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Competing Interests: Declaration of competing interest Authors report the following disclosures of conflicts of interest.

Background: Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent., Methods: This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure., Conclusions: This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent., Condensed Abstract: The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus., Competing Interests: Declaration of competing interest Shigeru Saito receives consulting fees from Elixir Medical which are paid to the NPO International TRI network, Holger Nef reports honoraria, payments for expert testimony, and support for attending meeting from Elixir Medical, Mark Webster reports research support from Elixir Medical to its institution, Stefan Verheye reports research support from Elixir Medical to its institution, consulting fees from Elixir and Neovasc, and honoraria for lecturers etc. from Elixir and Neovasc., (Copyright © 2023. Published by Elsevier Inc.)

Background: Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate., Methods: We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator., Results: In total, 3137 patients included by 92 centers received percutaneous coronary interventions (PCI) for acute MI in 51.5% and non-acute settings in 48.5%. RA was performed in 47.8% and had a higher median radiation exposure (3896 vs. 3082 cGycm 2 , p < 0.001). There was no difference in the amount of contrast used. There was also no difference in all-cause mortality (0.53% vs. 0.49%, p = 0.86), the combination of death, MI and stroke (1.87% vs. 1.83%, p = 0.94), but a trend towards more TMB (0.47% vs. 1.04%, p = 0.07) with FA. These outcomes were consistent across the subgroups of patients with ST-elevation MI, non-ST-elevation-ACS and stable coronary artery disease. Finally, QoL did not differ between RA and FA., Conclusions: In this contemporary GABI-R cohort, in which access site was left to the discretion of the operator, both access routes were safe and equal concerning QoL (ClinicalTrials.gov; NCT02066623)., Competing Interests: Declaration of competing interest, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population., Background: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation., Methods: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics., Results: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST., Conclusions: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: To identify potential differences in 2-year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS)., Background: Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus-eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated., Methods: German-Austrian ABSORB RegIstRy is a prospective all-comer multi-center observational study of consecutive patients who were considered for coronary revascularization with BVS. We compared 1499 patients with stable CAD to 1594 patients with ACS. Endpoints were major adverse cardiac events (MACE), TLF, and scaffold thrombosis., Results: While single vessel disease was more prevalent in ACS (46% vs. 37%, p < 0.0001), lesion complexity (B2/C stenosis 37% vs. 36%, bifurcation 2.4% vs. 3.4%, p < 0.05), number of implanted scaffolds/patient (1.34 vs. 1.43), scaffold length (18 vs. 18 mm) or the rate of high pressure postdilatation (68% vs. 70%) did not differ between ACS and stable CAD. Two-year MACE rates were 11.6% in ACS and 11.4% in stable CAD, TLF occurred in 7.0% versus 7.4% and target vessel revascularization in 8.8 versus 10.2% (n.s. for all). Definite scaffold thrombosis rates were not significantly different (ACS 1.9% vs. stable CAD 2.1%)., Conclusion: Real-world 2-year event rates after coronary revascularization with BVS are not significantly different between individuals with ACS as compared to stable CAD., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Aims: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure., Methods and Results: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT., Conclusion: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Interventional cardiovascular medicine has seen constant progress over the last few decades. Since the first angiograms and percutaneous transluminal coronary angioplasty were carried out, this progress has been tremendous and has led to a substantial decline in cardiovascular morbidity and mortality. The purpose of this article is to report and review the latest developments and evidence in robotics-assisted percutaneous coronary intervention (rPCI) and its potential future applications, opportunities, and limitations. Contemporary evidence shows that rPCI can lead to a significant reduction in radiation exposure as well as medical hazards for cardiologists. Rates of device and procedural success remain high and there is no evidence of a disadvantage for the patient. The accuracy of implantation with a reduced geographic mismatch is a further advantage that can result in a higher quality of treatment. Even in complex coronary lesions and procedures, rPCI seems to be safe and efficient. The latest developments include telestenting over hundreds of kilometers from a remote platform. Currently, the main limitations are the absence of large-scale randomized trials for the valid assessment of the benefits and disadvantages of rPCI as well as the technical limitations of the currently available rPCI systems. rPCI is a forward-looking innovation in cardiology that is applicable to a wide range of coronary interventions. Despite the present lack of knowledge and the limited data concerning the outcome for the patient, the available literature reveals promising results that should lead to improvements for physicians and patients.

Aims: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region., Methods and Results: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures., Conclusion: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.

Objectives: The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation., Background: Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse., Methods: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed., Results: A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years., Conclusions: Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Background: Limited data exist on bioresorbable scaffolds (BRS) in patients with acute coronary syndrome (ACS). The aim of the present study was to evaluate novolimus-eluting BRS (DESolve) as interventional treatment for patients with ACS, and to compare its 12-month outcomes with the everolimus-eluting bioresorbable scaffolds (Absorb)., Methods: In this retrospective study, patients with ACS (including unstable angina pectoris, ST-segment elevation myocardial infarction, or non-ST-segment elevation myocardial infarction) treated with either the Absorb or the DESolve BRS were evaluated in a 1:1 matched-pair analysis. Major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization, were evaluated as a major endpoint. The occurrence of scaffold thrombosis was also assessed., Results: A total of 102 patients were eligible for this analysis. The rate of MACE at 12 months was comparable between the Absorb and the DESolve group (8.3% vs. 6.8%, p = 0.738). The occurrence of target lesion revascularization (6.2% vs. 4.7%; p = 0.700) and scaffold thrombosis (4.1% vs. 2.1%; p = 0.580) was comparable as well. All instances of scaffold thrombosis occurred within 30 days of the index procedure., Conclusion: In this study, similar 12-month event rates were observed for both BRS types after implantation for the treatment of ACS.

Objective: To investigate the outcomes after bioresorbable scaffold (BRS) implantation in calcified coronary lesions. In calcified coronary lesions, durable metallic drug-eluting stent (DES) implantation is associated with worse clinical outcomes compared to noncalcified lesions. Although not recommended, BRSs were frequently implanted in calcified lesions in clinical practice. Their outcome is not well investigated., Methods: Between November 2013 and January 2016, 3326 patients were enrolled in the German-Austrian ABSORB ReglstRy (GABI-R). Lesion calcification severity was classified into no (n = 1144), mild (n = 1306), and moderate-to-severe (n = 690) calcification., Results: Patients with calcification were older (none: 59.1 ± 11.2 vs. mild: 61.6 ± 10.9 vs. moderate to severe: 62.4 ± 10.5 years, P < 0.001), had more diabetes (19.1 vs. 20.8 vs. 23.9%, P = 0.015), and more often had previous myocardial infarction (MI) (19.3 vs. 23.1 vs. 25.4%, P = 0.002). Despite a higher rate of postdilatations (P < 0.001), lesions with calcification had more residual stenosis (2.05 ± 9.36% vs. 3.11 ± 9.36% vs. 3.89 ± 9.39%, P < 0.001). Consequently, procedural success was achieved in 97.7 vs. 96.2 vs. 93.6% of cases in none, mild, and moderate-to-severe calcification (P < 0.001). At 24 months, cardiac death (0.3 vs. 0.7 vs. 1.6%, P = 0.009) was higher with increasing calcification. However, no significant between-group difference was observed in the incidence of target vessel MI, target vessel revascularization, or target lesion failure. The rate of probable scaffold thrombosis was significantly higher with increasing calcification., Conclusion: In GABI-R, ABSORB scaffolds in calcified lesions required more postdilation, led to more residual stenosis, but did not portend increased target lesion revascularization over 2 years. Nevertheless, coronary calcification severity emerged as a cardiovascular risk marker and was predictive of cardiovascular mortality. Clinicaltrial.gov NCT02066623.

Background: There is a large body of literature on acute myocardial infarction complicated by cardiogenic shock. However, very little is known about patients who are initially haemodynamically stable and develop cardiogenic shock during percutaneous coronary intervention., Methods: A total of 47,407 consecutive patients were prospectively enrolled in the PCI Registry of the Euro Heart Survey Programme. We analysed interventions with peri-procedural complications that were classified as 'shock induced by procedure' on the case report form. Clinical and procedural characteristics as well as hospital outcomes of haemodynamically stable patients who developed cardiogenic shock during percutaneous coronary intervention were evaluated. Patients with haemodynamic instability at presentation prior to intervention were excluded., Results: A total of 68 patients (0.2%) developed cardiogenic shock as a complication of percutaneous coronary intervention. The majority of cases comprised acute coronary syndrome (60.3%) with complex lesions (93.1%). Most patients had multi-vessel disease (82.1%) and an ejection fraction less than 40% (58.1%). In the multivariate analysis, left main disease (odds ratio (OR) 9.51), ST-segment elevation myocardial infarction (OR 5.31) and multi-vessel disease without left main involvement (OR 3.32) were the strongest independent predictors of peri-procedural cardiogenic shock. Among these patients procedural success was low (66.1%) and in-hospital mortality was very high (39.7%)., Conclusions: In this real-world registry the rate of haemodynamically stable patients who developed cardiogenic shock during percutaneous coronary intervention was very low. Patients at a priori high risk were more likely to be affected by this complication. The in-hospital mortality rate of these patients was very high.

Background: In randomized clinical trials, the risk of thrombotic events with the absorb bioresorbable vascular scaffold (BVS) was significantly higher than with metallic drug-eluting stents. We evaluated predictors of scaffold thrombosis in the large-scale, multicenter German-Austrian ABSORB RegIstRy., Methods and Results: 3178 patients with treatment of 4252 lesions using 5020 scaffolds were included. Follow-up rate at 6 months was 97.4%. Forty-five (1.42%) patients experienced definite/probable scaffold thrombosis during follow-up. Multiple regression analysis showed implantation of absorb BVS in bifurcation lesions [odds ratio (OR): 4.43; 95% confidence interval (CI): 1.69-11.59; P=0.0024] or treatment in the years 2013/2014 (OR: 1.88; 95% CI: 1.02-3.47; P=0.04) to be significant predictors of scaffold thrombosis. Excluding bifurcation lesions, the incidence of definite/probable scaffold thrombosis decreased from 1.8% (95% CI: 1.17-2.64%) in 2013/2014 to 0.89% (95% CI: 0.5-1.46%) in 2015/2016. In the latter period, absorb BVS were implanted more often in younger patients with less complex de novo lesions, and debulking devices and postdilatation were used more frequently. Between the two treatment periods, there was a significant reduction in myocardial infarction (2.73-1.24%, P<0.01; OR: 0.45; 95% CI: 0.26-0.77), definite/probable scaffold thrombosis (1.79-0.88%, P<0.05; OR: 0.49; 95% CI: 0.26-0.93), and target lesion failure and revascularization during follow-up., Conclusion: Improved procedural technique and more strict patient selection may explain a significant decrease in the absorb BVS thrombosis rates during the recruitment period of the large-scale German-Austrian ABSORB RegIstRy. In addition, treatment of bifurcation lesions was identified as an independent predictor of definite/probable scaffold thrombosis.

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.

Objectives: The objective was to investigate the acute mechanical effects of post-dilatation on bioresorbable scaffolds (BRS) as determined by optical coherence tomography (OCT)., Background: Post-dilatation with high-pressure balloons is regarded as a key component of BRS implantation for treatment of coronary artery stenoses. However, the impact of post-dilatation on BRS in vivo has not been thoroughly investigated., Methods: OCT was performed after the implantation procedure of 51 everolimus-eluting or novolimus-eluting polylactic acid-based BRS with (n = 27) or without non-compliant balloon post-dilatation (n = 24). The number of malapposed struts, strut fractures, edge dissections, residual in-scaffold area stenosis, and incomplete scaffold apposition area was analyzed over the complete length of each BRS with a spacing of 1 mm., Results: OCT revealed a significantly lower incomplete scaffold apposition area if post-dilatation was performed (0.16 ± 0.49 mm 2 with post-dilatation vs. 2.65 ± 2.78 mm 2 without post-dilatation, p < 0.001), as well as a significantly lower absolute number of malapposed struts (1 ± 2 with post-dilatation vs. 13 ± 13 without post-dilatation, p < 0.001). No significant differences regarding residual in-scaffold area stenosis, strut fracture, edge dissection, symmetry index, or eccentricity index were observed in patients with vs. without post-dilatation., Conclusion: Post-dilatation of BRS with non-compliant balloons significantly reduces the number of malapposed struts and incomplete scaffold apposition area without inducing higher rates of edge dissection or strut fracture.

Objectives: To examine ischemic and bleeding outcomes in patients on triple antithrombotic therapy (TAT) compared with dual antiplatelet therapy (DAPT) after the implantation of bioresorbable scaffolds (BRS)., Background: The optimal antithrombotic regimen in patients undergoing percutaneous coronary intervention that have an indication for oral anticoagulation is unclear, in particular among those undergoing BRS implantation., Methods: Consecutive patients of a single-center, all-comers BRS registry were included. Patients were followed up after 30days, 6 and 12months, and thereafter yearly. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), scaffold thrombosis (ST), death, myocardial infarction, and any bleeding as defined by BARC. Patients on TAT were matched to patients on DAPT., Results: A total of 607 patients were included. Fifty-five patients receiving TAT were matched with 165 patients treated with DAPT. Acute coronary syndrome was an indication for coronary angiography in 50.9% vs 50.4% groups (p=0.97). Major adverse cardiac events occurred in 16.4% of TAT patients vs. 8.9% DAPT patients (p=0.12), TLR in 5.5% vs. 1.9% (p=0.17), ST in 3.6% vs. 1.9% (p=0.46), and TVF in 3.6 vs. 1.9% (p=0.46). Patients died in 7.3% in the TAT group vs. 5.1% in the DAPT group (p=0.26). No severe bleeding was recorded in either of the groups., Conclusion: There was no difference in bleeding or ischemic events between the patients on TAT and those on DAPT after BRS implantation. The high rate of scaffold thrombosis in all of these patients, however, is not negligible., (Copyright © 2016. Published by Elsevier B.V.)

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., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The DESolve® scaffold (Elixir Medical Corporation, Sunnyvale, California, USA) is manufactured from a poly-l-lactide based polymer and elutes an anti-proliferative, anti-inflammatory drug, Novolimus from a poly-l-lactide based topcoat mixture. The strut thickness is 150μm and the scaffold has platinum-iridium radiopaque markers at both ends. Radial support is available during the early time period to prevent recoil. The scaffold biodegrades within 1year (>90% reduction in molecular weight) and then completely bioresorbs within 2years. The DESolve® scaffold permits a wide range of expansion with a consequently reduced risk for strut fracture. Lumen and scaffold enlargement is observed within 3-6months in both preclinical and clinical studies potentially allowing for the scaffolded region to respond to vasoactive stimuli. The device has a unique property of self-correction observed in bench top studies, which in clinical practice has the potential to eliminate minor malapposition following deployment., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Introduction and Objectives: The implantation of bioresorbable scaffolds (BRS) is an emerging technique used in percutaneous coronary interventions. Their application has been extended to more complex lesions, although evidence is only available for simple lesions. The present study evaluated scaffold implantation in long lesions, focusing on overlapping scaffolds., Methods: We retrospectively analyzed all consecutive patients eligible for stenting with everolimus-eluting poly-L-lactic acid-based BRS with a minimum total scaffold length of 28mm, irrespective of the number of BRS used. The main target parameters were major adverse cardiac events, comprising cardiac death, any myocardial infarction, and target lesion revascularization, and target lesion failure, including cardiac death, target vessel myocardial infarction, and target lesion revascularization. A subgroup analysis included patients with overlapping BRS., Results: A total of 250 patients were included. The reason for angiography was stable coronary artery disease in 36.4% (91 of 250), an acute coronary syndrome in 61.6% (154 of 250), and other reasons in 2.0% (5 of 250). Procedural success was achieved in 97.8% (267 of 273) of the lesions. During follow-up, the 12-month rates of major adverse cardiac event, target lesion failure, and scaffold thrombosis were 8.5%, 6.6%, and 2.3%, respectively. Subgroup analysis of 239 patients showed that there were no statistically relevant differences between patients with and without overlapping scaffolds after a 12-month follow-up., Conclusions: Long-segment stenting with a single scaffold or with multiple overlapping scaffolds is technically feasible with adequate mid-term outcomes. However, large-scale randomized studies are needed to provide further proof of concept., (Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Bifurcation lesions are a therapeutic challenge in the interventional treatment of coronary artery disease. Thus, consideration of anatomical aspects and selection of the most appropriate strategy for an individual bifurcation have an impact on the interventional outcome. Accordingly, assessment of the type of bifurcation stenosis, including the relevance of the side branches, vessel diameter and the angle between the two branches are critical for the optimal choice of interventional strategy. The fractional flow reserve (FFR) is a parameter that provides a measure of the severity of coronary stenosis and despite some limitations, FFR can be applied to bifurcation lesions. In addition, intravascular imaging tools, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) can be used to determine anatomical configurations.

The clinical benefit of thrombus aspiration (TA) in patients presenting with acute ST-elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) is not well defined. Furthermore, there is a large variation in the use of TA in real-world registries. Between 2005 and 2008, a total of 7146 consecutive patients with acute STEMI undergoing primary PCI were prospectively enrolled into the PCI Registry of the Euro Heart Survey Programme. For the present analysis, patients treated additionally with TA (n = 897, 12.6 %) were compared with those without TA (n = 6249, 87.4 %). Patients with hemodynamic instability at initial presentation (15.1 vs. 11.0 %; p < 0.001) and resuscitation prior to PCI (10.4 vs. 7.4 %; p = 0.002) were more frequently treated with TA. TIMI flow grade 0/1 before PCI was more often found among those with TA (73.5 vs. 58.6 %; p < 0.001). After adjustment for confounding factors in the propensity score analysis, TA was not associated with improved in-hospital survival (risk difference -1.1 %, 95 % confidence interval -2.7 to 0.6 %). In this European real-world registry, the rate of TA use was low. Hemodynamically unstable patients were more likely to be treated with TA. Consistent with the results of the TASTE study and the TOTAL trial, TA was not associated with a significant reduction in short-term mortality.

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., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.

Coronary perforation (CP) is a life-threatening complication that can occur during percutaneous coronary intervention (PCI). Little is known, however, about the incidence and clinical outcome of CP. We sought to investigate the occurrence of CP and its determinants and risk profile in a large-scale, prospective registry. From 2005 to 2008, unselected patients (n = 42,068) from 175 centers in 33 countries who underwent a PCI procedure were prospectively enrolled in the PCI registry of the Euro Heart Survey program. For the present analysis, patients experiencing CP during PCI (n = 124, 0.3%) were compared with those who underwent PCI without CP. Patients with CP were older, more often women, had more severe coronary disease, and underwent more complex types of coronary intervention. Independent factors associated with CP were the use of rotablation, intravascular ultrasound-guided PCI, bypass PCI, a totally occluded vessel, a type C lesion, peripheral arterial disease, and body mass index <25. More than 10% of the patients developed cardiac tamponade. In a small minority (3.3%), emergency bypass surgery had to be performed. The inhospital death rate was markedly elevated in patients with CP (7.3% vs 1.5%, p <0.001). After adjustment for the EuroHeart score, CP remained a strong predictor of hospital mortality (odds ratio 5.21, 95% confidence interval 2.34 to 11.60). In conclusion, in this real world, all-comers registry, the incidence of CP was low, occurred more often in patients who underwent more complex coronary interventions, and was associated with a fivefold higher hospital mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Acute myocardial infarction was one of the most common causes of death in Germany in 2011. According to the guidelines of the European Society for Cardiology, systemic fibrinolysis and primary percutaneous coronary intervention (PCI) are the methods of choice for acute treatment. Primary PCI should be given priority due to its superiority. The transradial access should be preferred due to the lower bleeding complication rate. In the selection of stents the new generation of drug-eluting stents (DES) are superior to the first generation of bare metal stents (BMS). It has now been demonstrated that the incident rates of DES (e.g. mortality, target vessel revascularization, early and late stent thrombosis and myocardial infarction) are significantly lower. For bioresorbable scaffolds (BRS) long-term results for the use in treatment of ST-elevation myocardial infarction (STEMI) are not yet available but initial results are very promising. However, the selection of a stent needs to be done on an individual basis in order to do justice to all aspects. Data with respect to thrombectomy in acute treatment are heterogeneous. Currently, a thorough consideration of all aspects is necessary because thrombus aspiration can also be associated with an increased rate of incidents. In a state of hemodynamic stability only so-called culprit lesions should currently be treated with a stent. Elective interventions on further stenoses should be carried out after consideration of individual factors and if necessary evaluation of the hemodynamic relevance.

Chronic total occlusions of coronary arteries occur in about 20% of patients with suspected coronary artery disease and are more frequent with increasing age. The success rate of interventions is lower (55-80%) compared to conventional lesions (>90%). Coronary CT angiography (coronary CTA) provides information about the occluded segment, which cannot be obtained from invasive angiograms (XA). We therefore hypothesized that preprocedural coronary CTA may improve success rates of percutaneous coronary intervention (PCI) for coronary arteries (CTO). 30 patients with chronic total coronary artery occlusions (mean age 73 years, 26 men) and predicted high complexity were imaged by coronary CTA prior to PCI for CTO. CT data sets were acquired with a 64 detector row dual source scanner and retrograde ECG gating, 0.6 mm collimation and z-flying focal spot, yielding isovoxel spatial resolution of about 0.4 mm. Based on the CT data sets, established complexity criteria for CTO (Euro CTO club, Di Mario et al. in EuroIntervention 3(1):30-43, 2007) were evaluated and compared to invasive coronary angiography. Three-dimensional volume-rendered images of the occluded coronary artery were displayed in the catheterization lab during PCI to guide the advancement of the wire. PCI success, defined as the ability to advance the guide wire into the distal lumen with thrombolysis in myocardial infarction III flow was compared to 43 controls without coronary CTA using propensity score matching based on established criteria of procedural success. The course of the occluded segments was visualized by coronary CTA in all cases. Calcification, lesion length, stump morphology and presence of side branches were underestimated by invasive angiograms when compared to coronary CTA. PCI success rate in 30 patients who underwent pre-procedural CTA was significantly higher than in patients without prior coronary CTA [unmatched: CT 90% (27/30) vs. no CT 63% (27/43), p = 0.009; matched: CT 88% (22/25) vs. no CT 64% (16/25) p = 0.03]. Through information not readily seen on invasive coronary angiography, coronary CTA can significantly enhance success rates of PCI for CTO.

Background: The role of adhoc multi-vessel percutaneous coronary intervention (MV-PCI) in patients with ST elevation myocardial infarction (STEMI) and non ST elevation acute coronary syndromes (NSTE-ACS) has not fully defined yet. Therefore, we sought to evaluate the impact of MV-PCI on in-hospital outcome of patients with MV disease presenting with ACS., Methods and Results: We evaluated 4, 457 haemodynamically stable patients with ACS and at least two major epicardial vessels with ≥70% stenosis of the contemporary Euro Heart Survey PCI registry. They were stratified into four categories: 419 STEMI and 734 NSTE-ACS patients undergoing MV-PCI and 2,118 STEMI and 1,186 NSTE-ACS patients undergoing culprit lesion (CL)-PCI only, respectively. In comparison to patients with CL-PCI hospital mortality was numerically lower among those undergoing MV-PCI for STEMI (1.4 versus 3.4%, P=0.03) and for NSTE-ACS (1.1 versus 2.1%, P=0.10). After adjustment for confounding variables no significant mortality difference was observed among patients treated with MV-PCI for STEMI (OR 0.48, 95%-CI 0.21-1.13) and for NSTE-ACS (OR 0.54, 95%-CI 0.24-1.22). However, the risk for non-fatal postprocedural myocardial infarction was markedly increased among patients undergoing MV-PCI for STEMI (8.8 versus 1.6%, P<0.0001) and for NSTE-ACS (5.3 versus 1.8%, P<0.0001)., Conclusions: In clinical practice MV-PCI in haemodynamically stable with ACS is used only in a minority of patients. There was no significant difference in hospital mortality between patients treated with MV- and CL-PCI, but MV-PCI was associated with a higher rate of postprocedural myocardial infarction., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)