Abstract Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

Aims: The aim of the study was to investigate long-term changes in lumen eccentricity and asymmetry at five years after implantation of the Absorb bioresorbable vascular scaffold (BVS). Methods and results: Out of 101 patients from the ABSORB cohort B trial, 28 patients (29 lesions) with serial optical coherence tomography (OCT) examination at four different time points (cohort B1: postprocedure, six months, two, and five years [n=13]; cohort B2: post-procedure, one, three, and five years [n=16]) were evaluated. The longitudinal variance in lumen diameter was assessed by asymmetry index (AI). An asymmetric lesion was defined as AI u003e0.3. The circularity of the lumen or scaffold was evaluated by the eccentricity index calculated as minimal divided by maximal luminal or scaffold diameter per cross-section. The lowest lumen eccentricity index within a scaffold segment (EIL) u003c0.7 was defined as an eccentric lesion. Post procedure, an eccentric lesion was observed in 72.4% and became concentric in 93.1% at five years (post EIL 0.67±0.05 vs. five-year EIL 0.80±0.10, p=0.03) with a modest reduction of the lumen area from baseline to five years by 0.75±0.32 mm2. Asymmetric lumen morphology was observed in 93.1% (n=27) post implantation and persisted until five-year follow-up. On serial OCT analyses, there was a substantial increase in the scaffold EI during the first two years (post 0.70±0.06, six months 0.76±0.08, two years 0.85±0.07); then, it remained stable whereas the lumen circularity improved further. There were no significant differences in major adverse cardiac events regarding the lumen morphology over the fiveyear follow-up. Conclusions: In patients treated with the Absorb BVS, the cross-sectional circularity improved over five years while the variance in longitudinal diameters remained. Regaining of lumen circularity is mainly caused by reshaping of the scaffold during the first two years.

AIMS:Bioresorbable vascular scaffolds (BVS) present different mechanical properties as compared to metallic platform stents. Therefore, the standard procedural technique to achieve appropriate deployment may differ. METHODS AND RESULTS:Fifty-two lesions treated with a 3 x 18 mm BVS were imaged with optical coherence tomography (OCT) post-implantation and screened for parameters suggesting non-optimal deployment. These included minimal scaffold area (minSA)<5 mm², residual area stenosis (RAS)>20%, edge dissections, incomplete scaffold/strut apposition (ISA)>5% and scaffold pattern irregularities. The angiographic proximal and distal maximal lumen diameters (DMAX) were measured by quantitative coronary angiography. Based on the DMAX values, the population was divided into three groups: DMAX <2.5 mm (n=13), DMAX between 2.5-3.3 mm (n=30) and DMAX >3.3 mm (n=9). All three groups presented with similar pre-implantation angiographic characteristics except for the vessel size and were treated with similar balloon/artery ratios. The group with a DMAX <2.5 mm presented with a higher percentage of lesions with minSA <5 mm² (30.8% vs. 10.0% vs. 0%; p=0.08) and edge dissections (61.5% vs. 33.3% vs. 11.1%; p=0.05). Lesions with >5% of ISA were significantly higher in the group with DMAX >3.3 mm (7.7% vs. 36.7% vs. 66.7%; p=0.02). RAS >20% was similar between all groups (46.2 vs. 53.3 vs. 77.8%; p=0.47) and scaffold pattern irregularities were only documented in three cases. CONCLUSIONS:BVS implantation guided with quantitative angiography may improve the OCT findings of optimal deployment. The clinical significance of these angiographic and OCT findings warranted long term follow-up of larger cohort of patients.

Culprit lesions of patients with ST-elevation MI (STEMI) are characterized by plaque rupture and thrombus formation, features which have been associated with delayed arterial healing as compared to stable lesions in response to durable polymer drug-eluting stents (DES) implantation as compared to

: This paper reads in tandem two major poems: Giacomo Leopardi’s canzone Alla Primavera, o delle favole antiche (“To Spring, or on the ancient myths”) and T. S. Eliot’s The Waste Land . Composed almost exactly one hundred years apart, the two works display some curious affinities in the “rites of Spring” they ironically enact. Eliot never expressed interest in Leopardi, but both poems meditate on classicism, romanticism

SYNTAX is a randomized controlled trial comparing percutaneous coronary intervention (PCI) using drug-eluting stents with coronary artery bypass graft surgery (CABG) in patients (pts) with 3 vessel and/or left main disease. We will analyze health economic data associated with CABG and PCI in the subset of France compared with select countries in the EU (Germany, Italy and UK). Costs will be estimated using 1-year resource utilization data including procedural resource use (stents, guidewires etc.), hospitalizations major procedures and work days lost. Estimates are based on French patterns of resource utilization, number of hospital days and break down of those in intensive care, or ward days. Where data did not allow reliable French estimate, a Bayesian statistical model was applied combining the observed resource utilization with priors based on data on less rare events. Effects are measured in terms of MACCE-free survival. In France, 105 pts were randomized to CABG and 103 to PCI in the SYNTAX trial. There were 156 hospitalizations in the first year in CABG pts compared with 139 in PCI pts. Overall, CABG pts in France spent 23.3 days (d) in hospital (see Table). PCI pts spent 9.2 d in hospital. After the index procedure, pts in the CABG arm spent 9.1 d in hospital whereas PCI pts spent 5.7 d. Economic data comparing short- and long-term medical care costs for pts with left main and/or 3-vessel CAD treated with either DES or CABG will be available at time of presentation. Additional analyses of the procedural resources utilized and costs associated with the procedures will be presented as a comparison between the French subset and countries in the EU.Empty CellMean Total Days in Hospital Per Patient*Mean Days in Hospital During Follow-upEmpty CellCABGPCICABGPCIIntensive Care Unit (ICU)8.84.31.81.3General Ward10.73.76.74.2Other Wards2.50.90.60.2Total Days23.39.29.15.7*Total days in hospital includes days spent during index procedure Total days in hospital includes days spent during index procedure

Objective: The objective of this study is to compare magnetic guidewire navigation in percutaneous coronary intervention (MPCI) to conventional percutaneous coronary intervention (CPCI) for the elective treatment of a single discrete stenosis. Background: Magnetic navigation actively steers an angioplasty wire-tip and may improve PCI procedures, but it is not known whether the intricacy and increased preparation necessary for using the system negatively influences the performance of simple procedures in terms of time and contrast use. Methods: The procedures of 44 patients (mean age 65 10 year) undergoing elective single vessel MPCI of a single discrete stenosis were matched for age, gender, and lesion location with 44 concurrent patients (mean age 65 10 year) undergoing CPCI. The major endpoint was procedural time. Results: Technical success was defined as an intraluminal wire position distal to the stenosis. Procedural outcome, contrast use, and costs were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for a higher incidence of previous MI and class III angina pectoris in the conventional group. The technical success rate was high and identical in both groups (97.7%). Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0 +/- 14.5 min vs. 24.7 +/- 14.0 min; 4.9 +/- 4.8 min vs. 7.3 +/- 10.3 min, P = NS). There was a significant reduction in median contrast use [60 ml/patient (41-100) vs. 100 ml/patient (64130); P = 0.006]. Conclusion: Magnetic navigation does not increase procedural time, irradiation, equipment use, or cost compared to conventional PCI of a single discrete stenosis. It proved feasible, yielding high rates of procedural success with less contrast use. (C) 2009 Wiley-Liss, Inc.