Predictors of long-term adverse events after Absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

AIMS: The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p<0.001) were independent predictors of MACE, whereas the use of intravascular imaging was independently associated with a reduction in MACE (HR 0.13, 95% CI: 0.06 to 0.28; p<0.001). CONCLUSIONS: Optimal Absorb BVS implantation and the use of intravascular imaging guidance are associated with lower rates of adverse events at long-term follow-up.

Mid-term outcomes of the Absorb BVS versus second-generation DES: A systematic review and meta-analysis.

BACKGROUND: Bioresorbable Vascular Scaffolds (BVS) were introduced to overcome some of the limitations of drug-eluting stent (DES) for PCI. Data regarding the clinical outcomes of the BVS versus DES beyond 2 years are emerging. OBJECTIVE: To study mid-term outcomes. METHODS: We searched online databases (PubMed/Medline, Embase, CENTRAL), several websites, meeting presentations and scientific session abstracts until August 8th, 2017 for studies comparing Absorb BVS with second-generation DES. The primary outcome was target lesion failure (TLF). Secondary outcomes were all-cause mortality, myocardial infarction, target lesion revascularization (TLR) and definite/probable device thrombosis. Odds ratios (ORs) with 95% confidence intervals (CIs) were derived using a random effects model. RESULTS: Ten studies, seven randomized controlled trials and three propensity-matched observational studies, with a total of 7320 patients (BVS n = 4007; DES n = 3313) and a median follow-up duration of 30.5 months, were included. Risk of TLF was increased for BVS-treated patients (OR 1.34 [95% CI: 1.12-1.60], p = 0.001, I2 = 0%). This was also the case for all myocardial infarction (1.58 [95% CI: 1.27-1.96], p<0.001, I2 = 0%), TLR (1.48 [95% CI: 1.19-1.85], p<0.001, I2 = 0%) and definite/probable device thrombosis (of 2.82 (95% CI: 1.86-3.89], p<0.001 and I2 = 40.3%). This did not result in a difference in all-cause mortality (0.78 [95% CI: 0.58-1.04], p = 0.09, I2 = 0%). OR for very late (>1 year) device thrombosis was 6.10 [95% CI: 1.40-26.65], p = 0.02). CONCLUSION: At mid-term follow-up, BVS was associated with an increased risk of TLF, MI, TLR and definite/probable device thrombosis, but this did not result in an increased risk of all-cause mortality.

Impact of calcium on procedural and clinical outcomes in lesions treated with bioresorbable vascular scaffolds - A prospective BRS registry study.

BACKGROUND: There is limited data on the impact of calcium (Ca) on acute procedural and clinical outcomes in patients with lesions treated with bioresorbable vascular scaffolds (BRS). We sought to evaluate the effect of calcium on procedural and clinical outcomes in a 'real world' population. METHODS: Clinical outcomes were compared between patients with at least 1 moderately or heavily calcified lesion (Ca) and patients with no/mild calcified lesions (non-Ca) enrolled in our institutional BRS registry. RESULTS: 455 patients (N) with 548 lesions (L) treated with 735 BRS were studied. Patients in the Ca group (N=160, L=200) had more complex (AHA B2/C lesion: 69.0% in Ca vs 14.9% in non-Ca, p<0.001) and significantly longer lesions (27.80±15.27 vs 19.48±9.92mm, p<0.001). Overall device success rate was 99.1% with no significant differences between the groups. Despite more aggressive lesion preparation and postdilation compared to non Ca, acute lumen gain was significantly less in Ca lesions (1.50±0.66 vs 1.62±0.69mm, p=0.040) with lower final MLD (2.28±0.41 vs 2.36±0.43, p=0.046). There were no significant differences in all-cause mortality, total definite scaffold thrombosis (ST), target lesion revascularization and myocardial infarction between the 2 groups. Late ST was more frequent in the Ca group compared to non Ca group (late ST: 2.1 vs 0%, p=0.02). CONCLUSIONS: Clinical outcomes after BRS implantation in calcified and non-calcified lesions were similar. A remarkable difference in timing of thrombosis was observed, with an increased rate of late thrombosis in calcified lesions.

Conformability in everolimus-eluting bioresorbable scaffolds compared with metal platform coronary stents in long lesions.

The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm-1, p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (median diastolic curvature from 0.305 to 0.283 cm-1, p = 0.056). Median Percentage relative change in diastolic curvature was lower in the BRS group compared with the MPS group (BRS vs. MPS: 7.48 vs. 29.4%, p = 0.013). By univariate analysis, use of MPS was an independent predictor of change in diastolic curvature (p = 0.022). In the deployment of long coronary scaffolds/stents (28 mm in length), BRS provides better conformability compared with MPS.

Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months.

AIMS: The aim of this study was to investigate the impact of dual antiplatelet therapy (DAPT) termination on late and very late scaffold thrombosis (ScT) in patients treated with the Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: Data from the registries of three centres were pooled (808 patients). To investigate the effect of DAPT termination on ScT after a minimum of six months, we selected a subgroup ("DAPT study cohort" with 685 patients) with known DAPT status >6 months and excluded the use of oral anticoagulants and early ScT. In this cohort, definite/probable ScT incidence for the period on DAPT was compared to ScT incidence after DAPT termination. ScT incidence was 0.83 ScT/100 py with 95% confidence interval (CI): 0.34-1.98. After DAPT termination, the incidence was higher (1.77/100 py; 95% CI: 0.66-4.72), compared to the incidence on DAPT (0.26/100 py, 95% CI: 0.04-1.86; p=0.12) and increased within the month after DAPT termination (6.57/100 py, 95% CI: 2.12-20.38; p=0.01). No very late ScT occurred in patients who continued on DAPT for a minimum of 18 months. CONCLUSIONS: The incidence of late and very late definite/probable ScT was acceptable. The incidence was low while on DAPT but potentially higher when DAPT was terminated before 18 months.

Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions.

AIMS: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). METHODS AND RESULTS: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. CONCLUSIONS: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Expanded clinical use of everolimus eluting bioresorbable vascular scaffolds for treatment of coronary artery disease.

BACKGROUND: Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice. METHODS: This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported. RESULTS: A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%. CONCLUSIONS: The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.

Comparison of acute expansion of bioresorbable vascular scaffolds versus metallic drug-eluting stents in different degrees of calcification: An Optical Coherence Tomography Study.

OBJECTIVES: The acute expansion of bioresorbable vascular scaffolds (BRS) and drug-eluting stents (DES) in lesions with different extent of calcification was compared by Optical Coherence Tomography (OCT). BACKGROUND: The acute mechanical performance of polymeric BRS in calcified lesions is poorly understood. METHODS: Acute device performance in lesions treated with either BRS(N = 50) or DES (N = 50) was compared using Optical Coherence Tomography (OCT). According to angiographic degree of calcification the lesions were divided in three groups: no/mild, moderate and heavy calcification. Device performance was assessed with the following parameters by OCT: mean scaffold area, eccentricity index (EI), symmetry index (SI) and percentage incomplete strut apposition (ISA). RESULTS: One hundred lesions from 85 patients (BRS/DES; 37/48) were analyzed. Scaffold area and SI were similar between BRS and DES groups in the three calcification subgroups. Compared to DES, EI in BRS was marginally lower in the no/mild calcification group (0.86 ± 0.03 versus 0.88 ± 0.03, p = 0.018) but was similar in the moderate and heavy calcification groups. Compared to DES, percentage ISA struts in BRS was similar in the no/mild calcification group and was significantly lower in the moderate and heavy calcification groups (2.96 ± 2.36 versus 6.78 ± 4.61%, p = 0.002 and 1.82 ± 2.40 versus 8.89 ± 8.25%, p = 0.025 respectively). CONCLUSIONS: With adequate lesion preparation, implantation of BRS in a population reflective of clinical practice, resulted in a similar luminal gain compared to DES as measured by OCT, regardless of the degree of angiographic calcification, while acute malapposition is lower with BRS in moderately and heavily calcified lesions. The clinical significance of our findings warrants further evaluation in future studies. © 2016 Wiley Periodicals, Inc.

Mid- to Long-Term Clinical Outcomes of Patients Treated With the Everolimus-Eluting Bioresorbable Vascular Scaffold: The BVS Expand Registry.

OBJECTIVES: This study sought to report on clinical outcomes beyond 1 year of the BVS Expand registry. BACKGROUND: Multiple studies have proven feasibility and safety of the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California). However, data on medium- to long-term outcomes are limited and available only for simpler lesions. METHODS: This is an investigator-initiated, prospective, single-center, single-arm study evaluating performance of the BVS in a lesion subset representative of daily clinical practice, including calcified lesions, total occlusions, long lesions, and small vessels. Inclusion criteria were patients presenting with non-ST-segment elevation myocardial infarction, stable/unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native previously untreated coronary artery. Procedural and medium- to long-term clinical outcomes were assessed. Primary endpoint was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization. RESULTS: From September 2012 to January 2015, 249 patients with 335 lesions were enrolled. Mean number of scaffolds per patient was 1.79 ± 1.15. Invasive imaging was used in 39%. In 38.1% there were American College of Cardiology/American Heart Association classification type B2/C lesions. Mean lesion length was 22.16 ± 13.79 mm. Post-procedural acute lumen gain was 1.39 ± 0.59 mm. Median follow-up period was 622 (interquartile range: 376 to 734) days. Using Kaplan-Meier methods, the MACE rate at 18 months was 6.8%. Rates of cardiac mortality, myocardial infarction, and target lesion revascularization at 18 months were 1.8%, 5.2%, and 4.0%, respectively. Definite scaffold thrombosis rate was 1.9%. CONCLUSIONS: In our study, BVS implantation in a complex patient and lesion subset was associated with an acceptable rate of adverse events in the longer term, whereas no cases of early thrombosis were observed.

Differential thrombotic prolapse burden in either bioresorbable vascular scaffolds or metallic stents implanted during acute myocardial infarction: The snowshoe effect: Insights from the maximal footprint analysis.

BACKGROUND: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated. METHODS: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed. RESULTS: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group. CONCLUSIONS: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material.

Everolimus-eluting bioresorbable vascular scaffolds implanted in coronary bifurcation lesions: Impact of polymeric wide struts on side-branch impairment.

BACKGROUND: Limited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment. METHODS: Patients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported. RESULTS: A total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm(2) vs Final: 2.17±1.09mm(2), p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11. CONCLUSIONS: The results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm.

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study.

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.

Neural substrates of spontaneous narrative production in focal neurodegenerative disease.

Conversational storytelling integrates diverse cognitive and socio-emotional abilities that critically differ across neurodegenerative disease groups. Storytelling patterns may have diagnostic relevance and predict anatomic changes. The present study employed mixed methods discourse and quantitative analyses to delineate patterns of storytelling across focal neurodegenerative disease groups, and to clarify the neuroanatomical contributions to common storytelling characteristics. Transcripts of spontaneous social interactions of 46 participants (15 behavioral variant frontotemporal dementia (bvFTD), 7 semantic variant primary progressive aphasia (svPPA), 12 Alzheimer's disease (AD), and 12 healthy older normal controls (NC)) were analyzed for storytelling frequency and characteristics, and videos of the interactions were rated for patients' level of social attentiveness. Compared to controls, svPPAs told more stories and autobiographical stories, and perseverated on aspects of self during the interaction, whereas ADs told fewer autobiographical stories than NCs. svPPAs and bvFTDs were rated as less attentive to social cues. Aspects of storytelling were related to diverse cognitive and socio-emotional functions, and voxel-based anatomic analysis of structural magnetic resonance imaging revealed that temporal organization, narrative evaluations patterns, and social attentiveness correlated with atrophy corresponding to known intrinsic connectivity networks, including the default mode, limbic, salience, and stable task control networks. Differences in spontaneous storytelling among neurodegenerative groups elucidated diverse cognitive, socio-emotional, and neural contributions to narrative production, with implications for diagnostic screening and therapeutic intervention.

Treatment of bioresorbable scaffold failure.

Bioresorbable scaffolds (BRS) are a promising new interventional treatment strategy for coronary artery disease (CAD). They are intended to overcome some of the shortcomings of metal drug-eluting stents (DES), mainly late reinterventions which occur at a consistent rate after one year and have not been reduced by the use of local drug elution. Initial experience in non-complex lesions established efficacy in opening the vessel and the concept of bioresorption. However, with the use of BRS in more complex lesions, the incidence of BRS failure, including both scaffold restenosis and thrombosis, has also increased. Therefore, understanding of both the pathophysiology and of the available treatment options of scaffold failure remains an important issue in ensuring procedural and long-term clinical success.

Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience.

BACKGROUND: As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been reported. We present angiographic and optical coherence tomography (OCT) findings in a series of patients treated in our center for definite bioresorbable scaffold thrombosis. METHODS AND RESULTS: Up to June 2014, 14 patients presented with definite BVS thrombosis in our center. OCT was performed in 9 patients at the operator's discretion. Angiographic and OCT findings were compared with a control group comprising 15 patients with definite metallic stent thrombosis. In the BVS group, time interval from index procedure to scaffold thrombosis ranged from 0 to 675 days. Incomplete lesion coverage by angiography was identified in 4 of 14 cases, malapposition by OCT in 5 of 9 cases, strut discontinuity in 2 of 9 cases, and underexpansion in 2 of 9 cases. Five patients had discontinued dual antiplatelet therapy, and in 3 of them discontinued dual antiplatelet therapy discontinuation had occurred the week preceding the event. There were no significant differences in angiographic or OCT findings between BVS and metallic stent thrombosis. CONCLUSIONS: Suboptimal implantation with incomplete lesion coverage, underexpansion, and malapposition comprises the main pathomechanism for both early and late BVS thrombosis, similar to metallic stent thrombosis. Dual antiplatelet therapy discontinuation seems to also be a secondary contributor in several late events. Our observations suggest that several potential triggers for BVS thrombosis could be avoided.

Appropriate use of bioresorbable vascular scaffolds in percutaneous coronary interventions: a recommendation from experienced users : A position statement on the use of bioresorbable vascular scaffolds in the Netherlands.

Percutaneous coronary interventions (PCI) have become a reliable revascularisation option to treat ischaemic coronary artery disease. Drug-eluting stents (DES) are widely used as first choice devices in many procedures due to their established good medium to long term outcomes. These permanent implants, however, do not have any residual function after vascular healing following the PCI. Beyond this initial healing period, metallic stents may induce new problems, resulting in an average rate of 2 % reinterventions per year. To eliminate this potential late limitation of permanent metallic DES, bioresorbable coronary stents or 'vascular scaffolds' (BVS) have been developed. In a parallel publication in this journal, an overview of the current clinical performance of these scaffolds is presented. As these scaffolds are currently CE marked and commercially available in many countries and as clinical evidence is still limited, recommendations for their general usage are needed to allow successful clinical introduction.

Current status of clinically available bioresorbable scaffolds in percutaneous coronary interventions.

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.