Relationship between stent length and very long-term target lesion failure following percutaneous coronary intervention for ST-elevation myocardial infarction in the drug-eluting stents era: insights from the EXAMINATION-EXTEND study.

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.

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.

Novel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial.

BACKGROUND: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug-eluting stents (DESs). The novel Supreme DES is designed to synchronize early drug delivery within 4 to 6 weeks of implantation, leaving behind a prohealing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long-term clinical outcomes is not known. METHODS: In an international, 2:1 randomized, single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-EES) in patients with acute and chronic coronary syndromes. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. The trial was designed to demonstrate noninferiority (margin of 3.58%) of the Supreme DES at 12 months compared with DP-EES (URL: https://www.clinicaltrials.gov; Unique identifier: NCT03168776). RESULTS: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-EES (N=543). At 12 months, target lesion failure occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-EES group (absolute risk difference, 0.32% [95% CI, -1.87 to 2.5]; Pnoninferiority=0.002]. There were no significant differences in rates of device success, clinically driven target lesion revascularization, or stent thrombosis at 12 months, and the safety composite of cardiovascular death and target vessel myocardial infarction was 3.5% versus 4.6% (hazard ratio, 0.76 [95% CI, 0.46-1.25]) with Supreme DES compared with DP-EES, although rates of combined clinically and non-clinically driven target lesion revascularization at 12 months were higher with Supreme DES. CONCLUSIONS: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be noninferior to the standard DP-EES. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03168776.

Clinical Features and Long-Term Outcomes in Very Young Patients with Myocardial Infarction with Non-Obstructive Coronary Arteries.

Background: The main cause of acute coronary syndrome (ACS) is coronary artery obstruction due to atherosclerotic plaque growth or thrombus formation secondary to plaque rupture or erosion. However, there is a subgroup of patients with signs and symptoms suggestive of ACS but without relevant coronary artery obstruction on coronary angiography. This population is defined as myocardial infarction with non-obstructive coronary arteries (MINOCA). The present study analyzes the clinical features and outcomes of very young patients with a diagnosis of MINOCA. Method: Nested case-control study of ≤40-year-old patients referred for coronary angiography due to clinical suspicion of ACS. Patients were divided into three groups: patients with obstructive coronary artery disease (CAD), patients diagnosed with MINOCA, and controls with non-coronary artery disease. Results: Of 19,321 coronary angiographies performed in our center in a period of 10 years, 408 (2.1%) were in patients ≤40 years old, and MINOCA was identified in 32 (21%) patients. The cardiovascular risk factors for obstructive CAD and MINOCA were very similar. The incidence of major adverse cardiovascular events (MACE) at follow-up was significantly higher in the MINOCA (HR 4.13 (95%CI 1.22-13.89) and obstructive CAD (HR 4.59 (95%CI 1.90-10.99) patients compared to controls. Cocaine use HR 14.58 (95%CI 3.08-69.02), family history of CAD HR 6.20 (95%CI 1.40-27.43), and depression HR 5.16 (95%CI 1.06-25.24) were associated with a poor outcome in the MINOCA population. Conclusion: Very young patients with MINOCA had a poor prognosis at long-term follow-up, similar to patients with obstructive CAD. Focusing efforts on secondary prevention is essential in this population.

Usefulness of the Hybrid RFR-FFR Approach: Results of a Prospective and Multicenter Analysis of Diagnostic Agreement between RFR and FFR-The RECOPA (REsting Full-Cycle Ratio Comparation versus Fractional Flow Reserve (A Prospective Validation)) Study.

BACKGROUND: The resting full-cycle ratio (RFR) is a novel resting index which in contrast to the gold standard (fractional flow reserve (FFR)) does not require maximum hyperemia induction. The objectives of this study were to evaluate the agreement between RFR and FFR with the currently recommended thresholds and to design a hybrid RFR-FFR ischemia detection strategy, allowing a reduction of coronary vasodilator use. MATERIALS AND METHODS: Patients subjected to invasive physiological study in 9 Spanish centers were prospectively recruited between April 2019 and March 2020. Sensitivity and specificity studies were made to assess diagnostic accuracy between the recommended levels of RFR ≤0.89 and FFR ≤0.80 (primary objective) and to determine the RFR "grey zone" in order to define a hybrid strategy with FFR affording 95% global agreement compared with FFR alone (secondary objective). RESULTS: A total of 380 lesions were evaluated in 311 patients. Significant correlation was observed (R 2 = 0.81; P < 0.001) between the two techniques, with 79% agreement between RFR ≤ 0.89 and FFR ≤ 0.80 (positive predictive value, 68%, and negative predictive value, 80%). The hybrid RFR-FFR strategy, administering only adenosine in the "grey zone" (RFR: 0.86 to 0.92), exhibited an agreement of over 95% with FFR, with high predictive values (positive predictive value, 91%, and negative predictive value, 92%), reducing the need for vasodilators by 58%. CONCLUSIONS: Dichotomous agreement between RFR and FFR with the recommended thresholds is significant but limited. The adoption of a hybrid RFR-FFR strategy affords very high agreement, with minimization of vasodilator use.

Impact of Comorbidities and Antiplatelet Regimen on Platelet Reactivity Levels in Patients Undergoing Transcatheter Aortic Valve Implantation.

ABSTRACT: The aim of our study is to assess the impact of anemia, chronic kidney disease, and diabetes mellitus on platelet reactivity (PR) in patients with severe aortic stenosis, both at baseline and after transcatheter aortic valve implantation (TAVI). This study is a prespecified subanalysis of the REAC-TAVI prospective, multicenter trial that included patients pretreated with aspirin + clopidogrel before TAVI. PR was measured at baseline and at 5 different time points after TAVI with the VerifyNow assay (Accriva Diagnostics, San Diego, CA), over a 3-month follow-up period. Patients with high PR (HPR) at baseline, before TAVI (n = 48) were randomized to aspirin + clopidogrel or aspirin + ticagrelor for 3 months, whereas those with normal PR (NPR) (n = 20) were continued on aspirin + clopidogrel. A "raiser response" in PR was defined as an increase in PR units >20% of baseline after TAVI. Patients with HPR before TAVI presented concomitant anemia and chronic kidney disease more frequently than their counterparts with NPR. Anemia and higher body mass index were independently associated with HPR to clopidogrel at baseline. Moreover, anemic patients with baseline HPR who were continued on clopidogrel presented higher PR after TAVI than patients with HPR switched to ticagrelor. All patients with baseline NPR presented a "raiser response" after TAVI, which was nonexistent among patients with HPR managed with ticagrelor. In summary, anemia seems as a relevant factor associated with baseline HPR and higher PR after TAVI in patients with baseline HPR randomized to clopidogrel, whereas ticagrelor proved more effective than clopidogrel at attaining sustained reductions in PR during follow-up, regardless of baseline comorbidities.

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.

Sex differences in delay times in ST-segment elevation myocardial infarction: A cohort study.

BACKGROUND: The present study analyzes a cohort of consecutive patients with ST-segment elevation acute myocardial infarction (STEMI), evaluating the ischemia-reperfusion times from the perspective of gender differences (females versus males), with a long-term follow-up. METHODS: Single-center analytical cohort study of patients with STEMI in a tertiary hospital, between January 2015 and December 2020. RESULTS: A total of 2668 patients were included, 2002 (75%) men and 666 (25%) women. The time elapsed from the onset of symptoms to the opening of the artery was 197min (IQR 140-300) vs 220min (IQR 152-340), p=0.004 in men and women respectively. A delay in health care significantly impacts the occurrence of cardiovascular adverse events at follow-up, HR 1.34 [95%CI 1.06-1.70]; p=0.015. CONCLUSIONS: Women took longer to go to health care services and had a longer delay both in the diagnosis of STEMI and in coronary reperfusion. It is imperative to emphasize the necessity of educating women about the recognition of ischemic heart disease symptoms, empowering them to raise early alarms and seek timely medical attention.

Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial.

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.

Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Wellens syndrome as an independent predictor of in-hospital cardiovascular complications.

INTRODUCTION: Wellens Syndrome was described for the first time in the eighties, as an equivalent pattern of a critical lesion of the anterior descending artery. Different risk factors have been associated with a worse prognosis during hospitalisation in patients with non-ST segment elevation acute coronary syndrome. However, it is unknown whether the presence of Wellens Syndrome alone contributes to an increase in in-hospital cardiovascular complications. MATERIAL AND METHOD: Analytical prospective cohort study in 141 patients with the diagnosis of acute coronary syndrome without ST segment elevation who underwent coronary angiography between 2016 and 2020. RESULTS: Wellens syndrome was diagnosed in 64 patients with a mean age of 66.31 ± 12.54, of which 21 patients had a cardiac event during hospitalisation: hemodynamic complication 14 (21.9%), refractory or recurrent angina 4 (6.3%) and Acute myocardial infarction 3 (4.7%) confirming a relative risk (RR): 4.88 (95% confidence interval (CI) 1.92-12.45) p = 0.001. CONCLUSIONS: The presence of Wellens Syndrome is independently associated with the appearance of cardiac complications during hospitalisation.Key pointsSW is now known to be a relatively frequent presentation of ACS, not addressed in depth in clinical practice guidelines for NSTEACS. This syndrome is generally caused by a severe ADA occlusion that, if not adequately treated, could evolve into a large infarction. According to the results of the different series published, the incidence of cardiovascular risk factors in SW is similar to other forms of presentation of ischaemic heart disease.At present, the exact relationship between the main cardiovascular risk factors and SW is unknown; in addition to the possible associations of this syndrome with in-hospital cardiovascular complications and its value as a predictor of the occurrence of cardiac complications, elements that are included in the results of the present study.

Cerebral embolic protection during transcatheter heart interventions.

Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), with the incidence of clinically apparent stroke seemingly fixed at around 3% despite TAVR's significant evolution during the past decade. Embolic showers of debris (calcium, atheroma, valve material, foreign material) are captured in the majority of patients who have TAVR using a filter-based cerebral embolic protection device (CEPD). Additionally, in systematic brain imaging studies, the majority of patients receiving TAVR exhibit new cerebral lesions. Mechanistic studies have shown reductions in the volume of new cerebral lesions using CEPDs, yet the first randomised trial powered for periprocedural stroke within 72 hours of a transfemoral TAVR failed to meet its primary endpoint of showing superiority of the SENTINEL CEPD. The present review summarises the clinicopathological rationale for the development of CEPDs, the evidence behind these devices to date and the emerging recognition of cerebral embolisation in many non-TAVR transcatheter procedures. Given the uniqueness of each of the various CEPDs under development, specific trials tailored to their designs will need to be undertaken to broaden the CEPD field, in addition to evaluating the role of CEPD in non-TAVR transcatheter heart interventions. Importantly, the cost-effectiveness of these devices will require assessment to broaden the adoption of CEPDs globally.

Impact of Age at the Time of the First ST-Elevation Myocardial Infarction on 10-Year Outcomes (from the EXAMINATION-EXTEND Trial).

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: <55, 55 to 65, 65 to 75, and >75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged <55 years (adjusted hazard ratio [HR] 0.24, 95% confidence interval [CI] 0.18 to 0.31, p = 0.001), 55 to 65 years (adjusted HR 0.26, 95% CI 0.20 to 0.34, p = 0.001), and 65 to 75 years (adjusted HR 0.38, 95% CI 0.30 to 0.50, p = 0.001) showed lower risk of POCE than those aged >75 years, led by a lower incidence of all-cause death (<55 : 6% vs 55 to 65: 11.9% vs 65 to 75: 25.7% vs >75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (<55: 3.7% vs 55 to 65: 5.8% vs 65 to 75: 10.9% vs >75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (<55: 7.4% vs 55 to 65: 4.9% vs 65 to 75: 1.8% vs >65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

Automatic Assessment of Transcatheter Aortic Valve Implantation Results on Four-Dimensional Computed Tomography Images Using Artificial Intelligence.

Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.

Validation of Quantitative Flow Ratio-Derived Virtual Angioplasty with Post-Angioplasty Fractional Flow Reserve-The QIMERA-I Study.

Background: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50-90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078-0.386) and low diagnostic accuracy (30.9%, 95% CI:20-43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR.

Bioactive or Drug-Eluting Stents in 75 Years or Older Patients: The BIODES-75 Registry.

BACKGROUND: TiNO-coated BAS have demonstrated competitive outcomes compared to drug-eluting stents (DES). These devices allow short antiplatelet regimens and may be a good option for the growing elderly population undergoing percutaneous coronary intervention (PCI). METHODS: Multicenter observational trial in routine clinical practice. A propensity-score matched analysis compared a prospective cohort of patients ≥ 75 years undergoing PCI with BAS, with a contemporary and retrospective cohort treated with last-generation DES. The co-primary endpoints of the study were the Target-Lesion-Failure (Cardiac death, non-fatal myocardial infarction, or target lesion revascularization) and Major Adverse Cardiovascular Events (total death, non-fatal myocardial infarction, stroke, or new revascularization) at 1 year. RESULTS: Whole population included 1000 patients, and 326 patients in each group were matched for analysis. No differences in primary endpoints were found: TLF 10.4% vs. 11% (HR 0.96 (Confidence Interval 95%, 0.36-1.7; p = 0.87)) and MACE 16.3% vs. 17.2% (HR 0.98 (Confidence Interval 95%; 0.3-1.5, p = 0.93)). Patients treated with BAS received shorter antiplatelets regimens (dual antiplatelet therapy at 1 year, 25.7% vs. 70.6%, p = 0.0001), and they presented lower incidence of bleeding (3.7% vs. 11.7%, HR 0.3 (IC 95% 0.16-0.6, p = 0.001)). CONCLUSION: In this real-life registry of patients ≥ 75 years, BAS were similar to the latest-generation DES in terms of efficacy and reduced the duration of the antithrombotic therapy, lowering bleeding events.

Contact pathway in surgical and transcatheter aortic valve replacement.

Background: Aortic valve replacement is the gold standard treatment for severe symptomatic aortic stenosis, but thrombosis of bioprosthetic valves (PVT) remains a concern. Objective: To analyze the factors involved in the contact pathway during aortic valve replacement and to assess their impact on the development of thromboembolic complications. Methods: The study was conducted in 232 consecutive patients who underwent: transcatheter aortic valve replacement (TAVR, N = 155), and surgical valve replacement (SAVR, N = 77) (MUVITAVI project). Demographic and clinical data, outcomes including a combined end point (CEP) of thrombotic events, and imaging controls were recruited. Samples were collected 24 h before and 48 h after valve replacement. FXII, FXI and (pre)kallikrein were evaluated by Western Blot and specific ELISA with nanobodies. Results: The CEP of thrombotic events was reached by 19 patients: 13 patients presented systemic embolic events and 6 patients subclinical PVT. Valve replacement did not cause FXII activation or generation of kallikrein. There was a significant reduction of FXI levels associated with the procedure, which was statistically more pronounced in SAVR than in TAVR. Cases with reductions of FXI below 80% of basal values had a lower incidence of embolic events during the procedure than patients in whom FXI increased above 150%: 2.7 vs. 16.7%; p: 0.04. Conclusion: TAVR or SAVR did not significantly activate the contact pathway. A significant reduction of FXI, was observed, particularly in SAVR, associated with lower incidence of thrombotic events. These results encourage evaluating the usefulness and safety of FXI-directed antithrombotic treatments in these patients.

Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Background: Nowadays, good clinical practice should be established in human research. Patient's rights and autonomy must be respected above the interest of the researcher, making mandatory to raise patient's awareness on the implications of participating in a clinical study. Contrary to popular belief, this is not always the case. This means that, after signing the informed consent form, some patients have difficulties understanding their responsibilities as participants. Materials and methods: This study is a prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff. Results: Females were underrepresented in the clinical trials performed in this study, 21.5%. Most of the participants had a low educational level (74.4%). Around 5 and 10% of the research participants were not aware they were part of a clinical study, and more 24% just trusted in the medical decision to be enrolled. After the interventional education, the following items: "given time and resolution of the patient doubts" (p-value = 0.003), "enough written information" (p-value = 0.006), "explanation of the risks of participating in the study," (p-value = 0.047) and understanding of the information provided to them showed an improvement regarding the study in which they were participating. Conclusion: The research participants understanding of their involvement in clinical trials is limited. An educational intervention on the research team can improve the process of empowerment and transit of information.

Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

BACKGROUND: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. OBJECTIVES: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. METHODS: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. RESULTS: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. CONCLUSIONS: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).