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Background To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or ‘bioresorbable vascular scaffolds’ (BVS) have been developed. Methods We reviewed all currently available clinical data on BVS implantation. Results Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implan- tation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individu-alised approach for patients treated with current generation BVS. Conclusion The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.

Item does not contain fulltext, AIMS: The aim of the study was to investigate whether bivalirudin versus unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous coronary intervention (PPCI) in large acute myocardial infarction (AMI). METHODS AND RESULTS: This multicentre open-label trial randomised 78 patients undergoing PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints included index of microcirculatory resistance (IMR), CMR-assessed microvascular obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and cell injury. No difference was observed in mean IS at five days (25.0+/-19.7 g for bivalirudin vs. 27.1+/-20.7 g for UFH; p=0.75). Early MVO was numerically lower with bivalirudin (5.3+/-5.8 g vs. 7.7+/-6.3 g; p=0.17), with no significant difference in ejection fraction at 90 days (54.6+/-12.0% vs. 49.1+/-12.1%; p=0.11). In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm (p=0.0003). Acute IMR was lower (43.5+/-21.6 vs. 68.7+/-35.8 mmHgxs, respectively; p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was observed with bivalirudin; the trial was discontinued for futility. CONCLUSIONS: This study did not achieve its primary endpoint of significant infarct size reduction in PPCI by prolonged bivalirudin infusion compared to UFH, even though complete thrombin inhibition was achieved in the acute phase, with a lower myocardial microcirculation resistance at the end of the procedure.

The present thesis represents a journey through our initial experience with the bioresorbable scaffold up to the implementation of this technology in complex scenarios such as unstable patients with acute thrombotic lesions, calcified plaques, coronary bifurcations, and even complex chronic total occlusions thus resembling as much as possible the entire spectrum of our daily clinical practice.

Microvascular injury is present in a large proportion of patients with ST-elevation myocardial infarction (STEMI) despite successful revascularization. Ticagrelor potentially mitigates this process by exerting additional adenosine-mediated effects. This study aims to determine whether ticagrelor is associated with a better microvascular function compared to prasugrel as maintenance therapy after STEMI. A total of 110 patients presenting with STEMI and additional intermediate stenosis in another coronary artery will be studied after successful percutaneous coronary intervention (PCI) of the infarct-related artery. Patients will be randomized to treatment with ticagrelor or prasugrel for 1 year. FFR-guided PCI of the non-infarct-related artery will be performed at 1 month. Microvascular function will be assessed by measurement of the index of microcirculatory resistance (IMR) in the infarct-related artery and non-infarct-related artery, immediately after primary PCI and after 1 month. The REDUCE-MVI study will establish whether ticagrelor as a maintenance therapy may improve microvascular function in patients after revascularized STEMI.

Aims: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI). Methods and results: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure. Conclusions: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes.

Objectives To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. Background Robust data on the outcome of BVS in the setting of ACS is still scarce. Methods Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. Results From September 2012-Octobe

Introduction: Although bioresorbable vascular scaffolds (BVS) have been used with promising results in patients with stable and unstable angina, little is known about the acute vascular response following BVS implantation in myocardial infarction. We present angiographic and OCT findings from the first patients undergoing bioresorbable vascular scaffold (BVS) implantation for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) in our institution. Methods: The first 5 patients with NSTEMI and the first 5 patients with STEMI who underwent BVS implantation in our institution, followed by optical coherence tomography (OCT) imaging of the treated culprit vessel, were included in this series. All patients underwent angiographic analysis pre- and post- BVS implantation, as well as OCT analysis, including qualitative and quantitative assessment. Results: Implantation was successful in all cases, as assessed by angiography and OCT. There were no cases with coronary spasm, distal embolization or no-reflow. No adverse clinical events were recorded in any patient at the 6-month follow up. Specific illustrative cases demonstrating the challenges of BVS implantation in myocardial infarction are presented. Conclusions: BVS implantation can potentially be used in the setting of thrombotic lesions encountered in myocardial infarction; however, the role of this treatment approach warrants systematic evaluation in prospective studies.

Background - As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been repor

Drug-eluting stents (DES) are widely used as first choice devices in percutaneous coronary interventions. However, certain concerns are associated with the use of DES, i.e. delayed arterial healing with a subsequent risk of neo-atherosclerosis, late stent thrombosis and hypersensitivity reactions to the DES polymer. Bioresorbable vascular scaffolds are the next step in percutaneous coronary interventions introducing the concept of supporting the natural healing process following initial intervention without leaving any foreign body materials resulting in late adverse events. The first-generation devices have shown encouraging results in multiple studies of selected patients up to the point of full bioresorption, supporting the introduction in regular patient care. During its introduction in daily clinical practice outside the previously selected patient groups, a careful approach should be followed in which outcome is continuously monitored.

Intravascular ultrasound (IVUS)-based reconstructions have been traditionally used to examine the effect of endothelial shear stress (ESS) on neointimal formation. The aim of this analysis is to compare the association between ESS and neointimal thickness (NT) in models obtained by the fusion of optical coherence tomography (OCT) and coronary angiography and in the recons

AimsWe evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI).Methods and resultsThe present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMI-flow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 ± 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 ± 1.92 mm2, minimum lumen area 5.95 ± 1.61 mm2, mean incomplete scaffold apposition area 0.118 ± 0.162 mm2, mean intraluminal defect area 0.013 ± 0.017 mm2, and mean percentage malapposed struts per patient 2.80 ± 3.90%. Scaffolds with >5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and target-vessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed.ConclusionIn the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data.

Background: The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Method(s): In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The prereference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and >=2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Result(s): At 2-year angiographic follow-up no differences in late lumen loss (0.29+/-0.16 mm vs 0.25+/-0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25+/-3.47 mm2 vs 13.09+/-3.38 mm2 p=0.0015), scaffold area (5.76+/-0.96 mm2 vs 6.41+/-1.30 mm2 p=0.0008) and lumen area (5.71+/-0.98 mm2 vs 6.20+/-1.27 mm 2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusion(s): Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.

First generation drug-eluting stents have considerably reduced in-stent restenosis and broadened the applications of percutaneous coronary interventions for the treatment of coronary artery disease. The polymer is an integral part of drug-eluting stents in that, it controls the release of an antiproliferative drug. The main safety concern of first generation drug-eluting stents with permanent polymers - stent thrombosis - has been caused by local hypersensitivity, delayed vessel healing, and endothelial dysfunction. This has prompted the development of newer generation drug-eluting stents with biodegradable polymers or even polymer-free drug-eluting stents. Recent clinical trials have shown the safety and efficacy of drug-eluting stents with biodegradable polymer, with proven reductions in very late stent thrombosis as compared to first generation drug-eluting stents. However, the concept of using a permanent metallic prosthesis implies major drawbacks, such as the presence of a foreign material within the native coronary artery that causes vascular inflammation and neoatherosclerosis, and also impedes the restoration of the vasomotor function of the stented segment. Bioresorbable scaffolds have been introduced to overcome these limitations, since they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. This update article presents the current status of these new technologies and highlights their future perspectives in interventional cardiology.

Purpose. To evaluate the atherosclerotic evolution in coronary bifurcations located proximally and distally to a bioresorbable scaffold. Methods. Thirty bifurcations located >5 mm beyond the scaffolded segment, being investigated with serial intravascular ultrasound virtual histology (IVUS-VH) examinations, at baseline and 2-years, in patients enrolled in the ABSORB cohort B1 study were included in this analysis. In each bifurcation, the frames portraying the proximal rim, in-bifurcation, and distal rim of the ostium of the side branch were analyzed. The geometric parameters and plaque types were evaluated at baseline and 2-years follow-up. Results: There were no significant differences in the geometrical parameters such as lumen, vessel and plaque areas as well as in the composition of the atheroma between baseline and 2-years follow-up.When we separately examined the bifurcations located proximally and distally to the scaffolded segment, no changes were found at the distal bifurcations, while at the proximal bifurcations there was a statistical significant decrease in the plaque burden (36.67 ± 13.33% at baseline vs. 35.06 ± 13.20% at 2 years follow-up, p = 0.04).Ten necrotic core rich plaques were found at baseline, of which 2 regressed to either fibrotic plaque or to intimal thickening at 2 years follow-up. The other 8 did not change. Disease progression was noted in 3 plaques (1 adaptive intimal thickening, 1 fibrotic and 1 fibrocal

Drug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of the physiologic function of the stented segment. Bioresorbable scaffolds (BRS) were introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Currently, several BRSs are available, undergoing evaluation either in clinical trials or in preclinical settings. The aim of this review is to present the new developments in BRS technology, describe the mechanisms involved in the resorption process, and discuss the potential future prospects of this innovative therapy.

Background: The prevalence and clinical sequelae of optical frequency domain imaging (OFDI)-detected intimal flaps caused by vessel trauma or plaque rupture in the proximal native coronary arteries have not been described. Methods and Results: OFDI investigation was performed following stent implantation in patients with ST-segment elevation myocardial infarction (STEMI). We defined a flap-like structure (FS) as a disruption or discontinuation of the endoluminal vessel surface, and classified as actual flap or artifact. FS in the left main stem, or maximally 20mm distal to the guiding catheter in the proximal right coronary artery were assessed. A total of 8,931 frames in 97 patients were analyzed in a frame-by-frame fashion (0.125-mm interval). OFDI identified 8 FS in 7 patients, none of which was evident angiographically. All FS were left untreated because the operators per protocol were blinded to the OFDI images. A total of 5 FS in 5 patients (5.1%) appeared to be actual flaps in which only the intima was involved (mean distance from guiding catheter: 4.8±2.7mm). The remaining 3 FS in 3 patients were artifacts; namely, residual blood and interface light reflectivity. There were no adverse cardiac events during 6-months follow-up. Conclusions: In 5.1% of STEMI patients, post-procedural OFDI identified flaps with minimal involvement of the intima in the p

Aims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. Methods and results: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56±0.43 mm with a mean minimum lumen diameter of 2.48±0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10±0.06 mm2), mean incomplete stent apposition area (0.12±0.13 mm2) and mean intraluminal mass area (0.05±0.03 mm2

Objective We investigated clinical outcomes after treatment of coronary bifurcation lesions with second generation drug eluting stents (DES). Design Post hoc analysis of a randomised, multicentre, non-inferiority trial. Setting Multicentre study. Patients All comers study with minimal exclusion criteria. Interventions Patients were treated with either zotarolimus or everolimus eluting stents. The patient population was divided according to treatment of bifurcation or non-bifurcation lesions and clinical outcomes were compared between groups. Main outcomes measures Clinical outcomes within 2-year follow-up. Results A total of 2265 patients were included in the present analysis. Two-year follow-up data were available in 2223 patients: 1838 patients in the non-bifurcation group and 385 patients in the bifurcation group. At 2-year follow-up the bifurcation and the non-bifurcation lesion groups showed no significant differences in terms of cardiac death (2.3 vs 2.1, p=0.273), target lesion failure (9.7% vs 13.8%, p=0.255), major adverse cardiac events (11.5% vs 15.1%, p=0.305), target lesion revascularisation (4.7% vs 6.0%, p=0.569), and definite or probable ste

Aims: To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES). Methods and results: Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive re

Background The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Methods In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The prereference vessel diameter (RVD) was <2.5 mm (smallvessel group) in 41 patients (41 lesions) and ≥2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Results At 2-year angiographic follow-up no differences in late lumen loss (0.29±0.16 mm vs 0.25±0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25±3.47 mm2 vs 13.09±3.38 mm2 p=0.0015), scaffold area (5.76±0.96 mm2 vs 6.41±1.30 mm2 p=0.0008) and lumen area (5.71±0.98 mm2 vs 6.20 ±1.27 mm2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusions Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positiv

Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background(s): BVS are a novel approach to treating coronary lesions and are untested in small vessels. Method(s): The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Result(s): At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 +/- 0.18 mm vs. 0.21 +/- 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 +/- 6.0% vs. 19.8 +/- 8.5%; p = 0.3643). Conclusion(s): The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels. © 2011 American College of Cardiology Foundation.

The purpose of this article is to investigate the prevalence of plaque prolapse (PP) after Xience V and Taxus Liberte stent implantation. During the study period 2006-2007, 200 consecutive patients underwent coronary revascularization for de novo lesions and received an intravascular ultrasound (IVUS) post-stenting evaluation, (n = 124 patients with Taxus Liberte and n = 76 with Xience V) (227 stent segments). Cross-sectional and longitudinal 3D IVUS images were analyzed in a blind fashion, evaluating the prevalence of PP and calculating its depth and angle. The angulation degree of the coronary artery at the lesion site pre-stent implantation was also evaluated by angiography. The prevalence of PP was 23.9% in Xience V versus 38.1% in Taxus Liberte (P = 0.025). The depth and angle of PP were greater in Taxus Liberte stent than Xience V stent (0.4 ± 0.1 mm versus 0.5 ± 0.2 mm, P = 0.004; and 32.0 ± 8.9° versus 44.6 ± 27.6°, P = 0.044, respectively). The angulation degree of the coronary artery at the lesion site was higher in presence of plaque prolapse than in its absence (48.2 ± 29.3° vs. 38.2 ± 28.1°, P = 0.013). By multivariate analysis, stent type was independently associated with incidence of plaque prolapse. Xience V stent has less plaque prolapse than Taxus Liberte stent. Stent design may play a role in the prevalence of plaque prolapse.

Fractional flow reserve (FFR) is an index of the physiological significance of a coronary stenosis. Patients who have lesions with a FFR of >0.80, even optimally treated with medication, have however a MACE rate ranging from 8 to 21%. Coronary plaques at high risk of rupture and clinical events can be also identified by virtu

Background: Scattering centers (SC) are often observed with optical coherence tomography (OCT) in some struts of bioresorbable vascular scaffolds (BVS). These SC might be caused by crazes in the polymer during crimpdeployment (more frequent at inflection points) or by other processes, such as physiological loading or hydrolysis (eventually increasing with time). The spatial distribution and temporal evolution of SC in BVS might help to understand their meaning. Methods and Results: Three patients were randomly selected from 12 imaged with Fourier-domain OCT at both baseline and 6 months in the ABSORB cohort B study (NCT00856856). Frame-by-frame analysis of the SC distribution was performed using spread-out vessel charts, and the results from baseline and 6 months were compared. A total of 4,328 struts were analyzed. At baseline and follow-up all SC appeared at inflection points. No significant difference was observed between baseline and 6 months in the number of SC struts (14.9 vs. 14.5%, P=0.754) or in the distribution of SC. The proportion and distribution of SC did not vary substantially among the patients analyzed. Conclusions: The SC observed in OCT imaging of the BVS are located exclusively at inflection points and do not increase with time. These findings strongly suggest that SC are caused by crazes in the polymer during crimp-deployment, ruling out any major role of hydrolysis or other time-dependent processes.

Aims: Bioresorbable vascular scaffolds (BVS) present different mechanical properties as compared to metallic platform stents. Therefore, the sta

Aims: The Svelte Stent-On-A-Wire (SOAW) is a thin strut novel device consisting of a balloon-expandable cobalt-chromium stent premounted onto a single lumen fixed-wire delivery catheter platform. We evaluated the performance of the novel Svelte SOAW in comparison with the MultiLink Vision (ML Vision) balloon-expandable stent, in porcine coronary arteries. Methods and results: Eight Yorkshire swine (30-day follow-up cohort) and eight Yucatan mini-swine (90-day follow-up cohort) were implanted with either Svelte or control ML Vision. Acute performance characteristics were graded by interventionalists during implantation. Angiographic assessments were performed at the index procedure and at 30 or at 90 days post implantation. Scanning electron microscopy (SEM), histological and histomorphometric analysis of s

Background: The second generation Bioresorbable Everolimus Eluting Vascular Scaffolds (BVS) are untested at the mid-term follow-up in the subset of small coronary vessels. We investigated the performance of the second generation BVS (Abbott Vascular, Santa Clara, CA) in small coronary arteries (<2.5mm) at 1-year follow-up Methods: The ABSORB Cohort B Trial is a multicentre single-arm, prospective, open-label trial enrolling 101 patients. In the present post-hoc analysis, the study population was sorted according to the pre-procedural reference vessel diameter (RVD) into two groups: 1) Small-vessel group with RVD <2.5mm (41 patients, 41 lesions) and 2) Large-vessel group with RVD >=2.5 mm (60 patients, 61 lesions). Clinical outcomes were assessed at one-year follow-up for the entire population and compared between the two groups. Out of the total population 45 patients were assigned to undergo 6-month coronary angiography and 56 patients (57 lesions) to have the procedure performed at one year. Result(s): At one-year after implantation no differences in Ischemia-Driven (ID) Major Adverse Cardiovascular Events (small vessels 3/41 cases, 7.3% vs. large vessels 4/60 cases, 6.7%,p=1.0000), Myocardial Infarction (small vessels 2/41 cases, 4.9% vs large vessels 1/60 case, 1.7%,p=0.5645) and ID-Target Lesion Revascularization (small vessels 1/41 case, 2.4% vs large vessels 3/60 cases, 5.0%, p=0.6445) were reported between the two groups. No Cardiac Death was observed. At 1-year angiographic follow-up, no differences were showed in late lumen loss (small vessels 0.27+/-0.32mm vs. large vessels 0.27+/-0.32mm, p=0.9852) and In-Scaffold Binary Restenosis (small vessels 0/21 cases, 0.0% vs large vessels 2/36 cases, 5.6% p=0.5263). Conclusion(s): The second generation BVS showed similar clinical and angiographic outcomes at 1-year follow-up in small and large vessels.

Implantation of a coronary stent results in a mechanical enlargement of the coronary lumen with stretching of the surrounding atherosclerotic plaque. Using intravascular ultrasound virtual-histology (IVUS-VH) we examined the temporal changes in composition of the plaque behind the struts (PBS) following the implantation of the everolimus eluting bioresorbable vascular scaffold (BVS). Using IVUS-VH and dedicated software, the composition of plaque was analyzed in all patients from the ABSORB B trial who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA) post-treatment and at 6-month follow-up. This dedicated software enabled analysis of the PBS after subtraction of the VH signal generated by the struts. The presence of necrotic core (NC) in contact with the lumen was also evaluated at baseline and follow-up. IVUS-VH data, recorded with s5i system, were available at baseline and 6-month follow-up in 15 patients and demonstrated an increase in both the area of PBS (2.45 ± 1.93 mm2vs. 3.19 ± 2.48 mm2, P = 0.005) and the external elastic membrane area (13.76 ± 4.07 mm2vs. 14.76 ± 4.56 mm2, P = 0.006). Compared to baseline there was a significant progression in the NC (0.85 ± 0.70 mm2vs. 1.21 ± 0.92 mm2, P = 0.010) and fibrous tissue area (0.88 ± 0.79 mm2vs. 1.15 ± 1.05 mm2, P = 0.027) of the PBS. The NC in contact with the lumen in the treated segment did not increase with follow-up (7.33 vs. 6.36%, P = 0.2). Serial IVUS-VH analysis of BVS-treated lesions at 6-month demonstrated a progression in the NC and fibrous tissue content of PBS.

Aims: We investigated the use of the CROSSER catheter, a CTO crossing device based upon high frequency mechanical vibration, as a first resort to treat patients with chronic total occlusions (CTO) while describing angiographic and computed tomography coronary angiography (CTCA) serving as predictors for success. Methods and results: Eighty consecutive patients were enrolled in this prospective multicentre registry of patients treated for a CTO. For 76.3% of the patients, this was the first attempt to open the CTO. Overall success rate was 75%. By conventional coronary angiography, the length of the occlusion was 26.7±14.1 mm and there was a difference in successful vs. unsuccessful cases (24.5±13.9 and 32.8±13.1, p=0.02). The presence of angulation, as defined qualitatively, was more prevalent in failed cases (60.0% vs. 32.2%, p=0.03). The mean ratio CROSSER distance within the occlusion site and length of the occlusion showed a trend towards statistical significance in successful procedures (0.56±0.90 vs. 0.30±0.34, p=0.08). During hospitali- sation, two patients had a non-fatal myocardial infarction. One patient experienced delayed onset of tamponade six hours postprocedure. At 30 days, two patients had PCI in a non-treated vessel and one patient had a transient ischaemic attack. Relation to the CROSSER catheter was inconclusive. Conclusions: The success rate of the use of a dedicated-CTO device -the CROSSER catheter- as a first choice to open a chronic total occlusion was 75%. By multivariate analysis, in a subset of patients that were imaged with computed tomography coronary angiography, the absence of angulation was related with higher success rate.

Aims: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). Methods and results: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10±0.46mm 2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57±1.3 mm 2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external el