Paclitaxel Eluting Stent Versus Conventional Stent in ST-Segment Elevation Myocardial Infarction - PASSION
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).
Patients Enrolled: 619
Mean Follow Up: One year
Mean Patient Age: Mean age 61 years
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
Cardiogenic shock, mechanical ventilation, failed fibrinolysis, or expected mortality of <6 months
Composite of death, recurrent MI, or TLR (within 5 mm of stent edges) at 1 year
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.
Aspirin (80-100 mg) and clopidogrel (300 mg loading dose followed by 75 mg/d for 6 months)
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.
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.
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.
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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