DENVER, CO — Distal embolic protection during PCI is beneficial in patients with acute coronary syndromes and large plaque burden, results of the Vacuum Aspiration Thrombus Removal (VAMPIRE) 3 trial suggest[1].
The primary end point of no-reflow phenomenon—a predictor of poor LV recovery and long-term mortality—was reduced from 41.7% without distal protection to 26.5% with distal protection with a filter device (P=0.0261).
In addition, “Distal protection reduced serious adverse procedural and in-hospital events,” Dr Kiyoshi Hibi (Yokohama City University Medical Center, Japan) reported at TCT 2017.
Distal protection with thrombus aspiration or filter devices has been cast off in clinical practice after studies showed no benefit or even more adverse events with its use. Among those, the multicenter EMERALD trial found no evidence of benefit on ST-segment resolution, infarct size, or event-free survival with use of a distal-embolic-protection device, despite removing atherothrombotic debris in 73% of patients with acute MI.
VAMPIRE 3 investigators at 13 clinical sites in Japan randomized 200 patients with acute MI or unstable angina with attenuated plaque >5 mm to PCI with thrombus aspiration and distal-filter protection (Filtrap, Nipro) or to PCI with thrombus aspiration alone. Attenuated plaque length was defined as pre-PCI intravascular ultrasound (IVUS) images with backward signal attenuation of >180° behind plaque without calcium.
Corrected TIMI frame count after revascularization was significantly lower in the distal-protection group than the conventional group (23.0 vs 30.5; P=0.0003), as was the incidence of in-hospital cardiac arrest/cardiogenic shock (0% vs 5.2%; P=0.028) and all in-hospital adverse events (1.0% vs 8.3%; P=0.0179).
Infarct size and creatine kinase-MB elevation were similar in both groups.
At 10-month follow-up in 149 patients, there was also no difference in percent diameter stenosis, late loss, or restenosis rates.
During a discussion of the results, panelist Dr Nick EJ West (Papworth Hospital, Cambridge, UK) congratulated the authors on their efforts, given the need to reduce no-reflow phenomenon in ACS patients.
“So far, all the big trials have not been able to tell us who they are; however, the technique that you used—using IVUS first, particularly in thrombus-laden lesions—was likely to lead to embolization, and you didn’t have any advantage in embolization,” West said. “Second, of course, you used your aspiration after the filter, when to my mind it would be much better to use the aspiration first and then put the filter in.”
Hibi replied that in daily practice aspiration is performed first and then IVUS, adding that IVUS is performed in about 80% to 90% of ACS patients in Japan, even those with ST-segment-elevation MI.
During a press briefing, discussant Dr Jonathan Hill (King’s College Hospital, London) said of the results, “I am convinced, but the concern is the dependence on imaging.”
He went on to describe Japan as “the extreme, with all of these cases entirely dependent on an imaging diagnosis,” and IVUS used in about 80% of ACS cases overall, compared with only about 10% in the United States.
“So to implement your protocol, I think, would be difficult, if there isn’t an acceptance of the requirement for intravascular imaging,” he said.
Press briefing moderator Dr Roxana Mehran (Ichan School of Medicine at Mount Sinai, New York City) remarked that VAMPIRE 3 is a “tremendous study because it is looking at these large-plaque-burden patients, and for the first time, even in a small number of patients, we’re seeing some clinical benefit.”
That said, she agreed that practice patterns with regard to IVUS are very different between the two countries and that “it is a rare event to use distal protection” in the US.
The study was funded by Boston Scientific, Nipro, and Japan Lifeline. Hibi reports receiving consulting fees/honoraria from Nipro and Boston Scientific. Mehran discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abiomed, Abbott Vascular, CardioKinetix, Spectranetics, AstraZeneca, Bayer, Eli Lilly, Novartis, OrbusNeich, Medtronic, Bristol-Myers Squibb, Claret Medical, Janssen, Osprey Medical, the Medicines Company, Boston Scientific, Shanghai Braccosine, Elixer, and Medscape.
Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
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