ENDEAVOR IV

Acronym: ENDEAVOR IV

ENDEAVOR IV

Lead investigator: Dr Martin Leon from Columbia University, New York

Source: Transcatheter cardiovascular Therapeutics, 2007

ENDEAVOR IV

RandomizedDesign:

1548 patients were enrolledSubjects:

To evaluate treatment with the Endeavor zotarolimus-eluting stent compared with treatment with the Taxus paclitaxel-eluting stent among patients with single de novo coronary lesions

Objective :

Mean age 63.5 yearsMean Patient Age:

ENDEAVOR IV

Primary endpoint:

Target vessel failure at 9 months

Inclusion criteria:

Patients with single de novo lesion in native coronary artery with a vessel diameter 2.5-3.5 mm

Mean Follow-Up: 12 months

ENDEAVOR IV

Patients were randomized to PCI with a zotarolimus-eluting stent (n = 773) or a paclitaxel-eluting stent (n = 775).

Predilitation was required.

The dose of zotarolimus was 10 µg per mm stent length.

Repeat angiographic follow-up was performed at 8 months in a subset of patients (n = 279).

Method:

ENDEAVOR IV

Baseline clinical characteristics were well-balanced between groups.

Prior MI was present in 22%. Treated lesion was the left anterior descending in 42% of patients.

The mean baseline percent diameter stenosis was 65%.

In the angiographic subgroup (n = 279), late loss was greater in the zotarolimus group than the paclitaxel group both in-stent (0.67 mm vs. 0.42 mm, p < 0.001) and in-segment (0.36 mm vs. 0.23 mm, p = 0.023).

Results:

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ENDEAVOR IV

Likewise, in-stent percent diameter stenosis was larger in the zotarolimus group (26.4% vs. 16.1%, p < 0.001).

Binary stenosis occurred in 13.3% of the zotarolimus group and 6.7% of the paclitaxel group (p = 0.075).

The primary endpoint of target vessel failure at 9 months met the noninferiority margin of difference, with an event rate of 6.6% in the zotarolimus group and 7.2% in the paclitaxel group, p < 0.001 for noninferiority(Fig 1).

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ENDEAVOR IV

6.60%

7.20%

6.20%

6.40%

6.60%

6.80%

7.00%

7.20%

Zotarolimusgroup

Paclitaxelgroup

Target vesselfailure rate

Legend: The primary endpoint of target vessel failure at 9 months met the noninferiority margin of difference, with an event rate of 6.6% in the zotarolimus group and 7.2% in the paclitaxel group, p <

0.001 for noninferiority.

Target vessel failure rate at 9 months

Fig 1

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ENDEAVOR IV

At 1 year, TVF had occurred in 7.7% of the zotarolimus group and 9.4% in the paclitaxel group and MACE in 6.5% and 6.6%, respectively.

Among the individual endpoints, there were few deaths (1.1% in each group) or myocardial infarctions (MI) (1.6% vs. 2.6%, respectively, p = 0.21).

Target vessel revascularization was similar between groups (6.3% vs. 6.7%, p = 0.75) (Fig 2).

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ENDEAVOR IV

6.30%

6.70%

6.00%

6.20%

6.40%

6.60%

6.80%

Zotarolimusgroup

Paclitaxelgroup

Target vesselrevascularization

Legend: Target vessel revascularization was similar between zotarolimus and paclitaxel group (6.3% vs. 6.7%, p = 0.75)

Target vessel revascularization

Fig 2

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ENDEAVOR IV

Overall stent thrombosis by 1 year trended higher in the zotarolimus group (0.8% vs. 0.1%, p = 0.124), with 3 of the 6 stent thrombosis events in the zotarolimus group occurring by 30 days and the remaining 3 events occurring at day 83, 145 and 171.

ENDEAVOR IV

Among patients undergoing PCI for a single de novo lesion in a native coronary artery, use of a zotarolimus-eluting stent was non-inferior to a paclitaxel-eluting stent for the primary endpoint of target vessel failure at 9 months.

The zotarolimus-eluting stent has previously been evaluated in comparison to the sirolimus-eluting stent in the ENDEAVOR 3 trial, which showed significantly greater late lumen loss with the zotarolimus-eluting stent on angiographic follow-up. Similar results were observed in the present study, which showed greater late lumen loss with the zotarolimus-eluting stent when compared to the paclitaxel-eluting stent. The difference in late lumen loss in the angiographic substudy did not translate into a difference in clinical events.

Conclusion:

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ENDEAVOR IV

While there was no difference in TVF or MACE through 1 year, stent thrombosis trended higher with the zotarolimus-eluting stent.

Longer follow-up is needed to determine if the excess in stent thrombosis with the zotarolimus-eluting continues to increase relative to the paclitaxel-eluting stent, as well as a larger experience in more patients to determine if the excess is confirmed.