First-in-man, multicentre assessment of the novel Acrobat Svelt balloon-expandable stent-on-a-wire system

ABSTRACT

Recently developed, the Acrobat SOAW (Stent-On-A-Wire) coronarysystem combines a very-thin (81 μ) balloon-expandable, Cro-Co (L605) stentmounted on a delivery system with a 0.012” integrated guidewire tip (distance fromthe tip of the wire to the stent is 22mm). We sought to determine the efficacyprofile of this novel device.Methods and results: SVELTE trial is a multicenter, international (Brazil,Netherlands and Colombia), prospective, non-randomised, single-arm study of theAcrobat SOAW for the treatment of de novo coronary lesions no longer than 18mmand located in native vessels of 2.5 to 3.5mm. DS was highly recommended andpost-dilatation was at operator’s discretion. Patients were oriented to stay on dualanti-platelet regimen for at least 1 month. Main exclusion criteria were PCI in thesetting of acute ST-elevation MI and bifurcation lesions. All patients werescheduled to undergo angiographic follow-up at 6 months. The primary endpoint ofthe study was the survival-free of combined MACE (cardiac death, myocardiuminfarction and target-lesion revascularisation) at 30 days. Secondary endpointsincluded 6-month in-stent late lumen loss and binary restenosis as well ascombined MACE rate.A total of 46 patients were enrolled with mean age of 63years old, 76.6% of male and 21.3% of diabetics. Mean RVD and lesion lengthwere 3.03mm and 12.67mm, respectively. The Acrobat stent was deployed in100% of the cases (89.6% of DS) achieving a procedure success rate of 97.8%.Up to 30 days there were no deaths, Q-Wave MIs or urgent TLR. Six-monthinvasive follow-up is ongoing and complete QCA assessment will be available atthe meeting.Conclusions: The Acrobat SOAW may potentially facilitate PCI by reducingtime/cost and minimising peri-procedural complications. The present trialrepresents the first-in-man assessment of this innovative concept.