OPTImized coronary interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE) study. Rationale and study design.

INTRODUCTION: Clinical events may occur after percutaneous coronary intervention (PCI), particularly in complex lesions and complex patients. The optimization of PCI result, using pressure guidewire and intracoronary imaging techniques, may reduce the risk of these events. The hypothesis of the present study is that the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with an unrestricted use of intracoronary tools that allow PCI optimization. METHODS AND ANALYSIS: Observational prospective multicenter international study, with a follow-up of 12 months, including 1064 patients treated with a cobalt­chromium everolimus-eluting stent. Inclusion criteria include any of the following: Lesion length > 28 mm; Reference vessel diameter < 2.5 mm or > 4.25 mm; Chronic total occlusion; Bifurcation with side branch ≥2.0 mm;Ostial lesion; Left main lesion; In-stent restenosis; >2 lesions stented in the same vessel; Treatment of >2 vessels; Acute myocardial infarction; Renal insufficiency; Left ventricular ejection fraction <30 %; Staged procedure. The control group will be comprised by a similar number of matched patients included in the "extended risk" cohort of the XIENCE V USA study. The primary endpoint will be the 1-year rate of target lesion failure (TLF) (composite of ischemia-driven TLR, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel). Secondary endpoints will include overall mortality, cardiovascular mortality, acute myocardial infarction, TVR, TLR, target vessel failure, and definitive or probable stent thrombosis at 1 year. IMPLICATIONS: The ongoing OPTI-XIENCE study will contribute to the growing evidence supporting the use of intra-coronary imaging techniques for stent optimization in patients with complex coronary lesions.

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry.

BACKGROUND: Myocardial revascularization failure (MRF) and Secondary revascularization (SR) are contemporary interventional cardiology challenges. AIM: To investigate the characteristics, management, and prognosis of patients with myocardial revascularization failure (MRF) and need for secondary revascularization (SR) in contemporary practice. METHODS: The REVASEC study is a prospective registry (NCT03349385), which recruited patients with prior revascularization referred for coronary angiography at 19 centers. The primary endpoint is a patient-oriented composite (POCE) at 1 year, including death, myocardial infarction, or repeat revascularization. RESULTS: A total of 869 patients previously revascularized by percutaneous intervention (83%) or surgery (17%) were recruited. MRF was found in 83.7% (41.1% stent/graft failure, 32.1% progression of coronary disease, and 10.5% residual disease). SR was performed in 70.1%, preferably by percutaneous intervention (95%). The POCE rate at 1 year was 14% in the overall cohort, with 6.4% all-cause death. In the multivariate analysis, lower POCE rates were found in the groups without MRF (9.4%) and with disease progression (11%) compared with graft/stent failure (17%) and residual disease (18%), hazard ratio 0.67 (95% confidence interval: 0.45-0.99), p = 0.043. At 1 year, the SR group had less chronic persistent angina (19% vs. 34%, p < 0.001), but a higher rate of repeat revascularization (9% vs. 2.9%, p < 0.001). CONCLUSION: MRF was found in 84% of patients with prior revascularization referred for coronary angiography. Stent/graft failure and residual coronary disease were associated with a worse prognosis. SR provided better symptom control at the expense of a higher rate of new revascularization.

Improvement in electrocardiographic parameters of repolarization related to sudden death in patients with ventricular dysfunction and left bundle branch block after cardiac resynchronization through His bundle pacing.

BACKGROUND: Cardiac resynchronization therapy (CRT) through permanent His bundle pacing (p-HBP) normalizes interventricular conduction disorders and QRS. Similarly, there are immediate and long-term changes in repolarization, which could be prognostic of a lower risk of sudden death (SD) at follow-up. We aimed to compare the changes in different electrocardiographic (ECG) repolarization parameters related to the risk of SD before and after CRT through p-HBP. METHODS: In this prospective, descriptive single-center study (May 2019 to December 2021), we compared the ECG parameters of repolarization related to SD in patients with non-ischemic dilated cardiomyopathy, left bundle branch block (LBBB), and CRT indications, at baseline and after CRT through p-HBP. RESULTS: Forty-three patients were included. Compared to baseline, after CRT through p-HBP, there were immediate significant changes in the QT interval (ms): 445 [407.5-480] vs 410 [385-440] (p = 0.006), QT dispersion (ms): 80 [60-100] vs 40 [40-65] (p < 0.001), Tp-Te (ms): 90 [80-110] vs 80 [60-95] (p < 0.001), Tp-Te/QT ratio: 0.22 [0.19-0.23] vs 0.19 [0.16-0.21] (p < 0.001), T wave amplitude (mm): 6.25 [4.88-10] vs - 2.5 [- 7-2.25] (p < 0.001), and T wave duration (ms): 190 [157.5-200] vs 140 [120-160] (p = 0.001). In the cases of the corrected QT (Bazzett and Friederichia) and the Tp-Te dispersion, changes only became significant at 1 month post-implant (468.5 [428.8-501.5] vs 440 [410-475.25] (p = 0.015); 462.5 [420.8-488.8] vs 440 [400-452.5] (p = 0.004), and 40 [30-52.5] vs 30 [20-40] (p < 0.001), respectively) (Table 1). Finally, two parameters did not improve until 6 months post-implant: the rdT/JT index, 0.25 [0.21-0.28] baseline vs 0.20 [0.19-0.23] 6 months post-implant (p = 0.011), and the JT interval, 300 [240-340] baseline vs 280 [257-302] 6 months post-implant (p = 0.027). Additionally, most of the parameters continued improving as compared with immediate post-implantation. CONCLUSIONS: After CRT through His bundle pacing and LBBB correction, there was an improvement in all parameters of repolarization related to increased SD reported in the literature.

His bundle pacing success and electrical parameter stability regardless of three-dimensional transthoracic echocardiography lead localization.

BACKGROUND OR PURPOSE: His bundle pacing (HBP) is the most physiological form of ventricular pacing. Few prospective studies have analyzed lead localization using imaging techniques and its relationship with electrical parameters and capture patterns. The objective of this study is to examine the correlation between electrical parameters and lead localization using three-dimensional transthoracic echocardiography (3D TTE). METHODS: This single-center, prospective, nonrandomized clinical research study (January 2018 to June 2020) included patients with an indication of permanent pacing, in whom 3D TTE was performed to define lead localization as supravalvular or subvalvular. RESULTS: A total of 92 patients were included: 56.5% of leads were supravalvular, and 43.5% were subvalvular, which resembles previous anatomic descriptions of autopsied hearts of His bundle localization within the triangle of Koch (ToK). R-wave sensing was higher when the His lead was localized subvalvular instead of supravalvular. His lead localization was not associated with HBP threshold or impedance differences, nor with the two different HBP patterns of capture, or with the ability of HBP to correct baseline BBB. The thresholds remained stable during follow-up visits, regardless of His lead localization. Higher R-wave sensing was observed during follow-up than at baseline, mainly in the subvalvular His leads. However, lead impedances in both positions decreased during follow-up. CONCLUSIONS: Lead localization in relation to the tricuspid valve did not influence the electrical performance of HBPs. Wide anatomical variations of the His bundle within the ToK explain our findings, reinforcing the idea that the technique for HBP should be fundamentally guided by electrophysiological and not anatomical parameters.

Changes in the Treatment Strategy Following Intracoronary Pressure Wire in a Contemporaneous Real-Life Cohort of Patients With Intermediate Coronary Stenosis. Results From a Nationwide Registry.

BACKGROUND: Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. AIMS: To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. METHODS: Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. RESULTS: 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0 %). The extent of coronary artery disease changed in 771 patients (54.5 %). There was a change in treatment strategy in 779 patients (55.1 %) (18.0 % if medical treatment; 68.8 % if PCI; 58.9 % if surgery (p < 0.001 for PCI vs medical treatment; p = 0.041 for PCI vs CABG; p < 0.001 for medical treatment vs CABG)). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6 % vs 8.2 %, p = 0.034). CONCLUSIONS: The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment.

Overlapping versus single long stents in long chronic total occlusions: insights of the Iberian CTO Registry.

BACKGROUND: It is unknown whether the availability of long drug-eluting stents modify the PCI strategy of long CTO. To describe the contemporary PCI strategy of long chronic total occlusions (CTO) using overlapping (OS) or single long stents (SS) and to analyze its results. METHODS: 2842 consecutive CTO PCIs were included. Those with an occlusion length ≥20 mm in which ≥1 drug eluting stent (DES) was implanted were analyzed. We compared procedural characteristics and clinical outcomes of CTO treated with OS or SS. RESULTS: 1088 CTO PCIs were analyzed (79.9% males; 64.7±10.6 years). Mean J-score was 2.8±0.9. A SS was used in 38.5% of cases and OS in 61.5%. Total stent length was 64.1±29.9 mm; it was higher in the OS group (OS: 79.9±25.5 mm vs. SS: 38.3±14.7 mm; P<0.0001). Mean number of stents in the OS group was 2.3±1. Very long stents (≥40 mm) were used in 27.4% of cases, more frequently in the OS group (OS:32.4% vs. SS:19.3%; P<0.0001). After a mean follow-up of 19±15.9 months, the rate of adverse events (MACE) was 2% (cardiac death: 1.6%, myocardial infarction: 1.6%, target lesion revascularization: 1.9% and stent thrombosis: 0.18%) with no significant differences between both groups. Overlapping was not an independent predictor of MACE. CONCLUSIONS: In long CTO PCIs, OS is more frequently used than single stenting, especially in more complex procedures. Clinical outcomes at a mid-term follow-up are favorable. Using newer generation DES, overlapping was not an independent predictor of MACE; however, a trend toward a higher event rate was observed in the OS group.

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study.

BACKGROUND: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS. METHODS: Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area measurements. Primary clinical end point was a composite of cardiovascular death, LMCA lesion-related nonfatal myocardial infarction, or unplanned LMCA revascularization. RESULTS: FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+/iFR- and 29 FFR-/iFR+) minimal lumen area was ≥6 mm2 in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, major adverse cardiac events incidence was 8.3% in the defer group and 13.3% in the revascularization group (hazard ratio, 0.71 [95% CI 0.30-1.72]; P=0.45). CONCLUSIONS: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of major adverse cardiac events. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03767621.

Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study.

OBJECTIVES: Elderly patients show a higher incidence of ischemic and bleeding events after percutaneous transluminal coronary intervention (PCI). We sought to investigate outcomes in elderly patients treated with antithrombotic strategy guided by bleeding and ischemic risks after revascularization with last generation everolimus-eluting stent (EES). METHODS: Prospective multicenter registry including patients over 75 years revascularized with EES and antithrombotic therapy guided by clinical presentation, PCI complexity and PRECISE DAPT score. Co-primary safety endpoints were: (1) composite of cardiac death, myocardial infarction and stent thrombosis and; (2) bleeding (BARC 2-5). Primary efficacy endpoint was target lesion revascularization. A matched group of patients revascularized with current drug-eluting stents and no such tailored antithrombotic therapy was used as control. RESULTS: Finally, 1064 patients were included in SIERRA-75 cohort, 80.8 ± 4.2 years, 36.6% women, 71% acute coronary syndromes (ACS) and 53.6% complex PCI. Co-primary safety endpoint of major adverse cardiovascular events was met in 6.2%, co-primary safety endpoint of bleeding in 7.8% and primary efficacy endpoint of TKLR in 1.5%. The multivariable adjusted model showed no significant association of the prescribed short/long dual antiplatelet therapy (DAPT) durations with any endpoint suggesting a well tailored therapy. No stent thrombosis reported in the subgroup with 1-3 months DAPT duration. As compared to control group, bleeding BARC 2-5 was significantly lower in SIERRA-75 group (7.4% vs. 10.2%, P = 0.04) as well as the net safety-efficacy endpoint (14.3% vs. 18.5%, P = 0.02). CONCLUSIONS: In elderly population, the application of this risks-adjusted antithrombotic protocol after revascularization with last generation EES seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes.

Subclavian angioplasty during coronary interventions using radial approach.

BACKGROUND: In the past years, the percentage of percutaneous coronary angiography and coronary interventions using radial access had significantly increased due to its higher safety, lower risk of major bleeding, and hence lower cardiovascular mortality. Subclavian artery stenosis is one of the challenges that may be met during transradial coronary interventions, which may necessitate femoral access crossover or conversion. AIMS: To evaluate the feasibility and safety of performing subclavian angioplasty via radial access during complex coronary interventions using the forearm approach. METHODS: A series of patients with complex radial approach due to subclavian stenosis received subclavian angioplasty during the procedure. We included 48 patients out of 22 500 procedures performed from February 2009 to February 2020. All patients did not have alternative vascular access due to extensive peripheral arterial disease (previous history of iliac stenting or distal aortic occlusion, which makes femoral access crossover difficult; also the contralateral radial/ulnar artery was very faint or not detectable at all). RESULTS: Mean age was 72 (10) years and 67% of patients were males. Subclavian angioplasty was successfully done in all patients via ipsilateral radial access; 44 patients (91.7%) required subclavian stenting, and 4 patients were treated by subclavian angioplasty without stenting. Coronary angiography or intervention was perfectly achieved through the revascularized subclavian artery; coronary stenting was successfully done in 36 patients as indicated. CONCLUSIONS: It can be concluded that percutaneous subclavian artery angioplasty can be done safely and effectively to facilitate complex transradial coronary procedures with an acceptable immediate technical success, especially in patients without alternative vascular access. Also, we may conclude that subclavian angioplasty may be successfully performed in patients with symptomatic upper limb ischemia, via the radial approach.

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

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.

Plaque modification in calcified chronic total occlusions: the PLACCTON study.

INTRODUCTION AND OBJECTIVES: Severe calcification is present in> 50% of coronary chronic total occlusions (CTOs) undergoing percutaneous intervention. We aimed to describe the contemporary use and outcomes of plaque modification devices (PMDs) in this context. METHODS: Patients were included in the prospective, consecutive Iberian CTO registry (32 centers in Spain and Portugal), from 2015 to 2020. Comparison was performed according to the use of PMDs. RESULTS: Among 2235 patients, wire crossing was achieved in 1900 patients and PMDs were used in 134 patients (7%), requiring more than 1 PMD in 24 patients (1%). The selected PMDs were rotational atherectomy (35.1%), lithotripsy (5.2%), laser (11.2%), cutting/scoring balloons (27.6%), OPN balloons (2.9%), or a combination of PMDs (18%). PMDs were used in older patients, with greater cardiovascular burden, and higher Syntax and J-CTO scores. This greater complexity was associated with longer procedural time but similar total stent length (52 vs 57mm; P=.105). If the wire crossed, the procedural success rate was 87.2% but increased to 96.3% when PMDs were used (P=.001). Conversely, PMDs were not associated with a higher rate of procedural complications (3.7 vs 3.2%; P=.615). Despite the worse baseline profile, at 2 years of follow-up there were no differences in the survival rate (PMDs: 94.3% vs no-PMDs: 94.3%, respectively; P=.967). CONCLUSIONS: Following successful wire crossing in CTOs, PMDs were used in 7% of the lesions with an increased success rate. Mid-term outcomes were comparable despite their worse baseline profile, suggesting that broader use of PMDs in this setting might have potential technical and prognostic benefits.

Design and Rationale for a Real-World Prospective, Multicenter Registry of Myocardial Revascularization Failure and Secondary Revascularization: The REVASEC Study.

AIM: To investigate key aspects of the problem of myocardial revascularization failure (MRF) and repeat or secondary myocardial revascularization (SR) in contemporary practice. METHODS: The registry of secondary revascularization (REVASEC) is an investigator-initiated, multicenter, prospective registry enhanced with data monitoring and independent event adjudication (ClinicalTrials.govNCT03349385). It includes patients with prior revascularization referred to coronary angiography for suspected MRF with broad inclusion criteria. The main objectives are to describe the characteristics of patients with prior revascularization referred for repeat angiography, to describe and the rate and mechanisms of MRF (stent or graft failure, coronary artery disease progression or residual coronary artery disease); to evaluate the management including medical treatment and SR of these patients; and to assess the prognosis according to the outlined causative mechanisms. The registry has one year follow up for the primary endpoint (Patient-oriented composite endpoint including all-cause death, any myocardial infarction or any new unplanned revascularization according to subsets of MRF), but extended follow-up will be carried out up to 5 years. CONCLUSION: The REVASEC Registry will provide updated data on the characteristics, patterns of treatment, and 1-year outcomes of patients with MRF and SR in contemporary clinical practice.

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol.

BACKGROUND: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes. STUDY AND DESIGN: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee. CONCLUSION: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

Long-term clinical, angiographic, and optical coherence tomography findings of Mg-based bioresorbable scaffold in patients with acute coronary syndrome.

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.

First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study.

OBJECTIVES: We sought to investigate stent healing and neointimal hyperplasia with ihtDEStiny drug-eluting stent (DES) by optical coherence tomography (OCT) examination conducted 9 months after implantation. BACKGROUND: The currently used DES present certain features that have been linked separately to their better performance in terms of efficacy and safety. METHODS: First-in-man, prospective and multicenter study including patients treated with ihtDEStiny stent undergoing OCT examination at 9 months follow up. The ihtDEStiny stent is a sirolimus eluting stent with an oval shape ultrathin struts (68 µm) and an abluminal coating of a fluoropolymer containing the antiplatelet agent triflusal. Primary endpoint was the percentage of obstruction of the in-stent volume by the neointima. RESULTS: In 58 patients (63 lesions) in-stent late lumen loss was 0.11 ± 0.23 mm (95% CI 0.05-0.16) with only in 6% of stents being > 0.5 mm and in-segment binary stenosis was 1.6%. In OCT mean neointima volume obstruction was 10.5 ± 6.9% with a mean neointima thickness of 110.9 ± 89.8 µm. The proportion of uncovered struts was 2.5%, malapposed struts 1.1% and malapposed/uncovered struts 0.7% and no subclinical thrombi detected. Mean incomplete stent apposition area was 0.1 ± 0.1 mm2. At 12 months target lesion revascularization rate was 3% and no stent thrombosis was reported. CONCLUSIONS: In this study the ihtDEStiny stent has shown a very low degree of neointimal proliferation associated with a low rate of uncovered/malapposed struts and total absence of subclinical thrombi at 9 months follow up.

Contrast FFR plus intracoronary injection of nitro-glycerine accurately predicts FFR for coronary stenosis functional assessment.

BACKGROUND: Fractional flow reserve (FFR) is the "gold standard" for assessing the physiological significance of coronary disease. In the last decade, several alternative adenosine-free indexes have been proposed in order to facilitate the dissemination of the functional evaluation of coronary stenosis. Our aim was to investigate whether radiographic contrast plus intracoronary nitroglycerin (cFFR-NTG) can predict functional assessment of coronary stenosis offering superior diagnostic agreement with FFR compared to non-hyperemic indexes and contrast mediated FFR (cFFR). METHODS: Three hundred twenty-nine lesions evaluated with pressure wire in 266 patients were prospectively included in this multicenter study. RESULTS: The ROC curves for cFFR-NTG using an FFR≤0.80 showed a higher accuracy in predicting FFR (AUC=0.97) than resting Pd/Pa (AUC=0.90, P<0.01) and cFFR (AUC=0.93.5, P<0.01). A significant (P<0.01) strong correlation was found between FFR and the four analyzed indexes: Pd/Pa (r=0.78); iFR/RFR (r=0.73); cFFR(r=0.89) and cFFR-NTG (r=0.93). cFFR-NTG showed the closest agreement at Bland-Altman analysis. The cFFR-NTG cut off value >0.84 showed the highest negative predictive value (88%), specificity (91%), sensitivity (94%) and accuracy (92%) of the studied indexes. CONCLUSIONS: Submaximal hyperemic adenosine-free indexes are an efficient alternative to adenosine for the physiological assessment of epicardial coronary disease. The most accurate index in predicting the functional significance of coronary stenosis using FFR as reference was cFFR-NTG.