A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial.

Background: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. Methods: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. Results: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). Conclusions: The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

A randomized controlled trial comparing BioMime Sirolimus-Eluting Stent with Everolimus-Eluting Stent: two-year outcomes of the meriT-V trial

BACKGROUND: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. METHODS: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. RESULTS: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs.

Clinical profile and prognosis of young patients with ST-elevation myocardial infarction managed by the emergency-intervention Codi IAM network.

INTRODUCTION AND OBJECTIVES: Data on the clinical profile and outcomes of younger patients with ST-elevation myocardial infarction (STEMI) is scarce. This study compared clinical characteristics and outcomes between patients aged<45 years and those aged ≥ 45 years with STEMI managed by the acute myocardial infarction code (AMI Code) network. Sex-based differences in the younger cohort were also analyzed. METHODS: This multicenter study collected individual data from the Catalonian AMI Code network. Between 2015 and 2020, we enrolled patients with an admission diagnosis of STEMI. Primary endpoints were all-cause mortality within 30 days, 1 year, and 2 years. RESULTS: Overall, 18 933 patients (23% female) were enrolled. Of them, 1403 participants (7.4%) were aged<45 years. Younger patients with STEMI were more frequently smokers (P<.001) and presented with cardiac arrest and TIMI flow 0 before pPCI (P<.05), but the time from first medical contact to wire crossing was shorter than in the older group (P<.05). All-cause mortality rates were lower in patients aged<45 years (P<.001). Among younger patients, cardiogenic shock was most prevalent in women than in their male counterparts (P=.002), with the time from symptom onset to reperfusion being longer (P<.05). Compared with men aged<45 years, younger women were less likely to undergo pPCI (P=.004). CONCLUSIONS: Despite showing high-risk features on admission, young patients exhibit better outcomes than older patients. Differences in ischemia times and treatment were observed between men and women.

Spontaneous Coronary Artery Dissection: Rediscovering an Old Cause of Myocardial Infarction.

Spontaneous coronary artery dissection is an uncommon, but not insignificant cause of acute coronary syndrome that overwhelmingly affects middle-aged women. The pathophysiology of coronary dissection appears to be an outside-in mechanism, where the initiating event is not an intimal tear but rather the formation of an intramural hematoma, which compromises blood flow by reducing the arterial lumen. Considering this mechanism, it is clear to see how intracoronary imaging techniques, such as optical coherence tomography and intravascular ultrasound, are most accurate in the diagnosis. However, they carry a high rate of complications and are therefore generally avoided when the clinical scenario and angiographic appearance both support the diagnosis of spontaneous coronary artery dissection. The natural history of the disease is toward healing of the vessel wall and restoration of blood flow. Therefore, conservative medical management is the preferred approach unless there are high-risk factors such as hemodynamic instability, signs of ischemia and severe proximal or multivessel lesions, in which percutaneous or surgical revascularization should be considered. Perioperative evaluation of these patients must take into account several aspects of this disease. Most of these patients will be receiving single or dual antiplatelet therapy, so one must consider the timing of the event and the surgical hemorrhagic risk when deciding to stop these therapies. Extracoronary vascular disease also must be assessed because it can have an effect on patient monitoring and risk of postoperative complications.

Clinical outcomes in spontaneous coronary artery dissection.

OBJECTIVE: Spontaneous coronary artery dissection (SCAD) is an infrequent cause of acute coronary syndrome. Our aim was to assess adverse events at follow-up from a nationwide prospective cohort. METHODS: The Spanish Registry on SCAD (SR-SCAD) included patients from 34 hospitals. All coronary angiograms were analysed by two experts. Those cases with doubts regarding the diagnosis of SCAD were excluded. The angiographic SCAD classification by Saw et al was followed. Major adverse cardiovascular and cerebrovascular event (MACCE) was predefined as composite of death, myocardial infarction, unplanned revascularisation, SCAD recurrence or stroke. All events were assigned by a Clinical Events Committee. RESULTS: After corelab evaluation, 389 patients were included. Most patients were women (88%); median age 53 years (IQR 47-60). Most patients presented as non-ST-segment-elevation myocardial infarction (54%). A type 2 intramural haematoma (IMH) was the most frequent angiographic pattern (61%). A conservative initial management was selected in 78% of patients. At a median time of follow-up of 29 months (IQR 17-38), 46 patients (13%) presented MACCE, mainly driven by reinfarctions (7.6%) and unplanned revascularisations (6.2%). Previous history of hypothyroidism (HR 3.79; p<0.001), proximal vessel involvement (HR 2.69; p=0.009), type 2 IMH (HR 2.12; p=0.037) and dual antiplatelet therapy (DAPT) at discharge (HR 2.18; p=0.042) were independent predictors of MACCE. CONCLUSIONS: In this large prospective cohort of patients with SCAD, prognosis was overall favourable, with events mainly driven by reinfarctions or unplanned revascularisations. History of hypothyroidism, proximal vessel involvement, type 2 IMH and DAPT at discharge were associated with MACCE. TRIAL REGISTRATION NUMBER: NCT03607981.

Revascularized ST-segment elevation myocardial infarction. Temporal trends in contemporary therapies and impact on outcomes.

INTRODUCTION AND OBJECTIVES: To assess, in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous intervention, the pace of introduction in clinical practice (2010-2017) of drug-eluting stents (DES), ticagrelor, prasugrel, and prolonged dual antiplatelet therapy (DAPT) duration, and their potential impact on the risk of 2-year outcomes. METHODS: Prospective and exhaustive community-wide cohort of 14 841 STEMI patients undergoing primary percutaneous intervention between 2010 and 2017. Index episodes were obtained from the Catalan Codi IAM Registry, events during follow-up from the Minimum Data Set and DAPT were defined by pharmacy dispensation. Follow-up was 24 months. The temporal trend for exposures and outcomes was assessed using regression models. RESULTS: Age> 65 years, diabetes, renal failure, previous heart failure, and need for anticoagulation at discharge were more frequent in later periods (P <.001). From 2010 to 2017, the use of DES increased from 31.1% to 69.8%, ticagrelor from 0.1% to 28.6%, prasugrel from 1.5% to 23.8%, and the median consecutive months on DAPT from 2 to 10 (P <.001 for all). Adjusted analysis showed a temporal trend to a lower risk of the main outcome over time: the composite of death, acute myocardial infarction, stroke and repeat revascularization (absolute odds reduction 0.005% each quarter; OR, 0.995; 95%CI, 0.99-0.999; P=.028). The odds of all individual components except stroke were reduced, although significance was only reached for revascularization. CONCLUSIONS: Despite a strong increase between 2010 and 2017 in the use and duration of DAPT and the use of ticagrelor, prasugrel and DES, there was no substantial reduction in major cardiovascular outcomes.

Clinical implications of arterial hypertension in patients with spontaneous coronary artery dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is a rare but increasingly recognized cause of acute coronary syndrome. Many patients with SCAD have associated coronary risk factors. However, the implications of arterial hypertension in SCAD patients remain unknown. OBJECTIVE: This study sought to assess the clinical implications of arterial hypertension in a nationwide cohort of patients with SCAD. METHODS: The Spanish SCAD registry (NCT03607981) prospectively enrolled 318 consecutive patients. All coronary angiograms were centrally analyzed to confirm the diagnosis of SCAD. Patients were classified according to the presence of arterial hypertension. RESULTS: One-hundred eighteen patients (37%) had a diagnosis of arterial hypertension. Hypertensive SCAD patients were older (60 ± 12 vs. 51 ± 9 years old) and had more frequently dyslipidemia (56 vs. 23%) and diabetes (9 vs. 3%) but were less frequently smokers (15 vs. 35%) than normotensive SCAD patients (all P < 0.05). Most patients in both groups were female (90 vs. 87%, NS) and female patients with hypertension were more frequently postmenopausal (70 vs. 47%, P < 0.05). Hypertensive SCAD patients had more severe lesions and more frequently multivessel involvement (15 vs. 7%, P < 0.05) and coronary ectasia (19 vs. 7%, P < 0.05) but showed a similar prevalence of coronary tortuosity (34 vs. 26%, NS). Revascularization requirement was similar in both groups (17 vs. 26%, NS) but procedural success was significantly lower (65 vs. 88%, P < 0.05) and procedural-related complications more frequent (65 vs. 41%, P < 0.05) in SCAD patients with hypertension. CONCLUSION: Patients with SCAD and hypertension are older, more frequently postmenopausal and have more coronary risk factors than normotensive SCAD patients. During revascularization SCAD patients with hypertension obtain poorer results and have a higher risk of procedural-related complications (NCT03607981).

Impact of Diabetes Mellitus on Vascular Healing Process After Everolimus-Eluting Stent Implantation: An Optical Coherence Tomography Study.

BACKGROUND/PURPOSE: To study the impact of diabetes mellitus (DM) on vascular healing process after implantation of everolimus-eluting stent (EES). METHODS/MATERIALS: Data from 3 prospective studies (HEAL-EES, REVER, and RESERVOIR), including patients with EES implantation and OCT follow-up, were merged. Differences in vascular healing process assessed by OCT were compared between DM and non-DM using generalized estimating equations. Neointimal proliferation, neointimal signal pattern (high, low, and layered), and uncovered/malapposed struts were evaluated. RESULTS: A total of 96 lesions (61 DM lesions and 35 non-DM lesions) were included. Mean OCT follow-up time was 8.9 ± 1.5 months and comparable between groups. DM were older, high frequently female and acute coronary syndrome, and received smaller stent than non-DM. No differences were observed in quantitative vascular healing process between groups. However, DM exhibited higher low and layered signal pattern neointima compared to non-DM at lesion level (p = 0.030) and cross-section level (p < 0.001). Uncovered/malapposed struts were comparable between groups. CONCLUSIONS: Quantitative vascular healing process was comparable between groups. However, DM was significantly associated with low signal pattern, which is characteristic of focal inflammation, after EES implantation. Further study might be required to study relationship between neointimal signal pattern and clinical events.

Alcohol Septal Ablation: An Option on the Rise in Hypertrophic Obstructive Cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) can cause symptoms due to the obstruction of the left ventricle outflow tract (LVOT). Although pharmacological therapy is the first step for treating this condition, many patients do not fully respond to the treatment, and an invasive approach is required to manage symptoms. Septal reduction therapies include septal myectomy (SM) and alcohol septal ablation (ASA). ASA consists of a selective infusion of high-grade alcohol into a septal branch supplying the basal interventricular septum to create an iatrogenic infarction with the aim of reducing LVOT obstruction. Currently, SM and ASA have the same level of indication; however, ASA is normally reserved for patients of advanced age, with comorbidities or when the surgical approach is not feasible. Recent data suggests that there are no differences in short- and long-term all-cause mortality, cardiovascular mortality and sudden cardiac death between ASA and SM. Despite the greater experience and refinement of the technique gained in recent years, the most common complication continues to be complete atrio-ventricular block, requiring a permanent pacemaker. Septal reduction therapies should be performed in experienced centres with comprehensive programs.

Influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con reestenosis en el stent / Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis

Introducción y objetivos La neoateroesclerosis es una de las causas de la reestenosis en el stent (RS). Nuestro objetivo es evaluar la influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con RS. Métodos Se trata de un análisis conjunto de los subestudios de tomografía de coherencia óptica (OCT) de los RIBS IV y V, 2 ensayos clínicos aleatorizados y multicéntricos que comparan el tratamiento con un balón recubierto con paclitaxel frente al stent liberador de everolimus en pacientes con RS. La evaluación con OCT se realizó basalmente y a los 6-9 meses. La neoateroesclerosis se definió en la OCT basal como una neoíntima con contenido calcificado o lipídico. Se evaluaron los resultados angiográficos y por OCT a los 6-9 meses y la aparición de eventos adversos cardiovasculares mayores a los 3 años de seguimiento en pacientes con y sin neoateroesclerosis tratados con balón recubierto con paclitaxel o stent liberador de everolimus. Resultados Se estudió mediante OCT a 64 pacientes en el momento del procedimiento. Se documentó neoateroesclerosis en 23 lesiones (36%). El seguimiento angiográfico a los 6-9 meses no mostró diferencias entre los pacientes con y sin neoateroesclerosis en reestenosis (5 [24%] frente a 6 [15%]; p=0,49), diámetro luminal mínimo (1,79±0,7 frente a 1,94±0,6 mm; p=0,41) o pérdida tardía (0,33±0,7 frente a 0,15±0,5; p=0,34). El seguimiento con OCT confirmó la ausencia de diferencias en los parámetros cuantitativos y las características del tejido de recubrimiento entre los 2 grupos. A los 3 años de seguimiento, la incidencia de eventos fue de 3 (13%) frente a 5 (12%) en los grupos con y sin neoateroesclerosis respectivamente (HR=0,94; IC95%, 0,22-3,93; p=0,93). Conclusiones En este estudio con una pequeña muestra de pacientes aleatorizados a tratamiento con balón recubierto con paclitaxel o stent liberador de everolimus por RS, ... (AU)

Introduction and objectives Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. Methods This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. Results Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). Conclusions In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR. (AU)

Spontaneous coronary artery dissection in old patients: clinical features, angiographic findings, management and outcome.

AIMS: Spontaneous coronary artery dissection (SCAD) is a relatively rare but well-known cause of acute coronary syndrome. Clinical features, angiographic findings, management and outcomes of SCAD in old patients (>65 years of age) remain unknown. METHODS AND RESULTS: The Spanish multicentre prospective SCAD registry (NCT03607981), included 318 consecutive patients with SCAD. Data were collected between June 2015 and April 2019. All angiograms were analysed in a centralized corelab. For the purposes of this study, patients were classified according to age in two groups <65 and ≥65 years old and in-hospital outcomes were analysed. Fifty-five patients (17%) were ≥65 years old (95% women). Older patients had more often hypertension (76% vs. 29%, P < 0.01) and dyslipidaemia (56% vs. 30%, P < 0.01), and less previous (4% vs. 18%, P < 0.001) or current smoking habit (4% vs. 33%, P < 0.001). An identifiable trigger was less often present in old patients (27% vs. 43%, P = 0.028). They also had more often severe coronary tortuosity (36% vs. 11%, P = 0.036) and showed more frequently coronary ectasia (24% vs. 9%, P < 0.01). Older patients were more often managed conservatively (89% vs. 75%, P = 0.025), with no significant differences in major adverse cardiac events during index admission (7% vs. 8%, P = 0.858). There were no differences between groups in terms of in-hospital stay, new acute myocardial infarction, unplanned coronary angiography or heart failure. CONCLUSION: Older patients with SCAD show different clinical and angiographic characteristics compared with younger patients. Initial treatment strategy was different between groups, though in-hospital outcomes do not significantly differ (NCT03607981).

Spontaneous Coronary Artery Dissection and Menopause.

Spontaneous coronary artery dissection (SCAD) is a relatively rare but well-known cause of acute coronary syndrome in women. The role of sexual hormones has been related to the pathophysiology of SCAD. However, clinical features, angiographic findings, management and outcomes of SCAD women in relation to menopause status remain unknown. The Spanish multicenter prospective SCAD registry (NCT03607981), included 318 consecutive patients with SCAD. All coronary angiograms were analyzed in a centralized Corelab. In this substudy, 245 women were classified according to their menopause state (pre-menopausal and post-menopausal). In-hospital outcomes were analyzed: 148 patients (60.4%) were post-menopausal. These patients were older (57 [52 to 66] vs 49 [44 to 54] years, p <0.01) and had more often hypertension (49% vs 27%, p <0.01) and dyslipidemia (46% vs 25%, p <0.01). Post-menopausal women showed more often previous history of acute coronary syndrome, including previous SCAD (9% vs 3%, p = 0.046), and presented less frequently as ST-segment elevation myocardial infarction on admission, compared with premenopausal women (34% vs 49%, p = 0.014). On the other hand, premenopausal women showed more often proximal and multisegment involvement (24% vs 7%, and 32% vs 18%, respectively, both p <0.01). Post-menopausal women were more often managed conservatively (85% vs 71%, p <0.01) and presented less frequently left ventricular dysfunction (both, p <0.01). There were no differences between groups in terms of in-hospital stay or mortality, new acute myocardial infarction, unplanned coronary angiography or heart failure. In conclusion, post-menopausal women with SCAD show different clinical and angiographic characteristics compared with pre-menopausal SCAD patients. Initial treatment strategy was different between groups, though in-hospital outcomes did not significantly differ (NCT03607981).

Spontaneous coronary artery dissection in Spain: clinical and angiographic characteristics, management, and in-hospital events.

INTRODUCTION AND OBJECTIVES: Spontaneous coronary artery dissection (SCAD) is an uncommon cause of acute coronary syndrome. The characteristics and in-hospital clinical course of patients with SCAD in Spain remain unknown. METHODS: We present data from consecutive patients included in the national prospective SCAD registry. Angiographic analysis was performed in a centralized core laboratory. RESULTS: Between June 2015 and April 2019, we included 318 patients with SCAD (358 lesions) from 31 centers. Median age was 53 years, and 88% were women. The most frequent presentation was non-ST-segment elevation acute myocardial infarction (53%). The most frequently involved artery was the left anterior descending coronary artery (44%), predominantly affecting the distal segments (39%) and secondary branches (54%). Most lesions (62%) appeared on angiography as intramural hematoma, without double lumen. Conservative management was selected as the initial approach in most patients (78%). During the index admission, 6% of patients had a major adverse event and 4 patients (1.3%) died. Independent predictors of adverse events were initial management with percutaneous coronary intervention (OR, 5.97; P=.004) and angiographic presentation as intramural hematoma (OR, 4.96; P=.028). CONCLUSIONS: In Spain, SCAD affects mainly middle-aged women. In most patients, the initial management strategy was conservative with excellent in-hospital survival. Initial management with percutaneous coronary intervention and angiographic presentation as intramural hematoma were related to the presence of in-hospital adverse events. Registered at ClnicalTrials.gov (Identifier: NCT03607981).

Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis.

INTRODUCTION AND OBJECTIVES: Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. METHODS: This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. RESULTS: Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). CONCLUSIONS: In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR.

Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI 'scoring' study.

BACKGROUND: Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. METHODS: RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. RESULTS: On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. CONCLUSION: This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').

Pulmonary ridge coverage and device-related thrombosis after left atrial appendage occlusion.

AIMS: The aim of this study was to evaluate the impact of pulmonary ridge (PR) coverage on both clinical and imaging follow-up outcomes in patients undergoing left atrial appendage occlusion (LAAO). METHODS AND RESULTS: The study included consecutive patients with non-valvular atrial fibrillation who underwent LAAO with disc and lobe devices. Patients were classified into two groups according to the PR coverage. A total of 147 patients were included. Among these, the PR was covered in 109 (74%) and uncovered in 38 (26%). Successful implantation was achieved in 98.6%. No differences in procedural outcomes were observed between the groups. The rate of procedural major adverse events was 3% (only major bleedings and/or vascular access complications). No device embolisation, cardiac tamponade or in-hospital mortality was observed. After a mean follow-up of 1.77±2.2 years, the annualised ischaemic stroke and major bleeding rate was 1.3%/year and 6.5%/year, respectively, without differences between groups. At follow-up, patients with a covered PR presented a lower incidence of device-related thrombosis (DRT) (1%) than those with an uncovered PR (27%); p<0.001. In multivariable analysis, the presence of PR coverage emerged as an independent predictor of DRT. CONCLUSIONS: Pulmonary ridge coverage was associated with a lower incidence of DRT after LAAO. Procedural and follow-up clinical outcomes did not differ between covered PR and uncovered PR patients.

Longitudinal Neointimal Distribution Pattern After Everolimus-Eluting Stent Implantation: Insights From Optical Coherence Tomography Study.

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.