A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

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.

The Incidence, Impact, and Techniques of Commissural Alignment in Transcatheter Aortic Valve Implantation: A Review.

In current clinical practice, commissural alignment of the transcatheter heart valve (THV) during transcatheter aortic valve implantation (TAVI) is seldom achieved. Orientation of the THV within the aortic root and the subsequent influence upon leaflet haemodynamic function, coronary blood flow, and ease of access to the coronary ostia are gaining significant interest. Herein, we review the incidence and clinical implications of commissural misalignment in TAVI and offer thorough descriptions of how optimal alignment can be achieved with several different contemporary THV devices.

Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.

Impact of age on the outcomes of Takotsubo syndrome.

BACKGROUND: The impact on age on the short-term and long-term prognosis in patients with Takotsubo syndrome (TTS) is unclear. We aimed to evaluate whether age has prognostic implications during hospital stay and long-term follow-up of TTS patients. METHODS: 688 consecutive patients were admitted for TTS in 7 tertiary centers from January-2008 to June-2021. We divided our cohort into two groups (patients <75 years and ≥75 years). Clinical, analytical, and hemodynamic variables as well as in-hospital management were registered and compared between groups. Mortality rates during hospital stay and follow-up were assessed. Adverse cardiovascular events (ACE) were defined as the composite of cardiovascular death, heart failure event, acute myocardial infarction, stroke and symptomatic arrhythmia. RESULTS: Median age was 74.7 years and 49.4 % were ≥75 years. 86.9 % were women and 22.3 % were secondary forms of TTS. In-hospital mortality was 3.6 % (1.5 % cardiovascular). Median clinical follow-up was 4.3 years. Mortality during the follow-up period was 23 % (5.0 % cardiovascular) while ACE were 22.5 %, mainly due to heart failure events. Kaplan-Meier curves showed both higher rates of mortality and ACE in ≥75 years group (30.2 % vs 15.8 %; p < 0.001 and 28.3 % vs 16.7 %; p < 0.001). Age was independently associated with higher rates of overall mortality and ACE in patients with TTS. Hypertension, absence of sinus rhythm, Killip class > I and a more impaired coronary microvascular resistance were also associated to ACE in TTS patients. CONCLUSIONS: Advanced age was associated with higher rate of overall mortality and ACE during long-term follow-up in TTS patients.

Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.

BACKGROUND: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging. METHODS: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (≤180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc. RESULTS: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with ≤180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles. CONCLUSIONS: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions.

Treatment with SGLT2 Inhibitors in Patients with Diabetes Mellitus and Extensive Coronary Artery Disease: Mortality and Cardiovascular Outcomes.

INTRODUCTION: Sodium-glucose type 2 cotransporter inhibitors (SGLT2-I) have shown solid benefits in reducing cardiovascular mortality and admissions for heart failure in patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease. However, no specific studies exist in patients with high-risk coronary artery disease (CAD). METHODS: Single-center, retrospective, observational study including patients with T2DM and a new diagnosis of extensive CAD (defined as left main disease or three main coronary vessel disease). Patients were recruited from 2015 until 2020, with a follow-up of at least 12 months. The primary outcome was to compare all-cause mortality in patients treated with or without SGLT2-I at discharge and adjusted by inverse probability of treatment weighting (IPTW) propensity score. RESULTS: A total of 420 patients were included: 104 (24.7%) were treated with SGLT2-I and 316 (75.3%) were not (non-SGLT2-I group). The presentation was acute coronary syndrome in 44.3%. The mean age was 71.2 ± 10.5 years. The mean left ventricular ejection fraction was 51.5 ± 12.5%, and the mean estimated glomerular filtration rate was 73.9 ± 22 ml/min. After a mean follow-up of 3 ± 1.6 years, all-cause mortality was 16.4%, and cardiovascular mortality was 9.5%. After IPTW, the risk of all-cause death was lower in the SGLT2-I group with a hazard ratio of 0.32 (95% confidence interval 0.12-0.81), p = 0.016. With regard to secondary outcomes, patients in the SGLT2-I group were associated with less renal function deterioration but an increase in unplanned revascularizations. CONCLUSIONS: In patients with T2DM and extensive CAD, treatment with SGLT2-I after discharge was associated with a reduced risk of all-cause death.

Resultados intrahospitalarios tras tratamiento percutáneo frente a quirúrgico en pacientes con estenosis aórtica y enfermedad arterial coronaria concomitante / In-hospital outcomes following percutaneous versus surgical intervention in the treatment of aortic stenosis and concomitant coronary artery disease

Introducción y objetivos: La enfermedad coronaria (EC) es frecuente en pacientes con estenosis aórtica; sin embargo, la estrategia terapéutica óptima sigue siendo objeto de debate. Investigamos los resultados periprocedimiento en pacientes sometidos a implante percutáneo de válvula aórtica con intervención coronaria percutánea (TAVI/ICP) frente al recambio valvular aórtico con injerto de derivación de arteria coronaria (RVAo/CABG) en pacientes con estenosis aórtica con EC.Métodos: Con los datos de alta del Sistema Nacional de Salud Español, se identificaron 6.194 pacientes (5.217 RVAo/CABG y 977 TAVI/ICP) entre 2016 y 2019. Se realizó un análisis emparejado por puntuación de propensión ajustado por características basales. El objetivo primario fue la mortalidad hospitalaria, Los objetivos secundarios fueron las complicaciones hospitalarias y rehospitalización cardiovascular a 30 días.Resultados: Tras el emparejamiento, se seleccionaron 774 parejas de pacientes. La mortalidad total hospitalaria fue más frecuente en el grupo quirúrgico (3,4 frente a 9,4%, p <0,001), al igual que el ictus periprocedimiento (0,9 frente a 2,2%, p=0,004), fallo renal agudo (4,3 frente a 16,0%, p <0,002), transfusión (9,6 frente a 21,1%, p <0,001) y neumonía intrahospitalaria (0,1 frente a 1,7%, p=0,001). La implantación de marcapasos permanente fue más frecuente en el tratamiento percutáneo (12,0 frente a 5,7%, p <0,001). Los centros de menor volumen (< 130 procedimientos por año) tuvieron mayor mortalidad hospitalaria para ambos procedimientos: TAVI/ICP (3,6 frente a 2,9%, p <0,001) y RVAo/CABG (9,3 frente a 6,8%, p <0,001). La rehospitalización cardiovascular a 30 días no difirió entre los grupos.(AU)

Introduction and objectives: Concomitant coronary artery disease (CAD) is prevalent among aortic stenosis patients; however the optimal therapeutic strategy remains debated. We investigated periprocedural outcomes among patients undergoing transcatheter aortic valve implantation with percutaneous coronary intervention (TAVI/PCI) vs surgical aortic valve replacement with coronary artery bypass grafting (SAVR/CABG) for aortic stenosis with CAD.Methods: Using discharge data from the Spanish National Health System, we identified 6194 patients (5217 SAVR/CABG and 977 TAVI/PCI) between 2016 and 2019. Propensity score matching was adjusted for baseline characteristics. The primary outcome was in-hospital all-cause mortality. Secondary outcomes were in-hospital complications and 30-day cardiovascular readmission.Results: Matching resulted in 774 pairs. In-hospital all-cause mortality was more common in the SAVR/CABG group (3.4% vs 9.4%, P <.001) as was periprocedural stroke (0.9% vs 2.2%; P=.004), acute kidney injury (4.3% vs 16.0%, P <.001), blood transfusion (9.6% vs 21.1%, P <.001), and hospital-acquired pneumonia (0.1% vs 1.7%, P=.001). Permanent pacemaker implantation was higher for matched TAVI/PCI (12.0% vs 5.7%, P <.001). Lower volume centers (< 130 procedures/y) had higher in-hospital all-cause mortality for both procedures: TAVI/PCI (3.6% vs 2.9%, P <.001) and SAVR/CABG (8.3 vs 6.8%, P <.001). Thirty-day cardiovascular readmission did not differ between groups.Conclusions: In this large contemporary nationwide study, percutaneous management of aortic stenosis and CAD with TAVI/PCI had lower in-hospital mortality and morbidity than surgical intervention. Higher volume centers had less in-hospital mortality in both groups. Dedicated national high-volume heart centers warrant further investigation.(AU)

Procedural and Technological Innovations Facilitating Ultra-low Contrast Percutaneous Coronary Interventions.

Ultra-low-dose contrast percutaneous coronary intervention (PCI) is a valuable approach in selected complex high-risk patients with renal failure. One of the objectives of ultra-low contrast PCI is to decrease the probability of developing postprocedural contrast-induced nephropathy (CIN), which predominately affects patients with baseline renal dysfunction. CIN is associated with poor clinical outcomes and increased healthcare-related costs. Another two clinical scenarios in which reduced dependence on contrast administration by the operator may contribute to improved safety are PCI in complex, high-risk indicated patients and in shock. In this review, we discuss the procedural techniques and recent technological innovations that enable ultra-low-dose contrast PCI to be performed in the cardiac cath lab.

Interventional Versus Conservative Strategy in Patients With Spontaneous Coronary Artery Dissections: Insights From DISCO Registry.

BACKGROUND: The optimal management of patients with spontaneous coronary artery dissection remains debated. METHODS: Patients enrolled in the DISCO (Dissezioni Spontanee Coronariche) Registry up to December 2020 were included. The primary end point was major adverse cardiovascular events, a composite of all-cause death, nonfatal myocardial infarction, and repeat percutaneous coronary intervention (PCI). Independent predictors of PCI and medical management were investigated. RESULTS: Among 369 patients, 129 (35%) underwent PCI, whereas 240 (65%) were medically managed. ST-segment-elevation myocardial infarction (68% versus 35%, P<0.001), resuscitated cardiac arrest (9% versus 3%, P<0.001), proximal coronary segment involvement (32% versus 7%, P<0.001), and Thrombolysis in Myocardial Infarction flow 0 to 1 (54% versus 20%, P<0.001) were more frequent in the PCI arm. In-hospital event rates were similar. Between patients treated with PCI and medical therapy, there were no differences in terms of major adverse cardiovascular events at 2 years (13.9% versus 11.7%, P=0.467), all-cause death (0.7% versus 0.4%, P=0.652), myocardial infarction (9.3% versus 8.3%, P=0.921) and repeat PCI (12.4% versus 8.7%, P=0.229). ST-segment-elevation myocardial infarction at presentation (odds ratio [OR], 3.30 [95% CI, 1.56-7.12]; P=0.002), proximal coronary segment involvement (OR, 5.43 [95% CI, 1.98-16.45]; P=0.002), Thrombolysis in Myocardial Infarction flow grade 0 to 1 and 2 (respectively, OR, 3.22 [95% CI, 1.08-9.96]; P=0.038; and OR, 3.98 [95% CI, 1.38-11.80]; P=0.009) and luminal narrowing (OR per 5% increase, 1.13 [95% CI, 1.01-1.28]; P=0.037) were predictors of PCI, whereas the 2B-angiographic subtype predicted medical management (OR, 0.25 [95% CI, 0.07-0.83]; P=0.026). CONCLUSIONS: Clinical presentation and procedural variables drive the choice of the initial therapeutic approach in spontaneous coronary artery dissection. If PCI is needed, it seems to be associated with a similar risk of short-to-mid-term adverse events compared to medical treatment. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04415762.

Propensity-matched analysis of long-term clinical results after ostial circumflex revascularisation.

BACKGROUND: Percutaneous coronary intervention (PCI) of the ostium of the left circumflex artery (LCx) is technically challenging. The aim of this study was to compare long-term clinical outcomes of ostial PCI located in the LCx versus the left anterior descending artery (LAD) in a propensity-matched population. METHODS: Consecutive patients with a symptomatic isolated 'de novo' ostial lesion of the LCx or LAD treated with PCI were included. Patients with a stenosis of >40% in the left main (LM) were excluded. A propensity score matching was performed to compare both groups. The primary endpoint was target lesion revascularisation (TLR); other endpoints included target lesion failure and an analysis of the bifurcation angles. RESULTS: From 2004 to 2018, 287 consecutive patients with LAD (n=240) or LCx (n=47) ostial lesions treated with PCI were analysed. After the adjustment, 47 matched pairs were obtained. The mean age was 72±12 years and 82% were male. The LM-LAD angle was significantly wider than the LM-LCx angle (128°±23° vs 108°±24°, p=0.002). At a median follow-up of 5.5 (IQR 1.5-9.3) years, the rate of TLR was significantly higher in the LCx group (15% vs 2%); with an HR of 7.5, 95% CI 2.1 to 26.4, p<0.001. Interestingly, in the LCx group, TLR-LM occurred in 43% of the TLR cases; meanwhile, no TLR-LM involvement was found in the LAD group. CONCLUSIONS: Isolated ostial LCx PCI was associated with an increase in the rate of TLR compared with ostial LAD PCI at long-term follow-up. Larger studies evaluating the optimal percutaneous approach at this location are needed.