours; LAD artery was the culprit in 50% of patients, 45% had multi-vessel disease.

Angiographic success was 96% in both groups; an average of 1.3 stents were used in both arms.

Concomitant medications: Aspirin (80-100 mg) and clopidogrel (300 mg loading dose

followed by 75 mg/day for 6 months

Concomitant medications: Aspirin (80-100 mg) and clopidogrel (300 mg loading dose

followed by 75 mg/day for 6 months


PASSION Trial: Primary EndpointPASSION Trial: Primary EndpointPASSION Trial: Primary EndpointPASSION Trial: Primary Endpoint

12.6%

8.7%

0

5

10

15

Paclitaxel-eluting stent Bare-metal stent

12.6%

8.7%

0

5

10

15


• The primary The primary endpoint of death, endpoint of death, reinfarction, or TLR reinfarction, or TLR did not differ did not differ significantly significantly between treatment between treatment groups (Hazard groups (Hazard ratio=0.68, p=0.12)ratio=0.68, p=0.12)

Composite endpoint of death, reinfarction, or TLR at one year Composite endpoint of death, reinfarction, or TLR at one year (%) (%)

Dea

th,

rein

farc

tion,

D

eath

, re

infa

rctio

n,

or T

LR (

%)

or T

LR (

%)


p=0.12p=0.12


PASSIONPASSION Trial: Components of Primary Endpoint Trial: Components of Primary EndpointPASSIONPASSION Trial: Components of Primary Endpoint Trial: Components of Primary Endpoint

• Occurrences of Death or Occurrences of Death or MI were not significantly MI were not significantly different between the different between the paclitaxel-eluting stent paclitaxel-eluting stent group and the bare metal group and the bare metal stent group (4.8% vs. stent group (4.8% vs. 6.5%, p=0.39)6.5%, p=0.39)

• There was also no There was also no difference in TLR (6.2% difference in TLR (6.2% vs. 7.4%, p=0.23)vs. 7.4%, p=0.23)

• There were 3 cases of There were 3 cases of stent thrombosis in each stent thrombosis in each groupgroup

% D

eath

/MI

and

TLR

% D

eath

/MI

and

TLR


Components of Primary endpoint (%)

0

2

4

6

8

10

Death/MI TLR


0

2

4

6

8

10

Death/MI TLR


p=0.39p=0.39p=0.23p=0.23

4.8%4.8%

6.5%6.5%6.2%6.2%

7.4%7.4%


PASSION Trial: LimitationsPASSION Trial: LimitationsPASSION Trial: LimitationsPASSION Trial: Limitations

• The TLR rate was very low in both arms which may The TLR rate was very low in both arms which may be due to the fact that not all patients were brought be due to the fact that not all patients were brought back for angiographic follow-up. The “oculostenotic back for angiographic follow-up. The “oculostenotic reflex” is thought to lead to higher TLR rates.reflex” is thought to lead to higher TLR rates.

• The TLR rate was very low in both arms which may The TLR rate was very low in both arms which may be due to the fact that not all patients were brought be due to the fact that not all patients were brought back for angiographic follow-up. The “oculostenotic back for angiographic follow-up. The “oculostenotic reflex” is thought to lead to higher TLR rates.reflex” is thought to lead to higher TLR rates.



PASSION Trial: SummaryPASSION Trial: SummaryPASSION Trial: SummaryPASSION Trial: Summary

• Among patients undergoing primary PCI for ST-elevation MI, use of paclitaxel-Among patients undergoing primary PCI for ST-elevation MI, use of paclitaxel-eluting stents was not associated with a difference in the primary composite eluting stents was not associated with a difference in the primary composite endpoint of death, MI or target lesion revascularization when compared to bare endpoint of death, MI or target lesion revascularization when compared to bare metal stents at one year.metal stents at one year.

• Occurrences of death or MI were not significantly different between the two groups Occurrences of death or MI were not significantly different between the two groups (4.8% vs. 6.5%, p=0.39) nor was there a difference in TLR (6.2% vs. 7.4%, (4.8% vs. 6.5%, p=0.39) nor was there a difference in TLR (6.2% vs. 7.4%, p=0.23).p=0.23).

• Although the TYPHOON trial showed that sirolimus-eluting stents significantly Although the TYPHOON trial showed that sirolimus-eluting stents significantly reduced target vessel failure compared with bare metal stents, it is difficult to reduced target vessel failure compared with bare metal stents, it is difficult to compare these results since PASSION enrolled patients with left main disease, compare these results since PASSION enrolled patients with left main disease, bifurcation lesions, and large thrombus while TYPHOON excluded these patients.bifurcation lesions, and large thrombus while TYPHOON excluded these patients.

• PASSION also used only the bare Express stent while TYPHOON used any bare PASSION also used only the bare Express stent while TYPHOON used any bare metal stent. metal stent.

• Among patients undergoing primary PCI for ST-elevation MI, use of paclitaxel-Among patients undergoing primary PCI for ST-elevation MI, use of paclitaxel-eluting stents was not associated with a difference in the primary composite eluting stents was not associated with a difference in the primary composite endpoint of death, MI or target lesion revascularization when compared to bare endpoint of death, MI or target lesion revascularization when compared to bare metal stents at one year.metal stents at one year.

• Occurrences of death or MI were not significantly different between the two groups Occurrences of death or MI were not significantly different between the two groups (4.8% vs. 6.5%, p=0.39) nor was there a difference in TLR (6.2% vs. 7.4%, (4.8% vs. 6.5%, p=0.39) nor was there a difference in TLR (6.2% vs. 7.4%, p=0.23).p=0.23).

• Although the TYPHOON trial showed that sirolimus-eluting stents significantly Although the TYPHOON trial showed that sirolimus-eluting stents significantly reduced target vessel failure compared with bare metal stents, it is difficult to reduced target vessel failure compared with bare metal stents, it is difficult to compare these results since PASSION enrolled patients with left main disease, compare these results since PASSION enrolled patients with left main disease, bifurcation lesions, and large thrombus while TYPHOON excluded these patients.bifurcation lesions, and large thrombus while TYPHOON excluded these patients.

• PASSION also used only the bare Express stent while TYPHOON used any bare PASSION also used only the bare Express stent while TYPHOON used any bare metal stent. metal stent.


paclitaxel eluting stent versus conventional stent in st-segment elevation myocardial infarction...

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