Autori italiani pubblicano

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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One-year results from the Assessing MICRO-vascular resistance via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoin primary PCI (AMICRO) trial.

Febbraio 28, 2023

Lo studio AMICRO aggiunge evidenze sul valore dell’IMR misurato subito dopo l’angioplastica primaria come predittore della variazione della funzione sistolica del ventricolo sinistro. In particolare abbiamo evidenziato una correlazione tra il valore di IMR ed il cambiamento della funzione ventricolare sinistra nei pazienti con infarto miocardico anteriore cioè nei casi dove vi era una importante quota di miocardio a rischio.

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Early and mid-term outcome of patients with low-flow–low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves.

Febbraio 13, 2023

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs).

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Safety and efficacy of different P2Y12 inhibitors in patients with acute coronary syndromes stratified by the PRAISE risk score: a multicentre study.

Febbraio 1, 2023

Aims: To establish the safety and efficacy of different dual antiplatelet therapy (DAPT) combinations in patients with acute coronary syndrome (ACS) according to their baseline ischaemic and bleeding risk estimated with a machine learning derived model [machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE) score].

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Clinical governance of patients with acute coronary syndromes.

Gennaio 17, 2023

Aims: Using the principles of clinical governance, a patient-centred approach intended to promote holistic quality improvement, we designed a prospective, multicentre study in patients with acute coronary syndrome (ACS). We aimed to verify and quantify consecutive inclusion and describe relative and absolute effects of indicators of quality for diagnosis and therapy.

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Multivessel vs. culprit-only percutaneous coronary intervention strategy in older adults with acute myocardial infarction.

Dicembre 20, 2022

Background: The optima revascularization strategy for senior patients admitted with acute myocardial infarction (AMI) in the context of multivessel coronary artery disease (MVCAD) remains unclear. We aimed to compare a strategy of culprit-vessel (CV) vs. multi-vessel percutaneous coronary intervention (MV-PCI) in older adults (≥75 years) with AMI.

Methods: We analyzed four randomized controlled trials designed to include older adults with AMI. The primary endpoint was all-cause death. The secondary endpoint was the composite of all-cause death, myocardial infarction, stroke and major bleeding (Net Adverse Clinical Events, NACE). A nonparsimonious propensity score and nearestneighbor matching was performed to account for bias.

Results: A total of 1,334 trial participants were included; of them, 770 (57.7%) underwent CV-PCI and 564 (42.3%) a MV-PCI strategy. After a median follow-up of 365 days, patients treated with MV-PCI experienced a lower rate of death (6.0% vs. 9.9%; p=0.01) and of NACE (11.2% vs. 15.5%; p=0.016). After multivariable analysis, MV-PCI was independently associated with a lower hazard of death (hazard ratio [HR]:0.65; 95% confidence interval [CI]:0.42- 0.96; p=0.03) and NACE (NACE 0.72[0.53- 0.98]; p=0.04). These results were confirmed in a matched propensity analysis, were consistent throughout the spectrum of older age and when analyzed by subgroups and when immortaltime bias was considered.

Conclusions: In the setting of older adults with MVCAD who were managed invasively for AMI, a MV-PCI strategy to pursue complete revascularization was associated with better survival and lower risk of NACE compared to a CV-PCI. Adequately sized RCTs are required to confirm these findings.

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One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients. 

Dicembre 5, 2022

Background: It is unknown whether contemporary drug-eluting stents have a similar safety profile in high bleeding risk patients treated with 1-month dual antiplatelet therapy following percutaneous coronary interventions.

Methods and Results: We performed an interventional, prospective, multicenter, single-arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable polymer everolimus-eluting stent followed by 1-month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1-year primary outcome occurred in 4.82% (95% CI, 3.17%-7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% (Pnoninferiority<0.001) notwithstanding the lower-than-expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%-2.50%), 3.42% (95% CI, 2.08%-5.62%), and 0.94% (95% CI, 0.35%- 2.49%), respectively. Conclusions: Among high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable- polymer everolimus-eluting stent, a 1-month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events.

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

Novembre 23, 2022

Background: Mitral-valve transcatheter edgeto-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.

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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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