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BACKGROUND: Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce. AIMS: This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group. METHODS: AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT. RESULTS: Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p

Background: In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up. Methods and results: All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p =.840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p =.391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p =.028 and 3.2% vs. 0.5%; p

Objectives This final report from the REMEDEE Registry assessed the long‐term safety and efficacy of the dual‐therapy COMBO stent in a large unselected patient population. Background The bio‐engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual‐therapy pro‐healing stent. Data of long‐term safety and efficacy of the this stent is lacking. Methods The prospective, multicenter, investigator‐initiated REMEDEE Registry evaluated clinical outcomes after COMBO stent implantation in daily clinical practice. One thousand patients were enrolled between June 2013 and March 2014. Results Five‐year follow‐up data were obtained in 97.2% of patients. At 5‐years, target lesion failure (TLF) (composite of cardiac death, target‐vessel myocardial infarction, or target lesion revascularization) was present in 145 patients (14.8%). Definite or probable stent thrombosis (ST) occurred in 0.9%, with no additional case beyond 3‐years of follow‐up. In males, 5‐year TLF‐rate was 15.6 versus 12.6% in females (p = .22). Patients without diabetes mellitus (DM) had TLF‐rate of 11.4%, noninsulin‐treated DM 22.7% (p = .001) and insulin‐treated DM 41.2% (p < .001). Patients presenting with non‐ST segment elevation acute coronary syndrome (NSTE‐ACS) had higher incidence of TLF compared to non‐ACS (20.4 vs. 13.3%; p = .008), while incidence with STE‐ACS was comparable to non‐ACS (10.7 vs. 13.3%; p = .43). Conclusion Percutaneous coronary intervention with the dual‐therapy COMBO stent in unselected patient population shows low rates of TLF and ST to 5 years. Remarkably, no case of ST was noted beyond 3 years.

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. Methods: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. Results: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). Conclusions: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

Background: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. Methods and results: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). Conclusion: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices. Electronic supplementary material The online version of this article (10.1007/s10554-019-01576-y) contains supplementary material, which is available to authorized users.

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Introduction The Genous stent is a bare metal stent (BMS) together with a technique of capturing endothelial progenitor cells. The successor of the Genous endothelial progenitor cell capturing (EPC) stent, the COMBO stent, combines this technique with the drug eluting polymer. The current studies showed promising results of the COMBO stent, however the additional value of EPC technique in overcoming neointimal hyperplasia has yet to be proven. Purpose This study sought to evaluate the efficacy and safety of the Genous EPC stent compared to BMS in a patient population with low risk for restenosis. Methods TRIAS-LR was an investigator-initiated, prospective, multicentre, single blind trial randomizing patients with low risk of restenosis 1:1 to Genous ECS or BMS. Patients were recruited between 2007 and 2014 at 31 sites across Europe. The study enrolment was terminated at 70% of the planned inclusion due to slow enrolment and change of guidelines. Patients or lesions were considered low risk if all of the following criteria were met: 1) reference vessel diameter >2.8mm, 2) lesion length Results In total, 838 patients were enrolled of whom 422 patients with 476 lesions were randomly assigned to Genous EPC stent and 416 patients with 480 lesions to BMS. The mean age was 64 years, 74% were males and in 76% patients were treated in elective setting. At 1 year TLF had occurred in 3.6% (n=15) of the Genous arm and in 6.1% (n=25) of the BMS arm (p=0.094; risk difference of −2.5%). However, this difference disappeared, at 5-years of follow-up; TLF rate was 12.6% (n=51) in the Genous arm versus 14.3% (n=58) in the BMS arm (p=0.385; risk difference of −1.7%). The secondary objective of the composite death or MI at 5 years occurred in 11.6% (n=47) in the Genous arm and 9.9% (n=40) in the BMS arm (p=0.479; risk difference of 1.7%). At 5 years definite stent thrombosis (ST) occurred in 0.5% (n=2) of the Genous arm, no definite ST had occurred in the BMS arm (p=0.162). Conclusion TRIAS-LR trial showed no differences between Genous EPC and BMS throughout 5-year follow-up in patients considered as low risk of restenosis. Kaplan-Meier plot of composite endpoints Funding Acknowledgement Type of funding source: Private company. Main funding source(s): OrbusNeich Medical BV

Background and purpose Diabetes mellitus (DM) is associated with increased risk of cardiovascular events after percutaneous coronary intervention (PCI). To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in patients with DM, we aimed to compare the 2-year outcomes of Absorb BVS versus 2nd generation drug eluting stents Xience (EES) by pooling diabetic patients treated with BVS or EES from two large, randomized controlled trial. Methods Patients with medically-treated DM and treated by Absorb BVS in the COMPARE-ABSORB and AIDA trial were pooled for analysis. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results Out of a total 3515 enrolled subjects in the two trials, 913 were diabetics. Compared with the non-diabetic patients, those with DM were older, more often to have a history of hypercholesterolemia, chronic renal failure, stroke, hypertension, heart failure, peripheral vascular disease and previous PCI. At 2-years, target lesion failure occurred in 10.8% of BVS DM patients and 7.6% of EES DM patients (adjusted HR 1.43, 95% CI: 0.87–2.34, P=0.115). The 2-year rates of cardiac death (2.4% vs 1.6%, P=0.385), TV-MI (5% vs 1.6%, P=0.123) and TLR (7.8% vs 5.8%, P=0.416) showed not significant difference. The 2-year incidence of definite device thrombosis was 3.2% in Absorb BVS versus 0.7% in Xience EES (adjusted HR 4.77, 95% CI: 1.01–22.43, P=0.048). Conclusion This pooling of the diabetic patients from two large scale RCTs compared BVS versus 2nd generation DES, showed an increased rate of device thrombosis in BVS-treated patients at 2 years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Aims Absorb bioresorbable scaffold (BRS) related events were noticed between 1 and 3 years – the approximate time of active scaffold bioresorption. This resulted in the recommendation for 3 year DAPT after Absorb BRS implantation. We aimed to evaluate the safety and efficacy of the Absorb BRS in comparison with Xience everolimus-eluting stent (EES) at 4 years follow-up in large unselected population. In addition, we aimed to assess the value of prolonged DAPT against scaffold thrombosis. Methods AIDA was an investigator-initiated, non-inferiority, multicenter, randomized, all-comers trial. Target vessel failure (a composite of cardiac death, target-vessel myocardial infarction and target-vessel revascularization) and device thrombosis at 4-year follow-up are the primary focus of this analysis. During the trial recommendation for DAPT was changed to up to 3-years post Absorb BVS implantation. Whether this adaption influenced the results after Absorb BVS will be assessed. Results Between August 2013 and December 2015, 1,845 patients were enrolled, of whom 924 were randomized to treatment with Absorb BRS and 921 to Xience EES. The baseline characteristics in the two study arms were well balanced. Of all patients, 18% had diabetes mellitus, more than 50% presented with ACS and the median SYNTAX score was 11. In the Absorb BRS arm, 97% of lesions were predilated and in 74% post-dilatation was performed. Four-year clinical outcomes are currently being adjudicated by an independent clinical event committee. The results will be available at EuroPCR 2020. Conclusions Absorb BRS is associated with higher rates of scaffold thrombosis throughout 3-year of follow-up. The performance of Absorb BRS beyond 3-years, in comparison with the Xience EES, in a large unselected population will be presented. (ClinicalTrials.gov Identifier: NCT01858077) Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Visual Abstract, Highlights • The bioresorption process of the Absorb BVS has been directly characterized only in a normal swine model and indirectly (by imaging surrogates) in clinical studies. • Using multimodality imaging and histology, this study indicates that in a diseased animal model, the resorption and integration of BVS into the arterial wall is not affected by the presence of untreated hyperlipidemia and atherosclerosis progression. • Imaging and histology suggest that BVS degradation progresses similarly in the presence of atherosclerosis compared with earlier data from nonatherosclerotic arteries. However, BVS is not immune to the development of neoatherosclerosis., Summary The integration of the Absorb bioresorbable vascular scaffold (BVS) into the arterial wall has never been tested in an in vivo model of atherosclerosis. This study aimed to compare the long-term (up to 4 years) vascular healing responses of BVS to an everolimus-eluting metallic stent in the familial hypercholesterolemic swine model of atherosclerosis. The multimodality imaging and histology approaches indicate that the resorption and vascular integration profile of BVS is not affected by the presence of atherosclerosis. BVS demonstrated comparable long-term vascular healing and anti-restenotic efficacy to everolimus-eluting metallic stent but resulted in lower late lumen loss at 4 years.

IMPORTANCE: Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI). OBJECTIVES: To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies. DESIGN, SETTING, AND PARTICIPANTS: This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019. INTERVENTIONS: Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy. MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045). CONCLUSIONS AND RELEVANCE: Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01813435

Background: Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events. Methods: We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition. Results: At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76–7.49]; P P P =0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02–3.15]; P =0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63–13.09; P P P P =0.034). Conclusions: The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01813435.

Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT. Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002. Condensed abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.

Background Predictors and clinical outcomes of stent thrombosis (ST) in women have not been well investigated. Present study aimed to identify predictors of definite ST and its impact on mortality in women undergoing percutaneous coronary intervention (PCI). Methods Patient-level data of women enrolled in 26 randomized trials of DES was pooled. The study population was stratified based on the presence or absence of definite ST. Cox proportional hazards models were used to determine the predictors of definite ST. To analyze the temporal impact of definite ST on mortality Cox regression with ST entered as time-updated covariate was used. Results Of 11,557 patients undergoing PCI with stent implantation, definite ST occurred in 105 patients (0.9%) over median follow-up of 3years. Independent predictors of ST were age (HR 1.03 per year decrease, 95% CI 1.00–1.05; p =0.041), diabetes mellitus (HR 2.25, 95% CI 1.27–3.99; p =0.005), non-ST-segment elevation myocardial infarction (NSTEMI) at presentation (HR 1.97, 95% CI 1.04–3.75; p =0.037) and stent diameter (HR 3.76 per mm decrease, 95% CI 1.66–8.53; p =0.002). Compared to women without ST, the adjusted hazard ratios for mortality in the first 7days, 8–30days, and beyond 30days from ST were 115.81 (95% CI 68.96–194.47); 37.44 (95% CI 17.31–80.98); 3.54 (95% CI 2.20–5.69), respectively. Conclusions In this large-scale pooled analysis of women, definite ST was uncommon yet associated with substantial mortality risk, which peaked early and rapidly attenuated over time. Younger age, diabetes, NSTEMI and stent diameter were found to be predictors of ST.

The percutaneous coronary intervention has undergone rapid evolution over the last 40 years and has become one of the most widely performed medical procedures. The introduction of intracoronary stents improved the safety and efficacy of percutaneous coronary intervention. But with the advent of stenting, a new potentially fatal enemy emerged: stent thrombosis. Ever since, adjunct pharmacological therapy, stent technique and technology have been adjusted to reduce the risk of stent thrombosis. The aim of the present article is to provide an overview of past, present and future aspects of percutaneous intervention in relation to stent thrombosis.

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.

AIMS Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention, might lead to better outcomes when compared to conventional treatment. ACS patients (STE-ACS patients in particular) are generally younger, and most often have lesions with softer plaques, a lower plaque burden and less extensive coronary artery disease. In this pre-specified subgroup analysis of the AIDA trial, we evaluated the clinical outcomes of Absorb BVS versus Xience EES treated patients presenting with or without ACS. Methods and results This analysis includes the 2-year outcomes of all 1845 patients randomized in the AIDA trial subdivided by clinical presentation, a pre-specified subgroup analysis. We compared patients presenting with ACS with those presenting without ACS (ACS versus no-ACS patients). Patients presenting with ACS were further sub-categorized according to the presence or absence of ST-segment elevation at presentation (STE-ACS versus NSTE-ACS patients). Baseline status by clinical presentation was known in all patients, and 842 (45.6%) patients presented with ACS, 456 (25.2%) with STE-ACS and 377 (20.4%) with NSTE-ACS.The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; p=0.49) and in no-ACS patients (11.7% versus 10.7% respectively; p=0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7% respectively, p=0.03) as well as in no-ACS patients (2.4% versus 0.2% respectively; p=0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (p=0.80) and for the endpoint of definite or probable device thrombosis (p=0.17). Conclusions In ACS patients within AIDA, we found no difference in rates of target vessel failure between the Absorb BVS and Xience EES groups. Rates of definite or definite/probable device thrombosis were higher in the Absorb BVS group throughout all clinical presentations. No significant interaction between ACS and no-ACS patients and the occurrence of TVF Acknowledgement/Funding The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular.

Background One of the major long-term disadvantages of percutaneous coronary intervention (PCI) remains in-stent restenosis and need for repeat revascularisation. The polymer-regulated delivery of cytotoxic or cytostatic drugs, on drug-eluting stents (DES), impede the natural healing response of the damaged vessel wall. In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. It is hypothesized that after immobilisation the EPCs differentiate into a functional endothelial layer and that this layer will prevent neointimal proliferation and thrombus formation. Anti-CD34+ antibodies are able to capture the EPCs. The Genous stent consist of a bare-metal stent with anti-CD34+ antibody coating. Purpose Demonstrating long-term performance of Genous EPC capturing stent (ECS) relative to DES regarding target lesion failure (TLF); the composite of cardiac death, myocardial infarction (MI) and any target lesion revascularisation (TLR) within 5 years. Methods We undertook an international, clinical trial in 26 centres planning to randomise 1300 patients with stable coronary artery disease and with a high risk of restenosis between treatment with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was substantially higher and treatment of new patients with an ECS would be unreasonable. The trial was terminated for safety reasons. Results A total of 622 were randomly assigned to receive either Genous ECS (304 patients, 367 lesions) or DES (318 patients, 388 lesions). Five year follow-up data was obtained in 95.5% of patients. TLF occurred in 29.1% of the ECS-treated patients and in 16.0% of the DES-treated patients (p Figure 1. KM curves of TLF at 5year fu. Conclusion The Genous ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. If the addition of a EPCs capturing layer on a DES, like the COMBO stent, provides a lower risk of restenosis compared to DES will be tested in the ongoing SORT-OUT X trial. Acknowledgement/Funding OrbusNeich

Background Data of long-term safety and efficacy of the COMBO dual-therapy stent is lacking. REMEDEE Registry evaluated the COMBO stent and showed low clinical event rates up to 3 year. We report the clinical outcomes at 4-year follow-up of this registry. Methods The REMEDEE Registry is a prospective, multicenter registry with minimal exclusion criteria, evaluating clinical outcomes after treatment with the COMBO stent. A 1000 patients were enrolled between June 2013 and March 2014. Target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR), at 4-year follow-up was the primary focus of this analysis. Results Four-year follow-up data were obtained in 97.3% of patients. TLF was present in 117 patients (11.9%). Cardiac death occurred in 45 patients (4.6%), TV-MI was observed in 25 patients (2.6%) and TLR was performed in 73 patients (7.5%). Of the 7.5% TLR at 4 years, 1.5% were beyond 2 years. Definite ST was seen in 7 patients (0.7%) and probable ST in 1 (0.1%). No definite or probable ST occurred between 3 and 4 years follow-up. At 4-year follow-up, 93.1% of patients were free of ischemic symptoms. Conclusion This registry showed excellent 4-year results after COMBO stent placement, with no ST beyond 3 years.

Females are underrepresented in clinical trials evaluating new stent technologies. This sub-analysis sought to assess sex-specific outcomes after bioresorbable scaffold implantation. The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1,845 patients were

Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI) might lead to better outcomes when compared to conventional treatment with metallic drug-eluting stents. ACS patients (STE-ACS

Already in the late 90s, Haffner et al. introduced diabetes mellitus (DM) as a coronary artery disease (CAD) equivalent condition (1). Several more recent similar investigations confirmed those earlier findings (2). Despite broad developments in pharmacotherapy and revascularizations techniques, the combination of DM and CAD still represents a major challenge for the clinician. The clinical guidelines advocate intensive medical therapy with lifestyle and pharmacologic interventions as the initial approach in patients with stable CAD (3,4). Contemporary, percutaneous coronary intervention (PCI) has become one of the most frequently performed therapeutic intervention in medicine. Revascularization for significant narrowed coronary lesions has been shown to improve ischemic endpoints (5). Whether optimal conservative therapy alone or in combination with revascularization strategies in stable CAD leads to more anti-ischemic benefit has been investigated extensively. In patients with DM, finding optimal treatment strategies are more crucial in view of the fact of their poor prognosis in comparison with non-diabetics (6,7). Multivessel CAD in patients with DM has been evaluated in the FREEDOM trial (8,9). Most patients had very extensive disease and CABG was superior regardless SYNTAX score. Event curves started to diverge beyond 2-years after randomization. Insulin treated patients fared worse than those not treated with insulin. Cardiovascular events were generally concordant to the main study in the insulin treatment subgroups.