Comparison of AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting With Direct Stenting Alone in Patients With Acute Myocardial Infarction - JETSTENT

Aug 04, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medrad Interventional/Possis
Date Presented:
01/01/2010
Date Published:
01/01/2010
Date Updated:
08/04/2010
Original Posted Date:
08/04/2010
References

Description:

The goal of the trial was to evaluate treatment with AngioJet rheolytic thrombectomy plus stenting compared with direct stenting alone among patients with acute myocardial infarction (MI).

Hypothesis:

AngioJet rheolytic thrombectomy would be superior at improving surrogate markers of myocardial reperfusion.

Study Design

  • Parallel
  • Randomized

Patients Enrolled: 501
Mean Follow Up: 12 months
Mean Patient Age: 63 years
Female: 24%

Patient Populations:

  • Patients with STEMI within 12 hours of symptom onset
  • TIMI thrombus grade 3-5
  • Infarct artery vessel diameter ≥2.5 mm

Exclusions:

  • Thrombolysis
  • Stroke within 30 days
  • Major surgery within 6 weeks
  • Limited life span
  • Participation in another study
  • Previous stenting of the infarct artery
  • Inability to identify the infarct artery

Primary Endpoints:

  • Co-primary efficacy endpoint: early ST-segment resolution, defined as 50% ST resolution at 30 minutes and final infarct size by scintigraphy at 1 month

Secondary Endpoints:

  • Composite of death, MI, urgent TVR, and stroke at 1, 6, and 12 months
  • Composite of death and readmission for congestive heart failure at 12 months
  • TIMI flow, TIMI blush, and corrected TIMI frame count

Drug/Procedures Used:

Patients with ST-elevation MI (STEMI) and at least moderate thrombus burden were randomized to AngioJet rheolytic thrombectomy plus stenting (n = 256) versus direct stenting alone (n = 245).

Temporary pacemaker and balloon predilatation were strongly discouraged unless absolutely necessary. Bare-metal stents were used in both groups.

Concomitant Medications:

All patients received aspirin, clopidogrel 600 mg before or immediately after percutaneous coronary intervention (PCI), heparin 70 U/kg, and abciximab.

Principal Findings:

Overall, 501 patients were enrolled. There was no difference in baseline characteristics between the groups. In the rheolytic thrombectomy group, the mean age was 63 years, 24% were women, 14% had diabetes, cardiogenic shock was present in 2.7%, time from symptoms to admission was 125 minutes, time from the emergency room to PCI was 34 minutes, reference vessel diameter was 2.9 mm, and prewiring Thrombolysis In Myocardial Infarction (TIMI) flow 0/1 was 84%.

Procedural time was 60 minutes in the rheolytic thrombectomy group versus 46 minutes in the direct stenting group (p < 0.001). Stents per patient were 1.26 versus 1.40 (p = 0.022), and mean stent length was 23.7 mm versus 25.9 mm (p = 0.05), respectively.

The primary outcome of at least 50% ST resolution at 30 minutes was 86% with rheolytic thrombectomy versus 79% with direct stenting alone (p = 0.043). Infarct size was 12% versus 13% (p = 0.40), respectively.

Major adverse cardiac events (MACE) at 1 month was 3.1% versus 6.9% (p = 0.05), death was 1.6% versus 2.9%, MI was 0.8% versus 1.2%, target vessel revascularization (TVR) was 0.8% versus 2.5%, and stroke was 0 versus 0.4%, respectively.

MACE at 6 months was 11.2% versus 19.4% (p = 0.011), death was 2.8% versus 4.5%, MI was 0.8% versus 1.2%, TVR was 7.2% versus 13.2%, and stroke was 0.4% versus 0.4%, respectively.

MACE at 12 months was 14.9% versus 22.7% (p = 0.036), death was 3.2% versus 6.4%, MI was 0.9% versus 1.4%, TVR was 9.9% versus 14.5%, and stroke was 0.9% versus 0.4%, respectively.

TIMI major bleeding was 3.9% versus 1.6% (p = 0.12), need for pacing was 0.08% versus 0% (p = 0.17), and perforation was 0% versus 0.04% (p = 0.33).

Interpretation:

Among patients with STEMI, rheolytic thrombectomy did not reduce the study's co-primary efficacy endpoint. The device improved myocardial reperfusion as assessed by ST-segment resolution; however, infarct size was similar between the groups. Rheolytic thrombectomy improved clinical outcomes at 1, 6, and 12 months. Rheolytic thrombectomy increased procedural time; however, it did not appear to increase procedural complications such as need for pacing or vessel perforation. The thrombectomy group was also associated with slightly fewer stents per patient and shorter total stent length.

Importantly, there was no signal for increased strokes, which was a concern in the AiMI trial. Notable differences in the current trial are that pacing was not routinely employed and the use of lytics was an exclusion criteria.

While this trial demonstrated benefit for rheolytic thrombectomy, the use of simpler aspiration thrombectomy catheters likely remains preferential. The Export catheter was beneficial in the TAPAS trial, and meta-analyses of aspiration thrombectomy devices have also demonstrated their benefit.

References:

Migliorini A, Stabile A, Rodriguez AE, et al., on behalf of the JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction: The JETSTENT Trial. J Am Coll Cardiol 2010;56:1298-1306. 

Presented by Dr. David Antoniucci at the ACC.10/i2 Summit, Atlanta, GA, March 2010.

Keywords: Stroke, Heparin, Emergency Service, Hospital, Cost of Illness, Percutaneous Coronary Intervention, Stents, Shock, Cardiogenic, Biomarkers, Metals, Coronary Thrombosis, Diabetes Mellitus, Myocardial Reperfusion


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