One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)

Background: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster\uae thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. Methods: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT ( 643-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration ( 656-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings ( 65type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. Results: 82 patients (5%) were discharged with 643-month DAPT (57 \ub1 27 days), and 1558 patients (94%) were discharged with 656-month DAPT (318 \ub1 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). Conclusions: As compared to those treated with R-DAPT ( 656-month), patients needing -S-DAPT ( 643-month) after PCI with Ultimaster\uae BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)

Background: The ULISSE registry evaluated the real-world performance of the Ultimaster\uae biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. Methods: In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. Results: At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p =.001), due to more cardiac deaths (3.4 vs. 1.1%; p =.002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p =.114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p =.526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p =.041), but similar rate of TLR (6 vs. 4%; p =.405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. Conclusions: This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients

The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent.

BACKGROUND: COMBO (OrbusNeich Medical, Hong Kong) is a dual-therapy coronary stent featuring sirolimus as antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collaboration aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI). METHODS: Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry and MASCOT studies were pooled together. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI) or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes were the individual components of the primary endpoint and stent thrombosis (ST). Endpoints were evaluated against performance goals based on the EAPCI (the European Association of Percutaneous Coronary Intervention) recommendations for new drug-eluting stents. RESULTS: A total of 6753 patients (mean age 63.7 ± 11.4 years, 23% women) were included. At 1-year follow-up, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and CD-TLR were 1.3%, 1.8%, and 2.5%, respectively. The rate of definite/probable ST was 0.73%, early ST (<1 month) was 0.48%, while late ST (1-12 months) was 0.26%. The performance goals were met for all of the evaluated endpoints. CONCLUSIONS: This large patient-level pooled analysis provides a comprehensive outline of the performance of the dual-therapy COMBO stent. The low rates of primary and secondary endpoints suggest that this stent technology may be a good alternative to other contemporary drug eluting coronary stent platforms

The GERDA experiment: status and perspectives

The GERDA experiment is located in the underground Gran Sasso laboratory. The experiment aims at studying the neutrinoless ββ decay of 76Ge. The implementation of the experiment is divided in two consecutive phases. Phase I will allow within one year of data taking to reach a sensitivity limit for the half life of the process of the order of 2.5×1025 years. Phase II, with an increased amount of active material and a background index lower by one order of magnitude than in Phase I, will allow to reach a half life limit of about 1.5×1026 years. In the present paper a brief review of the status of the experiment and its perspectives is given.JRC.D.4-Standards for Nuclear Safety, Security and Safeguard

RAAS inhibitors are not associated with mortality in COVID-19 patients: findings from an observational multicenter study in Italy and a meta-analysis of 19 studies

Objective: The hypothesis that been set forward that use of Renin Angiotensin Aldosterone System (RAAS) inhibitors is associated with COVID-19 severity. We set-up a multicenter Italian collaboration (CORIST Project, ClinicalTrials.gov ID: NCT04318418) to retrospectively investigate the relationship between RAAS inhibitors and COVID-19 in-hospital mortality. We also carried out an updated meta-analysis on the relevant studies. Methods: We analyzed 4,069 unselected patients with laboratory-confirmed SARS-CoV-2 infection and hospitalized in 34 clinical centers in Italy from February 19, 2020 to May 23, 2020. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received angiotensin-converting\u2013enzyme inhibitors (ACE-I) or angiotensin-receptor blockers (ARB) with patients who did not. Articles for the meta-analysis were retrieved until July 13th, 2020 by searching in web-based libraries, and data were combined using the general variance-based method. Results: Out of 4,069 COVID-19 patients, 13.5% and 13.3% received ACE-I or ARB, respectively. Use of neither ACE-I nor ARB was associated with mortality (multivariable hazard ratio (HR) adjusted also for COVID-19 treatments: 0.96, 95% confidence interval 0.77-1.20 and HR=0.89, 0.67-1.19 for ACE-I and ARB, respectively). Findings were similar restricting the analysis to hypertensive (N=2,057) patients (HR=1.00, 0.78-1.26 and HR=0.88, 0.65-1.20) or when ACE-I or ARB were considered as a single group. Results from the meta-analysis (19 studies, 29,057 COVID-19 adult patients, 9,700 with hypertension) confirmed the absence of association. Conclusions: In this observational study and meta-analysis of the literature, ACE-I or ARB use was not associated with severity or in-hospital mortality in COVID-19 patients