Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction - TITAX AMI

Oct 24, 2007
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Date Presented:
01/01/2007
Date Published:
01/01/2009
Date Updated:
10/24/2007
Original Posted Date:
10/24/2007
References

Description:

The goal of the trial was to evaluate use of a titanium-nitride-oxide coated stent compared with a paclitaxel-eluting stent among patients undergoing percutaneous coronary intervention (PCI) for ST elevation or non-ST elevation myocardial infarction.

Study Design

Patients Enrolled: 425
Mean Follow Up: One year
Mean Patient Age: Mean age 64 years
Female: 25

Patient Populations:

Non ST elevation MI or ST elevation MI.

Exclusions:

Unprotected left main disease; ostial or restenotic lesions; contraindication to aspirin, clopidogrel or heparins; life expectancy <12 months; and stent length needed longer than 28 mm.

Primary Endpoints:

Major adverse cardiac event (MACE) at 12 months, defined as the composite of target lesion revascularization (TLR), recurrent MI, or death from cardiac causes

Secondary Endpoints:

All-cause mortality, composite of cardiac death or reinfarction and stent thrombosis

Drug/Procedures Used:

Following visualization of the culprit lesion or a totally occluded infarct-related vessel during coronary angiography, patients were randomized to use of the titanium nitride oxide coated stent (n = 214) or paclitaxel-eluting stent (n = 211).

Principal Findings:

The index event was ST elevation MI in 42% of patients and non-ST elevation MI in 58%. Diabetes was present in 19% of patients. The infarct artery was the left anterior descending in 45% of patients and 67% had type B1 or B2 lesions. Multivessel PCI was performed in 12% of cases.

There was no difference in the primary endpoint of MACE at 1 year for the TITANOX stent compared with the paclitaxel-eluting stent (10.3% vs. 12.8%, p = 0.5). Among the components of the composite, MI trended lower with the TITANOX stent (4.2% vs. 8.1%, p = 0.1) and there was no difference in TLR (9.3% vs. 7.1%, p = 0.5) or cardiac death (0.5% vs. 1.9%, p = 0.2). The secondary endpoint of cardiac death or MI also trended lower with the TITANOX stent (4.2% vs. 8.5%, p = 0.08). Stent thrombosis was significantly lower with the TITANOX stent (0.9% vs. 4.3%, p = 0.03).

Interpretation:

Among patients undergoing PCI for ST elevation or non-ST elevation MI, there was no difference in MACE at 1 year with the TITANOX stent compared with the paclitaxel-eluting stent.

Titanium-nitride-oxide was selected for coating the stent based on the theory that nitride oxide can inhibit platelet aggregation, minimize fibrin growth, reduce inflammation and promote healing. While neither endpoint was significant different between groups, divergent results were observed for MI and TLR: MI was directionally lower with the TITANOX stent but TLR was directionally higher with the TITANOX stent. The rate of stent thrombosis at 1 year was significantly lower with the TITANOX stent than the paclitaxel-eluting stent.

References:

Karjalainen PP, Ylitalo A, Niemelä M, et al. Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction. Ann Med. 2009;41(8):599-607.

Presented by Dr. Pasi Karjalainen, at TCT 2007, Washington, DC.


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