Alert-LDL-2: adherence to guidelines and goals attainment in the treatment of diabetic patients with dyslipidemia.

BACKGROUND: Type 2 diabetes mellitus is associated with a cluster of lipid and apolipoprotein abnormalities which increase the risk for atherosclerotic cardiovascular disease. The aim of this study was to evaluate the adherence to guidelines-oriented dyslipidemia treatment in diabetic patients and to assess the efficacy of a territorial goal-oriented program. METHODS: One thousand seventy-one diabetic patients at very high cardiovascular risk were enrolled in this prospective study. They performed a clinical-laboratory follow-up program, received lifestyle recommendations and optimization of their antihyperlipidemic therapies. At the beginning and the 3-month follow-up visit, LDL-c data were collected, and further therapies were prescribed to the patients that did not reach the target. After 12 month follow-up, LDL-c data were collected again. RESULTS: Diabetic patients significantly improved mean LDL cholesterol levels during one-year follow-up (LDLc mean value 135 mg/dL at baseline, 60 mg/dL at the end of the study), obtaining a greater reduction compared to non-diabetic patients participating in the same program. Accordingly, the percentage of patients that reached the lipid target was significantly higher in diabetic patients after 3-months and 12- follow-ups (P<0.05). Diabetic patients assuming statins, both in monotherapy and in combination with ezetimibe, increased during the follow-up (74.1% at the enrolment vs. 88.2% one year later). GLP1ra-treated patients achieved the greatest reduction in cholesterol levels compared to baseline. CONCLUSIONS: The results of the study recommend encouraging strategies and appropriate treatments to achieve a targeted lipid profile in diabetic patients at very high cardiovascular risk.

[The OIBOH Registry (Optimal Intensification therapy in a Broad Observed High risk patient population with coronary disease): an Italian observational study of secondary prevention after a coronary event during the pandemic COVID-19 outbreak]. / Il registro OIBOH (Optimal Intensification therapy in a Broad Observed High risk patient population with coronary disease): studio italiano osservazionale di prevenzione secondaria dopo evento coronarico durante la pandemia COVID-19.

Razionale. In Italia la pandemia COVID-19 ha determinato importanti riorganizzazioni logistiche nell'erogazione delle cure ospedaliere e di specialistica ambulatoriale. Ciò ha spinto clinici e decisori pubblico-amministrativi della Sanità ad adottare nuovi modelli organizzativi in molteplici scenari clinici. Materiali e metodi. Il registro OIBOH (Optimal Intensification therapy in a Broad Observed High risk patient population with coronary disease) è uno studio osservazionale "cross-sectional" condotto in vari centri italiani di cardiologia ambulatoriale per valutare durante la pandemia COVID-19 la capacità di identificare in breve tempo i pazienti ad altissimo rischio cardiovascolare residuo dopo un evento coronarico recente (<12 mesi). Successivamente alla valutazione clinica iniziale, venivano arruolati i pazienti ritenuti ad altissimo rischio, registrando le caratteristiche cliniche e di trattamento in una scheda di raccolta dati elettronica.Risultati. Al registro hanno partecipato 134 centri di cardiologia ambulatoriale che hanno arruolato 1428 pazienti su 3227 esaminati fra quelli che avevano avuto accesso ad una visita cardiologica durante la pandemia nel periodo ottobre 2020-marzo 2021. Il criterio di arruolamento era costituito dall'aver avuto una diagnosi di coronaropatia confermata angiograficamente negli ultimi 12 mesi, per sindrome coronarica acuta (SCA) o cronica (SCC). La SCA come evento indice era presente nel 93% dei pazienti arruolati mentre la SCC nel 7%. L'età media era 67 ± 10 anni, il 25% era di sesso femminile. Il 96.1% dei pazienti con SCA e il 67.6% dei pazienti con SCC sono stati sottoposti a rivascolarizzazione coronarica. Il 46% e 47% dei pazienti con SCA e SCC, rispettivamente, era diabetico. Oltre il 65% dei pazienti presentava una malattia coronarica multivasale. È stata osservata una importante prevalenza di arteriopatia periferica (17.5% nei pazienti con SCA e 19.6% nei pazienti con SCC). I valori di pressione arteriosa e frequenza cardiaca risultavano ben controllati (128 ± 25.2 mmHg e 65 ± 12.3 b/min nei pazienti con SCA; 127 ± 23.4 mmHg e 67 ± 13.2 b/min nei pazienti con SCC). Viceversa, è stato riportato uno scarso controllo dei livelli di colesterolemia LDL, con un valore medio di 88.8 ± 38.6 mg/dl nei pazienti con SCA e 86 ± 36.6 mg/dl nei pazienti con SCC. Solo il 16.4% dei pazienti con SCA raggiungeva i livelli raccomandati dalle attuali linee guida europee. Nonostante l'estensivo uso di statine (>90%), si è rilevato un utilizzo limitato dell'associazione statina ad alta intensità + ezetimibe (solo il 22.4% dei pazienti). Estremamente basso è stato l'utilizzo di inibitori di PCSK9 (2.5%). La duplice terapia antiaggregante piastrinica (DAPT) è risultata complessivamente ben condotta fin dalla dimissione ospedaliera. Nei pazienti in DAPT, l'inibitore P2Y12 più utilizzato è risultato il ticagrelor alla dose di 90 mg, soprattutto dopo un evento coronarico acuto (in circa l'80% dei pazienti con SCA). Nella stragrande maggioranza dei casi (>90%) i cardiologi ambulatoriali hanno posto indicazione a prosecuzione della DAPT oltre i 12 mesi con aspirina e ticagrelor 60 mg bid. Conclusioni. La gestione del paziente con coronaropatia in fase cronica stabilizzata è molto complessa. Tale complessità logistico-gestionale si è accentuata durante la pandemia COVID-19. Il registro OIBOH ha evidenziato un'ottima capacità di identificare le problematiche clinico-prognostiche delle cardiologie ambulatoriali italiane, specie nei pazienti ad altissimo rischio residuo. Rimangono importanti aree di miglioramento come uno stretto controllo della colesterolemia LDL, mentre altre raccomandazioni delle linee guida, come la prosecuzione della DAPT con ticagrelor 60 mg oltre i 12 mesi, risultano ben applicate. L'implementazione dell'assistenza con la medicina digitale e l'intelligenza artificiale potrebbe migliorare di molto la performance dei clinici.

ALERT-LDL: adherence to guidelines in the treatment of patients with dyslipidemia.

The association between LDL-c levels and cardiovascular outcomes suggests tailoring lipid-lowering therapies according to total cardiovascular risk. We aimed to evaluate the adherence to guidelines-oriented dyslipidaemia's treatment in an outpatient population referring to ARCA cardiologists, and assess the efficacy of treatment's optimization for each specific level of risk. Three thousand seventy-five patients enrolled in this prospective study were classified according to cardiovascular risk category, and their therapies were optimized. At the beginning and the 3 month follow-up visit, LDL-c data were collected, and further therapies were prescribed to the patients that did not reach the target. A significant LDL-c reduction was observed in all subgroups at different cardiovascular risk at the end of the study (p < 0.05). The number of patients assuming statins, both in monotherapy and in combination with ezetimibe, increased during the follow-up (63% at the enrollment vs 89% after 12 months). At the enrollment, only 1.4% of patients were treated with PCSK-9 inhibitors while after 12 months the percentage increased both in high (5.8%) and very high-risk (18.4%) patients. At the beginning of the study, only 698/3075 patients (22.7%) reached lipid targets. At the end of the study, carried out by the referring cardiologists in the pertaining healthcare districts and specifically aimed to control the lipid profile, the percentage of patients on target increased in all risk categories (68.5%). Our results suggest carefully implementing measures that encourage outpatients and their cardiologists to achieve the targeted lipid profile according to cardiovascular risk.

Management of patients with chronic heart failure and type 2 diabetes mellitus: the SCODIAC-II study.

SCODIAC was a pilot study which revealed an increasing use of SGLT2i in 123 outpatients affected with Heart Failure (HF) and Type 2 Diabetes Mellitus. SCODIAC-II study, the second phase of the program, has been carried out to determine diagnostic and therapeutic pathways in a larger group of patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and cardiovascular therapies. 406 HF-diabetic patients, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, were enrolled in this retrospective study and divided in Group A, composed of 136 patients with preserved Ejection Fraction (HF-pEF)(> 45%) and Group B, formed of 270 patients with reduced EF (HF-rEF)(≤ 45%). All patients had performed periodic clinical and echocardiographic evaluations. The antidiabetic therapies resulted modified after 1 year with a greater use of GLP1-AR, gliptins and SGLT2i. Cardiovascular therapies resulted also modified with a greater use of sacubitril/valsartan and a reduction of ACEi and ARBs in HF-rEF patients. Echocardiography E velocity, A velocity and E/e' ratio resulted markedly reduced in 25 HF-pEF and in 60 HF-rEF patients treated with SGLT2i, in respect to both the whole sample of subjects at beginning and the other diabetic patients. LAVi resulted reduced only in HF-pEF patients and EF increased only in HF-rEF patients. The approach to the patients with HF and diabetes must necessarily take place in the healthcare districts, be multidisciplinary and integrated. SGLT2i could improve left ventricular function in HF-rEF patients and modify cardiovascular therapies, almost in this setting of patients.Trial registration The protocol was approved by the University of Naples Federico II Ethics Committee and registered at ClinicalTrial.gov (CT04375943). The principles outlined in the Declaration of Helsinki were followed.

Adherence to guidelines in the management of patients with chronic heart failure follow-up: role of periodic echocardiographic examinations.

BACKGROUND AND AIM: The Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure trial showed a poor adherence to the current therapeutic guidelines in 660 chronic heart failure (CHF) patients. The second phase, Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure follow-up, was aimed to determine if periodic echocardiographic evaluations could improve the prognosis of CHF patients and/or increase the adherence to the guidelines. MATERIAL AND METHODS: Among 528 CHF patients with reduced ejection fraction from the ALERT registry, 436 patients accepted to participate in the second phase of the study between February and September 2013 and completed the 3-year follow-up phase between February and September 2016. They were randomized into two groups: Group A (n = 218) followed by clinical evaluation and ECG every 3 months, and echocardiography every 6 months and Group B (n = 218) monitored only with clinical evaluation and ECG every 3 months. RESULTS: The number of vascular events that occurred resulted as similar in both the groups: there were 78 hospitalizations (37 in Group A vs. 41 in Group B); 9 home-treated vascular events (4 in Group A and five in Group B); and 16 cardiovascular deaths (9 and 7, respectively). The adherence to the guidelines at the end of the trial resulted as significantly improved in both the groups in comparison with the basal evaluation, without differences between the two groups. CONCLUSION: A strict follow-up of CHF patients was associated with a lower number of events and an improvement in the adherence to the guidelines. Periodic echocardiography does not modify these results.

Management of chronic heart failure: Role of home echocardiography in monitoring care programs.

AIM: To identify a possible role of home echocardiography for monitoring chronic heart failure (CHF) patients. METHODS: We prospectively investigated 118 patients hospitalized during the last year for CHF who could not easily reach the pertaining District Healthcare Center. The patients were followed up with 2 home management programs: one including clinical and electrocardiographic evaluations and also periodic home echocardiographic examinations (group A), the other including clinical and electrocardiographic evaluations only (group B). RESULTS: At the end of the 18-mo follow-up no signi-ficant differences were observed between the 2 groups as regards the primary endpoint: rehospitalization occurred in 4 patients of the group A and in 6 patients of the group B; major cardiovascular events occurred in 2 and in 3 patients, respectively. No significant differences were observed with respect to the secondary endpoints: one vascular event appeared in both the groups, 3 cardiovascular deaths occurred in group A and 2 in group B. No significant differences were observed between the 2 groups as regards the composite endpoint of death plus hospitalization. CONCLUSION: Home echocardiography for monitoring of CHF patients does not improve the cardiovascular endpoints. In our CHF patients, a low incidence of vascular events was observed.