Autori italiani pubblicano

Gender Differences in Takotsubo Syndrome.

Ottobre 18, 2022

Background: Male sex in takotsubo syndrome (TTS) has a low incidence and it is still not well characterized.

Objectives: The aim of the present study is to describe TTS sex differences.

Methods: TTS patients enrolled in the international multicenter GEIST (GErman Italian Spanish Takotsubo) registry were analyzed. Comparisons between sexes were performed within the overall cohort and using an adjusted analysis with 1:1 propensity score matching for age, comorbidities, and kind of trigger.

Results: In total, 286 (11%) of 2,492 TTS patients were men. Male patients were younger (age 69 ± 13 years vs 71 ± 11 years; p= 0.005), with higher prevalence of comorbid conditions (diabetes mellitus 25% vs 19%; p= 0.01; pulmonary diseases 21% vs 15%; p= 0.006; malignancies 25% vs 13%; p< 0.001) and physical trigger (55 vs 32% p< 0.01). Propensity-score matching yielded 207 patients from each group. After 1:1 propensity matching, male patients had higher rates of cardiogenic shock and in-hospital mortality (16% vs 6% and 8% vs 3%, respectively; both p< 0.05). Long-term mortality rate was 4.3% per patient-year (men 10%, women 3.8%). Survival analysis showed higher mortality rate in men during the acute phase in both cohorts (overall: p< 0.001; matched: p= 0.001); mortality rate after 60 days was higher in men in the overall (p= 0.002) but not in the matched cohort (p= 0.541). Within the overall population, male sex remained independently associated with both in-hospital (OR: 2.26; 95% CI: 1.16-4.40) and long-term mortality (HR: 1.83; 95% CI: 1.32-2.52). Conclusions: Male TTS is featured by a distinct high-risk phenotype requiring close in-hospital monitoring and long-term follow-up.

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Aspirin Therapy on Prophylactic Anticoagulation for Patients Hospitalized With COVID-19: A Propensity Score-Matched Cohort Analysis of the HOPE-COVID-19 Registry.

Settembre 30, 2022

Background: COVID-19 is an infectious illness, featured by an increased risk of thromboembolism. However, no standard antithrombotic therapy is currently recommended for patients hospitalized with COVID-19. The aim of this study was to evaluate safety and efficacy of additional therapy with ASA over prophylactic anticoagulation (PAC) in patients hospitalized with COVID-19 and its impact on survival.

Methods and Results: a total of 8.168 patients hospitalized for COVID-19 were enrolled in a multicenter-international prospective registry (HOPE COVID-19). Clinical data and inhospital complications, including mortality, were recorded. Study population included patients treated with PAC or with PAC and ASA. A comparison of clinical outcomes between patients treated with PAC versus PAC and ASA was performed using an adjusted analysis with propensity score matching. Of 7.824 patients with complete data, 360 (4.6%) received PAC and ASA a nd 2 .949 ( 37.6%) P AC. P ropensity-score matching yielded 298 patients from each group. In the propensity score-matched population, cumulative incidence of in-hospital mortality was lower in patients treated with PAC and ASA versus PAC (15% versus 21%, Log Rank P=0.01). At multivariable analysis in propensity matched population of patients with COVID-19, including age, sex, hypertension, diabetes, kidney failure, and invasive ventilation, ASA treatment was associated with lower risk of in-hospital mortality (hazard ratio [HR], 0.62; [95% CI 0.42-0.92], P=0.018).

Conclusions: combination PAC and ASA was associated with lower mortality risk among patients hospitalized with COVID-19 in a propensity score matched population compared to PAC alone.

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Association of statin pretreatment with presentation characteristics, infarct size and outcome in older patients with acute coronary syndrome: the Eldery ACS-2 trial.

Settembre 21, 2022

Background: prior statin treatment has been shown to have favourable effects on shortand long-term prognosis in patients with acute coronary syndrome (ACS). There are limited data in older patients. The aim of this study was to investigate the association of previous statin therapy and presentation characteristics, infarct size and clinical outcome in older patients, with or without atherosclerotic cardiovascular disease (ASCVD), included in the Elderly-ACS 2 trial.

Methods: data on statin use pre-admission were available for 1,192 of the 1,443 patients enrolled in the original trial. Of these, 531 (44.5%) were already taking statins. Patients were stratified based on established ASCVD and statin therapy. ACS was classified as non-ST elevation or ST elevation myocardial infarction (STEMI). Infarct size was measured by peak creatine kinase MB (CK-MB). All-cause death in-hospital and within 1 year were the major end points.

Results: there was a significantly lower frequency of STEMI in statin patients, in both ASCVD and No-ASCVD groups. Peak CK-MB levels were lower in statin users (10 versus 25 ng/ml, P< 0.0001). There was lower all-cause death in-hospital and within 1 year for subjects with ASCVD already on statins independent of other baseline variables. There were no differences in all-cause death for No-ASCVD patients whether or not on statins. Conclusions: statin pretreatment was associated with more favourable ACS presentation and lower myocardial damage in older ACS patients both ASCVD and No-ASCVD. The incidence of all-cause death (in-hospital and within 1 year) was significantly lower in the statin treated ASCVD patients.

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Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial.

Agosto 25, 2022

Background: In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol.

Methods and results: Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary endpoint was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1.103 (13.8%) of 7.980 patients in the experimental group and 785 (9.8%) of 7.988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary endpoint was 0.88 (95% CI, 0.75-1.03; p=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety endpoint of major bleeding was 1.00 (95% CI, 0.79-1.26; p=0.99). The per-protocol and intention-to-treat effect estimates were overall consistent.

Conclusions: Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus ASA for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by ASA alone at 2 years after coronary stenting.

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Optical coherence tomography, intravascular ultrasound o angiography guidance for distal left main coronary stentig. The ROCK sohort II study.

Luglio 26, 2022

Objectives: To test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly.

Background: Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited.

Methods: ROCK II is a multicenter, investigatordriven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS.

Results: A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascularimaging (p=0.039), with no difference between OCT and IVUS (p=0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p=0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p=0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found.

Conclusions: Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.

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Reduced Heart Failure and Mortality in Patients Receiving Statin Therapy Before Initial Acute Coronary Syndrome.

Luglio 25, 2022

Background: There is uncertainty regarding the impact of statins on the risk of atherosclerotic cardiovascular disease (ASCVD) and its major complication, acute heart failure (AHF).

Objectives: The aim of this study was to investigate whether previous statin therapy translates into lower AHF events and improved survival from AHF among patients presenting with an acute coronary syndrome (ACS) as a first manifestation of ASCVD.

Methods: Data were drawn from the International Survey of Acute Coronary Syndromes Archives. The study participants consisted of 14,542 Caucasian patients presenting with ACS without previous ASCVD events. Statin users before the index event were compared with nonusers by using inverse probability weighting models. Estimates were compared by test of interaction on the log scale. Main outcome measures were the incidence of AHF according to Killip class and the rate of 30-day all-cause mortality in patients presenting with AHF.

Results: Previous statin therapy was associated with a significantly decreased rate of AHF on admission (4.3% absolute risk reduction; risk ratio [RR]: 0.72; 95% CI: 0.62- 0.83) regardless of younger (40-75 years) or older age (interaction P = 0.27) and sex (interaction P = 0.22). Moreover, previous statin therapy predicted a lower risk of 30-day mortality in the subset of patients presenting with AHF on admission (5.2 % absolute risk reduction; RR: 0.71; 95% CI: 0.50-0.99).

Conclusions: Among adults presenting with ACS as a first manifestation of ASCVD, previous statin therapy is associated with a reduced risk of AHF and improved survival from AHF. (International Survey of Acute Coronary Syndromes [ISACS] Archives; NCT04008173).

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Association of sex with outcome in elderly patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Luglio 5, 2022

Background: Worse outcomes have been reported for women, compared with men, after an acute coronary syndrome (ACS). Whether this difference persists in elderly patients undergoing similar invasive treatment has not been studied. We investigated sexrelated differences in 1-year outcome of elderly acute coronary syndrome patients treated by percutaneous coronary intervention (PCI).

Methods: Patients 75 years and older successfully treated with PCI were selected among those enrolled in 3 Italian multicenter studies. Cox regression analysis was used to assess the independent predictive value of sex on outcome at 12-month follow-up.

Results: A total of 2.035 patients (44% women) were included. Women were older and most likely to present with ST-elevation myocardial infarction (STEMI), diabetes, hypertension, and renal dysfunction; men were more frequently overweight, with multivessel coronary disease, prior myocardial infarction, and revascularizations. Overall, no sex disparity was found about all-cause (8.3% vs 7%, P=.305) and cardiovascular mortality (5.7% vs 4.1%, P=113). Higher cardiovascular mortality was observed in women after STEMI (8.8%) vs 5%, P=.041), but not after non ST-elevation-ACS (3.5% vs 3.7%, P=.999). A sensitivity analysis excluding patients with prior coronary events (N=1.324, 48% women) showed a significantly higher cardiovascular death in women (5.4% vs 2.9%, P=.025). After adjustment for baseline clinical variables, female sex did not predict adverse outcome.

Conclusions: Elderly men and women with ACS show different clinical presentation and baseline risk profile. After successful PCI, unadjusted 1-year cardiovascular mortality was significantly higher in women with STEMI and in those with a first coronary event. However, female sex did not predict cardiovascular mortality after adjustment for the different baseline variables.

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Quantified mitral regurgitation and left atrial function in heart failure with reduced ejection fraction: interplay and outcome implications

Giugno 3, 2022

Aims: The clinical and prognostic importance of functional mitral regurgitation (FMR) in heart failure patients with reduced ejection fraction, (HFrEF) has been highly debated. This study aims to define FMR linkage to cardiovascular (CV) outcomes and the interplay with left atrial (LA) function in a prospective cohort of consecutive HFrEF outpatients.

Methods and results: Overall, 286 consecutive outpatients, with chronic HFrEF, were prospectively enrolled. FMR was quantified by effective regurgitant orifice area (EROA). Global peak atrial longitudinal strain (PALS) was measured by speckle tracking echocardiography. The primary endpoint was a composite of congestive heart failure hospitalization or CV death. During a mean follow-up of 4.1 ± 1.5 years, the primary endpoint occurred in 99 patients (35%). The spline modelling of the risk by FMR severity showed an excess event risk starting at about the EROA value of 0.1 cm2 . There was a remarkable graded association between the EROA strata, even if tested per 0.1 cm2 increase, and the risk of CV events (hazard ratio [HR] EROA per 0.10 cm2 increase: 1.42, 95% confidence interval [CI] 1.19-1.68; p<0.0001). E><0.0001). EROA ≥0.30 cm2 was associated with CV events regardless of LA function (HR 2.34, 95% CI 1.29-4.19; p=0.005). Less severe FMR (EROA ≥0.10 cm2 ) was associated with a dismal outcome only in patients with reduced LA function (PALS <14% (5-year CV event rate 51 ± 4%); conversely, the risk of events was relative reduced when preserved global PALS and FMR coexisted (5-year CV event rate 38 ± 6%). Conclusions: Our results refine the independent association between FMR and CV outcome among HFrEF outpatients. Within a moderate EROA range, LA function mitigates the clinical consequences of mitral regurgitation, providing measurable proof of the interplay between regurgitation and LA compliance.

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

Maggio 19, 2022

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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