Paclitaxel Eluting Stent Versus Conventional Stent in ST-Segment Elevation Myocardial Infarction - PASSION

Description:

The goal of the trial was to evaluate treatment with paclitaxel-eluting stents compared with bare-metal stents among patients undergoing primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI).

Study Design

Study Design:

Patients Enrolled: 619
Mean Follow Up: One year
Mean Patient Age: Mean age 61 years
Female: 24

Patient Populations:

STEMI with chest pain for >20 minutes and ST elevation in ≥2 contiguous leads; infarct-related artery with a de novo lesion suitable for stenting on diagnostic angiography

Exclusions:

Cardiogenic shock, mechanical ventilation, failed fibrinolysis, or expected mortality of <6 months

Primary Endpoints:

Composite of death, recurrent MI, or TLR (within 5 mm of stent edges) at 1 year

Drug/Procedures Used:

Patients were randomized to primary PCI with either paclitaxel-eluting stents (n = 309) or bare-metal stents (n = 310) with either the Express2 or Liberte stent. Use of the glycoprotein IIb/IIIa inhibitors abciximab or tirofiban was at the discretion of the treating physician. Patients did not undergo angiographic follow-up in this trial, but were followed for clinical events.

Concomitant Medications:

Aspirin (80-100 mg) and clopidogrel (300 mg loading dose followed by 75 mg/d for 6 months)

Principal Findings:

Mean time from symptom onset to angioplasty was 3 hours. Left anterior descending artery was the culprit in 50% of patients, and 45% of patients had multivessel disease. Procedural success was 95%. An average of 1.3 stents was used in both arms.

The primary endpoint of death, reinfarction, or target lesion revascularization (TLR) at 1 year did not differ between treatment groups (8.8% for paclitaxel-eluting stent group vs. 12.8% for bare-metal stent group, p = 0.12). Cardiac death or MI occurred in 5.5% of the paclitaxel-eluting stent group and 7.2% of the bare-metal stent group (p = 0.40). There was also no difference in TLR (5.3% vs. 7.8%, p = 0.23). There were three cases of stent thrombosis in each group.

Interpretation:

Among patients undergoing primary PCI for STEMI, use of paclitaxel-eluting stents was not associated with a difference in the primary composite endpoint at 1 year compared with bare-metal stents.

Drug-eluting stents have been widely studied in the setting of elective PCI, but little randomized data exist in the setting of STEMI. The present trial is the first large-scale randomized study with paclitaxel-eluting stents compared with bare-metal stents conducted exclusively in the STEMI population.

Another recent trial, the TYPHOON trial, did demonstrate a reduction in target vessel revascularization with sirolimus-eluting stents over bare-metal stents in STEMI patients. However, there were several important differences between the trial in addition to the different drug-eluting stent used, including an angiographic follow-up in the TYPHOON trial, which may have increased the repeat revascularization rate. The TLR rate in the present study was very low in both arms.

References:

Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 2006;355:1105-13.

Presented by Dr. Maurits T. Dirksen at the March 2006 i2 Annual Scientific Session, Atlanta, GA.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Coronary Restenosis, Drug-Eluting Stents, Sirolimus, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Angioplasty, Tyrosine, Percutaneous Coronary Intervention, Paclitaxel, Thrombosis, Chest Pain


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