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The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial.This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee.Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000).At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

BackgroundST-segment Elevation Myocardial Infarction (STEMI) complicated with no reflow after primary percutaneous coronary intervention is associated with adverse outcomes. Although several hyperemic drugs have shown to improve the Thrombolysis In Myocardial Infarction (TIMI) flow, optimal treatment of no reflow remains unsettled. Saline infusion at 20 ml/min via a dedicated microcatheter causes (flow-mediated) hyperemia. The objective is to compare the efficacy of pharmacologicvs. flow-mediated hyperemia in STEMI patients complicated with no reflow.MethodsSTEMI patients with no reflow were randomized to receive either adenosine or nitroprussidevs. flow-mediated hyperemia. The angiographic corrected TIMI Frame Count (cTFC) and the Minimal Microcirculatory Resistance (MMR), as assessed with intracoronary pressure-thermistor wire, dedicated microcatheter and thermodilution techniques, were compared after study interventions.ResultsSixty-seven were included (30 allocated to pharmacologic and 37 to flow-mediated hyperemia). After study interventions, cTFC (40.2±23.1vs. 39.2±20.7; p=0.858) and MMR (753.6±661.5vs. 993.3±740.8 Wood units; p=0.174) were similar between groups. TIMI 3 flow was observed in 26.7%vs. 27.0% (p=0.899). Flow-mediated hyperemia showed two different thermodilution patterns during saline infusion indicative of the severity of the no reflow phenomenon. In-hospital death and non-fatal heart failure were observed in 10.4% and 26.9%, respectively.ConclusionsBoth treatments showed similar (and limited) efficacy restoring coronary flow. Flow-mediated hyperemia with thermodilution pattern assessment allowed the simultaneous characterization of the no reflow degree and response to hyperemia. No reflow was associated with a high rate of adverse outcomes. Further research is warranted to prevent and to treat no reflow in STEMI patients (NCT04685941).

Introduction and objectives The vasomotor function of new-generation drug-eluting stents designed to enhance stent healing and reendothelialization is unknown. This study aimed to compare the endothelial function of the infarct-related artery (IRA) treated with bioactive circulating endothelial progenitor cell-capturing sirolimus-eluting stents (COMBO) vs polymer-free biolimus-eluting stents (BioFreedom) in ST-segment elevation myocardial infarction patients at 6 months. Secondary objectives were to compare the microcirculatory function of the IRA and stent healing at 6 months. Methods Sixty patients were randomized to bioactive sirolimus-eluting stent vs polymer-free biolimus-eluting stents implantation. At 6 months, patients underwent coronary angiography with vasomotor, microcirculatory and optical coherence tomography examinations. Endothelial dysfunction of the distal coronary segment was defined as ≥ 4% vasoconstriction to intracoronary acetylcholine infusion. Results Endothelial dysfunction was similarly observed between groups (64.0% vs 62.5%, respectively; P = .913). Mean lumen diameter decreased by 16.0 ± 20.2% vs 16.1 ± 21.6% during acetylcholine infusion (P = .983). Microcirculatory function was similar in the 2 groups: coronary flow reserve was 3.23 ± 1.77 vs 3.23 ± 1.62 (P = .992) and the index of microcirculatory resistance was 24.8 ± 16.8 vs 21.3 ± 12.0 (P = .440). Optical coherence tomography findings were similar: uncovered struts (2.3% vs 3.2%; P = .466), malapposed struts (0.1% vs 0.3%; P = .519) and major evaginations (7.1% vs 5.6%; P = .708) were observed in few cases. Conclusions Endothelial dysfunction of the IRA was frequent and was similarly observed with new-generation drug-eluting stents designed to enhance stent reendothelialization at 6 months. Endothelial dysfunction was observed despite almost preserved microcirculatory function and complete stent coverage. Larger and clinically powered studies are needed to assess the role of residual endothelial dysfunction in ST-segment elevation myocardial infarction patients. Registered in ClinicalTrials.gov: NCT04202172

Resumen Introduccion y objetivos Aun no se conoce la funcion endotelial de los nuevos stents farmacoactivos disenados para promover el recubrimiento y la reendotelizacion. El objetivo principal es comparar la funcion endotelial de la arteria responsable del infarto (ARI) tratada con stents bioactivos liberadores de sirolimus captadores de celulas progenitoras endoteliales circulantes (SES; COMBO) frente a la tratada con stents sin polimero liberadores de biolimus (BES; Biofreedom), asi como comparar la funcion microvascular de la ARI y el grado de cicatrizacion de ambos dispositivos a los 6 meses. Metodos Se aleatorizo a 60 pacientes con infarto agudo de miocardio con elevacion del ST (IAMCEST) a tratamiento con SES o BES. Tras 6 meses, todos los pacientes se sometieron a pruebas vasomotora mediante acetilcolina y nitroglicerina y de funcion microvascular mediante tecnicas de termodilucion y exploracion con tomografia de coherencia optica (OCT). Una respuesta vasoconstrictora a la acetilcolina ≥ 4% se definio como disfuncion endotelial. Resultados Ambos grupos presentaron similares porcentajes de disfuncion endotelial (el 64,0 frente al 62,5%; p = 0,913) y funcion microvascular. La reserva coronaria de flujo fue de 3,23 ± 1,77 frente a 3,23 ± 1,62 (p = 0,992) y el indice de resistencia microvascular, 24,8 ± 16,8 frente a 21,3 ± 12,0 (p = 0,440). Los hallazgos de la OCT fueron parecidos e indicaban una cicatrizacion avanzada: proporciones de struts sin recubrir (el 2,3 frente al 3,2%; p = 0,466), con mala aposicion (el 0,1 frente al 0,3%; p = 0,519) y de evaginaciones coronarias mayores (el 7,1 frente al 5,6%; p = 0,708). Conclusiones Tras 6 meses, los nuevos stents farmacoactivos presentaron con frecuencia parecidas disfunciones endoteliales de la ARI. La disfuncion endotelial se observo a pesar de la adecuada funcion microvascular y la cicatrizacion avanzada. Registrado en ClinicalTrials.gov: NCT04202172

Coronary lithotripsy (CL) works by fracturing the calcified plaque, allowing mean area gain, enhancing vessel compliance, and facilitating stent deployment. This study reports the safety, effectiveness, and durability of the clinical benefit of CL at long-term follow-up of a real-world multicenter registry.This was a prospective, multicenter, single-arm study that included consecutive patients with calcified lesions undergoing CL from August, 2018 to October, 2020 with a clinical follow-up of 20 months (interquartile range, 14.5-25). Exclusion criteria were a target lesion located in a vessellt;2.5 mm and/or the presence of dissection prior to CL. The primary endpoint was the rate of major adverse cardiovascular event (MACE, defined as death or target-lesion revascularization [TLR] or myocardial infarction [MI]) at follow-up.This registry included 109 patients (128 lesions). The population was elderly (mean age, 74 years old), with high rates of diabetic patients (58%), renal insufficiency (32%), and multivessel disease (76%). Most of the lesions were predilated with semicompliant/noncompliant balloons (25 with cutting balloon). Rotational atherectomy was used in 20 lesions. On average, CL required the use of 1 balloon delivering a mean of 60 pulses. Twelve patients presented with ST-segment-elevation MI and a culprit calcified coronary lesion undergoing CL. Successful CL was achieved in 99% of cases. There were few procedural complications, with 30-day freedom from MACE rate of 98%. The MACE rate at long-term follow-up was 5.6%.This is the first real-world, multicenter registry that confirms the safety and long-term efficacy of percutaneous coronary intervention for calcified lesions using CL in an unselected and high-risk population with a low long-term follow-up MACE rate.

Background This study aimed to assess the correlation between the standard of care, the index of microvascular resistance (IMR) versus the novel microvascular resistance (Rmicro) and to determine the pathologic cut-off value in a selected population with suspected coronary microvascular dysfunction (CMD). Methods One-hundred and twenty patients with high clinical suspicion of CMD due to ischemic symptoms in the absence of significant epicardial coronary lesions were prospectively included. Following a standardized systematic protocol, coronary flow reserve, IMR, fractional flow reserve, Q and Rmicro were measured in the left anterior descending coronary artery using a temperature/pressure sensor-tipped guidewire and a dedicated infusion catheter. Results There was a high prevalence of CMD with 50 (42%) patients showing an IMR ≥ 25. Median IMR was 23 [IQR: 14–34] and median Rmicro was 464 Woods Units (WU) [IQR: 354–636WU]. ROC analyses identified 500 WU as the optimal Rmicro cut-off to identify patients with an IMR ≥ 25, with an area under the ROC curve (C statistic) of 0.83 (95% CI: 0.74 to 0.89, p Conclusions Rmicro derived from continuous intracoronary thermodilution is an accurate index to measure microvascular resistances enabling the invasive diagnostic of CMD.

Background/purpose Everolimus-eluting stents (EES) are established as latest generation drug eluting stents . However, optical coherence tomography (OCT) assessment of neointimal distribution after EES implantation is lacking. We aimed to assess the longitudinal neointimal distribution pattern after EES implantation using OCT. Methods Data from 3 prospective studies (HEAL-EES, REVER and RESERVOIR), including patients with EES implantation and OCT follow-up study, were merged. Analyzed stents were divided into 3 segments of equal length (distal, medial, proximal). Longitudinal neointimal distribution patterns were compared between the 3 segments using generalized estimating equation. Neointimal thickness (NIT), neointimal area obstruction, and uncovered or malapposed struts were analyzed. Results In total, 86 patients (92 lesions) were analyzed. Time of OCT follow-up was 9.0 ± 1.5 months. NIT was 101.7 ± 65.4 μm and neointimal obstruction area was 12.2 ± 7.6%. The number of assessed struts was the same in all three segments. NIT tended to be higher at the medial segment (108.8 ± 71.1 μm) compared to distal (103.0 ± 63.4 μm) and proximal (93.3 ± 61.1 μm) (p = 0.076). Neointimal area obstruction was significantly different between the 3 segments (12.4 ± 7.5% [distal], 13.1 ± 7.7% [medial], 11.1 ± 7.5% [proximal]; p = 0.037). In the proximal segment, there was a significantly higher frequency of uncovered struts compared to medial and distal segments (3.9% vs. 2.1% vs. 2.5%, p = 0.009). The distribution of malapposed struts was not significantly different. Conclusions Distribution of neointimal hyperplasia seems to be different between stent segments, being higher in the medial segment as compared to proximal and distal. Whether this may reflect a response to local pre-interventional plaque burden centrally covered by the stent should be confirmed in a future study. Manuscript summary As optical coherence tomography based assessment of neointimal distribution after everolimus-eluting stent implantation is lacking, we analyzed data of 86 patients (92 lesions) from 3 prospective trials to evaluate neointimal distribution in distal, medial and proximal stent segments. Neointimal hyperplasia seemed to be different between the three segments, with a higher burden in the medial stent segment. Whether this reflects a response to local pre-interventional plaque burden centrally covered by the stent should be confirmed in a future study.

Resumen Introduccion y objetivos La litoplastia coronaria (LC) es una tecnica con balon que se utiliza para tratar lesiones calcificadas graves. Este estudio describe la experiencia inicial del tratamiento de lesiones calcificadas con LC en una poblacion no seleccionada y de alto riesgo. Metodos Registro prospectivo, multicentrico, que incluyo consecutivamente todos los casos con lesiones coronarias calcificadas que se trataron con LC entre agosto de 2018 y agosto de 2019. Los criterios de exclusion fueron lesiones localizadas en vaso pequeno ( Resultados Este registro incluyo a 57 pacientes (66 lesiones). Una poblacion de edad avanzada (72,6 ± 9,4 anos) con alta proporcion de pacientes diabeticos (56%), enfermedad renal cronica (35%) y enfermedad multivaso (84%). Todas las lesiones eran de tipo B/ C . Se predilataron mas del 75% de las lesiones con balones semidistensibles/no distensibles o cutting-balloon. Se utilizo rotablacion antes de la litoplastia en 5 lesiones (7,6%). En promedio, la LC necesito 1,17 balones de litoplastia y una media de 60 pulsos. El exito de la LC se logro en el 98%. En el 13% de los casos, el balon de litoplastia se rompio durante el procedimiento. Hubo pocas complicaciones durante el procedimiento: 2 casos de diseccion significativa (ninguna relacionada con ruptura del balon de litoplastia), que se trataron con exito mediante implante de stent farmacoactivo; 1 paciente presento trombosis del stent 2 dias despues de someterse con exito a la revascularizacion de la lesion objetivo. Conclusiones Este es un registro multicentrico de la practica clinica que respalda la factibilidad, la seguridad y la eficacia a corto plazo de la intervencion coronaria percutanea para lesiones coronarias calcificadas utilizando la LC con resultados prometedores en una poblacion no seleccionada y de alto riesgo.

Objectives. The aim of this study is to assess the utility of optical coherence tomography (OCT) in patients with exercise-related acute coronary syndrome (ACS) presenting with inconclusive angiographic findings. Background. Regular physical activity reduces the incidence of cardiovascular events. Nevertheless, the risk of ACS or sudden cardiac death (SCD) increases during sport. In adults older than 35 years, exercise-related ACS or SCD is associated with plaque rupture, but not infrequently patients present ambiguous angiographic findings. Methods. Between September 2015 and January 2020, patients admitted for ACS or SCD triggered by physical exertion and with coronary stenosis ≤50% were included in this prospective observational study. OCT was performed on the artery deemed to be responsible of the event. Results. Ten patients were enrolled, predominantly men (80%) of middle age (51 years old, IQR 41–63) with low cardiovascular risk burden. Cycling was the most frequent (50%) exercise-related trigger, 8 patients were regular sport practitioners, and 7 had the clinical event during strenuous exertion. Five patients presented with non-ST-elevation ACS, two with ST-elevation ACS, and three with SCD. Angiographic analysis showed nonsignificant stenosis in all patients (42% stenosis, IQR 36–46). OCT identified the etiology of the event in 9 patients (4 plaque erosion, 3 plaque rupture, 1 eruptive calcific nodule, and 1 coronary dissection). Treatment was adjusted according to OCT findings. Conclusions. OCT is a valuable technique to identify the etiology of exercise-related ACS or SCD in patients with nonobstructive coronary arteries and, as a result, may lead to a more specific treatment.

Aims The aim of this study was to compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold (BRS) and an everolimus-eluting metallic stent (EES) in STEMI patients. Methods and results This observational and retrospective study included 235 consecutive STEMI patients treated with BRS, compared with 235 STEMI patients treated with EES from the EXAMINATION trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation at five-year follow-up. Device thrombosis, according to the ARC criteria, was also evaluated. Optical coherence tomography (OCT) analysis was also performed at five years in event-free BRS patients. The cumulative incidence of five-year DOCE was higher in the BRS group as compared to the EES group (13.2% vs 7.6%, HR 1.87, 95% CI: 0.94-3.44, p=0.071), mainly driven by a higher rate of TLR (7.6% vs 1.7%, HR 1.15, 95% CI: 0.44-2.30, p=0.004). The five-year definite BRS thrombosis rate was also higher as compared to EES (4.2% vs 1.2%, HR 3.49, 95% CI: 0.95-12.82, p=0.054). OCT analysis showed a high incidence of neoatherosclerosis in the BRS group. Conclusions The five-year event risk was higher with BRS versus EES in STEMI. This suggests that the probability of obtaining favourable results at very long-term follow-up is low. Whether better results will be obtained with new-generation BVS remains to be determined.

Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; P non-inferiority < 0.001; P superiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032.

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.

Objectives Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES. Methods pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days. Results Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES. Conclusions In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).

The amphilimus-eluting stent (AES) is a thin-strut polymer-free stent that releases sirolimus formulated with a carrier from abluminal grooves. The RESERVOIR trial compared AES vs everolimus-eluting stents (EES) in patients with diabetes mellitus (DM) and showed non-inferior neointimal hyperplasia suppression at 9 months follow-up. The aim of this study was to assess comparative clinical outcomes at 5 years. The endpoints analyzed for this extended follow-up were target-vessel failure (TVF), target-vessel revascularization (TVR) and target-lesion revascularization (TLR). At 5-years, AES vs EES had similar risk of TVF (HR 0.54, 95% CI 0.20-1.47, p = 0.23), TVR (HR 0.36, 95% CI 0.12-1.14, p = 0.08) and TLR (HR 0.43, 95%CI 0.11-1.67, p = 0.22). Landmark analyses between 1 and 5 years also showed no significant differences between groups.

BACKGROUND This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months. METHODS Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bulach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%). RESULTS At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p

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.

Background: Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is known to be poor and to be partially improved by pre-treatment with loading dose of ticagrelor vs. clopidogrel. It is unknown if this vascular dysfunction is maintained at long-term follow-up and may be improved by 1-year dual antiplatelet therapy (DAPT) with ticagrelor vs. clopidogrel. Methods: The TIGER is a prospective, open-label, two parallel-group controlled clinical trial, which 1:1 randomized 50 CTO patients to pre-PCI loading dose and subsequent 1-year DAPT with ticagrelor vs. clopidogrel. Coronary blood flow (CBF) under stepwise adenosine infusion was assessed after drug loading dose and at follow-up and compared between the two drug groups, adjusting for time of follow-up. Results: Out of 50 patients with index CBF evaluation, 38 (76%) patients underwent angiographic follow-up (23 and 15 at 1 and 3-year, respectively). A higher CBF area under the curve (AUC), already observed after loading dose in ticagrelor vs. clopidogrel group (p=0.027), was maintained at follow-up (AUC 34815.22±24206.06 vs. AUC 22712.47±13768.95; p=0.071). Specifically, whereas high ticagrelor loading dose-related CBF was sustained at follow-up (p=0.933), clopidogrel loading dose-related CBF increased at follow-up (p=0.039). Conclusion: The TIGER trial showed that DAPT with ticagrelor may maintain a higher CBF in a recanalized CTO as compared to clopidogrel, whose treated patients exhibit a lower CBF immediately after PCI with slight increase at follow-up. The clinical value of such sustained higher coronary flow should be evaluated in a larger group of patients.

Background Despite technological advances in drug-eluting stents (DES) design, delayed vascular healing is still a problem, triggered by the polymers among others. This may induce restenosis and thrombosis. The development of biodegradable polymers and DES without polymer is thought to improve the vascular response and enhance earlier neointimal healing. Optical coherence tomography (OCT) is the best intracoronary imaging tool to evaluate endothelial coverage after stent implantation. Purpose We aimed to quantitatively assess the differences on intimal coverage between biodegradable-polymer, durable-polymer and without-polymer DES at 1 and 6-month follow-up OCT. Methods A total of 94 patients with de novo coronary lesions were treated with DES: 26% were treated with Biolimus A9 (BA9) stent without polymer, 30% were treated with Everolimus DES with biodegradable polymer (EESb) and 44% with Everolimus DES with persistent polymer (EESp). OCT analysis was performed blindly at an independent Core Lab at three stages: implantation, after one month and after six months. The primary endpoint was to compare neointimal coverage and apposition of these three different types of DES with OCT at one and six months after implantation. Results A total of 16034 struts were analysed (24% BA9, 29% EESb and 47% EESp). No significant differences were found among the groups regarding baseline clinical characteristics. When studying the strut coverage, it is remarkable the relatively low percentage of early neointimal coverage with no significant differences among stents one month after implantation (84–87%). After six months, there was better coverage in the three stent groups compared with one month (p Conclusions The new-generation DES with biodegradable-polymer or without polymer showed relatively poor early neointimal coverage and similar to the last generation durable-polymer EES. According to these results, DAPT may not be shortened in any of the three DES types studied. Funding Acknowledgement Type of funding source: None

Patients with heart failure (HF) display elevated levels of soluble fractalkine, a chemokine involved in inflammation processes, atherosclerosis and platelet activation. Further, fractalkine has been associated with reduced pharmacodynamic (PD) responsiveness to clopidogrel. The aim of this study was to investigate the association of fractalkine with the severity of HF and its impact on platelet activation and clopidogrel response in patients with coronary artery disease (CAD) with and without HF.This prospective PD study included 116 stable CAD patients on DAPT with aspirin and clopidogrel. Subjects were classified in two groups: patients with HF and reduced (40%) left ventricular ejection fraction (HFrEF group, n = 56) and patients without HF (no HF group, n = 60). Clinical severity of HF was graded according to NYHA classification. Platelet function assays included vasodilator-stimulated phosphoprotein assay, multiple electrode aggregometry and light transmittance aggregometry. Fractalkine and P-selectin concentrations were determined by ELISA.Fractalkine levels progressively increased with the severity of the disease in the HFrEF group (NYHA I: 471.2 ± 52.4 pg/ml, NYHA II: 500.5 ± 38.4 pg/ml, NYHA III: 638.9 ± 54.3 pg/ml, p for linear trend 0.023). Numerically higher concentrations of fractalkine were observed in the HFrEF group compared to the no HF group with borderline significance (p = 0.052). No significant differences in clopidogrel-induced platelet inhibition according to fractalkine values were observed in any of the groups.Fractalkine levels were increased in patients with HFrEF and positively associated with the functional severity of the disease. No evident impact of fractalkine on clopidogrel PD efficacy was found.

AIMS The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT). METHODS AND RESULTS Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p

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

Resumen Introduccion y objetivos Estudios recientes en animales han demostrado que la metformina (MF) perjudica la endotelizacion de los stents farmacoactivos (SFA). Se evaluo el efecto de la MF en el recubrimiento neointimal de los SFA en pacientes diabeticos por tomografia de coherencia optica (OCT). Metodos El ensayo RESERVOIR aleatorizo 116 lesiones en 112 pacientes con diabetes mellitus a stents liberadores de amphilimus o everolimus, a los que se realizo una OCT a los 9 meses. Los pacientes se dividieron en 3 grupos segun el tratamiento hipoglucemiante recibido: a) no MF; b) MF sin insulina, y c) MF con insulina. El objetivo primario fue el porcentaje de struts no recubiertos. Resultados Diecisiete pacientes (19 lesiones) al grupo sin MF; 53 pacientes (54 lesiones) al grupo MF sin insulina y 28 pacientes (28 lesiones) al grupo MF con insulina. Las caracteristicas basales fueron comparables, aunque los pacientes del grupo MF sin insulina tuvieron un mejor control glucemico (p Conclusiones El uso de MF no perjudica el recubrimiento neointimal de los SFA en diabeticos independientemente de que reciban o no tratamiento con insulina. De acuerdo a nuestros resultados, el uso de MF parece no estar desaconsejado en estos pacientes.

Objectives The study sought to compare the vasomotor and microcirculatory function of the infarct-related artery (IRA) between bioresorbable vascular scaffolds (BVS) and everolimus-eluting stents (EES) at 3 years. Background The ABSORB STEMI TROFI II study showed similar outcomes between BVS and EES in the context of ST-segment elevation myocardial infarction at 3 years. Methods Sixty-three consecutive event-free patients of the randomized TROFI II study were screened to undergo coronary angiography with vasomotor, microcirculatory, and optical coherence tomography (OCT) examination at 3 years. Vasomotion was defined as >4% change in mean lumen diameter to acetylcholine (ACH) and nitroglycerin as assessed by quantitative angiography. Microcirculatory examination was performed with pressure or thermodilution techniques. Results A total of 38 patients (20 BVS and 18 EES) were included. At 3 years, ≥60% of patients exhibited paradoxical vasoconstriction to ACH in the periscaffold or stent segments. Vasoconstriction to ACH and vasodilatation to nitroglycerin were more often observed in the scaffold or stent segment with BVS than with EES (77.8% vs. 25.0%; p = 0.008 and 61.1% vs. 18.8%; p = 0.018). The IRA-depending microcirculation showed similar index of resistance (23.8 vs. 22.4; p = 0.781), coronary flow reserve (2.4 vs. 1.9; p = 0.523), fractional flow reserve (0.91 vs. 0.93; p = 0.317), and absolute flow (135.5 ml/min vs. 147.3 ml/min; p = 0.791). OCT showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3% vs. 0%; p = 0.049) in the BVS group. Conclusions Both endothelium-dependent and -independent vasomotion of the IRA were more evident with BVS, as compared with EES, at 3 years. Functional microcirculatory parameters were mostly adequate and similar between BVS and EES. Clinical implications of these findings warrant further investigations.

AIMS The aim of the study was to investigate the association between in-stent neoatherosclerosis (NA) and atherosclerosis progression (AP) in non-culprit segments in patients with ST-elevation myocardial infarction at five years. METHODS AND RESULTS Sixty-two out of 169 consecutive patients included in the EXAMINATION study underwent optical coherence tomography (OCT) at five years. NA plaques were observed in 13 (21.0%), signal-rich bands (SRB) in 22 (35.5%) and AP in 11 (17.7%). NA plaques were more frequently observed in patients treated with two stents (53.8% vs. 20.4%; p=0.02). SRB were more frequently observed with longer stent length (29.8±11.6 vs. 22.5±9.1 mm; p

Aims: Current guidelines recommend an early invasive strategy in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). The role of an invasive strategy in frail elderly patients remains controversial. The aim of this substudy was to assess the impact of an invasive strategy on outcomes according to the degree of frailty in these patients. Methods and results: The LONGEVO-SCA registry included unselected NSTEACS patients aged =80 years. A geriatric assessment, including frailty, was performed during hospitalisation. During the admission, we evaluated the impact of an invasive strategy on the incidence of cardiac death, reinfarction or new revascularisation at six months. From 531 patients included, 145 (27.3%) were frail. Mean age was 84.3 years. Most patients underwent an invasive strategy (407/531, 76.6%). Patients undergoing an invasive strategy were younger and had a lower proportion of frailty (23.3% vs. 40.3%, p

Resumen Introduccion y objetivos La trombosis de stent (TS) es una complicacion grave tras la angioplastia coronaria, y la ecografia intravascular es una herramienta capaz de discernir las causas. El objetivo es comparar los hallazgos por ecografia intravascular entre stents metalicos (SM) y stents farmacoactivos (SFA) en pacientes con TS tardia (de 31 dias a 1 ano) o muy tardia (>1ano). Metodos Se incluyo a 114 pacientes (el 45,5% con SM y el 54,5% con SFA) de un total de 250 consecutivos con TS tardia o muy tardia en 7 hospitales espanoles. Se realizo una ecografia intravascular, que se analizo posteriormente para detectar la presencia de malaposicion, infraexpansion y neoateroesclerosis. Resultados El tiempo hasta la TS fue de 4,0 anos en los SM y 3,4 anos en los SFA (p = 0,04). La malaposicion fue similar en ambos grupos (el 36,5 frente al 46,8%; p = 0,18), aunque numericamente menor en los SM con trombosis muy tardia (el 26,6 frente al 48,0%; p = 0,07). La infraexpansion se observo de manera similar en ambos grupos (el 13,5 frente al 11,3%; p = 0,47). La neoateroesclerosis solo se observo en TS muy tardias y fue mas prevalente en los SM (22,9%) que en los SFA (6,0%; p = 0,02). A los 2,9 anos de seguimiento, las muertes cardiacas eran 0 frente a 6,9% respectivamente (p = 0,06) y las recurrencias de TS se produjeron en el 4,0 frente al 5,2% (p = 0,60). Conclusiones La malaposicion es el hallazgo mas frecuente en los pacientes con TS tardia y muy tardia, mas prevalente en los SFA con TS muy tardias. Sin embargo, la neoateroesclerosis se observo unicamente en pacientes con TS muy tardias, y principalmente en SM.

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.

Background Very late scaffold thrombosis (VLScT) occurs more frequently after bioresorbable scaffold (Absorb BVS 1.1, Abbott Vascular, Santa Clara, California) implantation than with metallic everolimus-eluting stents. Objectives The purpose of this study was to elucidate mechanisms underlying VLScT as assessed by optical coherence tomography (OCT). Methods The INVEST (Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis) registry is an international consortium of investigators who used OCT to examine patients with VLScT. Results Between June 2013 and May 2017, 36 patients with 38 lesions who had VLScT underwent OCT at 19 centers. VLScT occurred at a median of 20 months (interquartile range: 16 to 27 months) after implantation. At the time of VLScT, 83% of patients received aspirin monotherapy and 17% received dual-antiplatelet therapy. The mechanisms underlying VLScT were (in descending order) scaffold discontinuity (42.1%), malapposition (18.4%), neoatherosclerosis (18.4%), underexpansion or scaffold recoil (10.5%), uncovered struts (5.3%), and edge-related disease progression (2.6%). Discontinuity (odds ratio [OR]: 110; 95% confidence interval [CI]: 73.5 to 173; p Conclusions The leading mechanism underlying VLScT was scaffold discontinuity, which suggests an unfavorable resorption-related process, followed by malapposition and neoatherosclerosis. It remains to be determined whether modifications in scaffold design and optimized implantation can mitigate the risk of VLScT. (Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis [INVEST]; NCT03180931)

Objectives To explore the role of ticagrelor versus clopidogrel in coronary blood flow normalization immediately after chronic coronary total occlusion (CTO) recanalization. Background Coronary vascular function of a CTO immediately after recanalization is demonstrated to be poor. Methods The TIGER BVS is a prospective, double-randomized, open-label, two parallel-group controlled clinical trial to evaluate efficacy of ticagrelor versus clopidogrel in improving vascular function of coronary segment distal to CTO immediately after CTO recanalization. A total of 50 patients who receive CTO PCI will be randomized 1:1 to receive ticagrelor versus clopidogrel at least 3 days before the procedure. Immediately after CTO recanalization with Absorb BVS implantation, a specific study of vascular function under adenosine infusion will be performed. Patients will be therefore randomized 1:1 to receive angiographic follow-up with vascular function and optical coherence tomography analyses at 1- or 3-year follow-up. This study is registered on ClinicalTrials.gov with number NCT02211066. Conclusions The TIGER BVS trial will provide the first randomized comparison between ticagrelor versus clopidogrel in recovering vascular function in CTO patients. It will also provide important data on vascular restoration therapy of Absorb BVS in this scenario.

Aims Our aim was to describe the intravascular ultrasound (IVUS) findings of patients with late stent thrombosis (ST) undergoing percutaneous intervention, and to compare the pre- and post-intervention IVUS findings of patients treated with balloon angioplasty (BA) vs. additional stent implantation (ASI). Methods and results A total of 117 patients with late ST imaged with IVUS were included (51.2% had drug-eluting stent ST). Treatment was left to the operator's discretion: BA was performed in 53.8% and ASI in 46.2%. Pre-intervention, incomplete stent apposition (ISA) was observed in 69.8% vs. 63.0% (p=0.43), underexpansion in 33.3% vs. 18.5% (p=0.07) and restenosis in 15.9% vs. 27.8% (p=0.12), respectively. Post-intervention, persistent ISA was observed in 37.2% vs. 60.9% (p=0.03) and malapposition volume decreased by 43.6% vs. 2.6% (p=0.03). Persistent underexpansion was observed in 9.3% vs. 17.4% (p=0.26); however, the stent expansion index was largely increased with BA (from 0.75 to 0.88) compared to ASI (from 0.80 to 0.82); p=0.046. At two years, recurrent ST was observed in one (1.7%) vs. four (7.7%) patients, respectively; p=0.09. Conclusions Non-optimal IVUS criteria of stent implantation are often observed in patients with late ST. Treatment of late ST with BA leads to a larger reduction of malapposition and underexpansion with respect to ASI and is associated with favourable outcomes.

Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population.This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory.This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization.This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.

AIMS The aim of this study was to compare the hyperaemic flow and vasomotor response to endothelium-dependent stimuli between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) at 13 months. METHODS AND RESULTS Seventy non-diabetic patients aiming to achieve complete revascularisation were randomised 1:1 to BVS or EES implantation. At 13 months, invasive coronary angiography was performed using intracoronary pressure and Doppler ultrasound measurements at rest and maximal hyperaemia. A vasomotor test to endothelium-dependent (acetylcholine) and independent (nitroglycerine) stimuli and optical coherence tomography (OCT) were also performed. Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination. Doppler ultrasound average peak velocity (49.0±17.5 vs 49.3±18.3 cm/sec; p=0.95), coronary blood flow (97.4±53.5 vs 88.3±46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs 0.94±0.04; p=0.17) were similar between the groups. The vasomotor test showed vasoconstriction response to acetylcholine in 75.6% proximal and 72.2% distal peri-scaffold segments without differences between study devices. BVS had larger in-scaffold vasoconstriction than EES (60.0% vs 27.6%; p=0.01) despite similar neointima response as assessed by OCT. CONCLUSIONS BVS and EES had similar microcirculatory response to hyperaemia and predominant vasoconstrictive response in the peri-scaffold segments to endothelium-dependent stimuli. However, BVS exhibited larger vasoconstriction to endothelium-dependent stimuli in the scaffold segment.

Aims: Percutaneous treatment of coronary chronic total occlusion (CTO) is associated with important arterial remodelling after successful recanalisation. Bioresorbable vascular scaffold (BVS) implantation in CTO has been shown to be feasible and can be of interest when the scaffold achieves complete bioresorption. We sought to evaluate the three-year results in terms of clinical events, serial imaging outcomes and vasomotion response in CTO lesions successfully treated with BVS. Methods and results: A total of 33 patients (35 CTO lesions) successfully treated with BVS were included in the ABSORB-CTO study. Clinical outcomes, quantitative coronary angiography (QCA) and optical coherence tomography (OCT) assessment were analysed at one- and three-year follow-up. Vasomotion examination was also performed at three years. At three years, cumulative target vessel reocclusion was observed in four lesions (11.4%). By QCA, the in-scaffold segment presented a lumen loss of 0.23 +/- 0.46 mm compared with the baseline procedure (p=0.001) and a lumen gain of 0.05 +/- 0.29 mm between one and three years (p=0.220). By OCT, the mean neointimal area stenosis progressed from 11.45% at 12 months to 17.10% at 36 months (p

Objectives The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM). Background The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM. Methods This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up. Results A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group. Conclusions AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748 ).