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Configuration of two-stent coronary bifurcation techniques in explanted beating hearts: the MOBBEM study

Agosto 3, 2023

Background: In patients with complex coronary bifurcation lesions undergoing percutaneous coronary intervention (PCI), various 2-stent techniques might be utilised. The Visible Heart Laboratories (VHL) offer an experimental environment where PCI results can be assessed by multimodality imaging.

Aims: We aimed to assess the post-PCI stent configuration achieved by 2-stent techniques in the VHL and to evaluate the procedural factors associated with suboptimal results.

Methods: Bifurcation PCI with 2-stent techniques, performed by expert operators in the VHL on explanted beating swine hearts, was studied. The adopted bifurcation PCI strategy and the specific procedural steps applied in each procedure were classified according to Main, Across, Distal, Side (MADS)-2 and to their adherence to the European Bifurcation Club (EBC) recommendations. Microcomputed tomography (micro-CT) was used to assess the post-PCI stent configuration. The primary endpoint was “suboptimal stent implantation”, defined as a composite of stent underexpansion (<90%), side branch ostial area stenosis >50% and the gap between stents.

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Impact of biomarker type on periprocedural myocardial infarction in patients undergoing elective PCI.

Agosto 1, 2023

Background: Periprocedural myocardial infarction (MI) according to the Society for Cardiovascular Angiography and Interventions (SCAI) criteria has prognostic relevance among patients undergoing percutaneous coronary intervention (PCI). However, it is unclear whether the type of cardiac biomarker used for the diagnosis of periprocedural MI plays a role in terms of event frequency and outcomes.

Objectives: To compare the characteristics of SCAI periprocedural MI based on creatine kinase-myocardial band fraction (CK-MB) vs high-sensitivity cardiac troponin (hs-cTn) in patients undergoing elective PCI.

Methods and results: Between 2017 and 2021, periprocedural MI was assessed in a prospective study. The primary clinical outcome of interest was all-cause death at 1-year follow-up. A total of 1010 patients undergoing elective PCI were included. SCAI periprocedural MI based on CK-MB vs hs-cTnI occurred in 1.8 and 13.5% of patients, respectively. hs-cTnI periprocedural MI in the absence of concomitant CK-MB criteria was associated with lower rates of ancillary criteria, including angiographic, ECG, and cardiac imaging criteria. At 1-year follow-up, periprocedural MI defined by CK-MB (adjusted hazard ratio, HR, 4.27, 95% confidence intervals, CI, 1.23–14.8; P=0.022) but not hscTnI (adjusted HR 2.04, 95% CI 0.94–4.45; P=0.072) was associated with a higher risk of all-cause death. Hs-cTnI periprocedural MI was not predictive of death unless accompanied by CK-MB criteria (adjusted HR 4.64, 95% CI 1.32– 16.31; P=0.017).

Conclusion: In the setting of elective PCI, using hs-cTn instead of CK-MB resulted in a substantial increase in SCAI periprocedural MI events, which were not prognostically relevant in the absence of concurrent CK-MB elevations.

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PCSK9 Inhibition During the Inflammatory Stage of SARS-CoV-2 Infection

Luglio 24, 2023

Background: The intensity of inflammation during COVID-19 is related to adverse outcomes. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is involved in low-density lipoprotein receptor homeostasis, with potential influence on vascular inflammation and on COVID-19 inflammatory response.

Objectives: The goal of this study was to investigate the impact of PCSK9 inhibition vs placebo on clinical and laboratory outcomes in patients with severe COVID-19.

Methods: In this double-blind, placebocontrolled, multicenter pilot trial, 60 patients hospitalized for severe COVID-19, with groundglass opacity pneumonia and arterial partial oxygen pressure to fraction of inspired oxygen ratio ≤300 mm Hg, were randomized 1:1 to receive a single 140-mg subcutaneous injection of evolocumab or placebo. The primary endpoint was death or need for intubation at 30 days. The main secondary endpoint was change in circulating interleukin (IL)-6 at 7 and 30 days from baseline.

Results: Patients randomized to receive the PCSK9 inhibitor had lower rates of death or need for intubation within 30 days vs placebo (23.3% vs 53.3%, risk difference: –30%; 95% CI: –53.40% to –6.59%). Serum IL-6 across time was lower with the PCSK9 inhibitor than with placebo (30-day decline: –56% vs –21%). Patients with baseline IL-6 above the median had lower mortality with PCSK9 inhibition vs placebo (risk difference: –37.50%; 95% CI:–68.20% to –6.70%).

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Implantation of contemporary transchatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry

Giugno 12, 2023

Background: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM).

Aims: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli.

Methods: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intraannular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL).

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Acute kidney injuri after transcatheter aortic valve replacement mediates the effect of chronic kidney disease.

Maggio 29, 2023

Background: Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. However, it is controversial whether AKI affects prognosis per se, being linked to baseline chronic kidney disease (CKD) and bleeding complications. The aim of this study was to disentangle, applying mediation analysis, the association between AKI and clinical outcome, considering CKD and bleedings.

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Dual antiplatelet therapy duration after percutaneous coronary intervention in high bleeding risk: a meta-analysis of randomized trials.

Aprile 3, 2023

Aims: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) is still debated. The current study, using the totality of existing evidence, evaluated the impact of an abbreviated DAPT regimen in HBR patients.

Methods and results: A systematic review and meta-analysis was performed to search randomized clinical trials comparing abbreviated [i.e. very-short (1 month) or short (3 months)] with standard (≥6 months) DAPT in HBR patients without indication for oral anticoagulation. A total of 11 trials, including 9006 HBR patients, were included. Abbreviated DAPT reduced major or clinically relevant nonmajor bleeding [risk ratio (RR): 0.76, 95% confidence interval (CI): 0.61-0.94; I2=28%], major bleeding (RR: 0.80, 95% CI: 0.64-0.99, I2=0%), and cardiovascular mortality (RR: 0.79, 95% CI: 0.65-0.95, I2=0%) compared with standard DAPT. No difference in all-cause mortality, major adverse cardiovascular events, myocardial infarction, or stent thrombosis was observed. Results were consistent, irrespective of HBR definition and clinical presentation.

Conclusion: In HBR patients undergoing PCI, a 1 or 3 month abbreviated DAPT regimen was associated with lower bleeding and cardiovascular mortality, without increasing ischaemic events, compared with a ≥6-month DAPT regimen.

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Transcatheter Aortic Valve Replacement with the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

Marzo 27, 2023

L’OPERA-TAVI è il primo studio che ha confrontato le ultimissime generazioni delle due protesi aortiche transcatetere maggiormente diffuse nel mercato: la piattaforma Evolut PRO e PRO+ (auto-espandibile, sopra-anulare) e la piattaforma SAPIEN 3 Ultra (pallone espandible, intra-anulare). Gli endpoint principali dello studio, che ha utilizzato la metodologia di aggiustamento statistico del propensity score matching, erano il “device success” e “l’early safety endpoint”, definiti entrambi secondo le nuove definizioni VARC-3.

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Transient vs In-Hospital Persistent Acute Kidney Injury in Patients With Acute Coronary Syndrome.

Marzo 13, 2023

Il nostro studio è focalizzato sull’impatto prognostico della persistenza di danno renale residuo in seguito all’insufficienza renale acuta (AKI) nei pazienti con sindrome coronarica acuta (ACS) sottoposti a una strategia invasiva. Ci sono solide evidenze in letteratura che dimostrano come l’insorgenza di AKI nei pazienti sottoposti a coronarografia e/o angioplastica percutanea (PCI) si associ a un rischio maggiore di eventi avversi fatali e non fatali.

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Aspirin Therapy on Prophylactic Anticoagulation for Patients Hospitalized With COVID-19: A Propensity Score-Matched Cohort Analysis of the HOPE-COVID-19 Registry.

Settembre 30, 2022

Background: COVID-19 is an infectious illness, featured by an increased risk of thromboembolism. However, no standard antithrombotic therapy is currently recommended for patients hospitalized with COVID-19. The aim of this study was to evaluate safety and efficacy of additional therapy with ASA over prophylactic anticoagulation (PAC) in patients hospitalized with COVID-19 and its impact on survival.

Methods and Results: a total of 8.168 patients hospitalized for COVID-19 were enrolled in a multicenter-international prospective registry (HOPE COVID-19). Clinical data and inhospital complications, including mortality, were recorded. Study population included patients treated with PAC or with PAC and ASA. A comparison of clinical outcomes between patients treated with PAC versus PAC and ASA was performed using an adjusted analysis with propensity score matching. Of 7.824 patients with complete data, 360 (4.6%) received PAC and ASA a nd 2 .949 ( 37.6%) P AC. P ropensity-score matching yielded 298 patients from each group. In the propensity score-matched population, cumulative incidence of in-hospital mortality was lower in patients treated with PAC and ASA versus PAC (15% versus 21%, Log Rank P=0.01). At multivariable analysis in propensity matched population of patients with COVID-19, including age, sex, hypertension, diabetes, kidney failure, and invasive ventilation, ASA treatment was associated with lower risk of in-hospital mortality (hazard ratio [HR], 0.62; [95% CI 0.42-0.92], P=0.018).

Conclusions: combination PAC and ASA was associated with lower mortality risk among patients hospitalized with COVID-19 in a propensity score matched population compared to PAC alone.

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Association of statin pretreatment with presentation characteristics, infarct size and outcome in older patients with acute coronary syndrome: the Eldery ACS-2 trial.

Settembre 21, 2022

Background: prior statin treatment has been shown to have favourable effects on shortand long-term prognosis in patients with acute coronary syndrome (ACS). There are limited data in older patients. The aim of this study was to investigate the association of previous statin therapy and presentation characteristics, infarct size and clinical outcome in older patients, with or without atherosclerotic cardiovascular disease (ASCVD), included in the Elderly-ACS 2 trial.

Methods: data on statin use pre-admission were available for 1,192 of the 1,443 patients enrolled in the original trial. Of these, 531 (44.5%) were already taking statins. Patients were stratified based on established ASCVD and statin therapy. ACS was classified as non-ST elevation or ST elevation myocardial infarction (STEMI). Infarct size was measured by peak creatine kinase MB (CK-MB). All-cause death in-hospital and within 1 year were the major end points.

Results: there was a significantly lower frequency of STEMI in statin patients, in both ASCVD and No-ASCVD groups. Peak CK-MB levels were lower in statin users (10 versus 25 ng/ml, P< 0.0001). There was lower all-cause death in-hospital and within 1 year for subjects with ASCVD already on statins independent of other baseline variables. There were no differences in all-cause death for No-ASCVD patients whether or not on statins. Conclusions: statin pretreatment was associated with more favourable ACS presentation and lower myocardial damage in older ACS patients both ASCVD and No-ASCVD. The incidence of all-cause death (in-hospital and within 1 year) was significantly lower in the statin treated ASCVD patients.

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Supplemento a “HEALTH TALKS” testata di informazione tecnica e professionale in medicina, in corso di registrazione presso il Tribunale di Milano, direttore responsabile: Massimiliano Melis.
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