Clinical Research
Clinical Trial
Combined Angioplasty and Pharmacological Intervention Versus Thrombolysis Alone in Acute Myocardial Infarction (CAPITAL AMI Study)

https://doi.org/10.1016/j.jacc.2005.04.042Get rights and content
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Objectives

We compared a strategy of tenecteplase (TNK)-facilitated angioplasty with one of TNK alone in patients presenting with high-risk ST-segment elevation myocardial infarction (STEMI).

Background

Previous trials show that thrombolysis followed by immediate angioplasty for the treatment of STEMI does not improve ischemic outcomes compared with thrombolysis alone and is associated with excessive bleeding complications. Since the publication of these trials, however, significant pharmacological and technological advances have occurred.

Methods

We randomized 170 patients with high-risk STEMI to treatment with TNK alone (84 patients) or TNK-facilitated angioplasty (86 patients). The primary end point was a composite of death, reinfarction, recurrent unstable ischemia, or stroke at six months.

Results

At six months, the incidence of the primary end point was 24.4% in the TNK-alone group versus 11.6% in the TNK-facilitated angioplasty group (p = 0.04). This difference was driven by a reduction in the rate of recurrent unstable ischemia (20.7% vs. 8.1%, p = 0.03). There was a trend toward a lower reinfarction rate with TNK-facilitated angioplasty (14.6% vs. 5.8%, p = 0.07). No significant differences were observed in the rates of death or stroke. Major bleeding was observed in 7.1% of the TNK-alone group and in 8.1% of the TNK-facilitated angioplasty group (p = 1.00).

Conclusions

In patients presenting with high-risk STEMI, TNK plus immediate angioplasty reduced the risk of recurrent ischemic events compared with TNK alone and was not associated with an increase in major bleeding complications.

Abbreviations and Acronyms

ACT
activated clotting time
ASSENT
Assessment of the Safety and Efficacy of a New Thrombolytic Agent
CABG
coronary artery bypass graft surgery
IRA
infarct-related artery
PCI
percutaneous coronary intervention
STEMI
ST-segment elevation myocardial infarction
TIMI
Thrombolysis In Myocardial Infarction
TNK
tenecteplase

Cited by (0)

This study was supported by a peer-reviewed grant from the Canadian Institutes of Health Research (CIHR) and a CIHR Industry-Partnered Program with Hoffmann La-Roche Limited, Canada, and Guidant Corporation Canada.