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OBJECTIVES We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

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.

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.

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

Introduction and objectives In de novo heart failure with reduced ejection fraction (HFrEF) current guidelines support, an initial double combination therapy with angiotensin converting enzyme inhibitors/angiotensin-receptor blockers and betablockers, only adding minerocorticoid receptor antagonists if after treatment optimization left ventricular ejection fraction (LVEF) is still under 40%. An initial triple combination therapy could be an attractive initial approach in the stability phase after an acute HF episode in debut HFrEF; which is what we describe in this report and analyze the factors related to the treatment with triple neurohormonal blockade (TNHB). Methods Retrospective study of patients discharged from our centre between January 2009 and January 2016 with de novo HFrEF after an acute HF episode with these criteria: 15–85 year-old, creatinine ≤2.5 mg/dL, potassium Results A total of 280 patients fulfilled the criteria, 58% of them were discharged on TNHB. Mean age was 65.4 ± 12.5 years, LVEF 29.8 ± 7.3% and median NT-ProBNP 2917 pg/mL. After a mean follow-up of 43.4 ± 26.6 months, 72 patients died (25.7%), with a mean survival of 76 months. Patients treated with TNHB had a better risk profile (they were younger, better creatinine and lower pulmonary pressures) but poorer LVEF (28.7 ± 7.4% vs. 31.4 ± 6.7%; P = .002). Mean survival on TNHB was better (months, 82.1 ± 3.0 vs. 68.6 ± 3.8; P = .007). Multivariate analysis showed that TNHB was an independent predictor of better survival (HR, 1.79; 1.05–3.05; P = .03). Conclusions TNHB is commonly used in debut HFrEF, especially in younger patients with worse LVEF. In our cohort TNHB was an independent factor related to better survival.

Bioresorbable scaffolds (BRS) were conceived to ensure transient coronary artery support during antiproliferative drug delivery. However, the Absorb everolimus-eluting bioresorbable scaffold was found to be inferior to everolimus-eluting metallic stents (EES) in moderately complex coronary anatomies. We sought to investigate whether the Absorb represents a valuable option for the percutaneous treatment of patients with ST-elevation myocardial infarction (STEMI).We pooled the individual patient data of two randomised trials specifically designed to investigate the performance of Absorb versus EES in patients with acute myocardial infarction (MI). The primary outcome was lesion (in-segment) diameter stenosis at angiographic follow-up. The main secondary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI and target lesion revascularisation at one year. A total of 388 patients with STEMI were allocated to Absorb (n=227) or EES (n=161). Angiographic follow-up at one year was available for 332 (85.6%) patients. Lesion diameter stenosis was comparable between Absorb and EES (22.8±9.8% versus 23.6±11.2%; mean difference -0.8%, 95% confidence interval [CI]: -3.18-1.48, p=0.47). DOCE occurred in 21 patients at one year, with similar distribution between the Absorb and EES groups (5.3% versus 5.6%; hazard ratio 0.95, 95% CI: 0.40-2.26, p=0.91).This pooled analysis provides evidence for a comparable angiographic performance and suggests similar clinical performance of Absorb and EES in STEMI patients undergoing percutaneous revascularisation. The long-term durability of Absorb and the extent to which newer BRS platforms might have a potential role in STEMI deserve further investigation. Both trials were registered at www.clinicaltrials.gov (NCT01942070 and NCT01986803).

Background: The use of poly- l -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period ( Methods: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment–elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). Results: Between June 2017 and June 2018, 150 ST-segment–elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P =0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P P P =0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P =1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (−8.3±3.5% versus −2.4±1.3% in the SES group, P =0.003). Conclusions: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03234348.

Aims Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus (DM), reduced left ventricular ejection fraction (LVEF) and chronic kidney disease (CKD). However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. Methods DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded end-point, multi-center trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing a TAVI. Candidate patients should have prior history of HF admission plus ≥1 of the following criteria: 1) DM, 2) LVEF ≤40%, or 3) estimated glomerular filtrate rate between 25 and 75 mL/min/1.73 m2. A total of 1020 patients will be randomized (1:1) to dapagliflozin versus no dapagliflozin. Key secondary outcomes include: (i) Incidence rate of individual components of the primary outcome; (ii) Cardiovascular mortality; (iii) The composite of HF hospitalization or CV death; (iv) Total number of recurrent HF hospitalizations. Conclusion DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI. This article is protected by copyright. All rights reserved.

Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events’ outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). Conclusions Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

Cardiovascular diseases are the primary cause of deaths in the world. Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Due to its high prevalence and associated risks, early detection of AF is an important objective for healthcare systems worldwide. The growing demand for medical assistance implies increased expenses, which could be limited by implementing ambulatory monitoring techniques based on wearable devices, thus, reducing the number of people requiring observation in hospitals. One of the main challenges in this context is related to the large amount of data from patients to be analyzed, which points to the suitability of using computational intelligence techniques for it. The selection of the features to be extracted from data plays a key role in order for any classifier of heart rhythm to provide good results in this regard. This paper demonstrates that it is possible to achieve an accurate detection of AF using a very low number of relatively simple features extracted from photoplethysmographic signals, enabling the use of affordable wearable devices (with scarce processing and data storage resources) with this purpose over long periods of time. This fact has been validated in experiments using data from real patients under medical supervision.

ObjectivesTo assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BackgroundThe use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. MethodsAmong 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n =225) or PP-EES (n =231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9months. ResultsIn this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. ConclusionsThese results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

INTRODUCTION AND OBJECTIVES Health outcomes research is done from clinical registries or administrative databases. The aim of this work was to evaluate the concordance of the Minimum Basic Data Set (MBDS) with the DIOCLES (Descripcion de la Cardiopatia Isquemica en el Territorio Espanol) registry and to analyze the implications of use of the MBDS in the study of acute coronary syndrome in Spain. METHODS Through indirect identifiers, DIOCLES was linked with MBDS and unique matches were selected. Some of most relevant variables for risk adjustment of in-hospital mortality due to acute myocardial infarction were considered. Kappa coefficient was used to evaluate the concordance; sensitivity, specificity and positive and negative predictive values to measure the validity of the MBDS, and the area under ROC (receiver operating characteristic) curve to calculate its discrimination. The results were compared among hospitals quintiles according to their contribution to DIOCLES. The influence of unmatched episodes on results was assessed by a sensitivity analysis, using looser linking criteria. RESULTS Overall, 1539 (60.85%) unique matches were achieved. The prevalence was higher in DIOCLES (acute myocardial infarction: 71.09%; Killip 3-4: 9.17%; cerebrovascular accident: 0.97%; thrombolysis: 8.64%; angioplasty: 61.92% and coronary bypass: 1.75%) than in the MBDS (P < .001). The agreement level observed was almost perfect (κ = 0.863). The MBDS showed a sensitivity of 85.10% and a specificity of 98.31%. Most results were confirmed by using sensitivity analysis (79.95% episodes matched). CONCLUSIONS The MBDS can be a useful tool for outcomes research of acute coronary syndrome in Spain. The contrast of DIOCLES and MBDS with medical records could verify their validity.

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 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.

Trans-catheter aortic valve implantation (TAVI) is an increasingly adopted technique which provides a minimal invasive solution for patients who suffer from severe aortic stenosis. Some complications of the procedure could be annular rupture or paravalvular leakage, both related with adverse outcome. In TAVI with balloon expandable devices, a mismatch between those two factors leads to a conflict situation, where improving one worsens the other. The presented research proposes a methodology that uses numerical simulation to obtain certain TAVI outcomes related with aortic regurgitation due to paravalvular leakage, such as perivalvular area, aortic eccentricity or annular pressure. The application of the methodology for two patients shows the possibility of predicting those quantities. The highest stress values are distributed along the contact area. Results also show that a great deformation on the aortic annulus does not necessarily imply a higher stress; pressure can either be converted into root reshape or into root stretching. Validation of the results was done using scientific publications, clinical guidelines and clinical reports. Numerical simulation provides a suitable tool that could possibly contribute to optimize the planification procedure adjusting the mismatch between size and pressure.

BACKGROUND Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315) (c) 2021 by the American College of Cardiology Foundation.

Aortic stenosis (AS) disease is a narrowing of the aortic valve (AV) opening which reduces blood flow from the heart causing several health complications. Although a lot of work has been done in AV simulations, most of the efforts have been conducted regarding healthy valves. In this article, a new three-dimensional patient-specific biomechanical model of the valve, based on a parametric formulation of the stenosis that permits the simulation of different degrees of pathology, is presented. The formulation is based on a double approach: the first one is done from the geometric point of view, reducing the effective ejection area of the AV by joining leaflets using a zipper effect to sew them; the second one, in terms of functionality, is based on the modification of AV tissue properties due to the effect of calcifications. Both healthy and stenotic valves were created using patient-specific data and results of the numerical simulation of the valve function are provided. Analysis of the results shows a variation in the first principal stress, geometric orifice area, and blood velocity which were validated against clinical data. Thus, the possibility to create a pipeline which allows the integration of patient-specific data from echocardiographic images and iFR studies to perform finite elements analysis is proved.

Aim Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain at high risk of cardiovascular events despite the use of contemporary drug-eluting stents (DES). This trial aim to compare the clinical efficacy of 2 novel second-generation DES in patients with DM. Methods and results The Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial (ClinicalTrials.gov NCT03321032) is an investigator-initiated, prospective, randomized, controlled, multicenter study conducted exclusively in patients with DM. This study allows inclusion of the entire spectrum of patients with DM undergoing PCI, and the only exclusion criteria are shock at presentation, inability to consent or a life expectancy

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)

Aim Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. Study design This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. Conclusion This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR 50% and STR >= 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEM!, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events. (C) 2018 Elsevier Inc. All rights reserved.

AIMS The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. METHODS AND RESULTS This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority

Aims: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 mu m) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device.Methods and results: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29 +/- 0.33 mm in the SES group and 0.14 +/- 0.37 mm in the ZES group (p(non-inferiority) = 0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2 +/- 12.0% vs. 16.1 +/- 12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72).Conclusions: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at ninemonth follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

Objectives This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES). Background Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes. Methods In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status. Results Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm2 vs. 5.72 ± 1.77 mm2; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm2 vs. 5.55 ± 1.77 mm2; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72). Conclusions In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803)

Aims: The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications. Methods and results: A total of 514 first -attempt percutaneous PVT, closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in antral lesions were the type of device used (AMPLATZER AVP III vs. others, FIR 2.68 [1.29-5.54], p=0.008) and the number of procedures perfomied at the centre (top quartile vs. others, IIR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (>= 10 nun vs.

Acute myocardial infarction (AMI) is a common cause of hospital discharges and readmissions. Readmissions may indicate poor patient care and avoidable health expenditure, being key in quality improvement strategies. Our aim was to analyse cardiac diseases (CDs) readmissions in patients with AMI in Spain.A retrospective analysis of 33,538 hospital discharges with AMI being the "principal diagnosis" at hospitals of the Spanish National Health System in 2012 was performed using administrative data. We developed a logistic regression model and calculated 30-day, 3-month and 1-year CDs risk-standardized readmission rates (RSRRs) using a multivariate mixed model.Variables of the model (AMI location, age, previous angina pectoris/myocardial infarction or acute coronary syndrome, chronic kidney disease, rheumatic valvular disease, diabetes mellitus, vascular disease, female sex, chronic pulmonary disease, and anemia) were able to predict 30-day, 3-month and 1-year readmission rates and RSRRs after AMI (5.4%, 9.3% and 20.2%, respectively). For RSRRs the area under the ROC curve was 0.74 (p=0.0037), 0.77 (p=0.0041), and 0.73 (p=0.0025) for 1, 3months and 1-year readmission rate, respectively. Angioplasty, cardiology as the medical unit responsible for the discharge and a higher volume of activity (204 AMI) were all significantly (p0.001) associated with lower mortality, risk of development of heart failure and RSRRs.Angioplasty, cardiology as the medical unit responsible for the discharge and a higher volume of activity explain variability in CDs readmission rates after AMI, which can have implications for strategies to reduce readmissions rates.

Introduction and objectives To analyze the association between the development of network systems of care for ST-segment elevation myocardial infarction (STEMI) in the autonomous communities (AC) of Spain and the regional rate of percutaneous coronary intervention (PCI) and in-hospital mortality. Methods From 2003 to 2012, data from the minimum basic data set of the Spanish taxpayer-funded health system were analyzed, including admissions from general hospitals. Diagnoses of STEMI and related procedures were codified by the International Diseases Classification. Discharge episodes (n = 302 471) were distributed in 3 groups: PCI (n = 116 621), thrombolysis (n = 46 720), or no reperfusion (n = 139 130). Results Crude mortality throughout the evaluation period was higher for the no-PCI or thrombolysis group (17.3%) than for PCI (4.8%) and thrombolysis (8.6%) (P < .001). For the aggregate of all communities, the PCI rate increased (21.6% in 2003 vs 54.5% in 2012; P < .001) with a decrease in risk-standardized mortality rates (10.2% in 2003; 6.8% in 2012; P < .001). Significant differences were observed in the PCI rate across the AC. The development of network systems was associated with a 50% increase in the PCI rate (P < .001) and a 14% decrease in risk-standardized mortality rates (P < .001). Conclusions From 2003 to 2012, the PCI rate in STEMI substantially increased in Spain. The development of network systems was associated with an increase in the PCI rate and a decrease in in-hospital mortality.

Background Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. Methods and Results The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS patients and in all within 9 days post stenting. We found no significant difference in TLF between ACS and non-ACS patients and a low overall rate of TLF. Conclusions The COMBO stent is a safe and efficient device for patients presenting with ACS. Low ST rate and only early stent thrombosis were observed. © 2017 Wiley Periodicals, Inc.

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.

Background: We aimed to assess the impact of implementation of reperfusion networks, the type of hospital and specialty of the treating physician on the management and outcomes of ST segment elevation myocardial infarction in patients aged ⩾75 years. Methods: We analysed data from the Minimum Basic Data Set of the Spanish public health system, assessing hospital discharges between 2004 and 2013. Discharges were distributed in three groups depending on the clinical management: percutaneous coronary intervention, thrombolysis or no reperfusion. Primary outcome measure was all cause in-hospital mortality. For risk adjustment, patient comorbidities were identified for each index hospitalization. Results: We identified 299,929 discharges, of whom 107,890 (36%) were in-patients aged ⩾75 years. Older patients had higher prevalence of comorbidities, were less often treated in high complexity hospitals and were less frequently managed by cardiologists ( pConclusions: Elderly patients with ST segment elevation myocardial infarction are less often managed in high complexity hospitals and less often treated by cardiologists. Both factors are associated with higher in-hospital mortality.

BACKGROUND: The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. DESIGN: MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. CONCLUSIONS: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation. ispartof: AMERICAN HEART JOURNAL vol:209 pages:97-105 ispartof: location:United States status: published

Background: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. Methods: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents ( Results: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point ( P int =0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27–1.02; P =0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34–1.03; P =0.066). Conclusions: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00828087.

BackgroundThe COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. ObjectiveWe analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. MethodsMASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score≤3 and intermediate-to-high (IHBR) for score>3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n=1270) LBR and 44% (n=1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p=0.047) driven by cardiac death (1.7% vs. 0.7%, p=0.029) with similar rates of MI (1.8% vs. 1.1%, p=0.17), TLR (1.5% vs. 1.6%, p=0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p=0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p=0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p Conclusion Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

BACKGROUND No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. METHODS The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. FINDINGS Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; psuperiority=0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; pnon-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm(2) [SD 1·48] vs 5·38 mm(2) [1·51]; p

Objectives This registry evaluated the safety and clinical outcomes of the Combo stent in an all-comers population in routine clinical practice. We report 1-year results. Background Limitations of current generation drug-eluting stents (DES) are 3-fold: stent thrombosis, neoatherosclerosis related to impaired healing, and repeat revascularization due to (late-) in-stent restenosis. The Combo stent combines an abluminal biodegradable coating eluting sirolimus and a luminal anti-CD34+ antibody layer to attract endothelial progenitor cells in order to promote vessel healing, thus preventing neointima formation and restenosis. Methods The REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) post-market registry was an international, multicenter, prospective trial that evaluated clinical outcomes after deployment of the Combo stent, in an all-comers population of patients treated with a Combo stent in the setting of routine clinical care. Clinical endpoints were target lesion failure (TLF), defined as a composite of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR). Results Between June 2013 and March 2014, a total of 1,000 patients were included in the registry, 49.9% of whom presented with acute coronary syndrome. Mean age was 65 ± 11 years old (range: 34 to 94 years of age), and 74% of patients were male; 58.9% of 1,255 lesions were American Heart Association type B2 or C lesions. The primary endpoints were 5.7% TLF, 1.7% cardiac death, 0.7% target vessel MI, and 4.4% TLR. Definite stent thrombosis occurred in 0.5% of subjects; no thrombosis occurred after 9 days post-stenting. Conclusions This registry showed excellent 1-year results of novel Combo bioengineered stent technology in an all-comers patient population. (Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE]; NCT01874002 )

Aims: Prior percutaneous coronary intervention (PCI) is increasingly encountered in acute coronary syndrome (ACS) patients, with uncertain significance. We sought to evaluate the impact of prior PCI in ACS patients. Methods and results: Patients with ACS enrolled in the prospective PROSPECT registry underwent three-vessel intravascular ultrasound and virtual histology evaluation after successful PCI of the culprit lesion(s). We identified patients with prior PCI (>6 months before index ACS) and compared their outcomes to those without prior PCI. Time-to-event for major adverse cardiac events (MACE) was estimated up to three years, and the independent association between prior PCI and MACE was evaluated in a multivariable model. Among 696 patients enrolled, 77 (11.1%) had prior PCI. They were older and more likely to have prior myocardial infarction, chronic kidney disease, and congestive heart failure. At three years, patients with prior PCI had significantly higher rates of cardiac death, rehospitalisation for worsening angina, and MACE (adjusted HR=1.73 [95% CI: 1.09, 2.75], p=0.02), independent of other comorbidities and intravascular ultrasound findings. Conclusions: Prior PCI was noted in over 10% of patients with ACS and was associated with higher mortality and morbidity, independent of other comorbidities. Prior PCI should be considered a high-risk feature when evaluating ACS patients.

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p

AIMS: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES.METHODS AND RESULTS: A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES.CONCLUSIONS: This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.

Summary Background Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention. Methods We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038. Findings Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575–758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82–1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04). Interpretation Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population. Funding Gilead Sciences, Menarini.

Background Long-term outcomes of diabetic patients suffering from ST-segment elevation myocardial infarction (STEMI) and treated with second-generation drug-eluting stent have been scarcely evaluated. The aim of this posthoc subanalysis of the EXAMINATION trial was to compare 5-year outcomes according to the presence of diabetes mellitus. Methods From a total of 1,497 patients included in the trial, 258 were diabetics (n = 137, received everolimus-eluting stent (EES) and n = 121 bare-metal stent (BMS); whereas 1,239 were nondiabetics (n = 613 treated with EES and n = 626 with BMS). Patient-oriented combined endpoint (POCE) defined as all-cause death, any MI or any revascularization, and other clinical parameters were collected up to 5-years. All results were adjusted for various potential confounders. Results At 5-years, patients with diabetes showed similar rates of POCE between diabetics treated with EES and those treated with BMS (32.8% vs. 32.2%; p = 0.88). However, rates of TLR were significantly lower in the EES group (4.4% vs. 9.9%; HR 0.52 (0.29-0.94); P = 0.03). In non-diabetics, the use of EES was associated with a significant improvement in all-clinical parameters except for MI rate: POCE: [10.0% vs. 12.6%; HR 0.78(0.62-0.98); P = 0.038], all cause death: [7.0% vs. 12.1%; HR 0.62(0.42-0.90); P = 0.014], and [TLR: 4.2 vs. 6.7; HR 0.60 (0.37-0.98); P = 0.04]. Overall, diabetics showed higher rate of POCE at 5-years (32.6% vs. 21.5% in nondiabetics HR1.45[1.03-2.04];p = 0.03) driven by increased rates of MI and the need for revascularization that occurred in coronary segments remote from target lesions [2.7% vs. 1.1%; HR: 2.27 (1.12-5.23); P = 0.02 and 14% vs. 6.2%; HR: 2.11 (1.38-3.22); P = 0.001, respectively]. Conclusions Diabetics had worse clinical outcomes than nondiabetics after STEMI mainly due to atherosclerosis progression. At 5-years, the treatment with EES did not reduce the rate of POCE in diabetics but reduced the need for revascularization compared with BMS.

Background: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. Methods: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25–4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint—cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation—between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. Findings: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference −0·3% [one-sided 95% upper confidence bound 1·6%], p non-inferiority

AIMS: Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES).METHODS AND RESULTS: The current post-hoc analysis was performed in the PIONEER randomized trial (1:1 randomization to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at pre-procedural, post-procedural and 9-month angiography without pharmacologically induced hyperemia (contrast QFR). At 9 months, both the values of QFR distal to the stent (B-SES: 0.89 +/- 0.10 vs. R-ZES: 0.89 +/- 0.11, p=0.97) and the numbers of the vessels with QFR =0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% versus 3.5%, P=1.00). QFR gradient across the device (?QFR) at 9 months was also similar between both groups (B-SES: 0.03 +/- 0.04 vs. R-ZES: 0.03 +/- 0.07, p=0.95).CONCLUSIONS: Quantitative flow assessment 9 months after stenting did not differ between B-SES and R-ZES, despite of a significant difference in in-stent late lumen loss.

Background Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. Methods Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. Results The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was (sic)430 more costly than BMS ((sic) 8,305 vs. (sic)7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of (sic)3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of (sic)25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. Conclusions Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values., The EXAMINATION trial (NCT00828087) was funded by the Spanish Heart Foundation. SB has received speakers' fees from Abbott Vascular and St Jude Medical. MV has received an honorarium as a public speaker for Terumo, the Medicines Company, Medtronic, Iroko, Merck, Abbott, Ely Lilly, AstraZeneca, Cordis, Carbostent and Implantable Devices, and Bayer. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The other authors declare no competing interests.

Background The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization. Methods The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014–May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization. Results A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12). Conclusion The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. Clinicaltrials.gov identifier NCT02183454 .

Introduction Previous midterm follow-up reports after implantation of the Absorb™ everolimus-eluting bioresorbable scaffold (BRS; Abbott Vascular, Santa Clara, CA, USA) in stable coronary artery disease and acute coronary syndrome have shown an increase of scaffold thrombosis leading to an excess of the device-oriented composite endpoint (DOCE: a composite of cardiac death, target vessel myocardial infarction [TVMI], and clinically driven target lesion revascularisation [CD-TLR])1. In contrast, in the six-month primary report of ABSORB STEMI: the TROFI II Study (NCT01986803)2, which randomised patients with ST-elevation myocardial infarction (STEMI) to receive either the Absorb BRS or the XIENCE metallic everolimus-eluting stent (EES; Abbott Vascular), optical frequency domain imaging (OFDI)-derived healing score was comparable between the BRS arm and the EES arm. The aim of this report was to present the three-year clinical outcome results of the BRS and the metallic EES at the time when full resorption of the scaffold device can be expected. Methods The trial design and methods, as well as the study population, have been described in previous reports2. Follow-up information at three years was available in 100% of the study population (Figure 1). All clinical events were adjudicated by an independent clinical events adjudication committee. Time-to-event variables were compared by log-rank test. Results Clinical outcomes at three years are tabulated in Table 1. At three years, the rates of DOCE were 5.3% (5/95) in the BRS arm and 3.1% (3/96) in the EES arm without a statistically significant difference (p=0.465). There were two cardiac deaths (2.1%) in the BRS arm: one was adjudicated as cardiac death on day 280 since no information was available as the patient died overseas. The autopsy of the second patient who died on day 999 revealed no evidence of scaffold thrombosis. There were no cardiac deaths in the EES arm. Discussion Three years after implantation of BRS or EES, in the setting of primary PCI, the rates of DOCE and ST were low and not significantly different between both arms. It is of note that there were no cases of ST after two years, while most of the patients in both arms discontinued dual antiplatelet therapy between one and two years (Supplementary Table 1). The three-year clinical results are in line with the comparable OFDI-derived healing scores2 and neointimal quality3 at six months. In addition, the recent report in the subpopulation of the current cohort showed a better vasomotion in BRS than in EES and similar microcirculatory function as well as healing score at three years4. Although routine thrombectomy is not recommended in the recent guidelines, in treating STEMI patients with BRS, thrombectomy could facilitate better scaffold sizing to achieve better long-term outcome. In the substudy of the present trial4, intraluminal dismantling was observed by OCT in 26.3%. However, the fact that the substudy only included event-free patients precludes the understanding of the clinical implication of intraluminal dismantling. Limitations The trial was not powered to evaluate clinical endpoints. The implantation technique reflects the state of the art at the time of enrolment in 2014 and did not take into account the more recent findings on BRS usage in terms of size selection, lesion preparation and deployment technique. It remains to be elucidated whether the comparative clinical outcomes in this study performed in STEMI patients will be maintained after three years. Conclusions Three years after implantation of BRS or EES, in the setting of primary PCI, the rates of DOCE and ST were low and not significantly different between both arms. The three-year clinical results are in line with the comparable healing scores observed at six months. However, the study was not powered to assess clinical endpoints.

BACKGROUND Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated–stent group and in 154 patients (12.9%) in the bare-metal–stent group (risk difference, −3.6 percentage points; 95% confi dence interval [CI], −6.1 to −1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P

Background Small vessel disease (SMD) remains a major challenge because of the increased risk of restenosis. We sought to assess the efficacy and safety of a paclitaxel-eluting balloon (PEB) in patients with SMD. Methods and Results One-hundred and four patients with native coronary lesions in small vessels treated by using a PEB were included in this prospective multicenter registry. In each case, after regular balloon dilatation, a larger PEB was inflated for a minimum of 45–60 seconds. Patients were 65 ± 10 years old, 43% diabetic, and 58% presented acutely. Angiographic success was 93% (7% bailout BMS implantation due to coronary dissection). The rate of major adverse cardiac events (MACE) at 12 months was 4.8% (1.9% cardiac death, 1.0% MI, and 2.9% TLR). One definite stent thrombosis was reported at 6 months in a patient with bailout BMS implantation. At 7 months, late loss was 0.31 ± 0.2 mm. Bail-out BMS after DEB use, was an independent predictor of MACE, HR 18.74, 95%CI (2.58–135.84) and TLR, HR 30.99, 95%CI (2.79–344.07). Conclusion The use of this PEB for the treatment of SMD provides excellent 1-year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR. (J Interven Cardiol 2015;28:430–438)

Aims: The aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI). Methods and results: Individual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35, 95% CI: 0.16-0.74) and any TLR (OR 0.34, 95% CI: 0.21-0.54). Conclusions: Killip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00962416. The EXAMINATION trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00828087.