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OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous[TM] EPC capturing R stent[TM] during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. Results: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294). [ABSTRACT FROM AUTHOR]

Objectives: We investigated whether multiple biomarkers improve prognostication in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention.Background: Few data exist on the prognostic value of combined biomarkers.Methods: We used data from 1,034 STEMI patients undergoing primary percutaneous coronary intervention in a high-volume percutaneous coronary intervention center in the Netherlands and investigated whether combining N-terminal pro-brain natriuretic peptide, glucose, C-reactive protein, estimated glomerular filtration rate, and cardiac troponin T improved the prediction of mortality. A risk score was developed based on the strongest predicting biomarkers in multivariate Cox regression. The additional prognostic value of the strongest predicting biomarkers to the established prognostic factors (age, body weight, diabetes, hypertension, systolic blood pressure, heart rate, anterior myocardial infarction, and time to treatment) was assessed in multivariable Cox regression.Results: During follow-up (median, 901 days), 120 of the 1,034 patients died. In Cox regression, glucose, estimated glomerular filtration rate, and N-terminal pro-brain natriuretic peptide were the strongest predictors for mortality (p < 0.05, for all). A risk score incorporating these biomarkers identified a high-risk STEMI subgroup with a significantly higher mortality when compared with an intermediate- or low-risk subgroup (p < 0.001). Addition of the 3 biomarkers to established prognostic factors significantly improved prediction for mortality, as shown by the net reclassification improvement (0.481, p < 0.001) [corrected] and integrated discrimination improvement (0.0226, p = 0.03) [corrected].Conclusions: Our data suggest that addition of a multimarker to a model including established risk factors improves the prediction of mortality in STEMI patients undergoing primary percutaneous coronary intervention. Furthermore, the use of a simple risk score based on these biomarkers identifies a high-risk subgroup. [ABSTRACT FROM AUTHOR]

Background: Takayasu arteritis is a noninfective chronic vasculitis mainly involving the aorta and its main branches. The presentation of the disease is heterogeneous, ranging from asymptomatic to catastrophic illness., Case Presentation: A 52-year-old Caucasian woman with known Takayasu arteritis was referred to our hospital as she suffered symptoms suspicious for cerebral hypoperfusion. Computed tomography thorax angiography revealed occlusion of all aortic arch arteries and previous surgical bypasses. Cerebral perfusion depended on a few collaterals (from the distal common carotid artery to the right internal carotid artery and from the left and right internal mammary artery and the dorsal thoracic branches to both vertebral arteries). In addition, preoperative coronary angiography revealed an unusual and large collateral arising from the sinoatrial nodal artery to the left carotid artery., Conclusion: Takayasu arteritis is a relatively rare disease, with various and sometimes devastating neurological manifestations due to occlusion of the aortic arch branches. Our case highlights the importance of a thorough preoperative evaluation in search of collateral supply in symptomatic patients with Takayasu arteritis., (© 2023. The Author(s).)

Introduction: P2Y 12 -inhibitor monotherapy following 1-3 months of dual antiplatelet therapy (DAPT) reduces (major) bleeding without an apparent increase in ischemic events and has therefore emerged as an alternative to 6-12 months of DAPT following percutaneous coronary intervention (PCI). However, there are important differences between the available P2Y 12 -inhibitors (clopidogrel, prasugrel, and ticagrelor) as agents of choice for P2Y 12 -inhibitor monotherapy., Areas Covered: This review critically appraises the evidence for P2Y 12 -inhibitor monotherapy after PCI using either clopidogrel, prasugrel, or ticagrelor. Furthermore, we discuss ongoing trials and future directions for research., Expert Opinion: P2Y 12 -inhibitor monotherapy following 1-3 months of DAPT is an alternative to 6-12 months of DAPT following PCI. Ticagrelor may be considered the current preferred option due to its reliable effect on platelet reactivity and its predominant use in clinical trials. Prasugrel could serve as a useful substitute for those not tolerating ticagrelor, but more research into prasugrel monotherapy is warranted. Alternatively, clopidogrel can be used, although there are concerns of high platelet reactivity, especially when genotyping and/or platelet function testing are not used. Future research will need to address the minimal duration of DAPT before switching to P2Y 12 -inhibitor monotherapy and what the optimal antithrombotic therapy beyond 12 months is.

Second-generation drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. Besides the polymer and antiproliferative drug used, the metallic backbone of DES is an attractive target for further development. Ultrathin-strut DES (≤70 μm strut thickness) are more flexible, have an improved trackability and crossability compared to conventional second-generation DES. Importantly, ultrathin-strut DES reduce the risk of in-stent restenosis, thereby decreasing the risk of angiographic and clinical restenosis. In this narrative review, we will discuss the clinical outcomes of the commercially available ultrathin-strut DES., Competing Interests: Disclosures: Maik J Grundeken and Marcel AM Beijk have no financial or non-financial relationships or activities to declare in relation to this article., (© Touch Medical Media 2021.)

Purpose: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype., Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST)., Results: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients., Conclusions: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

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., (© 2020 Wiley Periodicals, Inc.)

Background: Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels., Objective: We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration., Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods., Results: The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74-1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93-5.00, p = 0.07., Conclusions: One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) experience greater ischemic events including clinically driven target lesion revascularization (CD-TLR). Whether the COMBO biodegradable-polymer sirolimus-eluting stent promotes better outcomes in these patients by virtue of endothelial progenitor cell capture technology is unknown., Objective: We examined one-year outcomes by CKD status from the COMBO collaboration., Methods: The COMBO collaboration was a patient-level pooled dataset from the REMEDEE and MASCOT registries (3,614 patients) of all-comers undergoing attempted COMBO stent PCI. The primary endpoint was one-year target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or CD-TLR. Secondary endpoints included stent thrombosis (ST)., Results: The study included 6.4% (n = 231) CKD and 93.6% (n = 3,361) non-CKD patients. CKD patients were older and included more women with greater prevalence of several comorbidities but similar rate of acute coronary syndrome (50.6% vs. 54.5%, p = .26). CKD patients underwent radial PCI less often (56.1% vs. 70.3%, p < .001) and received clopidogrel (78.6% vs. 68.3%) more often (p = .004). One-year TLF occurred in 7.9% CKD vs. 3.7% non-CKD patients, p = .001. CKD patients also demonstrated greater incidence of cardiac death (6.2% vs. 1.2%, p < .0001), TV-MI (2.7% vs. 1.1%, p = .04) but similar CD-TLR (2.7% vs 2.2%, p = .61) and definite/probable ST (1.4% vs. 0.8%, p = .42), compared to non-CKD patients., Conclusions: CKD patients treated with COMBO stents had significantly greater incidence of one-year TLF compared to non-CKD patients driven by cardiac death and to a lesser extent TV-MI but not CD-TLR. They had similar rates of definite/probable ST., (© 2020 Wiley Periodicals LLC.)

Background: In selected patients with an acute myocardial infarction (AMI) complicated by Cardiogenic shock (CS), mechanical circulatory support with Impella may be beneficial, although conclusive evidence is still lacking. Nevertheless, it has been suggested that Impella initiation prior to primary PCI might improve survival., Objective: To investigate the effect pre-PCI versus immediate post-PCI Impella initiation on short term mortality., Methods: A prospective, single center, observational study, was performed including all patients with STEMI complicated by CS, treated with primary PCI and Impella. Thirty day mortality was compared between patients with Impella initiation pre-PCI and immediately post-PCI., Results: A total of 88 patients were included. In the pre-PCI group (n = 21), admission heart rate was lower (84 versus 94 bpm, p = 0.04) and no IABP was implanted before Impella initiation, versus 17.9% in post-PCI group (n = 67), p = 0.04. Total 30-day all-cause mortality was 58%, and was lower in pre-PCI group, 47.6% versus 61.2% in the post-PCI group, however not statistically significant (HR 0.7, 95% CI 0.3-1.3, p = 0.21). Thirty-day cardiac mortality was significantly lower in the pre-PCI group, 19% versus 44.7% in the post-PCI group (HR 0.3, 95% CI 0.09-0.96, p = 0.042)., Conclusion: Pre-PCI Impella initiation in AMICS patients was not associated with a statistically significant difference in 30-day all-cause mortality, compared to post-PCI Impella initiation., Competing Interests: The authors have declared that no competing interests exist.

Background: In this study, we discovered and validated candidate microRNA (miRNA) biomarkers for coronary artery disease (CAD)., Method: Candidate tissue-derived miRNAs from atherosclerotic plaque material in patients with stable coronary artery disease (SCAD) (n=14) and unstable coronary artery disease (UCAD) (n=25) were discovered by qPCR-based arrays. We validated differentially expressed miRNAs, along with seven promising CAD-associated miRNAs from the literature, in the serum of two large cohorts (n=395 and n=1000) of patients with SCAD and UCAD and subclinical atherosclerosis (SubA) and controls, respectively., Result: From plaque materials (discovery phase), miR-125b-5p and miR-193b-3p were most upregulated in SCAD, whereas miR-223-3p and miR-142-3p were most upregulated in patients with UCAD. Subsequent validation in serum from patients with UCAD, SCAD, SubA and controls demonstrated significant upregulation of miR-223-3p, miR-133a-3p, miR-146-3p and miR-155-5p. The ischaemia-related miR-499-5p was also highly upregulated in patients with UCAD compared with the other groups (SCAD OR 20.63 (95% CI 11.16 to 38.15), SubA OR 96.10 (95% CI 40.13 to 230.14) and controls OR 15.73 (95% CI 7.80 to 31.72)). However, no significant difference in miR-499-5p expression was observed across SCAD, SubA and controls. MiR-122-5p was the only miRNA to be significantly upregulated in the serum of both patients with UCAD and SCAD., Conclusion: In conclusion, miR-122-5p and miR-223-3p might be markers of plaque instability., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Immobilisation of patients after transfemoral transcatheter aortic valve implantation (TF-TAVI) is the standard of care, mostly to prevent vascular complications. However, immobilisation may increase post-operative complications such as delirium and infections. In this trial, we determine whether it is feasible and safe to implement early ambulation after TF-TAVI., Methods: We prospectively included TF-TAVI patients from 2016 to 2018. Patients were assessed for eligibility using our strict safety protocol and were allocated (based on the time at which the procedure ended) to the EARLY or REGULAR group., Results: A total of 150 patients (49%) were deemed eligible for early mobilisation, of which 73 were allocated to the EARLY group and 77 to the REGULAR group. The overall population had a mean age of 80 years, 48% were male with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of 3.8 ± 1.8. Time to mobilisation was 4 h 49 min ± 31 min in the EARLY group versus 20 h 7 min ± 3 h 6 min in the REGULAR group (p < 0.0001). There were no differences regarding the primary endpoint. No major vascular complications occurred and a similar incidence of minor vascular complications was seen in both groups (4/73 [5.5%] vs 6/77 [7.8%], p = 0.570). The incidence of the combined secondary endpoint was lower in the EARLY group (p = 0.034), with a numerically lower incidence for all individual outcomes (delirium, infections, pain and unplanned urinary catheter use)., Conclusion: Early mobilisation (ambulation 4-6 h post-procedure) of TF-TAVI patients is feasible and safe. Early ambulation decreases the combined incidence of delirium, infections, pain and unplanned urinary catheter use, and its adoption into contemporary TAVI practice may therefore be beneficial.

Objectives: The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents., Background: The COMBO stainless-steel stent has an anti-CD34 + antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers., Methods: For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis., Results: At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score-matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99)., Conclusions: A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT-Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: In percutaneous coronary interventions, use of the radial artery may be limited by vascular anatomy or vascular complications, such as radial artery spasm, dissection or perforation. The balloon-assisted tracking (BAT) technique is a novel and innovative method to successfully perform transradial procedures in patients with difficult vascular anatomy, severe tortuosity or radial artery spasm. In addition, the BAT technique can serve as a bail-out technique when vascular complications such as artery dissection or perforation occur., Objective: We analysed data of all percutaneous coronary intervention patients in whom the BAT technique was undertaken in daily practice and report acute and long-term outcomes., Results: A total of 62 patients were included and, in most patients, the BAT technique was performed for radial spasm. Most patients were administered benzodiazepines or nitrates before the BAT technique was performed. The primary end point, defined as successful passage of the catheter through the artery of the arm using the BAT technique, was 98%. 11% of patients developed a complication within 24 h (haematoma, prolonged pain or visible vascular damage at the end of procedure); all completely recovered at follow-up. No complications occurred during long-term follow-up., Conclusion: BAT is a low-risk and easy-to-use technique that increases the success rate of radial artery access and may prevent vascular complications.

Aims: Mortality in cardiogenic shock patients remains high. Short-term mechanical circulatory support with Impella can be used to support the circulation in these patients, but data from randomised controlled studies and 'real-world' data are sparse. The aim is to describe real-life data on outcomes and complications of our 12 years of clinical experience with Impella in patients with cardiogenic shock after acute myocardial infarction and to identify predictors of 6-month mortality., Methods: We describe a single-centre registry from October 2004 to December 2016 including all patients treated with Impella for cardiogenic shock after acute myocardial infarction. We report outcomes and complications and identify predictors of 6-month mortality., Results: Our overall clinical experience consists of 250 patients treated with Impella 2.5, Impella CP or Impella 5.0. A total of 172 patients received Impella therapy for cardiogenic shock, of which 112 patients had cardiogenic shock after acute myocardial infarction. The mean age was 60.1±10.6 years, mean arterial pressure was 67 (56-77) mmHg, lactate was 6.2 (3.6-9.7) mmol/L, 87.5% were mechanically ventilated and 59.6% had a cardiac arrest before Impella placement. Overall 30-day mortality was 56.2% and 6-month mortality was 60.7%. Complications consisted of device-related vascular complications (17.0%), non-device-related bleeding (12.5%), haemolysis (7.1%) and stroke (3.6%). In a multivariate analysis, pH before Impella placement is a predictor of 6-month mortality., Conclusions: Our registry shows that Impella treatment in cardiogenic shock after acute myocardial infarction is feasible, although mortality rates remain high and complications occur.

Background: Interventional cardiologists are inevitably exposed to low-dose radiation, and consequently are at risk for radiation induced diseases like cataract and left-sided brain tumours. Operator behaviour may possibly be the largest influencer on radiation exposure. We hypothesised that awareness regarding radiation exposure grows as skill and the general experience in the catheterization laboratory increase., Objectives: In this study we determined the difference in the relative radiation exposure of staff interventional cardiologists compared with cardiology fellows-in-training., Methods: During this prospective trial the operator's radiation exposure (E in µSv) was measured at chest height during 766 diagnostic catheterisations and percutaneous coronary interventions. Also, the patient exposure (DAP in mGy·cm 2 ), representing the amount of radiation administered by the operator per procedure, was collected. The primary outcome of this study was the difference in relative exposure between staff interventional cardiologists versus cardiology fellows-in-training (E/DAP)., Results: From January to May 2017, staff interventional cardiologists performed 637 procedures and cardiology fellows-in-training 129 procedures. The performance of relatively complex procedures by staff interventional cardiologists resulted in a 74% higher use of radiation compared with fellows-in-training. Consequently, staff interventional cardiologists were exposed to 50% higher levels of actual radiation exposure. However, when correcting for the complexity of the procedure, by comparing the relative operator exposure (E/DAP), fellows-in-training were exposed to a 34% higher relative exposure compared with staff interventional cardiologists (p = 0.025)., Conclusions: In the current study, when corrected for complexity, cardiology fellows-in-training were exposed to significantly higher radiation levels than staff interventional cardiologists during catheterisation procedures.

Vasospastic angina (VSA) is considered a broad diagnostic category including documented spontaneous episodes of angina pectoris produced by coronary epicardial vasospasm as well as those induced during provocative coronary vasospasm testing and coronary microvascular dysfunction due to microvascular spasm. The hallmark feature of VSA is rest angina, which promptly responds to short-acting nitrates; however, VSA can present with a great variety of symptoms, ranging from stable angina to acute coronary syndrome and even ventricular arrhythmia. VSA is more prevalent in females, who can present with symptoms different from those among male patients. This may lead to an underestimation of cardiac causes of chest-related symptoms in female patients, in particular if the coronary angiogram (CAG) is normal. Evaluation for the diagnosis of VSA includes standard 12-lead ECG during the attack, Holter monitoring, exercise testing, and echocardiography. Patients suspected of having VSA with a normal CAG without a clear myocardial or non-cardiac cause are candidates for provocative coronary vasospasm testing. The gold standard method for provocative coronary vasospasm testing involves the administration of a provocative drug during CAG while monitoring patient symptoms, ECG and documentation of the coronary artery. Treatment of VSA consists of lifestyle adaptations and pharmacotherapy with calcium channel blockers and nitrates.

Transcatheter aortic valve implantation (TAVI) has evolved to standard treatment of severe aortic stenosis in patients with an intermediate to high surgical risk. Computed tomography coronary angiography (CTCA) could partially replace invasive coronary angiography to diagnose significant coronary artery disease in the work-up for TAVI. A literature search was performed in MEDLINE and EMBASE for papers comparing CTCA and coronary angiography in TAVI candidates. The primary endpoint was the diagnostic accuracy of CTCA, compared to coronary angiography, for detection of significant (>50% diameter stenosis) coronary artery disease, measured as sensitivity, specificity, positive-(PPV) and negative predictive value (NPV). Seven studies were included, with a cumulative sample size of 1,275 patients. The patient-based pooled sensitivity, specificity, PPV and NPV were 95, 65, 71 and 94% respectively. Quality assessment revealed excellent and good quality in terms of applicability and risk of bias respectively, with the main concern being patient selection. In conclusion, on the basis of a significance cut-off value of 50% diameter stenosis, CTCA provides acceptable diagnostic accuracy for the exclusion of coronary artery disease in patients referred for TAVI. Using the routinely performed preoperative computed tomography scans as a gatekeeper for coronary angiography could decrease additional coronary angiographies by 37% in this high-risk and fragile population.

Objectives: The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort., Background: The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization., Methods: The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF., Results: A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF., Conclusions: In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis., Background: Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts., Methods: In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES., Results: At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group., Conclusion: This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure., (© 2017 Wiley Periodicals, Inc.)

Objectives: The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR)., Background: The treatment of ISR remains challenging in contemporary clinical practice., Methods: In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months., Results: A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65)., Conclusions: In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery spasm may be the underlying mechanism in up to 10% of cases of acute coronary syndrome (ACS) and sudden cardiac death. Asian individuals exhibit a 3-times greater incidence of spasm than Caucasians; this is likely due to different types of mechanisms. Consequently, solid data is limited about the long-term prognosis in Caucasian patients presenting with ACS and/or out-of-hospital cardiac arrest (OHCA) caused by coronary spasm., Methods: Between 2002 and 2015, thirty Caucasian patients with coronary artery spasm presenting with ACS (N = 29) and/or OHCA (N = 11) were enrolled in this prospective registry. Follow-up, consisting of regular outpatient visits, was conducted with a mean follow-up period of 7.5 ± 3.3 years. Outcomes included presence of stable angina pectoris, recurrence of ACS, occurrence of implantable cardioverter defibrillator (ICD) shocks and death., Results: The majority of patients (60%) remained asymptomatic during the entire follow-up period. At the end of the follow-up period only 3 patients still experienced stable angina (10%). Only 2 patients (7%) had a recurrent cardiac event, in which the ICD provided appropriate shock therapy. Half of the patients treated with stenting (N = 6), required re-interventions., Conclusion: Coronary spasm with ACS and/or OHCA in a Caucasian patient cohort has a relatively benign prognosis in the majority of patients in long-term follow-up, if treated appropriately with medical therapy. Both the role of ICD in OHCA secondary to coronary spasm, and the efficacy of stenting to treat vasospastic angina, warrant further study in large-sized prospective clinical trials.

Background: Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD's efficacy in a real-world situation., Methods and Results: In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in mGy·cm 2 ), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD ( P =0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD ( P <0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD ( P =0.009)., Conclusions: In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968., (© 2017 American Heart Association, Inc.)

Background: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter., Methods and Results: In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor-equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of +0.11 Hg/cm/s (limits of agreement: -0.13 to 0.36), proportional to mean hyperemic stenosis resistance (Spearman ρ =0.61; P=0.001). Passing-Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of -0.033 (limits of agreement: -0.09 to 0.03), proportional to mean fractional flow reserve (Spearman ρ =0.40; P=0.036). Passing-Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity., Conclusions: Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis., (© 2016 American Heart Association, Inc.)

Background: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) poses a high-risk for distal coronary thromboembolic events. Glycoprotein IIb/IIIa inhibitors are frequently used in hope of reducing the impact of this, although the safety and efficacy of these drugs to improve outcomes in this setting are understudied., Methods: Patients were included if they had prior coronary artery bypass surgery and subsequently underwent PCI of ≥1 SVG graft at a Dutch academic center between 1997 and 2008. These patients were matched 1:1 based on peri-procedural use of abciximab using a propensity-score matching algorithm based on 17 variables. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association between abciximab use and MACCE (the composite measure of mortality, myocardial infarction, stroke and repeat revascularization) at 30days and up to 1year., Results: The composite of 30-day MACCE occurred in 18 patients (15.3%) in the abciximab group and 16 patients (13.6%) in the propensity matched control group (OR: 1.13, 95% CI: 0.57-2.21, p=0.73). At 1-year follow-up, MACCE rates were also similar (32.5% vs. 33.9%, HR: 0.97, 95% CI: 0.59-1.59). Major bleeding (BARC types 3a-c) was higher in the abciximab group (11.9% vs. 4.2%, OR: 2.80, 95% CI: 1.01-7.77). Ischemic outcomes did not differ among patients with acute coronary syndromes., Conclusion: The use of intravenous abciximab was not associated with improved clinical outcomes up to 1-year among patients undergoing SVG PCI, but was related to more bleeding., (Copyright © 2015 Elsevier Inc. All rights reserved.)

In contrast to the use of cytotoxic or cytostatic drugs, a 'pro-healing' approach may have an effect that is beneficial on clinical outcomes. The endothelial progenitor cell capturing stent (ECS) technology accelerates re-endothelialization after implantation in animal models and in the human arteriovenous shunt model. Several clinical studies have shown its safety in non-complex lesions. However, in the prevention of in-stent restenosis in complex lesions, the ECS is less effective compared with drug-eluting stents. The novel COMBO dual therapy stent is the first stent to combine accelerated endothelial coverage and control of neo-intimal proliferation using a pro-healing technology with an abluminal elution of sirolimus. In the randomized REMEDEE trial, the COMBO dual therapy stent showed similar angiographic and clinical outcomes compared to the paclitaxel-eluting stent. The REMEDEE-OCT study showed equal vascular healing as assessed by optical coherence tomography of the COMBO dual therapy stent compared to the Xience-V stent.

Objectives: To describe clinical outcome after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) due to graft failure., Background: Limited data are available on outcome after PCI for graft failure-induced ACS in the drug-eluting stent (DES) era., Methods: Patients were identified who underwent PCI either with DES or BMS for ACS due to graft failure between January 2003 and December 2008. Follow-up was performed at 1 year and April 2011. The primary endpoint was the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR). Kaplan-Meier estimates were calculated at 1 and 5-year follow-up. Predictors were identified by backward selection in Cox proportional hazards models., Results: A total of 92 patients underwent PCI, of which 77 were treated with bare metal stents (BMS) and 15 with DES. Patient and procedural characteristics were similar in both groups. Mean follow-up was 3.2 years. Five-year composite event rate was 65.9% after BMS vs. 43.4% after DES implantation (P = 0.17). Individual endpoints were comparable in both groups. Recurrence of angina, hospitalization, and repeat interventions were similar. After multivariable adjustment, the use of DES was not associated with a significant reduction in the primary endpoint (HR = 0.44, 0.18-1.04, p = 0.06)., Conclusion: In patients presenting with ACS due to acute graft failure, long-term outcomes remain poor. In a nonrandomized comparison with BMS, DES use was not associated with significant improved long-term clinical outcomes., (Copyright © 2012 Wiley Periodicals, Inc.)

Aims: To describe long-term outcome following surgical and percutaneous revascularization in graft failure., Methods: We analyzed consecutive patients with graft failure after heart-team assignment to percutaneous coronary intervention (PCI) or redo coronary artery bypass grafting (CABG) between 2003 and 2008. The primary endpoint was the composite of death, myocardial infarction (MI) or target vessel revascularization (TVR). Kaplan-Meier event rate estimates were calculated up to a 5-year follow-up. Independent predictors for outcomes were identified by backward selection in a multivariable Cox proportional hazard model., Results: We identified 287 patients treated for graft failure: 243 with PCI and 44 with redo CABG. Patients undergoing PCI more frequently presented with ST-elevated myocardial infarction (STEMI) (P < 0.001), multivessel disease (P < 0.001), vein graft failure (P = 0.04), a history of MI (P < 0.001) and shorter time-to-graft failure (P = 0.001). Bare-metal stents (BMS) were used in 81.3% of the PCI-treated lesions and drug-eluting stents (DES) in 18.7%. The median follow-up was 3.9 years. Five-year rate of composite all-cause death, MI or TVR was 57.6% after PCI and 51% after CABG (P = 0.51). Repeat revascularization [TVR and target lesion revascularization (TLR)] was 30.7 and 21.3% after PCI, and 8.0 and 3.2% following CABG (P = 0.009; P = 0.008). In the PCI group, BMS was associated with higher rates of TVR (35.1 vs. 12.6%; P = 0.04) and TLR (24.8 vs. 7.6%; P = 0.04), but similar rate of death or MI compared with DES. Independent predictors for the primary outcome were creatinine [hazard ratio 1.008 per μmol/l, 95% confidence interval (CI) 1.005-1.011, P < 0.001] and peak creatine kinase MB (hazard ratio 1.001 per U/l, 95% CI 1.000-1.002, P = 0.027)., Conclusion: Clinical outcomes are similarly poor after heart-team triage for surgical or percutaneous intervention in patients with graft failure. Repeat revascularization occurred more frequent after PCI, particularly following BMS implantation.

Objectives: We evaluated 30-day and 1-year clinical outcomes after percutaneous or surgical coronary revascularisation in patients with unprotected left main coronary artery (ULMCA)-related acute myocardial infarction (AMI)., Design: Single-centre registry., Patients: Between January 1998 and December 2008, 84 patients with ULMCA-related AMI underwent revascularisation treatment in our institution (55 underwent percutaneous coronary intervention (PCI), 29 underwent coronary artery bypass graft surgery (CABG))., Methods: One-year clinical follow-up was obtained for all patients. Univariable and multivariable analyses were performed to find predictors for 30-day mortality and treatment allocation., Results: In the PCI-group, all-cause mortality was 64% at 30 days and 69% at 1 year. In the CABG-group, this was 24% at 30 days and 1 year. Independent predictors of 30-day mortality were cardiogenic shock (HR 2.83), thrombolysis in MI (TIMI) 0/1 flow (HR 2.27) and diabetes mellitus (HR 2.65). Treatment allocation to PCI was primarily determined by TIMI 0/1 flow on baseline angiogram (OR 150). In patients with TIMI 2/3 flow on initial angiogram, treatment allocation was determined by presentation with cardiogenic shock (OR 5.61), year of inclusion (OR 1.72), and distal/bifurcation disease (OR 0.11)., Conclusions: Thirty-day mortality was high in patients presenting with an ULMCA-related AMI, both in the PCI as in the CABG-treatment group. Presentation with cardiogenic shock, TIMI 0/1 flow on initial angiogram and diabetes mellitus were independently predicting of 30-day mortality, whereas treatment allocation was primarily determined by presentation with TIMI 0/1 flow.

Objectives: This study sought to evaluate 30-day all-cause mortality of patients treated with primary percutaneous coronary intervention (PCI) presenting with an acute myocardial infarction (AMI) due to an unprotected left main coronary artery (ULMCA) culprit lesion. In addition, an average estimated mortality rate was extrapolated from the available data., Background: There are limited data available on clinical outcome after primary PCI in patients presenting with AMI with unprotected left main as the infarct-related coronary artery., Methods: Medical literature databases were searched to identify cohort studies reporting on primary PCI for unprotected left main-related AMI. A total of 13 retrospective studies meeting all pre-specified criteria were included in the meta-analysis. No randomized trials were available. The primary endpoint for the meta-analysis was 30-day all-cause mortality., Results: This meta-analysis comprises a total of 977 patients, of which 252 (26%) presented in cardiogenic shock. Thirty-day all-cause mortality was evaluated using a forest plot analysis and showed higher event rates in patients presenting with cardiogenic shock among all subgroups. The average estimated 30-day all-cause mortality was 15% in patients presenting without signs of cardiogenic shock and 55% in patients presenting with cardiogenic shock (relative risk: 3.74, 95% confidence interval [CI]: 2.95 to 4.76, p < 0.001)., Conclusions: In this large meta-analysis of patients treated with primary PCI for AMI due to an ULMCA culprit lesion, the 30-day all-cause mortality in patients presenting with shock is much higher than in patients not presenting with shock. The estimated all-cause mortality data may serve as a benchmark for future reference., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Antiplatelet therapy is recommended after coronary artery bypass grafting, because it improves saphenous vein graft (SVG) patency and clinical outcomes. We investigated the association between prehospital antiplatelet regimens and outcomes after SVG intervention. Patients who underwent SVG intervention from 2003 to 2008 were divided into 3 groups: (1) no antiplatelet therapy, (2) the use of aspirin or clopidogrel, and (3) the use of dual antiplatelet therapy (DAPT) at admission. Clinical follow-up examinations were performed at 30 days and 1 year. The primary outcome was the composite of all-cause mortality, myocardial infarction, the need for revascularization, and stroke at 30 days. The relation between antiplatelet therapy and outcomes was adjusted for factors associated with the outcomes. A total of 225 patients underwent SVG intervention, 87% were men, and the mean age was 70 years. Of the 225 patients, 21 (9.4%) were not receiving antiplatelet therapy, 102 (45.3%) were receiving aspirin/clopidogrel, and 102 (45.3%) were receiving DAPT. The patients without antiplatelet therapy were more frequently women, had presented earlier after coronary artery bypass grafting, and were less frequently taking other cardiac-related medications. The patients taking aspirin or DAPT were more often smokers and had a greater peripheral vascular burden. The incidence of the 30-day and 1-year primary outcomes was greater in patients without preadmission antiplatelet use (38.1% vs 14.9% and 13.9%, overall p = 0.01; 52.4% vs 29.5% and 28.3%, overall p = 0.03). After adjustment, antiplatelet use remained associated with the primary outcome. In conclusion, prehospital use of antiplatelet therapy was associated with a lower occurrence of major adverse cardiac events after SVG intervention. We did not find that DAPT improved outcomes compared to single antiplatelet therapy., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: To evaluate the clinical results of diabetic patients undergoing percutaneous coronary intervention (PCI) for coronary artery lesions carrying a low risk of restenosis treated with a bare-metal stent (BMS)., Background: There is a discrepancy between current international guidelines on the use of BMS in diabetics with low risk of restenosis coronary artery lesions., Methods and Results: Registry data from diabetic patients who underwent non-urgent PCI in a high-volume tertiary referral hospital in the Netherlands was used. The main outcomes were target lesion revascularization (TLR) and the composite of cardiac death, myocardial infarction, and target vessel revascularization at 1-year of follow-up. A total of 1,951 patients were included, of which 1,596 non-diabetics (non-DM), 231 non-insulin requiring diabetics (NIRDM), and 124 insulin requiring diabetics (IRDM).TLR rates in non-DM versus NIRDM were similar (6.3% vs. 5.6%; P = 0.68), whereas TLR in IRDM was higher (6.3% vs. 11.3%; P = 0.03). The composite of cardiovascular clinical outcomes was not significantly different in non-DM versus NIRDM (9.5% vs. 13.4%; P = 0.07), though in IRDM the incidence was higher (9.5% vs. 17.7%; P < 0.01)., Conclusion: No differences were observed in TLR or composite clinical endpoint at 1-year between non-DM and NIRDM after BMS placement in coronary artery lesions carrying a low risk of restenosis. The presence of IRDM was associated with higher TLR rates when treated with BMS. These results imply that BMS placement may be considered in patients with NIRDM but further work is required to define treatment strategies and, more importantly, improve the outcomes in diabetics., (Copyright © 2012 Wiley Periodicals, Inc.)

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Objective: We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous™ endothelial progenitor cell capturing R stent™ placement in patients from the e-HEALING registry., Background: Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended., Methods: Patients were analyzed according to continuation or discontinuation of DAPT at a 30-day and 6-month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression., Results: No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65-1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55-1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable., Conclusions: In a post-hoc analysis of e-HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding., (Copyright © 2011 Wiley Periodicals, Inc.)

Background: We assessed the 3-year clinical outcome in our single-center cohort of mainly unselected patients treated with the endothelial progenitor cell capturing stent (ECS). The ECS is coated with CD34+ antibodies specifically targeting the circulating endothelial progenitor cells population to accelerate endothelialization that in turn may prevent the occurrence of in-stent restenosis and stent thrombosis (ST)., Methods: All patients in our study had coronary artery lesions that were treated with an ECS. The majority of patients had complex lesions with an estimated high risk of restenosis., Results: A total of 405 patients were enrolled. The primary end-point of target lesion failure (TLF) was defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). At 3 years, TLF was 18.3% and TLR was 14.2%. Early ST occurred in 2 patients. No cases of late and very late definite ST were reported., Conclusions: This single-center study demonstrates the safety at 3 years of the ECS in an unselected patient population, including a fair number of patients with complex lesions, reflecting daily practice. Our data compare well with drug-eluting stent and bare metal stent registries enrolling unselected patient populations. Importantly, in our analysis, no cases of late or very late definite ST were reported., (©2011, Wiley Periodicals, Inc.)

Background: In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr., Methods: A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent., Results: Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%)., Conclusions: In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year., Background: A "pro-healing" approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions., Methods: We undertook an international, clinical trial in 26 centers planning to randomize 1,300 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 higher and treatment of new patients with an ECS would be unreasonable., Results: At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority)., Conclusions: Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: We assessed the 1-year clinical outcome in a large cohort of unselected patients treated with an endothelial progenitor cell (EPC) capturing coronary stent., Background: The novel EPC capturing stent is coated with CD34+ antibodies that bind circulating EPCs to the stent surface, thereby accelerating endothelialization of the stent struts; it is hypothesized that this may prevent restenosis and stent thrombosis., Methods: A total of 405 unselected patients were treated percutaneously with the EPC capturing stent. The majority of patients had complex lesions with an estimated high risk of restenosis., Results: The primary endpoint defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 1-year was 13.3%, mainly attributable to TLR which was 10.9%. The occurrence of definite and probable ST was low, 0.5 and 0.7%, respectively. Based on the risk of restenosis, in patients with an estimated high risk of restenosis (n = 249), the composite primary endpoint was 16.1% versus 9.0% in patients with an estimated low risk (n = 155). Moreover, the 1 year clinical outcomes in diabetic patient compared well with the nondiabetic patients., Conclusion: In this single-center study, the 1-year clinical follow-up in a "real-world" population treated with the EPC capturing stent showed good results. Currently, large randomized studies are conducted to evaluate the long-term safety and efficacy of this stent., (Copyright © 2011 Wiley-Liss, Inc.)

Aims: e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous™ EPC capturing R stent™. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis., Methods and Results: We planned a 5,000 patient registry with ≥1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received ≥1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively., Conclusions: Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

Objective: In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. However, their role in humans is less well understood. In the present study, the authors aimed to evaluate the relationship between the number of preprocedural EPCs defined as CD34+/KDR+/CD133+ cells and angiographic late loss as a measure of the growth of in-stent intimal hyperplasia., Design Setting Patients and Interventions: The 59 study patients were treated in the authors' clinic with a Genous EPC capturing stent, a bare metal stent (BMS) or a drug-eluting stent, and angiographic follow-up occurred between 6 and 13 months., Results: The authors found no relationship between preprocedural EPCs and angiographic late loss, irrespective of stent type. Though statistically not significant, patients with a high number of preprocedural CD34 cells and treated with a Genous stent or BMS showed a numerically higher late loss (in Genous patients: 1.03±0.76 mm vs 0.71±0.50 mm, p=0.15; in BMS patients: 1.06±0.73 mm vs 0.35±0.62 mm, p=0.08)., Conclusions: Considering these and other varied observations, further studies aimed at identifying the biological mechanism and the individual roles of EPCs and/or CD34 cells in endothelial repair after coronary vessel stenting are needed.