Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation - PASSION: 1- and 5-Year Follow-Up

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).

Hypothesis:

Paclitaxel-eluting stents would be superior at reducing the need for revascularization.

Study Design

  • Randomized

Patients Enrolled: 619
Mean Follow Up: 5 years
Mean Patient 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
  • Expected mortality of <6 months

Primary Endpoints:

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

Secondary Endpoints:

  • MACE at 5 years
  • Individual components of MACE
  • Stent thrombosis

Drug/Procedures Used:

Patients undergoing primary PCI were randomized to paclitaxel-eluting Express2 stent (n = 309) or bare-metal stents (n = 310) with either the Express2 or Liberte platform. 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.

At 5 years, cardiac death, MI, or TLR was 18.6% versus 21.8% (p = 0.28), cardiac death was 8.9% versus 11.5% (p = 0.28), MI was 6.8% versus 4.3% (p = 0.21), and TLR was 7.7% versus 10.5% (p = 0.21), respectively, for paclitaxel-eluting stents versus bare-metal stents. Cumulative definite stent thrombosis was 3.9% versus 1.7% (p = 0.14), and definite or probable stent thrombosis was 4.2% versus 3.4% (p = 0.68), respectively. Censoring events that occurred within 30 days, the cumulative 5-year incidence of definite stent thrombosis, was 2.9% versus 0.6%, respectively.

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 relatively 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.

The TYPHOON trial demonstrated a reduction in target vessel revascularization with sirolimus-eluting stents over bare-metal stents in STEMI patients. However, there were several important differences between that 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.

At 5 years, cardiac death, MI, or TLR remained similar between the groups; however, late stent thrombosis (between 30 days and 5 years) was increased with paclitaxel-eluting stents. The long-term safety of newer generation drug-eluting stents, especially in STEMI, is even less well known.

References:

Vink MA, Dirksen MT, Suttorp MJ, et al. Five-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation) trial. JACC Cardiovasc Interv 2011;4:24-29.

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. Maarten Vink at the ACC.10/i2 Summit, Atlanta, GA, March 2010.

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, Fibrinolytic Agents, Angioplasty, Balloon, Coronary, Tyrosine, Paclitaxel, Thrombosis, Chest Pain


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