Paclitaxel- or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty - PASEO

Sep 08, 2009
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
01/01/2009
Date Updated:
09/08/2009
Original Posted Date:
09/08/2009
References

Description:

The goal of the trial was to evaluate treatment with paclitaxel-eluting stents (PES) versus sirolimus-eluting stents (SES) versus bare-metal stents (BMS) among patients with ST-elevation myocardial infarction (STEMI).

Hypothesis:

PES or SES would be more effective in preventing target lesion revascularization (TLR).

Study Design

  • Randomized
  • Parallel

Patients Screened: 323
Patients Enrolled: 270
Mean Follow Up: 2 years
Mean Patient Age: 62 years
Female: 29%

Patient Populations:

  • Patients with STEMI within 12 hours from symptom onset

Exclusions:

  • Active internal bleeding or bleeding disorder within the last month
  • History of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Allergy to one of the study medications
  • History of stroke within the last month
  • History of surgical procedure or trauma within the last month
  • Aortic dissection
  • Fibrinolytic therapy within the previous 24 hours
  • Thrombocytopenia
  • Hemorrhagic retinopathy
  • Currently taking warfarin
  • Pregnancy

Primary Endpoints:

  • TLR at 1 year

Secondary Endpoints:

  • Death
  • MI
  • Death or MI
  • Stent thrombosis

Drug/Procedures Used:

Patients with STEMI were randomized to PES (n = 90) versus SES (n = 90) versus BMS (n = 90).

Concomitant Medications:

Patients were treated with aspirin, clopidogrel 300 mg, unfractionated heparin 70 U/kg, and an upstream glycoprotein IIb/IIIa inhibitor.

Principal Findings:

Overall, 270 patients were randomized. There was no difference in baseline characteristics. For BMS, the mean age was 62 years, 29% were women, 26% were diabetics, 16% presented in cardiogenic shock, 50% had an anterior MI, and the total ischemic time was 292 minutes. The mean stent diameter was 3.1 mm, the mean total stent length was 20.3 mm, and direct stenting was performed 27% of the time. There were 1.3 stents per patient for PES (p = 0.023 vs. BMS), 1.2 for SES, and 1.1 for BMS.

The incidence of the primary outcome, TLR at 1 year, was 4.4% for PES (p = 0.021 vs. BMS), 3.3% for SES (p = 0.008 vs. BMS), and 14.4% for BMS.

At 2 years, death was 6.7%, 5.6%, and 10%, MI was 5.6%, 6.7%, and 11.1%, TLR was 5.6%, 4.4%, and 17.8%, and stent thrombosis was 1.1%, 0%, and 1.1%, respectively for PES, SES, and BMS. There were no very late stent thromboses (>1 year) in any group.

At a median of 4.3 years, TLR was 6.7%, 5.6%, and 22.2% (p < 0.05), definite stent thrombosis was 1.1%, 1.1%, and 1.1%, and death was 8.9%, 7.8%, and 13.5% (p = NS), respectively for PES, SES, and BMS.

Interpretation:

Among patients with STEMI, drug-eluting stents (PES or SES) were associated with less TLR at 1 year compared with BMS. By 2 years and even longer, the reduction in TLR was sustained. There were no important safety signals. Death, MI, or stent thromboses were similar across the groups. This trial is limited by its relatively small sample size; however, the findings are similar to a recent meta-analysis on the topic that included 13 randomized clinical trials.

References:

Di Lorenzo E, Sauro R, Varricchio A, et al. Long-term outcome of drug-eluting stents compared with bare-metal stents in ST-elevation myocardial infarction. Results of the Paclitaxel- or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial. Circulation 2009;120:964-72.

Di Lorenzo E, De Luca G, Sauro R, et al. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) randomized trial. JACC Intv 2009;2:515-23.

Keywords: Paclitaxel, Shock, Cardiogenic, Coronary Restenosis, Thrombosis, Drug-Eluting Stents, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus


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