Five-Year Efficacy and Safety of TiNO-Coated Stents Versus Drug-Eluting Stents in Acute Coronary Syndrome: A Meta-Analysis.

(1) Background: Percutaneous coronary interventions (PCI) in patients with acute coronary syndrome (ACS) are performed with titanium-nitride-oxide-coated stents (TiNOSs) or drug-eluting stents (DESs). The initial completion of this prospective systematic literature review (SLR) of prospective randomized controlled trials (RCTs) showed that TiNOSs are non-inferior to DESs in major adverse cardiac event (MACE) rates and present a lower risk of recurrent myocardial infarction (MI) at 1-year follow-up. This iteration of the SLR protocol performs the critical assessment of 5-year follow-up outcomes with clinical validity and generalizability assessments. (2) Methods: The previously described SLR and meta-analysis protocol, per PRISMA, Cochrane methods, and GRADE, was applied to 5-year follow-up outcomes. (3) Results: Three RCTs were eligible, comprising 1620 patients with TiNOS vs. 1123 with DES. The pooled risk ratios (RRs) and 95% confidence intervals were MACE 0.82 [0.68, 0.99], MI 0.58 [0.44, 0.78], cardiac death (CD) 0.46 [0.28, 0.76], ischemia-driven target lesion revascularization (TLR) 1.03 [0.79, 1.33], probable or definite stent thrombosis (ST) 0.32 [0.21, 0.59], and all-cause mortality (TD) 0.84 [0.63, 1.12]. The evidence certainty was high in MACE, CD, MI, and ST, and moderate in TLR and TD. (4) Conclusions: TiNOSs in ACS at 5-year follow-up appear safer than DESs and equally efficacious. The pooled RRs stratified by clinical presentation and stent type will be required to test this meta-analysis's clinical validity and generalize its results to patient populations with varying proportions of clinical presentations and DES options.

Titanium-Nitride-Oxide-Coated vs Everolimus-Eluting Stents in Acute Coronary Syndrome: 5-Year Clinical Outcomes of the TIDES-ACS Randomized Clinical Trial.

Importance: Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents. Objective: To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES). Design, Setting, and Participants: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023. Main outcome: The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up. Results: A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively. Conclusion and relevance: In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES. Trial Registration: ClinicalTrials.gov Identifier: NCT02049229.

Estudio comparativo de la cobertura neointimal entre los stents con recubrimiento de titanio-óxido nítrico y los liberadores de everolimus en el sindrome coronario agudo / Comparative study of neointimal coverage between titanium-nitric oxide-coated and everolimus-eluting stents in acute coronary syndromes

Introducción y objetivos Evaluar mediante tomografía de coherencia óptica (OCT) el proceso de cicatrización neointimal tras el implante de stents de cromo cobalto con recubrimiento de titanio-óxido nítrico (TiNO) y de stents de platino-cromo liberadores de everolimus (SLE) con polímero biodegradable en pacientes con síndrome coronario agudo. Métodos Los pacientes fueron aleatorizados (1:1) para recibir el stent TiNO o SLE. Se obtuvieron imágenes de OCT a los 30 días (cohorte A, n=52) y a los 6 meses (cohorte B, n=30) de seguimiento. El objetivo primario del estudio fue el porcentaje de struts no cubiertos por paciente. Resultados En la cohorte A, el porcentaje de struts no cubiertos fue menor con los stents TiNO que con los SLE (3,2% frente a 19,6%, p <0,001). El porcentaje de struts mal apuestos fue del 0,4% en el grupo TiNO y del 2,1% en el grupo SLE (p <0,001). En la cohorte B, el porcentaje de struts no cubiertos también fue menor con los stents TiNO (0,0% frente a 8,7% (p <0,001). El porcentaje de struts mal apuestos fue del 0% en el grupo de stent TiNO y del 0,3% en el grupo de SLE (p=0,008). A ninguno de los pacientes se les tuvo que repetir la revascularización durante los 6 meses de seguimiento. Conclusiones Tras una intervención percutánea por síndrome coronario agudo, el implante de un stent TiNO se asoció a un menor porcentaje de struts no cubiertos y mal apuestos por paciente, en comparación con el SLE, en un seguimiento temprano y a medio plazo (AU)

Introduction and objectives To evaluate by optical coherence tomography neointimal healing response after implantation of cobalt-chromium-based titanium-nitride-oxide-coated (TiNO) stents and platinum-chromium-based biodegradable-polymer-coated everolimus-eluting stents (EES) in patients with acute coronary syndrome. Methods Patients were randomized (1:1) to receive either a TiNO-stent or EES. Optical coherence tomography images were obtained at 30-day (cohort A, n = 52) and 6-month (cohort B, n = 30) follow-up. The primary endpoint was the percentage of uncovered struts per patient. Results In cohort A, the percentage of uncovered struts was lower with TiNO-stents vs EES (3.2% vs 19.6%, P <.001). The percentage of malapposed struts was 0.4% in the TiNO-group and 2.1% in the EES group (P <.001). In cohort B, the percentage of uncovered struts was also lower with TiNO-stents (0.0% vs 8.7% (P <.001). The percentage of malapposed struts was 0% in the TiNO-stent group and 0.3% in the EES group (P=.008). None of the patients had repeat revascularization during the 6 months of follow-up. Conclusions Following percutaneous intervention for acute coronary syndrome, TiNO stent implantation was associated with a lower percentage of uncovered and malapposed struts per patient, compared with EES, at early and mid-term follow-up (AU)

Comparative study of neointimal coverage between titanium-nitric oxide-coated and everolimus-eluting stents in acute coronary syndromes.

INTRODUCTION AND OBJECTIVES: To evaluate by optical coherence tomography neointimal healing response after implantation of cobalt-chromium-based titanium-nitride-oxide-coated (TiNO) stents and platinum-chromium-based biodegradable-polymer-coated everolimus-eluting stents (EES) in patients with acute coronary syndrome. METHODS: Patients were randomized (1:1) to receive either a TiNO-stent or EES. Optical coherence tomography images were obtained at 30-day (cohort A, n = 52) and 6-month (cohort B, n = 30) follow-up. The primary endpoint was the percentage of uncovered struts per patient. RESULTS: In cohort A, the percentage of uncovered struts was lower with TiNO-stents vs EES (3.2% vs 19.6%, P <.001). The percentage of malapposed struts was 0.4% in the TiNO-group and 2.1% in the EES group (P <.001). In cohort B, the percentage of uncovered struts was also lower with TiNO-stents (0.0% vs 8.7%, (P <.001). The percentage of malapposed struts was 0% in the TiNO-stent group and 0.3% in the EES group, (P=.008). None of the patients had repeat revascularization during the 6 months of follow-up. CONCLUSIONS: Following percutaneous intervention for acute coronary syndrome, TiNO stent implantation was associated with a lower percentage of uncovered and malapposed struts per patient, compared with EES, at early and mid-term follow-up. This study is registered under ClinicalTrials.gov, with number NCT02464397.

Efficacy and Safety of TiNO-Coated Stents versus Drug-Eluting Stents in Acute Coronary Syndrome: Systematic Literature Review and Meta-Analysis.

(1) Background: Practice guidelines define drug-eluting stents (DES) as the standard of care in coronary percutaneous coronary intervention (PCI), including in acute coronary syndrome (ACS). This is based on comparisons with bare-metal stents (BMS). However, non-drug-eluting titanium-nitride-oxide-coated stents (TiNOS) have not been taken into account. The objective of this study is to determine whether TiNOS can be used as an alternative to DES in ACS. (2) Methods: A prospective systematic literature review (SLR), conducted according to the PRISMA guidelines, was performed, wherein multiple literature databases from 2018 and 2022 were searched. Prospective, randomised, controlled trials comparing outcomes after PCI with TiNOS vs. DES in any coronary artery disease (CAD) were searched. Clinical outcomes were meta-analytic pooled risk ratios (RR) of device-oriented Major Adverse Cardiac Events (MACE) and their components. The analysis stratified outcomes reported with ACS-only vs. ACS jointly with chronic coronary syndrome (CCS). (3) Results: Five RCTs were eligible, comprising 1855 patients with TiNOS vs. 1363 with DES at a 1-year follow-up. Three enrolled patients presented with ACS only and two with ACS or CCS. The latter accounted for most of the patients. The one-year pooled RRs in those three RCTs were as follows: MACE 0.93 [0.72, 1.20], recurrent myocardial infarction (MI) 0.48 [0.31, 0.73], cardiac death (CD) 0.66 [0.33, 1.31], clinically driven target lesion revascularization (TLR) 1.55 [1.10, 2.19], and stent thrombosis (ST) 0.35 [0.20, 0.64]. Those results were robust to a sensitivity analysis. The evidence certainty was high in MACE and moderate or low in the other endpoints. (4) Conclusions: TiNOS are a non-inferior and safe alternative to DES in patients with ACS.

Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome: The Randomized TIDES-ACS Trial.

OBJECTIVES: This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS). BACKGROUND: Previous generation TiNO-coated stents showed acceptable performance in patients with ACS. METHODS: In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months. RESULTS: A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27). CONCLUSIONS: In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).

Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold.

BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

Value of DAPT score to predict adverse outcome in patients with atrial fibrillation undergoing percutaneous coronary intervention: A post-hoc analysis from the AFCAS registry.

BACKGROUND: The DAPT score identifies patients with expected benefit from extended dual antiplatelet therapy beyond 1year after percutaneous coronary intervention (PCI). In a post-hoc analysis from the AFCAS registry, we explored the value of DAPT score to predict outcome in patients with atrial fibrillation (AF) undergoing PCI. METHODS AND RESULTS: Outcome measures included major adverse cardiac/cerebrovascular events (MACCE) [all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack] and bleeding events. At 12-month follow-up, patients with a DAPT score≥1 had a higher incidence of MACCE, all-cause death, myocardial infarction (p=0.004, p=0.006, and p=0.013, respectively), but a similar bleeding rate (p=0.66), versus those with a DAPT score <1. In a subgroup of patients at high risk of stroke who received triple therapy for 1month only, DAPT score ≥1 was associated with a higher incidence of MACCE, all-cause death, myocardial infarction (p=0.002, p=0.015, and p=0.039, respectively), but a similar bleeding rate (p=0.81). CONCLUSIONS: In AF patients undergoing PCI, a DAPT score ≥1 was associated with a higher incidence of thrombotic events, and a similar incidence of bleeding events, compared with a DAPT score <1. These results were consistent in patients at high risk of stroke who received triple therapy for 1month.

Outcome of octogenarians with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry.

BACKGROUND: More evidence is needed on the optimal antithrombotic regimen in elderly patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). HYPOTHESIS: Octogenarian patients (aged ≥80 years) with AF who underwent PCI have worse 12-month clinical outcome, compared with younger patients. METHODS: We performed a post-hoc analysis of data from the prospective, multicenter AFCAS registry, which enrolled consecutive patients with AF who underwent PCI and stenting. Outcome measures included major adverse cardiac/cerebrovascular events (MACCE; all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack) and bleeding events at 12-month follow-up. RESULTS: Out of 925 AF patients enrolled in AFCAS registry, 195 (21.1%) were ≥80 years. Mean age was 82.9 ± 2.6 years; 41.5% were women; 32.3% had diabetes mellitus. Compared with patients aged <80 years, there were more females among the octogenarians (P < 0.001). Compared with younger patients, octogenarians smoked and had dyslipidemia less often, and presented more frequently with acute coronary syndrome. The frequency and duration of antithrombotic regimens prescribed at discharge were comparable. At 12-month follow-up, overall MACCE rate was higher in octogenarians compared with younger patients (27.7% vs 20.1%, P = 0.02). The rate of acute myocardial infarction was higher in octogenarians (9.2% vs 4.9%, P = 0.02), but the rates of all bleeds and BARC >2 bleeds were similar (P = 0.13, P = 0.29, respectively). CONCLUSIONS: In real-world patients with AF undergoing PCI, patients aged ≥80 years had higher incidence of MACCE at 12-month follow-up compared with younger patients, although they received comparable antithrombotic treatment. The rates of bleeding events were similar.

Time in therapeutic range and major adverse outcomes in atrial fibrillation patients undergoing percutaneous coronary intervention: The Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS) registry.

BACKGROUND: Combination of oral anticoagulation (OAC) and antiplatelets is used in atrial fibrillation (AF) patients undergoing percutaneous coronary intervention and stent (PCI-S) procedure but is associated with increased bleeding when triple antithrombotic therapy (TAT) is used. Our aim was to analyze the impact of time in therapeutic range (TTR) on outcomes, in patients prescribed with TAT. METHODS: Ancillary analysis from the AFCAS registry in patients assigned to TAT. TTR was calculated with Rosendaal method. Outcomes were analyzed according to TTR tertiles (T1 [≤56.8%] vs. T2 [56.9-93.8%] vs. T3 [≥93.9%]). Major bleeding was the primary outcome. RESULTS: Of 963 patients enrolled, 470(48.8%) were prescribed with TAT at discharge and qualified for this analysis. Median [IQR] TTR was 80.0% [45.3-100%]. After 359 [341-370] days, major bleeding rates were progressively lower with increasing TTR tertiles (T1 vs. T2 vs. T3: 10.3% vs. 4.7% vs. 2.3%, P=.006). Kaplan-Meier analysis demonstrated a progressively lower risk for major bleeding across tertiles (P=.006). Patients in the highest TTR tertile had a non-significant lower risk for major adverse coronary and cerebrovascular events (MACCE) (log-rank: 4.905, P=.086). Cox regression analysis showed that T2 and T3 were inversely associated with major bleeding (hazard ratio [HR]:0.39, P=.050 and HR: 0.21, P=.005). Continuous TTR was inversely associated with major bleeding (HR: 0.98, P<.001). For MACCE, adjusted Cox analysis found a non-significant lower risk for T3 (HR: 0.64, P=.128). CONCLUSIONS: In AF patients undergoing PCI-S prescribed TAT, good quality anticoagulation control (as reflected by TTR) was closely related to bleeding outcomes during follow-up. Despite some suggestive trends for an inverse relationship between TTR and MACCE, no definitive conclusions can be drawn, and further large studies are needed.

Outcome of poor initial TIMI flow in patients presenting with acute coronary syndrome.

OBJECTIVES: We explored the predictors and outcome of poor, versus good, initial TIMI flow in patients with acute coronary syndrome (ACS). DESIGN: We performed post-hoc analysis of a randomized trial of patients presenting with ACS who received 2 comparative stents. Poor initial TIMI flow was defined as baseline TIMI flow grade 0/1 at the initial coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Stent thrombosis (ST) was adjudicated according to the criteria of definite ST described by the Academic Research Consortium. Propensity score-matched analysis was performed. We report data after 5-year follow-up. RESULTS: Of 827 patients enrolled, 279 (33.7%) had initial TIMI 0/1 flow. Median follow-up duration was 5.0 years. Presentation by ST-elevation myocardial infarction and target vessel other than left anterior descending artery predicted initial TIMI 0/1 flow. MACE rate was comparable between the 2 subgroups (14% versus 15.9%, in patients with poor versus good initial TIMI flow, respectively, p = .46). Individual endpoints were comparable (p > .05 for all). Definite ST was more frequent in patients with initial TIMI 0/1 flow (3.6% versus 1.5%, respectively, p = .048). This was driven by more frequent early events (30 days) (p = .036); late/very late events were comparable (p = 1.0). CONCLUSIONS: Predictors of poor initial TIMI flow included presentation by ST-elevation myocardial infarction, and target vessel other than left anterior descending artery. Definite ST occurred more in patients with poor, versus good, initial TIMI flow, mainly driven by difference in early events.

Renal sympathetic denervation for treatment of patients with heart failure: summary of the available evidence.

Heart failure syndrome results from compensatory mechanisms that operate to restore - back to normal - the systemic perfusion pressure. Sympathetic overactivity plays a pivotal role in heart failure; norepinephrine contributes to maintenance of the systemic blood pressure and increasing preload. Cardiac norepinephrine spillover increases in patients with heart failure; norepinephrine exerts direct toxicity on cardiac myocytes resulting in a decrease of synthetic activity and/or viability. Importantly, cardiac norepinephrine spillover is a powerful predictor of mortality in patients with moderate to severe HF. This provided the rationale for trials that demonstrated survival benefit associated with the use of beta adrenergic blockers in heart failure with reduced ejection fraction. Nevertheless, the MOXCON trial demonstrated that rapid uptitration of moxonidine (inhibitor of central sympathetic outflow) in patients with heart failure was associated with excess mortality and morbidity, despite reduction of plasma norepinephrine. Interestingly, renal norepinephrine spillover was the only independent predictor of adverse outcome in patients with heart failure, in multivariable analysis. Recently, renal sympathetic denervation has emerged as a novel approach for control of blood pressure in patients with treatment-resistant hypertension. This article summarizes the available evidence for the effect of renal sympathetic denervation in the setting of heart failure. Key messages Experimental studies supported a beneficial effect of renal sympathetic denervation in heart failure with reduced ejection fraction. Clinical studies demonstrated improvement of symptoms, and left ventricular function. In heart failure and preserved ejection fraction, renal sympathetic denervation is associated with improvement of surrogate endpoints.

Percutaneous revascularization of coronary chronic total occlusion: Toward a reappraisal of the available evidence.

Chronic total occlusion (CTO) is a challenging subset of coronary artery disease that is commonly encountered in real-world practice; it is associated with worse long-term prognosis. Observational studies suggest that percutaneous coronary intervention (PCI) for CTO is associated with reduction in myocardial ischemia and improvement in quality of life and left ventricular function. Some observational studies suggested that CTO-PCI is associated with improvement of the 'hard' clinical endpoints; others did not. Nearly all these studies compared the clinical outcome of successful versus failed PCI, rather than comparing the outcome of a whole CTO-PCI cohort versus a 'true' control group. Interestingly, in observational studies that compared the outcome of CTO-PCI versus optimal medical treatment, long-term mortality was comparable between the two strategies. In patients with multi-vessel disease and CTO, complete revascularization is more often achieved by coronary artery bypass grafting than by PCI; the SYNTAX score of these patients often favors surgical revascularization according to the current guidelines. The current guidelines reflect the divergence of opinion on the usefulness/benefit of CTO-PCI, mainly due to the lack of randomized trials. Evidence is awaited from three ongoing randomized controlled trials comparing PCI versus optimal medical treatment in the setting of CTO.

The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis.

OBJECTIVES: The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. BACKGROUND: CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell-capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed. METHODS: In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis. RESULTS: The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level-based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models-adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 µm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days. CONCLUSIONS: The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence tomographic analysis. The percentage of uncovered stent struts per stent was somewhat higher after COMBO versus CoCr EES implantation as detected by optical coherence tomography, associated with reduced neointimal thickness.

Synergic impact of oral anticoagulation control and renal function in determining major adverse events in atrial fibrillation patients undergoing percutaneous coronary intervention: insights from the AFCAS registry.

BACKGROUND: In patients with atrial fibrillation (AF), quality of oral anticoagulation control as well as impaired renal function are associated with adverse outcomes. Our objective was to analyze if there was a synergistic impact of these factors in determining adverse outcomes in AF patients undergoing percutaneous coronary intervention and stent (PCI-S). METHODS: Post-hoc analysis from the Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS) registry. Poor oral anticoagulation control was defined as time in therapeutic range (TTR) <65%, while impaired renal function as creatinine clearance (CrCl) <60 ml/min. RESULTS: Of the whole cohort, 448 were eligible for this post-hoc analysis. Of these, 27.9% had TTR <65%only (Group I), 19.2% had CrCl <60 ml/min only (Group II), while 13.8% had both conditions (Group III). At follow-up, patients in Group III had a higher rate of major adverse cardiovascular and cerebrovascular events (MACCE) (p = 0.007), while patients in Groups I and III had higher rates of major bleeding. Kaplan-Meier analyses showed that patients in Group III had higher risk for MACCE (LogRank: 14.406, p = 0.003), while Group I and Group III patients had higher risk for major bleeding (LogRank: 12.290, p = 0.006). On Cox regression, presence of both conditions independently increased MACCE risk (p = 0.001), while TTR <65% alone and the presence of both conditions were independently associated with major bleeding (p = 0.004 and p = 0.028, respectively). CONCLUSIONS: There was a synergic impact of oral anticoagulation control and renal function in determining major adverse events in AF patients undergoing PCI-S. Use of poor anticoagulation control and impaired renal function in combination would help identify AF patients undergoing PCI-S at risk for MACCE and/or major bleeding.

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial.

OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

Comparison of two different sampling intervals for optical coherence tomography evaluation of neointimal healing response after coronary stent implantation.

BACKGROUND/OBJECTIVES: Optical coherence tomography (OCT) is widely used for evaluation of healing response to stent implantation. We sought to test the agreement between the 1-mm and 0.6-mm sampling intervals for assessment of the percentage of uncovered and malapposed struts by OCT. METHODS: Thirty-eight patients presenting with acute coronary syndrome were randomized to receive either a titanium-nitride-oxide-coated stent (n=19) or an everolimus-eluting stent (n=19). Neointimal strut coverage and strut apposition were evaluated by OCT at 2-month follow-up. Two independent investigators performed offline OCT image analysis at 1-mm intervals. One investigator repeated the measurements at 0.6-mm intervals and measurements were compared between the two sampling intervals. RESULTS: At a median follow-up of 60 [8] days, 694 cross-sections (7603 struts) and 1138 cross-sections (12,331 struts) were analysed at 1-mm and at 0.6-mm intervals, respectively. The median [IQR] percentage of uncovered struts was 3.27% [11.1] versus 3.38% [9.76] (p=0.001), and the mean (±SD) percentage was 7.69±9.99% versus 6.27±8.14% (p=0.004), for the 1-mm sampling interval versus the 0.6-mm sampling interval analysis, respectively; the median percentage of malapposed struts was 0.42% [2.04] versus 0.12% [1.63], respectively, (p=0.003). The intraclass correlation coefficient between the two observers for the percentage of uncovered struts was 0.95. CONCLUSIONS: The OCT-evaluated strut-level measurements of neointimal healing after stent implantation differ significantly between the 1-mm and the 0.6-mm sampling intervals.

Usefulness of Post-coronary Dilation to Prevent Recurrent Myocardial Infarction in Patients Treated With Percutaneous Coronary Intervention for Acute Coronary Syndrome (from the BASE ACS Trial).

Stent underexpansion is associated with worse outcome after stent implantation. Whether post-dilation (PD) improves outcome in patients with acute coronary syndrome (ACS) remains unclear. We performed post hoc analysis of outcome in patients from the BASE ACS (A prospective randomized comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome) trial who underwent PD versus those who did not. The BASE ACS trial randomized 827 patients (1:1) with ACS to receive either titanium-nitride-oxide-coated bioactive stents or everolimus-eluting stents. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Of 827 patients enrolled in the BASE ACS trial, 357 (43.2%) underwent PD. Median follow-up duration was 5 years. Patients who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not (4.5% vs 8.5%, respectively, p = 0.02). The rates of MACE (15.7% vs 15.1%, respectively, p = 0.81), and the other endpoints, were not significantly different (p >0.5 for all). The results were consistent in propensity score-matched analysis (270 pairs). In patients treated with bioactive stents, those who underwent PD had a trend for a fewer nonfatal MI events (p = 0.076). Comparably, in patients treated with everolimus-eluting stents, MACE and all the individual end points were comparable (p >0.5 for all). In conclusion, patients treated with early percutaneous coronary intervention for ACS who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not; MACE rates were not significantly different.