Background Elderly patients have high ischemic and bleeding rates after acute coronary syndrome; however, the occurrence of these complications over time has never been studied. This study sought to ...characterize average daily ischemic rates ( ADIRs ) and average daily bleeding rates ( ADBRs ) over 1 year in patients aged >74 years with acute coronary syndrome undergoing percutaneous coronary intervention who were randomized in the Elderly ACS 2 trial, comparing low-dose prasugrel (5 mg daily) with clopidogrel (75 mg daily). Methods and Results ADIRs and ADBRs were calculated as the total number of events, including recurrent events, divided by the number of patient-days of follow-up and assessed within different clinical phases: acute (0-3 days), subacute (4-30 days), and late (31-365 days). Generalized estimating equations were used to test the least squares mean differences for the pairwise comparisons of ADIRs and ADBRs and the pairwise comparison of clopidogrel versus prasugrel effects. Globally, ADIRs were 2.6 times (95% CI, 2.4-2.9) higher than ADBRs . ADIRs were significantly higher in the clopidogrel arm than in the low-dose prasugrel arm in the subacute phase ( P
<0.001) without a difference in ADBRs ( P
=0.35). In the late phase, ADIRs remained significantly higher with clopidogrel ( P
<0.001), whereas ADBRs were significantly higher with low-dose prasugrel ( P
<0.001). Conclusions Ischemic burden was greater than bleeding burden in all clinical phases of 1-year follow-up of elderly patients with acute coronary syndrome treated with percutaneous coronary intervention. Low-dose prasugrel reduced ischemic events in the subacute and chronic phases compared with clopidogrel, whereas bleeding burden was lower with clopidogrel in the late phase. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01777503.
During the COVID-19 outbreak, healthcare Authorities of Lombardy modified the regional network concerning time-dependent emergencies. Specifically, 13 Macro-Hubs were identified to deliver timely ...optimal care to patients with acute coronary syndromes (ACS). Aim of this paper is to present the results of this experience.
This is a multicenter, observational study. A total of 953 patients were included, presenting with STEMI in 57.7% of the cases. About 98% of patients received coronary angiography with a median since first medical contact to angiography of 79 (IQR 45–124) minutes for STEMI and 1262 (IQR 643–2481) minutes for NSTEMI.
A total of 107 patients (11.2%) had SARS-CoV2 infection, mostly with STEMI (74.8%). The time interval from first medical contact to cath-lab was significant shorter in patients with COVID-19, both in the overall population and in STEMI patients (87 (IQR 41–310) versus 160 (IQR 67–1220) minutes, P = 0.001, and 61 (IQR 23–98) versus 80 (IQR 47–126) minutes, P = 0.01, respectively). In-hospital mortality and cardiogenic shock rates were higher among patients with COVID-19 compared to patients without (32% vs 6%, P < 0.0001, and 16.8% vs 6.7%, P < 0.0003, respectively).
During the COVID-19 outbreak in Lombardy, the redefinition of ACS network according to enlarged Macro-Hubs allowed to continue with timely ACS management, while reserving a high number of intensive care beds for the pandemic. Patients with ACS and COVID-19 presented a worst outcome, particularly in case of STEMI.
We report the case of a male smoker who is overweight and has no leisure time physical activity until a first acute inferolateral myocardial infarction at the age of 44 years, which was treated using ...coronary stenting of the left circumflex artery. He was discharged with an ejection fraction of 0.45 and the indication to quit smoking and initiate regular aerobic physical activity. After that episode, he started regular mountain hiking in the Alps, Andes, and, finally, in the Himalayas and Karakorum, where, up to the age of 65 years, he climbed 5 peaks of altitude >8,000 m, always solo and without oxygen, despite a recurrent myocardial infarction because of occlusion at the distal edge of the previously implanted stent. This case supports the indication that high-altitude per se is not contraindicated in patients with well-compensated coronary artery disease, even after an acute MI.
Background Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive ...use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. Methods A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. Results A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. Conclusions This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.
We aimed to appraise the predictive accuracy of a novel and user-friendly risk score, the ACEF (age, creatinine, ejection fraction), in patients undergoing PCI for coronary bifurcations.
A ...multicentre, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 in 22 Italian centres. Patients with complete data to enable computation of the ACEF score were divided into three groups according to tertiles of ACEF score. The primary endpoint was 30-day mortality. The discrimination of the ACEF score as a continuous variable was also appraised with area under the curve (AUC) of the receiver-operating characteristic. A total of 3,535 patients were included: 1,119 in the lowest tertile of ACEF score, 1,190 in the mid tertile, and 1,153 in the highest tertile. Increased ACEF score was associated with significantly different rates of 30-day mortality (0.1% in the lowest tertile vs. 0.5% in the mid tertile and 3.0% in the highest tertile, p<0.001), with similar differences in myocardial infarction (0.3% vs. 0.7% and 1.8%, p<0.001) and major adverse cardiac events (MACE, 0.5% vs. 1.2% and 4.3%, p<0.001). After an average follow-up of 24.4±15.1 months, increased ACEF score was still associated with a higher rate of all-cause death (1.3% vs. 2.4% and 11.0%, p<0.001), cardiac death (0.9% vs. 1.4% and 7.2%, p<0.001), myocardial infarction (3.4% vs. 2.7% and 5.7%, p<0.001), MACE (13.6% vs. 15.9% and 22.3%, p<0.001), and stent thrombosis (2.3% vs. 1.8% and 5.0%, p<0.001). Discrimination of ACEF score was satisfactory for 30-day mortality (AUC=0.82 0.77-0.87, p<0.001), 30-day MACE (AUC=0.73 0.67-0.78, p<0.001), long-term mortality (AUC=0.77 0.74-0.81, p<0.001), and moderate for long-term MACE (AUC=0.60 0.57-0.62, p<0.001).
The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality.
The residual burden of coronary artery disease after percutaneous coronary intervention (PCI) has been associated with worse ischemic outcome. However, data are conflicting in elderly patients. The ...aim of our study was to verify the incremental value of the residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (rSS) over clinical variables and baseline SYNTAX score (bSS) in predicting 1-year mortality or cardiovascular events.
A post hoc analysis of data collected in the Elderly-ACS 2 multicenter randomized trial was performed. We included 630 patients aged > 75 years with multivessel coronary disease undergoing PCI for acute coronary syndrome (ACS). The primary outcome was a composite of death, recurrent myocardial infarction, and stroke at 1-year follow up. Change in c-statistic and standardized net benefit were used to evaluate the incremental value of the rSS.
Event rates were significantly higher in patients with incomplete revascularization (rSS > 8). When the rSS was included in a core Cox regression model containing age, previous myocardial infarction, and ACS type, the hazard ratio for patients with score values > 8 was 2.47 (95% confidence interval, 1.51-4.06). However, the core model with rSS did not increase the c-statistic compared with the core model with the bSS (from 0.69 to 0.70) and gave little incremental value in the standardized net benefit.
In elderly patients with ACS with multivessel disease undergoing PCI, incomplete revascularization was associated with worse outcome at 1-year follow-up. However, there was no clear incremental value of the rSS in the prediction of 1-year adverse outcome compared with a model including clinical variables and bSS.
Le fardeau résiduel de la coronaropathie après une intervention coronarienne percutanée (ICP) a été associé à de moins bons résultats sur le plan ischémique. Les données recueillies chez les patients âgés sont toutefois contradictoires. Cette étude avait donc pour objectif de valider la valeur ajoutée du score SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) résiduel (SSr) par rapport aux paramètres cliniques et au score SYNTAX initial (SSi) pour prédire la mortalité à 1 an et les manifestations cardiovasculaires.
Une analyse a posteriori des données de l’étude multicentrique avec répartition aléatoire Elderly-ACS 2 a été effectuée. Pour ce faire, 630 patients âgés de plus de 75 ans, atteints d’une coronaropathie multitronculaire et ayant subi une ICP pour traiter un syndrome coronarien aigu (SCA) ont été retenus. Le critère d’évaluation principal était composé du décès, de l’infarctus du myocarde récurrent et de l’accident vasculaire cérébral (AVC) au moment du suivi à 1 an. La variation de la statistique C et le bénéfice net normalisé ont servi à évaluer la valeur ajoutée du SSr.
Les manifestations étaient significativement plus fréquentes chez les patients dont la revascularisation était incomplète (SSr > 8). Lorsque le SSr a été pris en compte dans un modèle de régression de Cox de base ayant pour facteurs l’âge, les antécédents d’infarctus du myocarde et le type de SCA, le rapport des risques instantanés pour les patients ayant un score > 8 était de 2,47 (intervalle de confiance à 95 % : 1,51-4,06). L’intégration du SSr dans le modèle de base n’a toutefois pas donné lieu à une statistique C plus élevée que celle du SSi (0,70 vs 0,69) et conférait peu de valeur ajoutée sur le plan du bénéfice net normalisé.
Chez les patients âgés présentant un SCA et une atteinte multitronculaire, et subissant une ICP, la revascularisation incomplète a été associée à de moins bons résultats au moment du suivi à 1 an. Le SSr n’a toutefois pas été clairement associé à une valeur ajoutée pour prédire une issue défavorable à 1 an comparativement à un modèle reposant sur des paramètres cliniques et le SSi.
BACKGROUND—Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome (ACS), and display higher on-clopidogrel platelet reactivity as compared ...to younger patients. Prasugrel 5 mg provides more predictable platelet inhibition, as compared to clopidogrel, in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding.
METHODS—In a multicenter, randomized, open-label, blinded-endpoint trial, we compared a once daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years with ACS undergoing percutaneous coronary intervention (PCI). The primary endpoint was the composite of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg.
RESULTS—Enrolment was interrupted, according to pre-specified criteria, after a planned interim analysis, when 1443 patients (40% women, mean age 80 years) had been enrolled, with a median follow-up of 12 months, due to futility for efficacy. The primary endpoint occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (HR 1.007, 95% CI, 0.78-1.30; P =0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel vs 1.9% with clopidogrel (OR 0.36, C.I. 0.13-1.00, p=0.06). Bleeding Academic Research Consortium types ≥2 were 4.1% with prasugrel vs 2.7% with clopidogrel (OR 1.52, C.I. 0.85-3.16, P= 0.18).
CONCLUSIONS—The present study in elderly ACS patients showed no difference in the primary endpoint between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in the light of premature termination of the trial.
CLINICAL TRIAL REGISTRATION—URLhttps://clinicaltrials.gov/ Unique IdentifierNCT01777503
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