VAcuuM asPIration thrombus REemoval 3 - VAMPIRE 3

Aug 24, 2018
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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:
Nipro, Boston Scientific, and Japan Lifeline.
Date Published:
08/01/2018
Date Updated:
08/24/2018
Original Posted Date:
08/08/2018
References

Contribution To Literature:

The VAMPIRE 3 trial showed that distal filter protection was superior at preventing no-reflow.

Description:

The goal of the trial was to evaluate distal filter protection compared with conventional percutaneous coronary intervention (PCI) among patients with attenuated plaque ≥5 mm in length on the incidence of no-reflow.

Study Design

  • Randomized
  • Parallel

Patients undergoing PCI with attenuated plaque ≥5 mm in length identified by intravascular ultrasound (IVUS) were randomized to distal filter protection (n = 98) vs. conventional PCI (n = 96). Sequence of events was: 1) guidewire advanced though lesion, 2) thrombus aspiration, 3) treatment group as per randomization. Patients in the distal filter protection group underwent aspiration thrombectomy after stent deployment.

  • Total number of enrollees: 194
  • Duration of follow-up: In-hospital
  • Mean patient age: 67 years
  • Percentage female: 21%
  • Percentage with diabetes: 32%

Inclusion criteria:

  • Unstable angina, non–ST-segment elevation myocardial infarction (STEMI), or STEMI undergoing PCI
  • Target vessel diameter 2.5-5 mm

Exclusion criteria:

  • Cardiogenic shock or cardiac arrest
  • Left main trunk or saphenous vein graft lesions
  • In-stent restenosis
  • Balloon dilatation necessary before IVUS
  • End-stage renal disease or chronic kidney disease (creatinine >1.5 mg/dl)

Principal Findings:

The primary outcome, no-reflow, occurred in 26.5% of the distal protection group vs. 41.7% of the conventional PCI group (p = 0.026).

Secondary outcomes:

  • Corrected TIMI (Thrombolysis in Myocardial Infarction) frame count after revascularization: 23.0 in the distal protection group vs. 30.5 in the conventional PCI group (p = 0.0003)
  • Cardiac death or cardiac arrest/cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation: 0% in the distal protection group vs. 5.2% in the conventional PCI group (p = 0.028)

Interpretation:

Among patients undergoing PCI with attenuated plaque ≥5 mm in length identified by IVUS, distal filter protection was beneficial. Compared with conventional PCI, distal filter protection reduced the incidence of no-reflow, improved the corrected TIMI frame count after revascularization, and reduced adverse clinical events. Among unselected patients with STEMI, the routine use of distal filter protection has been shown to be nonbeneficial. By study design, patients in the distal filter group were encouraged to undergo aspiration thrombectomy after advancement of the guidewire and after stent deployment; therefore, the benefit of distal filter protection in this study might be realized only by being coupled with aspiration thrombectomy. Larger studies powered for clinical outcomes are warranted.

References:

Hibi K, Kozuma K, Sonoda S, et al., on behalf of the VAMPIRE 3 Investigators. A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound. JACC Cardiovasc Interv 2018;11:1545-55.

Editorial Comment: Kubo T, Akasaka T. Benefit of Distal Protection During Percutaneous Coronary Intervention in Properly Selected Patients. JACC Cardiovasc Interv 2018;11:1556-8.

Keywords: Acute Coronary Syndrome, Angina, Unstable, Cardiopulmonary Resuscitation, Defibrillators, Extracorporeal Membrane Oxygenation, Heart Arrest, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Shock, Cardiogenic, Stents, Thrombectomy, Thrombosis, Ultrasonography


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