Autori italiani pubblicano

Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes.

Objectives: The aim of this study was to compare short dual antiplatelet therapy (DAPT) and de-escalation in a network meta-analysis using standard DAPT as common comparator.

Background: In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), shortening DAPT and de-escalating to a lower potency regimen mitigate bleeding risk. These strategies have never been randomly compared.

Methods: Randomized trials of DAPT modulation strategies in patients with ACS undergoing PCI were identified. All-cause death was the primary outcome. Secondary outcomes included net adverse cardiovascular events (NACE), major adverse cardiovascular events, and their components. Frequentist and Bayesian network meta-analyses were conducted. Treatments were ranked on the basis of posterior probability. Sensitivity analyses were performed to explore sources of heterogeneity.

Results: Twenty-nine studies encompassing 50,602 patients were included. The transitivity assumption was fulfilled. In the frequentist indirect comparison, the risk ratio (RR) for all-cause death was 0.98 (95% CI: 0.68-1.43). De-escalation reduced the risk for NACE (RR: 0.87; 95% CI: 0.70-0.94) and increased major bleeding (RR: 1.54; 95% CI: 1.07-2.21). These results were consistent in the Bayesian meta-analysis. De-escalation displayed a >95% probability to rank first for NACE, myocardial infarction, stroke, stent thrombosis, and minor bleeding, while short DAPT ranked first for major bleeding. These findings were consistent in node-split and multiple sensitivity analyses. Conclusions: In patients with ACS undergoing PCI, there was no difference in all-cause death between short DAPT and de-escalation. De-escalation reduced the risk for NACE, while short DAPT decreased major bleeding. These data characterize 2 contemporary strategies to personalize DAPT on the basis of treatment objectives and risk profile.

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Long-term complications in patients implanted with subcutaneous implantable cardioverter defibrillators: real-world data from the extended ELISIR experience

Background: recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverterdefibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion.

Objective: the aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort.

Methods: patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.

Results: a total of 1.254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twentyseven patients (2.2%) had unanticipated
generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P<.001), chronic kidney disease (HR 1.960 [1.191-3.225]; P=.008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P=.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P=.007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P=.001) were protective factors. Conclusion: the overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

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Haemodynamic impact of MitraClip in patients with functional mitral regurgitation and pulmonary hypertension.

Dottor Mandurino Mirizzi, qual è il take home message del vostro lavoro?
La selezione dei pazienti per la riparazione transcatetere valvolare mitralica con MitraClip rappresenta ancora oggi una sfida. In particolare, per i pazienti affetti da insufficienza mitralica funzionale (FMR) severa l’intervento di MitraClip si è rivelato essere una valida opzione solo in casi selezionati.

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Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy. A Systematic Review and Meta-Analysis.

Objectives: The aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.
Background: At present, limited observational data exist supporting TAVR in the context of bicuspid anatomy.
Methods: Primary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually.

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