A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

Interplay between COVID-19, pollution, and weather features on changes in the incidence of acute coronary syndromes in early 2020.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has caused an unprecedented change in the apparent epidemiology of acute coronary syndromes (ACS). However, the interplay between this disease, changes in pollution, climate, and aversion to activation of emergency medical services represents a challenging conundrum. We aimed at appraising the impact of COVID-19, weather, and environment features on the occurrence of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in a large Italian region and metropolitan area. METHODS AND RESULTS: Italy was hit early on by COVID-19, such that state of emergency was declared on January 31, 2020, and national lockdown implemented on March 9, 2020, mainly because the accrual of cases in Northern Italy. In order to appraise the independent contribution on changes in STEMI and NSTEMI daily rates of COVID-19, climate and pollution, we collected data on these clinical events from tertiary care cardiovascular centers in the Lazio region and Rome metropolitan area. Multilevel Poisson modeling was used to appraise unadjusted and adjusted effect estimates for the daily incidence of STEMI and NSTEMI cases. The sample included 1448 STEMI and 2040 NSTEMI, with a total of 2882 PCI spanning 6 months. Significant reductions in STEMI and NSTEMI were evident already in early February 2020 (all p<0.05), concomitantly with COVID-19 spread and institution of national countermeasures. Changes in STEMI and NSTEMI were inversely associated with daily COVID-19 tests, cases, and/or death (p<0.05). In addition, STEMI and NSTEMI incidences were associated with daily NO2, PM10, and O3 concentrations, as well as temperature (p<0.05). Multi-stage and multiply adjusted models highlighted that reductions in STEMI were significantly associated with COVID-19 data (p<0.001), whereas changes in NSTEMI were significantly associated with both NO2 and COVID-19 data (both p<0.001). CONCLUSIONS: Reductions in STEMI and NSTEMI in the COVID-19 pandemic may depend on different concomitant epidemiologic and pathophysiologic mechanisms. In particular, recent changes in STEMI may depend on COVID-19 scare, leading to excess all-cause mortality, or effective reduced incidence, whereas reductions in NSTEMI may also be due to beneficial reductions in NO2 emissions in the lockdown phase.

Impact of temporary traffic bans on the risk of acute coronary syndromes in a large metropolitan area.

BACKGROUND: Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes. METHODS: Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing precoronavirus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis). RESULTS: A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis.Fortnight and Sunday analyses did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P>0.05). Conversely, Weekly analysis showed non-significant changes for STEMI, but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P=0.043), as well as the 3 days before vs. the 3 days after the ban (P=0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) <2.5 µm or PM <10 µm (all P>0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P=0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P=0.046), and an increase in benzene during the ban in comparison to the Sunday before (P=0.039). CONCLUSIONS: Temporary traffic ban may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.

339 Interplay between COVID-19, pollution, and weather features on changes in the incidence of acute coronary syndromes in early 2020.

Aims: Coronavirus disease 2019 (COVID-19) has caused an unprecedented change in the apparent epidemiology of acute coronary syndromes (ACS). However, the interplay between this disease, changes in pollution, climate, and aversion to activation of emergency medical services represents a challenging conundrum. We aimed at appraising the impact of COVID-19, weather, and environment features on the occurrence of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in a large Italian region and metropolitan area. Methods and results: Italy was hit early on by COVID-19, such that state of emergency was declared on January 31, 2020, and national lockdown implemented on March 9, 2020, mainly because the accrual of cases in Northern Italy. In order to appraise the independent contribution on changes in STEMI and NSTEMI daily rates of COVID-19, climate and pollution, we collected data on these clinical events from tertiary care cardiovascular centers in the Lazio region and Rome metropolitan area. Multilevel Poisson modeling was used to appraise unadjusted and adjusted effect estimates for the daily incidence of STEMI and NSTEMI. The sample included 1448 STEMI and 2040 NSTEMI, with a total of 2882 PCI spanning 6 months. Significant reductions in STEMI and NSTEMI were evident already in early February 2020 (all P < 0.05), concomitantly with COVID-19 spread and institution of national countermeasures. Changes in STEMI and NSTEMI were inversely associated with daily COVID-19 tests, cases, and/or death (P < 0.05). In addition, STEMI and NSTEMI incidences were associated with daily NO2, PM10, and O3 concentrations, as well as temperature (P < 0.05). Multi-stage and multiply adjusted models highlighted that reductions in STEMI were significantly associated with COVID-19 data (P < 0.001), whereas changes in NSTEMI were significantly associated with both NO2 and COVID-19 data (both P < 0.001). Conclusion: Reductions in STEMI and NSTEMI in the COVID-19 pandemic may depend on different concomitant epidemiologic and pathophysiologic mechanisms. In particular, recent changes in STEMI may depend on COVID-19 scare, leading to excess all-cause mortality, or effective reduced incidence, whereas reductions in NSTEMI may also be due to beneficial reductions in NO2 emissions in the lockdown phase.

Angiographic predictors of recurrent stent thrombosis (from the Outcome of PCI for stent-ThrombosIs MultIcentre STudy [OPTIMIST]).

Stent thrombosis is a catastrophic occurrence burdened by a high mortality rate and a tendency to recur. We sought to evaluate the angiographic risk factors for recurrent stent thrombosis (rST) in a subpopulation of 91 Outcome of PCI for stent-ThrombosIs Multicenter STudy (OPTIMIST) patients who underwent quantitative angiographic evaluation by an independent core laboratory. The Academic Research Consortium criteria were used for rST adjudication. A multivariate Cox proportional hazards model was applied to estimate the hazard ratios and the corresponding 95% confidence intervals for the occurrence of Academic Research Consortium-defined, definite rST (primary end point), definite or probable rST (secondary end point), and definite or probable or possible rST (secondary end point). A total of 8 definite rST events occurred during a median follow-up of 244 days (range 165 to 396), of which 5 were early and 3 were late. In the multivariate model, a residual thrombus score of > or =3 (hazard ratio 6.5, 95% confidence interval 1.4 to 30.7, p = 0.017) and a larger postprocedural reference vessel diameter (hazard ratio 4.5, 95% confidence interval 1.5 to 13.3, p = 0.006) were significantly associated with the primary end point. When the same model was applied to the 15 definite and probable rST events, only a residual thrombus score of > or =3 (hazard ratio 7.8, 95% confidence interval 2.5 to 24.5, p <0.001) was significantly associated with rST. Finally, when possible rST events were included (18 patients), a residual thrombus score of > or =3 remained associated with the dependent variable (hazard ratio 6.1, 95% confidence interval 2.0 to 18.2, p = 0.001), along with a larger postprocedural reference vessel diameter. In conclusion, when performing percutaneous coronary intervention for stent thrombosis, the residual thrombus burden and larger reference vessel were potent risk factors for rST.

The use of functional tests and planned coronary angiography after percutaneous coronary revascularization in clinical practice. Results from the AFTER multicenter study.

BACKGROUND: The follow-up strategies after percutaneous coronary intervention (PCI) have relevant clinical and economic implications. The purpose of this prospective observational multicenter study was to evaluate the effect of clinical, procedural and organizational variables on the execution of functional testing (FT) and planned coronary angiography (CA) after PCI, and to assess the impact of American College of Cardiology (ACC)/American Heart Association (AHA) guidelines on clinical practice. METHODS: Four hundred twenty consecutive patients undergoing PCI were categorized as class I, IIB and III indications for follow-up FT according to ACC/AHA guidelines recommendations. Furthermore, all patients were grouped according to the presence or absence of FT and/or planned CA over 12 months after PCI. Multivariable analysis was used to assess the potential predictors of test execution. RESULTS: During the 12-month follow-up at least one test was performed in 72% of patients with class I indication, 63% of patients with class IIB indication and 75% of patients with class III indication (p=ns). A total of 283 patients (67%) underwent testing. The use of tests was associated with younger age (R.R. 0.94, C.I. 0.91+/-0.97, p<0.001), a lower number of diseased vessels (R.R. 0.60, C.I. 0.43+/-0.84, p=0.003), follow-up by the center performing PCI (R.R. 2.64, C.I. 1.43+/-4.86, p=0.002), and the specific center at which PCI was performed. Most asymptomatic patients completed their testing prematurely with respect to the risk period for restenosis. CONCLUSIONS: The use of FT and planned CA after PCI is unrelated to patient's symptom status, and depends on patient's age and logistics. ACC/AHA guidelines have no influence in clinical practice, and test timing is not tailored to the risk period for restenosis.

Angiographic and clinical outcome of invasively managed patients with thrombosed coronary bare metal or drug-eluting stents: the OPTIMIST study.

AIMS: Stent thrombosis (ST) is a major complication of percutaneous coronary interventions (PCIs). An invasive management by re-PCI is the commonly adopted treatment for ST, but data on outcome are limited. METHODS AND RESULTS: We performed a 2-year multicentre registry enrolling consecutive patients with angiographically confirmed ST undergoing PCI. The primary angiographic endpoint was optimal angiographic reperfusion (TIMI 3 + blush grade 2 or 3). The primary clinical endpoints were death and major adverse coronary and cerebrovascular events (MACCEs) at 6 months. A total of 110 patients underwent 117 urgent PCI during the study. Patients with drug-eluting stent (DES) thrombosis, compared with those with bare metal stent (BMS) thrombosis, exhibited a higher rate of late or very late presentation and of anti-platelet therapy withdrawal. Optimal angiographic reperfusion was obtained in 64% of the patients. Death and MACCE rates at 6 months were 17 and 30%, respectively. Clinical outcome was similar for BMS and DES thrombosis. Very late ST, implantation of stent during PCI for ST, and failure to achieve optimal angiographic reperfusion were the independent predictors of 6-month mortality. CONCLUSION: DES and BMS thromboses have different clinical features, but a similar poor outcome. Indeed, PCI for ST is associated with a low rate of reperfusion and to a high rate of death and MACCE, calling for action in order to prevent its occurrence and to improve its management.

The Outcome of PCI for stent-ThrombosIs MultIcentre Study (OPTIMIST): rationale and design of a multicenter registry.

BACKGROUND: Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population. METHODS: We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization). CONCLUSIONS: The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.

[Non-ST-elevation myocardial infarction with normal coronary arteries, clinical features and coronary artery flow]. / Valutazione del flusso coronarico nei pazienti con infarto miocardico acuto senza sopraslivellamento del tratto ST e rilievo angiografico di coronarie normali.

BACKGROUND: No assessment has been made up today concerning clinical features, coronary artery flow and mid-term prognosis between acute non-ST-elevation myocardial infarction (NSTEMI) patients without epicardial coronary disease and those with epicardial coronary artery stenosis > 50% of at least one vessel. METHODS: We evaluated consecutive NSTEMI patients who had undergone coronary angiography within the first 48 hours of infarction. We examined their age, sex, smoking habits, the incidence of diabetes, dyslipidemia, hypertension, and left ventricular ejection fraction. The coronary blood flow was assessed according to the conventional TIMI flow grade and with the TIMI frame count (TFC). RESULTS: From October 1, 2001 to December 31, 2003, 50 patients out of 996 with NSTEMI (20 males, 30 females, mean age 60 +/- 13 years), showed normal coronary arteries (5%). This subset of patients was compared with 50 NSTEMI patients with coronary stenosis. Patients of the first group were younger and more frequently female with respect to NSTEMI patients with coronary stenosis. The differences between the two groups with respect to diabetes, hypertension, dyslipidemia incidence and ejection fraction (52 vs 47%) were not statistically significant. With the corrected TFC (cTFC) method we found a slow flow in at least one coronary vessel in a high percentage of NSTEMI patients with normal coronary arteries. When we compared normal vessels between the two groups, we found a higher cTFC in NSTEMI patients with normal coronary arteries than in NSTEMI patients with coronary stenosis. After a 16 +/- 8 months of follow-up we observed 8 events in the normal vessel group and 10 in the coronary stenosis group (p = NS). CONCLUSIONS: The possible hypothesis of microvessel dysfunction as a pathogenesis of a slow flow in NSTEMI patients with normal coronary arteries is strong. Further studies are warranted to investigate microvessel disease and characteristics and possible causes of abnormalities. A larger perspective study with a longer follow-up is needed as well to evaluate the prognosis in this subset of patients.

Infecçöes respiratórias agudas em crianças em centro de saúde / Acute respiratory infections in children in a health center

Estudou-se 150 crianças, com idade até 5 anos, que procuraram atendimento no Centro de Saúde Escola "Prof. Samuel B. Pessoa". Os resultados mostraram que cerca de 50% delas apresentavam infecçäo respiratória aguda por ocasiäo do atendimento. A análise dos fatores ambientais envolvidos com a afecçäo só mostrou associaçäo com o número de fumantes na família