I prefer the MitraClip in these cases: the 5-year COAPT data.

The COAPT 5-year data demonstrate that compared with medical treatment transcatheter edge-to-edge repair (TEER) with the MitraClip in symptomatic patients with Grade 3+/Grade 4+ secondary mitral regurgitation (SMR) reduced by nearly half the annualized hospitalization risk (33 vs. 57%), by almost 30% the death rate (57 vs. 67%) and achieved significant and durable SMR reduction in 95% of patients. Control patients who crossed over to TEER at 2 years had better prognosis, but nearly half of them died before reaching crossover eligibility. Death or hospitalization for heart failure (HHF) occurred in 73.6% of TEER patients and 91.5% of controls within 5 years, pointing to a need for further study to address left ventricle (LV) dysfunction, the underlying cause of patient's disease. MTRA-FR targeted SMR using the same device and did not improve the composite endpoint of all-cause mortality or HHF at 12 months. Possible reasons for the discrepancy include enrolment of patients with more severe MR and less-advanced LV disease (dilation/dysfunction), less-procedural complications, and higher success in reducing MR in COAPT compared with MITRA-FR. Thus, the ideal patient for MitraClip treatment would be one with severe MR, but with no too severe LV dilation/dysfunction, which is what differentiates COAPT patients from those in MITRA-FR.

Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.

Clinical outcomes and predictors in patients with previous cardiac surgery undergoing mitral valve transcatheter edge-to-edge repair.

BACKGROUND: Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes. OBJECTIVE: aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO). METHODS: Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups. RESULTS: A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001). CONCLUSIONS: MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.

Predictors of optimal procedural result after transcatheter edge-to-edge mitral valve repair in secondary mitral regurgitation.

BACKGROUND: Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree to

Long-term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real-World Multicenter European Study.

OBJECTIVES: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. BACKGROUND: IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients. METHODS: This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed. RESULTS: In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30). CONCLUSION: This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.

Plaque assessment by coronary CT angiography may predict cardiac events in high risk and very high risk diabetic patients: A long-term follow-up study.

BACKGROUND AND AIMS: The aim of the present study is to evaluate whether advanced coronary atherosclerosis analysis by CCTA may improve prognostic stratification among diabetic patients at high cardiovascular risk (CV risk). METHODS AND RESULTS: The study population consisted of 265 consecutive diabetic patients at high CV risk who underwent CCTA for suspected CAD between January 2011 and December 2016. For every patients both traditional and advanced, qualitative and quantitative coronary plaque analysis were performed. The occurrence of cardiac death, ACS, and non-urgent revascularization were recorded at follow-up. Among the 265 patients enrolled, 21 were lost to follow-up, whereas 244 (92%) had a complete follow-up (mean 45 ± 22 months) and were classified at high (n = 67) or very high cardiovascular risk (n = 177), according to ESC Guidelines. A total of 63 events were recorded (3 Cardiac Death, 3 NSTEMI, 8 unstable angina, 36 late non-urgent revascularization and 13 non-cardiac death) in 57 different patients. Elevated fibro-fatty plaque volume was the only predictor of events over age, gender and traditional risk factor when ACS and MACE were considered as end-points [HR (95% CI) 6.01 (1.65-21.87), p = 0.006 and 3.46 (2.00-5.97); p < 0.001]. CONCLUSION: The present study confirms the prognostic role of advance coronary atherosclerosis evaluation beyond risk factors and stenosis severity, even in diabetics. Despite the very high cardiovascular risk of study population, a not negligible portion (23%) of patients exhibited totally normal coronaries.

Transcatheter mitral valve replacement: there is still work to be done.

Transcatheter mitral valve replacement (TMVR) is a novel therapeutic option for patients with severe mitral regurgitation (MR) at high or prohibitive surgical risk. Most TMVR technologies under investigation use either a trans-apical or a trans-septal approach via dedicated multistep anchoring systems. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, notably a greater and more sustained MR reduction. At the same time, significant engineering challenges and potential disadvantages must be acknowledged. Preclinical and clinical studies have shown promising results, demonstrating TMVR feasibility. Nevertheless, further development, testing, and trials are needed before considering TMVR as a definitive therapeutic option for MR in a wide range of anatomical scenarios.

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity-matched analysis.

AIMS: In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. METHODS AND RESULTS: We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). CONCLUSIONS: In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

Recommendations in pre-procedural imaging assessment for TAVI intervention: SIC-SIRM position paper part 2 (CT and MR angiography, standard medical reporting, future perspectives).

Non-invasive cardiovascular imaging owns a pivotal role in the preoperative assessment of patient candidates for transcatheter aortic valve implantation (TAVI), providing a wide range of crucial information to select the patients who will benefit the most and have the procedure done safely. This document has been developed by a joined group of experts of the Italian Society of Cardiology and the Italian Society of Medical and Interventional Radiology and aims to produce an updated consensus statement about the pre-procedural imaging assessment in candidate patients for TAVI intervention. The writing committee consisted of members and experts of both societies who worked jointly to develop a more integrated approach in the field of cardiac and vascular radiology. Part 2 of the document will cover CT and MR angiography, standard medical reporting, and future perspectives.

Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in Acute Coronary Syndrome: Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials.

BACKGROUND: New randomized, controlled trials have become available on oral P2Y12 inhibitors in acute coronary syndrome. We aimed to evaluate current evidence comparing the efficacy and safety profile of prasugrel, ticagrelor, and clopidogrel in acute coronary syndrome by a meta-analysis of randomized controlled trials. METHODS: We performed a network meta-analysis and direct pairwise comparison analysis of efficacy and safety outcomes from 12 randomized controlled trials including a total of 52 816 patients with acute coronary syndrome. RESULTS: In comparison with clopidogrel, ticagrelor significantly reduced cardiovascular mortality (hazard ratio [HR], 0.82 [95% CI, 0.72-0.92]) and all-cause mortality (HR, 0.83 [95% CI, 0.75-0.92]), whereas there was no statistically significant mortality reduction with prasugrel (HR, 0.90 [95% CI, 0.80-1.01] and HR, 0.92 [95% CI, 0.84-1.02], respectively). In comparison with each other, there were no significant differences in mortality (HR prasugrel versus ticagrelor, 1.10 [95% CI, 0.94-1.29] and 1.12 [95% CI, 0.98-1.28]). In comparison with clopidogrel, prasugrel reduced myocardial infarction (HR, 0.81 [95% CI, 0.67-0.98]), whereas ticagrelor showed no risk reduction (HR, 0.97 [95% CI, 0.78-1.22]). Differences between prasugrel and ticagrelor were not statistically significant. Stent thrombosis risk was significantly reduced by both ticagrelor and prasugrel versus clopidogrel (28%-50% range of reduction). In comparison with clopidogrel, both prasugrel (HR, 1.26 [95% CI, 1.01-1.56]) and ticagrelor (HR, 1.27 [95% CI, 1.04-1.55]) significantly increased major bleeding. There were no significant differences between prasugrel and ticagrelor for all outcomes explored. CONCLUSIONS: Prasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ticagrelor only. There was no efficacy and safety difference between prasugrel and ticagrelor. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019155648.

Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.

Progressive growth of coronary aneurysms after bioresorbable vascular scaffold implantation: Successful treatment with OCT-guided exclusion using covered stents.

The development and progressive enlargement over time of multiple saccular coronary artery aneurysms (CAA) after implantation of everolimus-eluting stent and bioresorbable vascular scaffolds (BVS) have been reported. CAA was successfully excluded by two overlapped covered stents expanded inside a long metallic drug-eluting stent to avoid dislodgment at the overlap point. Optical coherence tomography (OCT) was repeatedly performed to monitor CAA expansion and to guide treatment through precise measurement of aneurysm length and vessel size at the landing zone. At 10-month follow-up, coronary computed tomography angiography showed persistent CAA exclusion. To the best of our knowledge, this is the first report of this technique to exclude a long CCA segment.

Revival of a forgotten valve: use of the percutaneous clip for the treatment of tricuspid regurgitation.

Tricuspid regurgitation (TR) is common in patients with left-sided valvular heart disease and is independently associated with increased mortality and morbidity because it leads to right-sided heart failure and recurrent hospitalization. The prognostic benefit of isolated TR surgical repair or replacement is unclear and medical treatment of decompensated right heart failure alone does not prevent the progression of the disease. Recently, minimal invasive catheter-based techniques have emerged as a feasible and effective option for TR treatment in selected high-risk patients who would clinically benefit from tricuspid valve repair. We provide an overview of the current state of transcatheter TR treatment using the edge-to-edge technique.

Prognostic impact of admission high-sensitivity C-reactive protein in acute myocardial infarction patients with and without diabetes mellitus.

BACKGROUND: High-sensitivity C-reactive protein (hs-CRP) elevation frequently occurs in acute myocardial infarction (AMI) and is associated with adverse outcomes. Since diabetes mellitus (DM) is characterized by an underlying chronic inflammation, hs-CRP may have a different prognostic power in AMI patients with and without DM. METHODS: We prospectively included 2064 AMI patients; hs-CRP was measured at hospital admission. Patients were grouped according to hs-CRP quartiles and DM status. The primary endpoint was a composite of in-hospital mortality, cardiogenic shock, and acute pulmonary edema. Two-year all-cause mortality was the secondary endpoint. RESULTS: Twenty-six percent (n = 548) of patients had DM and they had higher hs-CRP levels than non-DM patients (5.32 vs. 3.24 mg/L; P < 0.0001). The primary endpoint incidence in the overall population (7%, 9%, 13%, 22%; P for trend < 0.0001), in DM (14%, 9%, 21%, 27%; P = 0.0001), and non-DM (5%, 8%, 10%, 19%; P < 0.0001) patients increased in parallel with hs-CRP quartiles. The adjusted risk of the primary endpoint increased in parallel with hs-CRP quartiles in DM and non-DM patients but this relationship was less evident in DM patients. In the overall population, the adjusted OR of the primary endpoint associated with an hs-CRP value ≥ 2 mg/L was 2.10 (95% CI 1.46-3.00). For the same risk, hs-CRP was 7 and 2 mg/L in patients with and without DM. A similar behavior was observed for the secondary endpoint when the HR associated with an hs-CRP value ≥ 2 mg/L found in the overall population was 2.25 (95% CI 1.57-3.22). For the same risk, hs-CRP was 8 and 1.5 mg/L in DM and non-DM patients. CONCLUSIONS: This study shows that hs-CRP predicts in-hospital outcome and two-year mortality in AMI patients with and without DM. However, in DM patients, the same risk of developing events as in non-DM patients is associated to higher hs-CRP levels.

Management of Structural Heart Disease and Acute Coronary Syndromes in the COVID-19 Pandemic.

Transcatheter interventions for structural heart disease (SHD) now represent an effective alternative to surgery in selected patients. A clear premise is that delay in or neglect of treating patients in need of SHD intervention is associated with unavoidable morbidity and mortality because many of them have life-threatening conditions. However, the recent outbreak of coronavirus-associated disease-2019 (COVID-19) is placing an unprecedented strain on patients, physicians and world healthcare systems that resulted in deferral of elective and semi-elective procedures, such as SHD, and delay in the treatment of patients with acute coronary syndrome (ACS). We hereby present the case for a focused resumption of transcatheter SHD interventions in selected centers, in order to preserve patient safety and avoid that death rate will extend far beyond that directly associated with COVID-19. A similar approach should be applied to the invasive management of ACS. Indeed, a proactive and vigilant stance on managing SHD and ACS is crucial, especially in the context of the COVID-19 pandemic, when the risk of overlooking severely sick patients or postponing life-saving treatments is high. If such corrective measures are not put into effect, we may expect in the near future an excess of avoidable fatalities indirectly due to COVID-19 but truly caused by cardiovascular diseases, as well as an exceedingly large number of patients with severe heart failure leading to shorter life expectancy, reduced quality of life and increased healthcare cost.

Motorized fractional flow reserve pullback: Accuracy and reproducibility.

OBJECTIVES: The present study aimed at determining the accuracy and reproducibility of motorized FFR pullbacks in patients with stable coronary artery disease. BACKGROUND: Fractional flow reserve (FFR) is recommended for decision making regarding myocardial revascularization. The distribution of epicardial resistance along coronary vessels can be assessed using FFR pullbacks. METHODS: Duplicated FFR pullbacks were acquired using a motorized device at a speed of 1 mm/s in intermediate coronary stenosis. In addition, a single FFR value was measured at an anatomical landmark. The agreement between FFR measurements was assessed using the Bland-Altman method, Pearson's correlation coefficient and area under the pullback curve (AUPC). RESULTS: In 20 vessels, 37,326 FFR values were obtained. The mean FFR from the pullbacks was 0.91 ± 0.08 whereas the mean FFR at the distal location was 0.85 ± 0.09. The mean difference between pullbacks was -0.002 (LOA -0.058 to 0.054). The difference in AUPC between the two FFR pullbacks was 2.1 ± 1.6%. At pre-specified anatomical locations, the mean difference between the FFR derived from the pullback data and the measured FFR was 0 (LOA -0.040 to 0.039). The repeatability of the distal FFR measurement was high (bias -0.003, LOA -0.046 to 0.041). CONCLUSION: A motorized FFR pullback was accurate to assess the distribution of epicardial resistance in patients with intermediate coronary artery disease. The reproducibility of the FFR pullback was high. Further studies are required to determine the potential usefulness of a hyperemic FFR pullback strategy for decision making and treatment planning.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. METHODS: In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. RESULTS: At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. CONCLUSIONS: This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients.

The revolution project: replacing coronary artery angiography with coronary computed tomography with functional evaluation.

In the last two decades, several studies and widespread clinical use demonstrated that coronary computed tomography angiography (CCTA) is an appropriate method for the non-invasive assessment of patients with suspected stable coronary artery disease (CAD) and low-to-intermediate pretest likelihood of CAD. Moreover, a growing body of literature is showing that CCTA may have also a clinical role in patients with high pretest likelihood of CAD, known CAD and complex and diffuse disease. Particularly, the SYNTAX II trial demonstrated the feasibility of planning interventional and surgical coronary procedures with CCTA thanks to its ability to combine, in a single method, precise stenosis quantification, accurate plaque characterization, functional assessment with fractional flow reserve derived from standard acquired CCTA datasets, and selection of the revascularization modality for any individual patient and of the vessels that need to be revascularized. More recently, the SYNTAX III Revolution trial showed, in patients with three-vessel CAD with or without left main involvement, that treatment decision-making between percutaneous coronary intervention and coronary artery bypass grafting based on CCTA only has an almost perfect agreement with the treatment decision derived from invasive coronary angiography (ICA). The high degree of correlation between CCTA and ICA suggests the potential feasibility of treatment decision-making based solely on non-invasive imaging and clinical information. New research prospects have opened up for the future to demonstrate the true feasibility and safety of this innovative approach in the clinical arena.

Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial.

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry.

BACKGROUND: The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). METHODS: We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). RESULTS: Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. CONCLUSIONS: In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.