OCT-assessment of scaffold resorption: Analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.

BACKGROUND: The aim of this study was to analyze individual differences in resorption of bioresorbable vascular scaffolds (BRS) through optical coherence tomography (OCT) analysis and to identify factors potentially influencing the resorption process. METHODS: Between April 2016 and July 2017 clinically driven invasive coronary angiography and OCT examinations were performed in 36 patients who had previously been treated with a total of 48 BRS (ABSORB BVS, Abbott Vascular, Santa Clara, CA). For each scaffold, a new BRS-RESORB-INDEX (BRI) was calculated. RESULTS: The mean time interval since implantation was 789 ± 321 days. In OCT, BRS struts remained detectable in all 48 BRS. Normalized light intensity as a marker for the resorption of BRS struts increased with time in a linear fashion (Spearman Rho: p < .001, correlation coefficient = .90; R2 [linear] = .91). Multivariable analysis identified diabetes (BRI of patients with diabetes vs. patients without diabetes: 0.34 ± 0.13 vs. 0.58 ± 0.22; p = .002) and presence of Peri-strut low intensity areas (PSLIA, BRI of 10 patients with PSLIA vs. 26 patients without PSLIA: 0.44 ± 0.21 vs. 0.61 ± 18; p = .027) as independent predictors for a prolonged BRS resorption, whereas the resorption rate in ACS patients (STEMI, NSTEMI, and unstable angina; n = 13) was significantly higher as compared to patients without ACS (0.62 ± 0.17 vs. 0.43 ± 0.24; p = .012). CONCLUSION: In humans, BRS resorption rate is significantly influenced by numerous factors. Our data suggest that diabetes and PSLIA are associated with a prolonged resorption process, whereas in ACS patients, BRS resorption appears to be significantly faster.

Bioresorbable scaffolds in daily clinical routine: a practical review of all-comers results.

PURPOSE OF REVIEW: Bioresorbable scaffolds (BRS) are a major advancement in interventional cardiology, but experience with BRS use in daily routine is currently limited. Here, we review technical features of commercially available BRS and place them in context with current clinical scientific evidence. RECENT FINDINGS: Everolimus and novolimus-eluting poly-L-lactic acid (PLLA)-based BRS are commercially available in Europe. The everolimus-eluting BRS is the most widely investigated BRS and several all-comers investigations with this device are ongoing. Of the patients in these studies, 37-100% underwent catheterization due to acute coronary syndrome and up to 25% were diabetic. Up to 64.7% of all lesions treated were considered to be complex. Follow-up varied between 30 days and 1 year. The target lesion revascularization rate was up to 10% and scaffold thrombosis was 0-3%. SUMMARY: Accumulating data on BRS application are now available. Several studies have demonstrated that BRS implantation is technically feasible in a variety of different patient subsets and clinical presentations, and follow-up results support BRS use. Patients with acute coronary syndrome represent the most investigated subpopulation, and results suggest that BRS use for this indication is reasonable.

Comparison of Exo-Seal(®) and Angio-Seal (®) for arterial puncture site closure: A randomized, multicenter, single-blind trial.

BACKGROUND: The use of extravascular femoral closure devices in patients undergoing coronary angiography/intervention has not been sufficiently evaluated. We sought to define the impact of an extravascular polyglycolic acid (PGA) plug for the closure of a femoral access site in patients undergoing coronary angiography and/or percutaneous coronary intervention. METHODS: In this prospective, single-blind, multicenter trial we randomly assigned 319 patients to vessel closure with Angio-Seal(®) or Exo-Seal(®). We hypothesized that the use of an extravascular closure device is not inferior to an anchor/plug-mediated device regarding the occurrence of the composite primary endpoint: hematoma > 5 cm, significant groin bleeding (TIMI major bleed), false aneurysm, and device failure. RESULTS: There was no significant difference in patient baseline characteristics or procedural results. After 24 h the primary endpoint occurred in nine patients (5.6 %) in the Angio-Seal(®) group and in 13 patients (8.2 %) inthe Exo-Seal(®) group (p = 0.38). Hematoma > 5 cm was noted in three patients (1.9 %) receiving Angio-Seal(®) vs. two patients (1.3 %) receiving Exo-Seal(®) (p = 0.99). In one patient (0.6 %) of the Exo-Seal(®) group, TIMI major bleeding occurred, requiring transfusion (p = 0.49). There were four (2.5 %) false aneurysms found in patients treated with Angio-Seal(®) and two (1.3 %) in patients treated with Exo-Seal(®) (p = 0.68). There was a trend for a higher incidence of device failure in the Exo-Seal(®) group (1.2 vs. 5.2 %, p = 0.06). At telephone interview after 30 days, there was no significant difference found regarding the events readmission with surgery of puncture site, infection, bleeding, hematoma, or pain. CONCLUSION: In the present study, there were no significant differences found regarding the occurrence of hematoma > 5 cm, major bleeding, false aneurysm, and device failure between Angio-Seal(®) and Exo-Seal(®) 24 h after device implantation.

A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.

AIMS: Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please). METHODS AND RESULTS: AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups. CONCLUSIONS: In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. CLINICAL TRIALS REGISTRATION: NCT02151812 (http://clinicaltrials.gov/).

Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.

OBJECTIVES: The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. BACKGROUND: The BRS promised some advantages in terms of complete biodegradation within 2-4 years, restored vascular physiology, and absence of potential stent-related long-term complications. However, the implication of BRS for off-label indications and further long-term follow-up of this particular patient group is not well described. METHODS: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). RESULTS: A total of 3188 patients were enrolled. Patients were divided into two groups: on-label BRS use (33.0%) and off-label use (66.9%) if at least one off-label use criteria was met. The incidence of scaffold thrombosis in confirmed cases was significantly higher in off-label group (1.3% versus 0.5%, p = 0.04; OR 2.41 (95% CI 1.00-5.82) with also a trend toward higher myocardial infarction rate (2.3% versus 1.4%, p = 0.077; OR 1.70 (95% CI 0.95-3.03) and cardiovascular death (1.2% versus 1.1%, p = 0.76, OR 1.11 (95% CI 0.56-2.21) at 6-month follow-up. CONCLUSIONS: In a real-world setting, the majority patients were treated with BRS for off-label indications. The off-label use of BRS compared to confirmed indications appears to be associated with a higher rate of clinical endpoints considering more complex lesions and higher morbidity in this patients' group. Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb® bioresorbable scaffold implantation: results from the GABI-R® registry.

Effect of Plaque Composition, Morphology, and Burden on DESolve Novolimus-Eluting Bioresorbable Vascular Scaffold Expansion and Eccentricity - An Optical Coherence Tomography Analysis.

OBJECTIVE: This study of patients treated with novolimus-eluting bioresorbable scaffold (BRS) investigated the impact of plaque burden on the acute mechanical performance of the BRS and the short-term outcome. METHODS: A total of 15 patients were enrolled. The following parameters were derived from optical coherence tomography (OCT) during the final pullback: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, scaffold expansion index (SEI), scaffold eccentricity index (SEC), symmetry index, strut fracture, and edge dissection. Fibrous plaque (FP) and calcific plaque (CP) characteristics were measured at each 200 µm longitudinal cross-section. The patients were divided into two groups based on their medians of the respective plaque characteristics. RESULTS: OCT analysis showed a lumen area of 11.4 ±â€¯1.9 mm2 and a scaffold area of 11.5 ±â€¯2.1 mm2. The mean eccentricity index overall was 0.65 ±â€¯0.16 and mean symmetry index 0.39 ±â€¯0.25. Statistically, scaffold expansion was not significantly influenced by a greater plaque burden as represented by greater CP area (SEI in group with CP area <0.52 mm2 84.1% vs. SEI of 86.6% in group with CP area ≥0.52 mm2, p = 0.06), thicker CP (85.7% vs. 85.1%, p = 0.06), greater CP arc angle (88.0% vs. 81.7%, p = 0.08), and CP being closer to the lumen (84.2% vs. 86.5%, p = 0.08). Scaffold expansion was also not significantly influenced by FP burden. The eccentricity of the implanted scaffolds was not dependent on the CP burden. On the other hand, a greater FP burden favoured a lower eccentricity index, indicating less circular expansion. Thus, greater FP area, FP thickness, and FP arc angle resulted in a more eccentric scaffold expansion. CONCLUSION: In contrast to previously studied BRS, the expansion and eccentricity characteristics of the novolimus-eluting scaffold did not show the strong dependency of plaque composition, morphology, and burden. As assessed by OCT, only eccentricity was significantly affected by the FP burden. A greater FP plaque arc in our cohort and device-specific properties, e.g. self-correction, may explain the lack of a relationship between plaque, expansion, and eccentricity.

Annular versus supra-annular sizing for TAVI in bicuspid aortic valve stenosis.

AIMS: We sought to compare annular versus supra-annular sizing for transcatheter aortic valve implantation (TAVI) in patients with a bicuspid aortic valve (BAV). METHODS AND RESULTS: In this retrospective single-centre analysis, we measured the aortic annulus (Ann) and intercommissural distance (ICD) on multidetector computed tomography scans in 217 BAV patients. With annular sizing being the default method for prosthesis size selection in all cases, we determined clinically relevant sizing errors and assessed the hypothetical impact of supra-annular sizing. Overall there was no significant difference between ICD and Ann (25.1 [23.5; 27.3] vs. 25.4 [23.6; 27.1] mm; p=0.24); intra-individually, ICD was similar to Ann in 26.7%, smaller in 40.1%, and larger in 33.2%. Annular sizing was appropriate in 96.3%, oversized in 0.5%, and undersized in 3.2% of cases. Supra-annular sizing would have resulted in a divergent size selection in 38.7% (smaller: 17.5%, larger: 19.8%, ICD out of range for TAVI prostheses: 1.4%) with potential improvement in a few cases with annular sizing errors, but potential worsening due to improper size selection in a much larger proportion of patients. CONCLUSIONS: Annular sizing for TAVI in BAV is feasible and safe. The added value of supra-annular sizing is questionable.

Everolimus- Versus Novolimus-Eluting Bioresorbable Scaffolds for the Treatment of Coronary Artery Disease: A Matched Comparison.

OBJECTIVES: The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario. BACKGROUND: eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients. METHODS: Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis. RESULTS: A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups. CONCLUSIONS: The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed.

Long-term clinical outcome after implantation of the self-expandable STENTYS stent in a large, multicenter cohort.

OBJECTIVE: The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort. BACKGROUND: Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis. PATIENTS AND METHODS: Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4-3.3) years. RESULTS: TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF. CONCLUSION: Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.

Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R.

AIMS: The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R). METHODS AND RESULTS: Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001. CONCLUSIONS: cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.

Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R).

AIMS: The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). METHODS AND RESULTS: A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. CONCLUSIONS: GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Long Coronary Lesions: A Subanalysis of the International, Multicenter GHOST-EU Registry.

OBJECTIVES: The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for "long coronary lesions." BACKGROUND: The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers. METHODS: The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization. RESULTS: Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). CONCLUSIONS: In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

Everolimus-eluting bioresorbable scaffold implantation for the treatment of bifurcation lesions - Implications from early clinical experience during daily practice.

BACKGROUND/PURPOSE: The clinical performance of bioresrobable scaffolds (BRSs) in bifurcation lesion is not well investigated so far and information can currently mostly be gleaned from the results of bench testing. The present analysis evaluates the technical feasibility of BRS use in this type of lesion and its mid-term clinical outcome. METHODS/MATERIALS: Consecutive patients with bifurcation lesions treated with at least one everolimus-eluting BRS were enrolled. Procedural success was defined as successful delivery and deployment of at least one BRS and a residual diameter stenosis ≤30%. The primary endpoint (major adverse cardiac events, MACE) included death due to cardiac cause, clinically driven percutaneous or surgical target lesion revascularization (TLR), and any myocardial infarction at the 12-month follow-up. RESULTS: A total of 28 patients were eligible for this evaluation. Median age was 67 (52-73) years and in 46.4% (13/28) an acute coronary syndrome was present. The procedural success rate was 97.1% (33/34). The 1-year Kaplan Meier event rates for MACE, target lesion revascularization, and scaffold thrombosis were 16.1%, 12.1%, and 8.1%, respectively. Half of these patients discontinued the antiplatelet therapy prematurely. CONCLUSIONS: The results for BRS use in bifurcation lesions are not in line with previous studies investigating primarily simple lesions. The impaired outcomes are most likely related to the early stage of BRS use and an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. Hypothesis generated from this investigation has to be proven in further studies. SUMMARY: Technical feasibility of everolimus-eluting bioresorbable scaffold implantation in bifurcation lesion and the clinical mid-term outcomes were evaluated in a real world scenario. Technical success rate was high; however the clinical results were not in line with previous studies investigating primarily simple lesions. The impaired outcomes were mostly driven by an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy.

Bioabsorbable vascular scaffold overexpansion: insights from in vitro post-expansion experiments.

AIMS: While bioresorbable vascular scaffolds (BVS) are increasingly used in clinical practice, their behaviour when post-dilated beyond their recommended maximum overexpansion diameter remains sparsely documented. We aimed to test the overexpansion of the BVS scaffold in vitro and evaluate the impact of excessive scaffold oversizing on focal point support. METHODS AND RESULTS: We examined the post-expansion behaviour of the bioresorbable vascular scaffold (3.0 mm and 3.5 mm Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) after overexpansion with non-compliant (NC) balloons of increasing diameters. After each oversizing step, the scaffolds were measured and inspected for strut disruption using microscope and optical coherence tomography imaging. Point force mechanical measurements on single scaffold struts were also performed to evaluate the impact of excessive scaffold overstretching on focal mechanical support. 3.0 mm and 3.5 mm scaffold sizes could be post-expanded up to 1 mm above their nominal diameters without any strut fracture when deployed without an external constraining model. Importantly, when overexpansion of both scaffold sizes was repeated using a constraining silicone lesion model, only post-expansion with an NC balloon size 0.5 mm larger than the scaffold nominal sizes could be performed without strut fractures. Point force compression analysis on single struts shows that overstretched struts with fractures provided lower focal strength compared to overexpanded ring segments without fractures and normal segments expanded at nominal pressure. CONCLUSIONS: In our experiments, only overexpansion with an NC balloon 0.5 mm larger than the BVS size was feasible for BVS deployed inside an arterial lesion model. Overexpansion of the BVS scaffold beyond recommended post-dilation limits can lead to strut disconnections and focal loss of mechanical support.

Current status of bioresorbable scaffolds in the treatment of coronary artery disease.

State-of-the-art drug-eluting metal stents are the gold standard for interventional treatment of coronary artery disease. Although they overcome some disadvantages and limitations of plain balloon angioplasty and bare-metal stents, some limitations apply, most notably a chronic local inflammatory reaction due to permanent implantation of a foreign body, restriction of vascular vasomotion due to a metal cage, and the risk of late and very late stent thrombosis. The development of biodegradable scaffolds is a new approach that attempts to circumvent these drawbacks. These devices provide short-term scaffolding of the vessel and then dissolve, which should theoretically circumvent the side effects of metal drug-eluting stents. Various types of these bioresorbable scaffolds are currently under clinical evaluation. This review discusses different concepts of bioresorbable scaffolds with respect to material, design, and drug elution and presents the most recent evidence.

Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold.

OBJECTIVES: To evaluate safety and efficacy of the everolimus-eluting bioresorbable scaffold (BVS) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: According to the current guidelines, drug-eluting stents are the treatment of choice in patients with STEMI. BVS represents a new technology capable to restore the native vessel vasomotion and potentially avoiding long-term limitations such as stent thrombosis. METHODS: From October 2012 to May 2013, patients with evidence of STEMI eligible for BVS implantation were included in this study. Exclusion criteria were not defined. RESULTS: A total of 25 patients, respectively 31 lesions, were treated. Procedural success was achieved in 97%. Two major adverse cardiac events occurred during hospitalization and follow-up: one patient with cardiogenic shock at the index procedure subsequently died. One patient suffered from instable angina with need for interventional revascularization of a previously untreated vessel. One target vessel failure as a consequence of an intra-procedural dissection was seen. However, no target lesion failure was noted. During 132.7 ± 68.7 days of follow-up none of the patients died. CONCLUSION: Our findings suggest that implantation of BVS in STEMI patients is feasible in this small cohort of highly selected patients. Further evaluation in randomized-controlled trials is needed.

Cobalt-chrome MULTI-LINK VISION-stent implantation in diabetics and complex lesions: results from the DaVinci-Registry.

AIMS: Restenosis in bare-metal stents is in part related to stent design and material. Optimized strut design of cobalt-chrome (CoCr) stents may yield nearly comparable results to drug-eluting stents (DES) in selected lesions. The prospective multicenter DaVinci registry investigates the clinical outcome of a CoCr coronary stent (MULTI-LINK VISION), particularly in terms of patients with diabetes and complex lesions (B1, B2, C). METHODS AND RESULTS: The prospective internet-based registry included 1,344 patients (76% males, aged 66 +/- 10 years) undergoing stent implantation (n = 1,642) in 32 centres from July 2003 to June 2004. Follow-up data (median 9 +/- 1 months) of this cohort were available for 1,289 patients (98.1%). Of these patients 327 (26.2%) were diabetics. In total, 1,429 de-novo lesions (A 11.9%, B1 47.7%, B2 31.6%, C 8.8%) were treated with the CoCr stent. The predefined primary endpoint was defined as a composite of death, Q-wave myocardial infarction (STEMI), non-STEMI (NSTEMI), target vessel revascularization (TVR) by coronary bypass graft (CABG) or PCI at 270 days (target vessel failure, TVF). Secondary endpoints include death, time to the first myocardial infarction, TVR and CABG. The cumulative incidence of major adverse cardiac events (MACE) was 12.4% with 0.8% deaths, 1.5% non-fatal MI, and 9.7% TVR. TVF in the overall cohort was documented in 137 (10.8%) patients. For diabetics and complex lesions TVF was 13.8% (95% CI 4.2-18) and 11.4% (95% CI 2.0-13.3), respectively. CONCLUSION: This large registry confirms good acute and long-term success of CoCr stents making this strategy valuable, particularly in a special cohort (diabetics and complex lesions) as long as late stent thrombosis with DES plays a role and short-term antiplatelet therapy is favoured.

How to revascularize patients with diabetes mellitus: bypass or stents and drugs?

The diabetic patient is at high risk for coronary artery disease. Incidence as well as severity of the disease is highly increased in comparison to non-diabetic patients. The revascularization of the diabetic patient is a great challenge, since the longterm results are disappointing when compared to non-diabetic patients. The success of coronary artery bypass grafting is limited by increased perioperative mortality and a faster occlusion of especially venous bypass grafts. In percutaneous interventions the excessive high restenosis rates worsen longterm results. Several clinical trials investigated the outcome of the two revascularization strategies and could demonstrate at least a tendency towards better results when the operative approach was chosen. Particularly, the BARI trial showed reduced mortality for surgery when compared to percutaneous coronary interventions. However, in this trial, in 87% of patients undergoing bypass surgery all stenoses were successfully treated, whereas in patients undergoing percutaneous coronary intervention only 76% of all stenoses were primarily successfully treated. In addition, no stents were used in this trial.Furthermore, the enrollment of the previous trials dates one decade ago. These trials do therefore not necessarily represent the current standard therapy, especially for percutaneous coronary interventions. The restenosis rate could be decreased in recent years by means of drug-eluting stents and an aggressive antiplatelet therapy from more than 50% to less than 10% leading to considerably improved long-term results. Therefore, percutaneous coronary interventions have developed to be a reasonable alternative to bypass surgery. Different clinical trials are currently underway (BARI 2D, CarDIA, FREEDOM) comparing the outcome of the two approaches.