ABSTRACT
BACKGROUND: Little data exist on the relationship between total stent length (TSL) and cardiovascular outcomes at very-long follow-up in patients with ST-elevation myocardial infarction (STEMI) in the 2nd generation drug-eluting stents (DES) era. AIM: To analyze the relationship between TSL and 10-year target-lesion failure (TLF) in STEMI patients treated with percutaneous coronary intervention enrolled in the EXAMINATION-EXTEND. METHODS: The EXAMINATION-EXTEND was an extended-follow-up study of the EXAMINATION trial, which randomized 1:1 STEMI patients to receive DES or bare metal stent (BMS). The primary endpoint was TLF, defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TVMI), or definite/probable stent thrombosis (ST). Relationship between stent length and TLF was evaluated in the whole study group in a multiple-adjusted Cox regression model with TSL as a quantitative variable. Subgroup analysis was also performed according to stent type, diameter, and overlap. RESULTS: A total of 1,489 patients with a median TSL of 23 mm (Q1-Q318-35 mm) were included. TSL was associated with TLF at 10 years (adjusted HR per 5 mm increase of 1.07; 95% CI, 1.01-1.14; P = .02). This effect was mainly driven by TLR and was consistent regardless of stent type, diameter, or overlap. There was no significant relationship between TSL and TV-MI or ST. CONCLUSIONS: In STEMI patients, there is a direct relationship between TSL implanted in the culprit vessel and the risk of TLF at 10 years, mainly driven by TLR. The use of DES did not modify this association.
Subject(s)
Cardiovascular Agents , Drug-Eluting Stents , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , ST Elevation Myocardial Infarction/surgery , Follow-Up Studies , Treatment Outcome , Stents , Prosthesis DesignABSTRACT
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.
Subject(s)
Coronary Artery Disease , Diabetes Mellitus , Drug-Eluting Stents , Percutaneous Coronary Intervention , Coronary Artery Disease/etiology , Coronary Artery Disease/therapy , Humans , Percutaneous Coronary Intervention/methods , Prosthesis Design , Sirolimus/analogs & derivatives , Sirolimus/therapeutic use , Treatment OutcomeABSTRACT
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, Bülach, 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 < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse. CONCLUSIONS: At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.
Subject(s)
Acute Coronary Syndrome , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/therapy , Coronary Angiography , Humans , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Sirolimus , Tomography, Optical Coherence , Treatment OutcomeABSTRACT
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 (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. 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<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], 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.
Subject(s)
Angioplasty, Balloon, Coronary , ST Elevation Myocardial Infarction/surgery , Sirolimus/therapeutic use , Tissue Scaffolds , Absorbable Implants , Acetylcholine/pharmacology , Aged , Coronary Angiography , Coronary Restenosis/epidemiology , Drug-Eluting Stents , Endothelium, Vascular/drug effects , Endothelium, Vascular/physiopathology , Female , Humans , Incidence , Magnesium , Male , Middle Aged , Nitroglycerin/pharmacology , Polyesters , Risk Factors , ST Elevation Myocardial Infarction/drug therapy , Sample Size , Sirolimus/administration & dosage , Thrombectomy , Vasodilation/drug effects , Vasodilator Agents/therapeutic use , Vasomotor System/physiopathologyABSTRACT
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.
Subject(s)
Acute Coronary Syndrome , Coronary Stenosis , Coronary Vessels , Death, Sudden, Cardiac , Physical Exertion/physiology , Plaque, Atherosclerotic , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/etiology , Coronary Angiography/methods , Coronary Stenosis/complications , Coronary Stenosis/diagnosis , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/pathology , Female , Humans , Incidence , Male , Middle Aged , Plaque, Atherosclerotic/complications , Plaque, Atherosclerotic/diagnosis , Prospective Studies , Tomography, Optical Coherence/methodsABSTRACT
AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. STUDY DESIGN: This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. CONCLUSION: This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
Subject(s)
Absorbable Implants , Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Drug-Eluting Stents , Magnesium , ST Elevation Myocardial Infarction/therapy , Sirolimus/administration & dosage , Vasomotor System/physiopathology , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/adverse effects , Humans , Multicenter Studies as Topic , Prospective Studies , Prosthesis Design , Randomized Controlled Trials as Topic , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/physiopathology , Single-Blind Method , Sirolimus/adverse effects , Spain , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon-expandable (BEV) and self-expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes. METHODS: We retrospectively analyzed patients undergoing TAVI. Platelet counts after TAVI were collected. Two groups were created: DPC ≤ 30% and DPC > 30%. VARC-2 criteria were used to define outcomes. RESULTS: Study population was composed of 195 patients (age 77.5 ± 6.7, 57.4% males). All of them but one experienced DPC (mean DPC 31.9 ± 15.3%). DPC was significantly higher among the patients treated with BEV compared to those treated with SEV (36.3 ± 15.1% vs 27.7 ± 14.4, P < 0.001). After multivariate analysis, the use of BEV was independently associated with a higher rate of DPC > 30% (67.4% vs 36.0%; OR 3.4; 95% CI, 1.42-8.16). At 30 days, the DPC > 30% was associated with a higher rate of life-threatening/major bleeding, major vascular complications, in-hospital sepsis and mortality. At one year, there were no statistically significant differences in the mortality rate between groups (6.35% vs 10.0%, HR 1.54; 95% CI, 0.56-4.25). CONCLUSIONS: In this study, the use of BEV was associated with a higher risk of DPC after TAVI. A DPC rate > 30% was associated with an increased risk of major complications at 30 days.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Thrombocytopenia/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve Stenosis/blood , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Female , Hospital Mortality , Humans , Male , Platelet Count , Prosthesis Design , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Spain , Thrombocytopenia/blood , Thrombocytopenia/diagnosis , Thrombocytopenia/mortality , Time Factors , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is known to be poor. We sought if ticagrelor may augment adenosine-induced coronary blood flow vs. clopidogrel immediately after successful CTO percutaneous coronary intervention (PCI).
Subject(s)
Clopidogrel/therapeutic use , Coronary Occlusion/drug therapy , Coronary Occlusion/surgery , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/therapeutic use , Purinergic P2Y Receptor Antagonists/therapeutic use , Ticagrelor/therapeutic use , Coronary Circulation/drug effects , Humans , Prospective Studies , Treatment OutcomeABSTRACT
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.
Subject(s)
Absorbable Implants , Clopidogrel/administration & dosage , Coronary Circulation/drug effects , Coronary Occlusion/therapy , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/administration & dosage , Ticagrelor/administration & dosage , Chronic Disease , Clopidogrel/adverse effects , Coronary Angiography , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/physiopathology , Female , Humans , Male , Multicenter Studies as Topic , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies , Prosthesis Design , Randomized Controlled Trials as Topic , Recovery of Function , Ticagrelor/adverse effects , Time Factors , Treatment OutcomeSubject(s)
Coated Materials, Biocompatible , Coronary Restenosis/surgery , Diabetes Mellitus , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , Sirolimus/analogs & derivatives , Sirolimus/pharmacology , Coronary Angiography , Coronary Restenosis/complications , Coronary Restenosis/diagnosis , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/pharmacology , Male , Polymers , Prospective Studies , Prosthesis Design , Single-Blind Method , Treatment OutcomeABSTRACT
BACKGROUND: Prognostic impact of anaemia in the elderly with acute coronary syndromes has not been specifically analysed, and little information exists about causes of mortality in this setting. METHODS: We prospectively included consecutive patients with acute coronary syndromes. Anaemia was defined as haemoglobin < 130 g/L in men, and < 120 g/L in women. Primary outcome was mid-term mortality and its causes. Analyses were performed by Cox regression method. RESULTS: We included 2128 patients, of whom 394 (18.6%) were aged 75 years or older. Anaemia was more common in the elderly (40.4% vs 19.5%, p <0.001). Mean follow-up was 386 days. Anaemia independently predicted overall mortality (HR 1.47, 95% CI 1.05-2.06), cardiac mortality (HR 1.76, 95% CI 1.06-2.94) and non-cardiac mortality (HR 1.59, 95% CI 1.03-2.45) in the overall cohort. In young patients the association between anaemia and mortality was significant only for non-cardiac causes. The association between anaemia and mortality was not significant in the elderly (HR 1.08, 95% CI 0.71-1.63, p 0.736). CONCLUSIONS: The impact of anaemia on cause specific of mortality seem to be different according to age subgroup. The association between anaemia and mortality was not observed in elderly patients from our series.
Subject(s)
Acute Coronary Syndrome/epidemiology , Anemia/epidemiology , Cause of Death , Frail Elderly , Registries , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Age Factors , Aged , Aged, 80 and over , Anemia/diagnosis , Anemia/therapy , Comorbidity , Cross-Sectional Studies , Female , Geriatric Assessment , Humans , Incidence , Male , Prognosis , Proportional Hazards Models , Risk Assessment , Severity of Illness Index , Sex Factors , Spain , Survival Analysis , Tertiary Care CentersABSTRACT
BACKGROUND: iMAP is a new intravascular ultrasound (IVUS) derived technique for tissue characterization using spectral analysis. Since there is a need for reproducibility data to design longitudinal studies, we sought to assess the in vivo reproducibility of this imaging technique. METHODS: iMAP (40 MHz, Boston Scientific Corporation) was performed in patients referred for elective percutaneous intervention and in whom a nonintervened vessel was judged suitable for a safe IVUS analysis. Overall 20 patients with 20 non-angiographically significant lesions were assessed by two independent observers. Five of these 20 patients received an additional iMAP analysis using a new IVUS catheter and using the same catheter after its engagement and reengagement. RESULTS: The interobserver relative difference in plaque area was 2.5%. Limits of agreement for lumen, vessel, and plaque area measurements were 1.62, -2.47 mm(2) ; 2.09, -3.71 mm(2) ; 2.80, -3.72 mm(2) ; respectively. Limits of agreement for fibrotic, lipidic, necrotic, and calcified measurements were 1.32, -1.44 mm(2) ; 0.24, -0.36 mm(2) ; 1.50, -2.26 mm(2) ; 0.09, -0.11 mm(2) ; respectively. The intercatheter and intracatheter relative difference in plaque area were 0.9% and 4.1%, respectively. Although the variability for compositional measurements increased using two different catheters or using the same catheter twice, the variability for compositional measurements keeps always below 10%. CONCLUSIONS: Our analysis demonstrates that the geometrical and compositional iMAP analysis is acceptably reproducible.
Subject(s)
Coronary Artery Disease/diagnostic imaging , Coronary Vessels/diagnostic imaging , Plaque, Atherosclerotic/diagnostic imaging , Ultrasonography, Interventional/methods , Aged , Coronary Vessels/surgery , Female , Follow-Up Studies , Humans , Male , Prospective Studies , ROC Curve , Reproducibility of Results , Treatment OutcomeABSTRACT
INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.
Subject(s)
Diabetes Mellitus , Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Drug-Eluting Stents/adverse effects , Myocardial Infarction/diagnosis , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/adverse effects , Prognosis , Sirolimus , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/surgery , ST Elevation Myocardial Infarction/complications , Treatment OutcomeABSTRACT
Background: Longitudinal changes in gut microbiome and inflammation may be involved in the evolution of atherosclerosis after an acute coronary syndrome (ACS). We aimed to characterize repeated profiles of gut microbiota and peripheral CD4+ T lymphocytes during the first year after an ACS, and to address their relationship with atherosclerotic plaque changes. Methods: Over one year we measured the microbiome, peripheral counts of CD4+ T populations and cytokines in 67 patients shortly after a first ACS. We compared baseline measurements to those of a matched population of 40 chronic patients. A subgroup of 20 ACS patients underwent repeated assessment of fibrous cap thickness (FCT) of a non-culprit lesion. Results: At admission, ACS patients showed gut dysbiosis compared with the chronic group, which was rapidly reduced and remained low at 1-year. Also, their Th1 and Th2 CD4+ T counts were increased but decreased over time. The CD4+ T counts were related to ongoing changes in gut microbiome. Unsupervised clustering of repeated CD4+ Th0, Th1, Th2, Th17 and Treg counts in ACS patients identified two different cell trajectory patterns, related to cytokines. The group of patients following a high-CD4+ T cell trajectory showed a one-year reduction in their FCT [net effect = -24.2 µm; p = 0.016]. Conclusions: Patients suffering an ACS show altered profiles of microbiome and systemic inflammation that tend to mimic values of chronic patients after 1-year. However, in one-third of patients, this inflammatory state remains particularly dysregulated. This persistent inflammation is likely related to plaque vulnerability as evident by fibrous cap thinning (Clinical Trial NCT03434483).
ABSTRACT
BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).
Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Lithotripsy , Vascular Calcification , Humans , Coronary Vessels , Prospective Studies , Treatment Outcome , Heart , Lithotripsy/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Vascular Calcification/diagnostic imaging , Vascular Calcification/therapyABSTRACT
BACKGROUND: ST-elevation myocardial infarctions (STEMI) caused by proximal left-anterior descending (LAD) lesions have more myocardium at risk and worse outcomes than those located in other segments. The aim is to compare outcomes of patients with STEMI and proximal-LAD lesions treated with bare-metal stents (BMS) versus everolimus-eluting stents (EES). METHODS: The EXAMINATION trial randomized 1498 STEMI patients to BMS versus EES. The primary end point was the patient-oriented combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization. The secondary end point included the device-oriented combined of cardiac death, target-vessel MI and target-lesion revascularization (TLR). RESULTS: STEMI with a proximal-LAD occlusion was observed in 290 patients (BMS = 132 and EES = 158). Both groups were similar except for diabetes (12.9% vs 24.1%; P = .016). At 1 year, the primary end point was observed in 18.9% and 9.5% of patients treated with BMS and EES, respectively (P = .023). The secondary end point was observed in 11.4% and 5.1%, respectively (P = .053). There were no differences in cardiac death (4.5% vs 3.8%; P = .750) and MI (1.5% vs 0%; P = .121). BMS had higher rate of TLR compared to EES (6.8% vs 1.3%; P = .014). Patients with proximal-LAD STEMI had higher mortality than patients with non proximal-LAD STEMI (5.5% vs 2.9%; P = .027). Proximal-LAD lesions treated with BMS tended to increase the risk of the primary end point compared with other segments (18.9% vs 13.0%; P = .079). However, EES implanted in proximal-LAD had similar outcomes compared with other locations (9.5% vs 12.0%; P = .430). Adjusting for confounders, the interaction between BMS and proximal-LAD location was associated with the primary end point. CONCLUSION: Patients with STEMI and proximal-LAD lesions treated with EES have better outcomes compared with BMS at 1 year. Although further investigations are required, it seems reasonable to consider EES for proximal-LAD STEMI-lesions.
Subject(s)
Drug-Eluting Stents , Electrocardiography , Myocardial Infarction/surgery , Myocardial Revascularization/methods , Sirolimus/analogs & derivatives , Coronary Angiography , Everolimus , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/pharmacology , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Prospective Studies , Sirolimus/pharmacology , Spain/epidemiology , Survival Rate , Treatment OutcomeABSTRACT
OBJECTIVES: To assess the usefulness of the MGuard stent in patients with ST-segment elevation myocardial infarction (STEMI) in whom a high thrombus burden persists after manual aspiration. BACKGROUND: In some patients with STEMI, a high thrombus burden may persist after manual aspiration. These patients may be at high risk of distal embolization and therefore impaired myocardial reperfusion. The MGuard is a novel mesh-covered stent designed to minimize thrombus embolization. METHODS: Single-arm, prospective registry of patients with STEMI and high thrombus burden after aggressive thrombus aspiration treated with the MGuard stent. High thrombus burden was defined as thrombus burden grade 4 or 5 according to the TIMI score. Lesions with a side branch ≥2 mm and patients with cardiogenic shock were not included. The study end-points were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST-segment resolution. RESULTS: Fifty-six patients were included. After MGuard stent implantation >85% of cases had thrombus score = 0. Final TIMI 3 flow was achieved in 82% of cases, normal myocardial blush in 55%, and complete ST-segment resolution in 59%. Occlusion of a side branch (<2 mm) occurred in 2 cases (3.5%), embolization to a distal branch in 5 cases (8.9%), and transient no-reflow in 4 cases (7.1%). Major adverse cardiac events rate at 9 months was 3.6%, including 1 definite acute stent thrombosis and 1 target-vessel revascularization. CONCLUSIONS: The MGuard stent may be useful to prevent distal embolization in patients with STEMI and high thrombus burden despite mechanical aspiration.
Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Embolic Protection Devices , Myocardial Infarction/therapy , Stents , Thrombectomy , Coronary Circulation , Female , Humans , Male , Middle Aged , Prospective Studies , RegistriesABSTRACT
AIMS: This study aimed to assess, in patients with cardiogenic shock secondary to unprotected left main coronary artery-related myocardial infarction (ULMCA-related AMICS), the incidence and predictors of no recovery of left ventricular function during the admission. METHODS AND RESULTS: This was an observational study conducted at two tertiary care centres (2012-20). The main outcome measured was death or requirement for heart transplantation (HT) or left ventricular assist devices (LVAD) during the admission. A total of 70 patients were included. Percutaneous coronary intervention (PCI) was successful in 53/70 patients (75.7%). The combined endpoint of death or requirement of HT or LVAD during the admission occurred in 41/70 patients (58.6%). The highest incidence of the primary endpoint was observed among patients with profound shock and occluded left main coronary artery (LMCA) (20/23, 87%, P < 0.001). Although a successful PCI reduced the incidence of the event in the whole cohort (51.9% vs. 82.4% in failed PCI, P = 0.026), this association was not observed among this last group of complex patients (86.7% vs. 87.5% in failed PCI, P = 0.731). The predictive model included left ventricular ejection fraction, baseline ULMCA Thrombolysis In Myocardial Infarction flow, and severity of shock and showed an optimal ability for predicting death or requirements for HT or LVAD during the admission (area under the curve 0.865, P < 0.001). CONCLUSIONS: ULMCA-related AMICS was associated with a high in-hospital mortality or need for HT or LVAD. Prognosis was especially poor among patients with profound shock and baseline occluded LMCA, with a low probability of recovery regardless of successful PCI.