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Introduction and Objectives: This article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC)., Methods: All interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board., Results: A total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism., Conclusions: The 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022., Methods: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC., Results: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease., Conclusions: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background ST-segment-elevation myocardial infarction complicated with no reflow after primary percutaneous coronary intervention is associated with adverse outcomes. Although several hyperemic drugs have been shown to improve the Thrombolysis in Myocardial Infarction 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 pharmacologic versus flow-mediated hyperemia in patients with ST-segment-elevation myocardial infarction complicated with no reflow. Methods and Results In the RAIN-FLOW (Treatment of Slow-Flow After Primary Percutaneous Coronary Intervention With Flow-Mediated Hyperemia) study, 67 patients with ST-segment-elevation myocardial infarction and no reflow were randomized to receive either pharmacologic-mediated hyperemia with intracoronary adenosine or nitroprusside (n=30) versus flow-mediated hyperemia (n=37). The angiographic corrected Thrombolysis in Myocardial Infarction frame count and the minimal microcirculatory resistance, as assessed with intracoronary pressure-thermistor wire, dedicated microcatheter, and thermodilution techniques, were compared after study interventions. Both Thrombolysis in Myocardial Infarction frame count(40.2±23.1 versus 39.2±20.7; P =0.858) and minimal microcirculatory resistance (753.6±661.5 versus 993.3±740.8 Wood units; P =0.174) were similar between groups. Thrombolysis in Myocardial Infarction 3 flow was observed in 26.7% versus 27.0% ( P =0.899). Flow-mediated hyperemia showed 2 different thermodilution patterns during saline infusion indicative of the severity of the no reflow phenomenon. In-hospital death and nonfatal heart failure were observed in 10.4% and 26.9%, respectively. Conclusions Both 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 patients with ST-segment-elevation myocardial infarction. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04685941.

Aims: Spontaneous coronary artery dissection (SCAD) is a relatively infrequent cause of acute coronary syndrome. Clinical features, angiographic findings, management, and outcomes of SCAD patients who present reduced left ventricular ejection fraction (LVEF) remain unknown., Methods and Results: The Spanish multicentre prospective SCAD registry (NCT03607981), included 389 consecutive patients with SCAD. In 348 of these patients, LVEF could be assessed by echocardiography during the index admission. Characteristics and outcomes of patients with preserved LVEF (LVEF ≥50%, n = 295, 85%) were compared with those with reduced LVEF (LVEF <50%, n = 53, 15%). Mean age was 54 years and 90% of patients in both groups were women. The most frequent clinical presentation in patients with reduced LVEF was ST-segment elevation myocardial infarction (STEMI) (62% vs. 36%, P < 0.001), especially anterior STEMI. Proximal coronary segment and multi-segment involvement were also significantly more frequent in these patients. No differences were found on initial revascularization between groups. Patients with reduced LVEF significantly received more often neurohormonal antagonist therapy, and less frequently aspirin. In-hospital events were more frequent in these patients (13% vs. 5%, P = 0.01), with higher rates of death, cardiogenic shock, ventricular arrhythmia, and stroke. During a median follow-up of 28 months, the occurrence of a combined adverse event did not statistically differ between the two groups (19% vs. 12%, P = 0.13). However, patients with reduced LVEF had higher mortality (9% vs. 0.7%, P < 0.001) and readmission rates for heart failure (HF) (4% vs. 0.3%, P = 0.01)., Conclusion: Patients with SCAD and reduced LVEF show differences in clinical characteristics and angiographic findings compared with SCAD patients with preserved LVEF. Although these patients receive specific medications at discharge, they had higher mortality and readmission rates for HF during follow-up., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

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; Pnon-inferiority < 0.001; Psuperiority = 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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10 -6  mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%; P =0.014). High-dose acetylcholine (10 -4  mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%; P =0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES; P =0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.

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.

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., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary perforations (CP) have been described as a rare but potentially fatal complication in percutaneous coronary interventions (PCI). Our aim is to compare temporal trends in frequency, management and outcomes of coronary perforations (CP)., Methods: All cases of CP recorded in our prospective institutional percutaneous coronary intervention (PCI) registry from 2003 to 2015 were included. Patients were divided in 2 groups according to the time frame in which the CP occurred: the early period (before 2009, when the chronic total occlusions and primary PCI programs started) and the current period. The primary endpoint was the composite of in-hospital serious adverse events, including final TIMI flow 0-1, cardiac tamponade, emergent cardiac surgery or death., Results: Overall, 88 CP occurred in 17,566 procedures (0.50%). Of these, 17 (0.26%) occurred during the early period and 71 (0.64%) during the current period (P<0.001). CP management differed between groups, with less CP sealed by intracoronary devices in the early period than in the current one (23.5% vs. 47.9%, P=0.068). Moreover, patients with CP during the early period experienced more in-hospital serious adverse events (69% vs. 31% respectively, OR 3.18, 95% CI: 1.07-9.45, P=0.037)., Conclusions: Expansion of indications and complexity of PCI in the current era may be associated with an increased frequency of CP. However, progress in technical and device management of CP have led to an improvement in the prognosis of this feared complication.

Background: The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment-elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment-elevation myocardial infarction at 5 years., Methods and Results: One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel-related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P<0.01), length of uncoverage (3.4 versus 1.4 mm; P=0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P=0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P=0.02) and malapposition length (1.3 versus 0.4 mm; P=0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P=0.35) and macrophage accumulations (19.4% versus 48.4%; P=0.02) were numerically more frequent with BMS., Conclusions: Despite substantial dropout of patients, the healing pattern in event-free ST-segment-elevation myocardial infarction patients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00828087., (© 2016 American Heart Association, Inc.)

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)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To compare the degree of endothelial dysfunction (ED) in patients treated with everolimus-eluting stent (EES) versus bare metal stent (BMS) implantation., Methods and Results: This is an observational study. A total of 30 elective patients (15 treated with EES and 15 with BMS) were recruited. All patients underwent coronary angiography and intracoronary acetylcholine (Ach) test at different doses at six months after stent implantation. Quantitative coronary angiography analysis was performed to evaluate the changes in mean luminal diameter (MLD) of the segments distal to the distal stent edge after increasing doses of Ach. Both EES and BMS groups had similar baseline characteristics except for stent length (18.6±2.5 vs. 16.5±2.5 mm; p=0.033) and diameter (3.1±0.2 vs. 3.4±0.3 mm; p=0.007). The vasomotion test showed that EES had 3.14% of MLD decrease after Ach infusion and BMS had 2.35% of vasoconstriction (p=0.62). After adjustment for baseline characteristics, no statistical difference was observed between groups., Conclusions: In our study EES implantation was associated with a low degree of ED and had a similar vasomotion response as compared to BMS. Prospective randomised investigations are warranted to confirm these findings.

Background: Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES)., Study Design: This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013., Conclusions: The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748)., (© 2014 Wiley Periodicals, Inc.)

Aims: Chronic total occlusions (CTO) are the final stage of atherosclerosis. Occluded coronary arteries have large plaque burden and negative remodelling. The aim of this study was to assess lumen and vessel changes of segments located distal to successfully recanalised CTO., Methods and Results: Ninety-one CTO treated with drug-eluting stents underwent quantitative coronary angiography (QCA) at baseline and at 12-18 months; 31 underwent serial intravascular ultrasound (IVUS) imaging. Angiographic changes were assessed with QCA as differences in minimal, mean and maximal lumen diameter (MinLD, MeanLD and MaxLD, respectively). Vessel changes were assessed with IVUS as changes in plaque and vessel volume. At follow-up, angiographic MinLD increased 23.9% (from 0.88±0.32 to 1.09±0.35 mm; p<0.01), MeanLD 16.4% (from 1.59±0.44 to 1.85±0.45 mm; p<0.01) and MaxLD 11.7% (from 2.39±0.67 to 2.67±0.70 mm; p<0.01). Lumen enlargement was greater in non-restenotic lesions, small lumen area at the end of the index procedure and low LDL-cholesterol levels during the study. By IVUS, lumen volume increased 26.9% (from 108.1±89.2 to 137.3±115.3 mm3; p<0.01), vessel volume increased 12.1% (from 207.1±170.2 to 232.2±196.0 mm3; p<0.01) and plaque volume tended to decrease 3.9% (from 98.9±88.7 to 94.9±89.3 mm3; p=0.07). Small lumen at baseline was related to greater lumen enlargement., Conclusions: Segments distal to recanalised CTO showed a notable lumen and vessel enlargement with a trend toward mild plaque regression. Low LDL-cholesterol levels increase lumen enlargement.

Background: Coronary artery bypass graft (CABG) is recommended for patients with unprotected left main stenosis (ULMS). Percutaneous coronary intervention (PCI) is only recommended in specific anatomic conditions as in patients with low/mid SYNTAX score (SS). The aim of this study was to assess if the clinical and anatomic global risk classification (GRC) can enhance the indication of both revascularization therapies., Methods: A total of 407 patients with ULMS treated with CABG (n = 285) or PCI (n = 122) were prospectively collected. The decision to treat with CABG or PCI was dependent on patient and physician's choice. Patients with ST-elevation myocardial infarction, shock, or valve disease were excluded. Clinical follow-up was obtained at 3 years., Results: Patients with low GRC (n = 151) treated with CABG vs those with PCI had similar cardiac mortality (5.9% vs 0%, respectively; P=.17) and major adverse cardiac events (MACE; 18.5% vs 12.5%, respectively; P=.40). Patients classified as mid GRC (n = 175) had similar cardiac death (11.1% vs 10.3%; P=.85) and MACE rates (20.7% vs 22.4%; P=.92) with CABG or PCI, respectively. Patients with high GRC (n = 81) treated with CABG had numerically fewer cardiac deaths (16.3% vs 28.1%; P=.16) and lower MACE rates (24.5% vs 40.6%; P=.048) than with PCI. Statistical models using the GRC as a predictor of cardiac death showed better goodness-of-fit than the SS., Conclusion: Patients with low/mid GRC have similar mid-term outcomes with either CABG or PCI; patients with high GRC seem to benefit from CABG. Although further investigations are required, GRC is a better predictor of outcomes than SS.

To date, there is limited data on levels of platelet inhibition achieved in patients with ST-elevation myocardial infarction (STEMI) who are loaded with clopidogrel and aspirin (ASA) prior to undergoing primary percutaneous coronary intervention (P-PCI). The aim of this investigation was to evaluate the percentage of STEMI patients with high on-treatment platelet reactivity (HPR) to clopidogrel at the time of initiating P-PCI and its association with the initial patency of the infarct-related artery (IRA). This prospective pharmacodynamic study included 50 STEMI patients, previously naïve to oral antiplatelet agents, who received 500-mg ASA and 600-mg clopidogrel loading doses prior to P-PCI. Platelet function assessment was performed at the beginning of the procedure using various assays, including VerifyNow™ system (primary endpoint), light transmission aggregometry and multiple electrode aggregometry. The percentage of patients with suboptimal response to clopidogrel and ASA assessed with the VerifyNow™ system was 88.0% and 28.6%, respectively. Similar results were obtained with the other assays used. A higher percentage of patients with initial patency of the IRA was observed among those patients without HPR compared with those with HPR to clopidogrel (66.7% vs 15.9%; p=0.013), while no differences were observed regarding postprocedural angiographic or electrocardiographic outcomes. In conclusion, this study shows that a high percentage of STEMI patients have inadequate levels of clopidogrel-induced and, to a lesser extent, aspirin-mediated platelet inhibition when starting a P-PCI procedure, and suggests that a poor response to clopidogrel might be associated with impaired initial TIMI flow in the IRA.