19 research outputs found

    Rationale and Design of the PARTHENOPE Trial: A Two-by-Two Factorial Comparison of Polymer-Free vs. Biodegradable-Polymer Drug-Eluting Stents and Personalized vs. Standard Duration of Dual Antiplatelet Therapy in All-Comers Undergoing PCI.

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    BACKGROUND Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DESIGN The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 13 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the non-inferiority between stents with respect to a device-oriented composite endpoint of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SUMMARY The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI

    Colorectal Cancer Stage at Diagnosis Before vs During the COVID-19 Pandemic in Italy

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    IMPORTANCE Delays in screening programs and the reluctance of patients to seek medical attention because of the outbreak of SARS-CoV-2 could be associated with the risk of more advanced colorectal cancers at diagnosis. OBJECTIVE To evaluate whether the SARS-CoV-2 pandemic was associated with more advanced oncologic stage and change in clinical presentation for patients with colorectal cancer. DESIGN, SETTING, AND PARTICIPANTS This retrospective, multicenter cohort study included all 17 938 adult patients who underwent surgery for colorectal cancer from March 1, 2020, to December 31, 2021 (pandemic period), and from January 1, 2018, to February 29, 2020 (prepandemic period), in 81 participating centers in Italy, including tertiary centers and community hospitals. Follow-up was 30 days from surgery. EXPOSURES Any type of surgical procedure for colorectal cancer, including explorative surgery, palliative procedures, and atypical or segmental resections. MAIN OUTCOMES AND MEASURES The primary outcome was advanced stage of colorectal cancer at diagnosis. Secondary outcomes were distant metastasis, T4 stage, aggressive biology (defined as cancer with at least 1 of the following characteristics: signet ring cells, mucinous tumor, budding, lymphovascular invasion, perineural invasion, and lymphangitis), stenotic lesion, emergency surgery, and palliative surgery. The independent association between the pandemic period and the outcomes was assessed using multivariate random-effects logistic regression, with hospital as the cluster variable. RESULTS A total of 17 938 patients (10 007 men [55.8%]; mean [SD] age, 70.6 [12.2] years) underwent surgery for colorectal cancer: 7796 (43.5%) during the pandemic period and 10 142 (56.5%) during the prepandemic period. Logistic regression indicated that the pandemic period was significantly associated with an increased rate of advanced-stage colorectal cancer (odds ratio [OR], 1.07; 95%CI, 1.01-1.13; P = .03), aggressive biology (OR, 1.32; 95%CI, 1.15-1.53; P &lt; .001), and stenotic lesions (OR, 1.15; 95%CI, 1.01-1.31; P = .03). CONCLUSIONS AND RELEVANCE This cohort study suggests a significant association between the SARS-CoV-2 pandemic and the risk of a more advanced oncologic stage at diagnosis among patients undergoing surgery for colorectal cancer and might indicate a potential reduction of survival for these patients

    De verborum Vitruvianorum significatione, sive, Perpetuus in M. Vitruvium Pollionem commentarius

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    M. Vitruvii Pollionis architecti vitaauctore Bernardino Baldo ... ; accedit vita Vitruvii, eodem auctoreIll.: Holzschnitte: 8 kleine Abb. im TextBuchschmuck: Holzschnitte: 2 Druckermarken (Pinie, Motto "Honos erit huic quoque pomo"; auf Titelseite und letztem Bl.v), InitialenDatumsangabe der Textabfassung (S. 198): Urbini, v. Kal. Maii anno 161

    Bernardini Baldi In Tabulam Aeneam Eugubinam, Lingua Hetrusca veteri perscriptam, Divinatio

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    BERNARDINI BALDI IN TABULAM AENEAM EUGUBINAM, LINGUA HETRUSCA VETERI PERSCRIPTAM, DIVINATIO Bernardini Baldi In Tabulam Aeneam Eugubinam, Lingua Hetrusca veteri perscriptam, Divinatio (1) Titelblatt (1) Praefatio (3) Alphabetum Etruscum Hebraico ritu (5) Tabellae Exemplar (6) Ad commodiorem lectionem ita Romane scribi (7) Latina Tabulae ad verbum explicatio (8) Interpretationis ratio; atque de lingua Etrusca (11) Kolophon (23) Fotodokumentation (25

    Bernardini Baldi In Tabulam Aeneam Eugubinam, Lingua Hetrusca veteri perscriptam, Divinatio

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    BERNARDINI BALDI IN TABULAM AENEAM EUGUBINAM, LINGUA HETRUSCA VETERI PERSCRIPTAM, DIVINATIO Bernardini Baldi In Tabulam Aeneam Eugubinam, Lingua Hetrusca veteri perscriptam, Divinatio (1) Titelblatt (1) Praefatio (3) Alphabetum Etruscum Hebraico ritu (5) Tabellae Exemplar (6) Ad commodiorem lectionem ita Romane scribi (7) Latina Tabulae ad verbum explicatio (8) Interpretationis ratio; atque de lingua Etrusca (11) Kolophon (23) Fotodokumentation (25

    Scamilli impares Vitruviani a Bernardino Baldo,... nova ratione explicati...

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