arterial revascularization therapies part ii: a non- randomized comparison of contemporary pci and...

Arterial Revascularization Therapies Part II: a non-Arterial Revascularization Therapies Part II: a non-randomized comparison of contemporary PCI and randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients coronary artery bypass grafting (CABG) in patients

with multi-vessel coronary artery lesionswith multi-vessel coronary artery lesions

Arterial Revascularization Therapies Part II: a non-Arterial Revascularization Therapies Part II: a non-randomized comparison of contemporary PCI and randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients coronary artery bypass grafting (CABG) in patients

with multi-vessel coronary artery lesionswith multi-vessel coronary artery lesions

ARTS-II TrialARTS-II TrialARTS-II TrialARTS-II Trial

Presented atPresented atThe American College of Cardiology 2005The American College of Cardiology 2005

www. Clinical trial results.org

Sirolimus-eluting stent3.7 stents per patient

Avg total length: 73 mmn = 607

Sirolimus-eluting stent3.7 stents per patient


ARTS-II TrialARTS-II TrialARTS-II TrialARTS-II Trial

ACC 2005ACC 2005

Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions

18.2% diabetic28% 3 vessel disease7.5% type C lesions

Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions


607 patients with multivessel coronary lesions


607 patients with multivessel coronary lesions


CABG

n = 602

CABG

n = 602

Bare Metal Stent2.8 stents per patient


Bare Metal Stent2.8 stents per patient


Endpoints: Primary – Major adverse cardiac and cerebrovascular events (MACCE), including

death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial

Secondary – MACCE at 30 days, 6 months, 3 and 5 years.

– Total cost at 30 days

– Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years

Endpoints: Primary – Major adverse cardiac and cerebrovascular events (MACCE), including

death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial

Secondary – MACCE at 30 days, 6 months, 3 and 5 years.

– Total cost at 30 days

– Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years


ARTS II: Event free survival ARTS II: Event free survival ARTS II: Event free survival ARTS II: Event free survival

96.9%91.5% 89.5%90.7%

78.1%73.7%

92.0%95.9%

88.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

Survival free fromdeath/CVE/MI

Survival free fromreintervention

Survival free from MACE

ARTS II: DES ARTS I: BMS ARTS I: CABG

96.9%91.5% 89.5%90.7%

78.1%73.7%

92.0%95.9%

88.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

110%

Survival free fromdeath/CVE/MI

Survival free fromreintervention

Survival free from MACE

ARTS II: DES ARTS I: BMS ARTS I: CABG

ACC 2005ACC 2005

At one year, there was no difference in event-free survival between the ARTS II SES group and the ARTS I CABG group. However, the ARTS II group showed significantly higher rates of

survival free from cardiac death, MI, and reintervention than the ARTS I bare metal stent group. The groups were not significantly different in the primary endpoint of survival free from MACCE.

p = <0.001

p = 0.003 p = 0.46


ARTS II: MACCE at one year ARTS II: MACCE at one year ARTS II: MACCE at one year ARTS II: MACCE at one year

10.4%

26.5%

11.6%

0%

5%

10%

15%

20%

25%

ARTS II ARTS I: BMS ARTS I: CABG

10.4%

26.5%

11.6%

0%

5%

10%

15%

20%

25%


TCT 2004TCT 2004

Overall MACCE at 1 year

• At 1 year, there was no difference in the incidence of MACCE between the ARTS II SES group and the ARTS I CABG group.

• The ARTS I bare metal stent group was associated with a significantly higher rate of 1 year MACCE compared to the other groups

ACC 2005ACC 2005


ARTS II: components of MACCE ARTS II: components of MACCE ARTS II: components of MACCE ARTS II: components of MACCE

1.0% 0.8% 1.2%2.0%

5.4%

2.7%1.8%

5.0% 4.7%

12.3%

2.7%1.8%

3.5%

7.0%

3.0%

0%1%2%3%4%5%6%7%8%9%

10%11%12%13%14%

death CVE MI CABG PCI


1.0% 0.8% 1.2%2.0%

5.4%

2.7%1.8%

5.0% 4.7%

12.3%

2.7%1.8%

3.5%

7.0%

3.0%

0%1%2%3%4%5%6%7%8%9%

10%11%12%13%14%

death CVE MI CABG PCI


%

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p=NSp=NS

p=NS p=NS

At one year, there was no difference in any components of MACCE, including death, cerebrovascular events (CVE), MI, or revascularization with CABG or PCI between the ARTS II

SES group and ARTS I CABG patients. The ARTS I bare metal stent group was associated with a significantly higher rate of revascularization with PCI compared to the ARTS II SES group.


ARTS II: SummaryARTS II: SummaryARTS II: SummaryARTS II: Summary

• Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.

• The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions.

• While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another.

• Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.

• The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions.

• While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another.

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