Angiographic and intravascular ultrasound predictors of sidebranch failure during PCI with provisional side branch stentingapproach in complex coronary bifurcation lesions

Previous randomised trials comparing single vs. double stenting inbifurcation lesions demonstrated cross-over from one to two stent strategy up to30% when single “provisional” stenting was primarily attempted. We sought toinvestigate the predictors of side branch (SB) failure in complex bifurcation lesionstreated with provisional stenting...

PCI in patients with coronary artery disease and previous CABG: acute and long-term results

Cross-talk between PCI and surgeryAims: Ten years after the CABG, roughly 50% of the venous grafts are occludedor with severe obstructions, diminishing the benefits of the surgical procedure atlong term. In this context, percutaneous coronary intervention (PCI) with stentimplantation has evolved as a less invasive alternative to treat these patients.Methods and results: This is a single-center study including all consecutivepatients with previous CABG who were referred to cardiac catheterisation due torecurrence of angina or presence of ischaemia in non-invasive tests betweenDecember 2008 and December 2009. We sought to determine the incidence ofdeath, AMI, stroke and repeat revascularisation (RR) at 30 days and 2 yearsamong patients who were selected to undergo PCI. A total of 751 patients wereenrolled, 108 were treated with PCI and 31 underwent a second CABG (14% and4.1% of those referred to coronariography respectively). The mean age in the PCIgroup was 67 years with 80% of men, and a high overall prevalence of diabetes(45%), hypertension (88%) and chronic renal disease (21%). The reason forcardiac catheterisation was recurrent angina in 87% of the cases (stablesymptoms in 53.4% and acute coronary syndrome in 33.6%). Single-vessel PCIwas performed in most cases (93.1%), being the LAD territory the most frequentlyintervened (31.8%) and native arteries treated more frequently than vein grafts(61.4% vs. 38.6%). Complete revascularisation was achieved in only 47.4% ofthe cases. The rate of success for PCI was 97% and the following 30-dayscomplications were detected: 0.9% cardiac death, 2.8% AMI and 0.9% stroke.

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

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.

Preliminary results of the multicentric, double-blinded,randomised, Vestasync II trial

Aims: Durable polymers in 1st generation DES have been linked to local coronaryinflammation that could ultimately result in life-threatening adverse events.Polymer-free DES systems have been developed as an attractive alternative tominimise these undesired effects. We sought to assess the safety and efficacy ofthe novel VESTAsync™ Eluting Stent (VES) combining a Cro-Co platform with ananothin-microporous hydroxyapatite surface coating impregnated with apolymer-free low-dose of Sirolimus (55μg). In its first-in-man (FIM) assessment, 15patients were enrolled and at the end of 8 months, late loss and% of stentobstruction considerably low (0.36mm and 4.0%, respectively) with this novelDES.Methods and results: The Vestasync II trial is a randomised (2:1), double-blindedmulticenter comparison of the VES to its platform, the Gen X stent, withmicroporous hydroxyapatite surface coating but without sirolimus. Patients wereeligible if they presented single de novo lesions in native coronary arteries with3.0-3.5mm diameter and ≤ 14mm in length. Primary endpoint was 9-month in-stentlate loss and% of stent obstruction. Lifelong AAS and 6-month clopidogrel wereprescribed to all pts. Seventy-five patients were enrolled. Baseline characteristicsincluded mean age of 57 years and 23% of diabetics. RVD and lesion length were2.67±0.4mm and 14.0±2.0mm. Procedure success was obtained in all cases.Three patients (4.2%) presented non-Q wave MI during hospitalisation with noother MACE. After discharge, there were two cases of TLR and no MI, death orstent thrombosis. Complete invasive follow-up was achieved for all patients. QCAand IVUS analysis are being processed by independent corelabs and detailedresults will be available at the meeting.Conclusions: In confirming the enthusiastic results of its FIM evaluation, theVESTAsync™ Sirolimus-Eluting Stent should be next evaluated in a larger trial withmore complex angiographic profile and clinical endpoints.