Emilia Solinas

Effectiveness of Drug-Eluting Stent Implantation for Patients With Unprotected Left Main Coronary Artery Stenosis

This study was aimed to evaluate outcomes of patients with unprotected left main coronary artery (LMCA) stenosis who were treated with drug-eluting stents. Sixty-three consecutive patients with unprotected LMCA stenosis were treated with sirolimus-eluting stents in 52 (83%) patients and paclitaxel-eluting stents in 11 (17%) patients, in whom percutaneous intervention was considered the sole alternative because of high surgical risk and/or patient preference. Urgent percutaneous coronary intervention within 24 hours after angiography was performed in 6 (10%) patients. The patients were predominantly at high surgical risk with 35 (56%) having EuroSCORE >6 and 39 (62%) having Parsonnet score >15. Involvement of the distal LMCA was observed in 46 (73%) patients. Procedural success was achieved in all patients. Intravascular ultrasound was used in 51 (81%) patients. Single-stenting strategy was adopted in 36 (78%) patients with bifurcation stenosis. There were no death, Q-wave myocardial infarction, stent thrombosis, or urgent repeat revascularization events during hospitalization. Over a mean follow-up of 11.7 +/- 7.7 months, 18 (29%) patients experienced major adverse cardiac events, including 3 (5%) deaths, 7 (11%) myocardial infarctions, and 10 (16%) target lesion revascularizations. Stent thrombosis developed in 1 (0.6%) patient at 35 days after the procedure. Bifurcation involvement was an independent predictor of major adverse cardiac events by multivariate analysis (hazard ratio 12.90, 95% confidence interval 1.36 to 122.45, p = 0.0259). In conclusion, drug-eluting stent placement for unprotected LMCA stenosis may be a feasible therapeutic alternative in patients at high surgical risk. However, bifurcation stenosis remains a significant predictor of unfavorable clinical outcome.

Angiographic Patterns of Drug-Eluting Stent Restenosis and One-Year Outcomes After Treatment With Repeated Percutaneous Coronary Intervention

Patterns of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation and outcomes after treatment have not been studied systematically in all comers. We compared patterns of ISR and outcomes of repeated percutaneous coronary intervention in consecutive patients with DES-ISR. A total of 137 patients with 182 lesions underwent repeated percutaneous coronary intervention for DES-ISR at Columbia University Medical Center from August 2004 to April 2006. DES-ISR was treated with repeated DES placement in 84% of patients and balloon angioplasty in 16%. There was 1 stent thrombosis at 30 days, and at 1 year, major adverse cardiac events occurred in 10% of patients, driven primarily by an 8% rate of target-lesion revascularization. After exclusion of 12 patients with multiple ISR lesions, data were further analyzed from 125 patients with 152 DES-ISR lesions, of which 118 were originally treated with sirolimus-eluting stents and 34 were treated with paclitaxel-eluting stents (PES-ISR). Baseline features were well matched between the 2 groups, except that patients with PES-ISR were older. A focal pattern of ISR was observed in 69.5% of patients overall. However, patients originally treated with a PES had a significantly higher frequency of diffuse-intrastent ISR in comparison with sirolimus-eluting stent ISR (30.3% vs 13.6%, p = 0.03). In conclusion, the pattern of ISR in most DES-ISR in this unselected patient population was focal, with higher rates of diffuse intrastent restenosis seen with PES-ISR. Treatment with either repeated DES implantation or balloon angioplasty for DES-ISR was safe and associated with low overall rates of target-lesion revascularization and major adverse cardiac events at 1 year.

64-slice computed tomography coronary angiography: diagnostic accuracy in the real world

PurposeThis study was done to evaluate the diagnostic accuracy of 64-slice computed tomography coronary angiography (CTCA) for the detection of significant coronary artery stenosis in the real clinical world.Materials and methodFrom the CTCA database of our institution, we enrolled 145 patients (92 men, 52 women, mean age 63.4 ± 10.2 years) with suspected coronary artery disease. All patients presented with atypical or typical chest pain and underwent CTCA and conventional coronary angiography (CA). For the CTCA scan (Sensation 64, Siemens, Germany), we administered an IV bolus of 100 ml of iodinated contrast material (Iomeprol 400 mgI/ml, Bracco, Italy). The CTCA and CA reports used to evaluate diagnostic accuracy adopted ≥50% and ≥70%, respectively, as thresholds for significant stenosis.ResultEleven patients were excluded from the analysis because of the nondiagnostic quality of CTCA. The prevalence of disease demonstrated at CA was 63% (84/134). Sensitivity, specificity and positive and negative predictive values for CTCA on a per-segment, per-vessel, and per-patient basis were 75.6%, 85.1%, 97.6%; 86.9%, 81.8%, 58.0%; 48.2%, 68.1%, 79.6%; and 95.7%, 92.3%, 93.5%, respectively. Only two out of 134 eligible patients were false negative. Heart rate did not significantly influence diagnostic accuracy, whereas the absence or minimal presence of coronary calcification improved diagnostic accuracy. The positive and negative likelihood ratios at the per-patient level were 2.32 and 0.041, respectively.ConclusionCTCA in the real clinical world shows a diagnostic performance lower than reported in previous validation studies. The excellent negative predictive value and negative likelihood ratio make CTCA a noninvasive gold standard for exclusion of significant coronary artery disease.RiassuntoObiettivoValutare l’accuratezza diagnostica dell’angiografia coronarica non invasiva con tomografia computerizzata (CT-CA) a 64 strati nell’individuazione delle stenosi coronariche significative (riduzione del lume coronarico ≥50%) basando la valutazione sulla refertazione clinica.Materiali e metodiDal database della CT-CA sono stati arruolati nello studio 145 pazienti (92 maschi, 52 femmine, età media 63,4±10,2 anni) con sospetta malattia coronarica. I pazienti si presentavano con dolore toracico atipico o angina pectoris stabile e hanno poi eseguito CT-CA e coronarografia convenzionale (CAG). Per la scansione CT-CA (Sensation 64, Siemens, Germania) sono stati iniettati endovena 100 ml di mezzo di contrasto. (Iomeprol 400 mgI/ml, Bracco, Italia). I referti della CT-CA e della CAG sono utilizzati per la valutazione dell’accuratezza diagnostica utilizzano la definizione di stenosi ≥50% per la CT-CA e ≥70% per la CAG.RisultatiUndici pazienti sono stati esclusi dall’analisi per CT-CA di qualità insufficiente. La prevalenza di malattia dimostrata alla CAG era del 63% (84/134). Sensibilità, specificità, valore predittivo positivo e negativo della CT-CA nella determinazione delle stenosi significative utilizzando un’analisi per segmento, per vaso e per paziente sono risultate del 75,6%, 85,1%, 97,6%; 86,9%, 81,8%, 58,0%; 48,2%, 68,1%, 79,6%; e 95,7%, 92,3%, 93,5%, rispettivamente. Solo due pazienti su 134 eleggibili per lo studio sono risultati falsi negativi. La frequenza cardiaca non ha mostrato influenzare significativamente l’accuratezza diagnostica, mentre la presenza di scarse o assenti calcificazioni coronariche ha determinato un incremento dei valori di accuratezza diagnostica. I likelihood ratio positivo e negativo nell’analisi per paziente sono risultati 2,32 e 0,041, rispettivamente.ConclusioniLa CT-CA nel mondo reale mostra una performance diagnostica inferiore rispetto agli studi di validazione pubblicati in letteratura. I valori ottimali di valore predittivo negativo e likelihood ratio negativo collocano la CT-CA tra le metodiche non invasive gold standard per l’esclusione di malattia coronarica critica.

Twenty-four months clinical outcomes of sirolimus-eluting stents for the treatment of small coronary arteries: the long-term SES-SMART clinical study.

AIMS It has been demonstrated that, in comparison with bare-metal stents (BMS), sirolimus-eluting stents (SES) reduce restenosis after the percutaneous revascularization of small coronary arteries, but the long-term clinical outcomes of this treatment have not yet been investigated. METHODS AND RESULTS The long-term SES-SMART clinical study was a multicentre, prospective, randomized, single-blind study of 257 patients receiving a SES or BMS in a small coronary artery, who were evaluated at discharge, 30 days, 8 and 24 months after stenting. The clinical endpoint of the study was a 24 months composite of major adverse cardiac and cerebrovascular events, which included death, non-fatal myocardial infarction, ischaemia-driven target lesion revascularization (TLR), and cerebrovascular accident. The 24 months follow-up was completed by 254 patients (98.8%). The use of SES was associated with a significantly lower incidence of the clinical endpoint (12.6% vs. 33.1%; HR 0.30, 95% CI: 0.17-0.55; P < 0.0001), which was not only due to a reduction in TLR (7.9% vs. 29.9%; HR 0.30, 95% CI: 0.16-0.59; P < 0.0001), but also to a reduction in myocardial infarction (1.6% vs. 10.2%; HR 0.09, 95% CI: 0.01-0.66; P = 0.018). CONCLUSION In comparison with BMS, the use of SES in the percutaneous revascularization of small coronary arteries is associated with improved clinical outcomes after 2 years follow-up.

Research and Clinical Applications of Optical Coherence Tomography in Invasive Cardiology: A Review

In cardiology, optical coherence tomography (OCT) is an invasive imaging technique based on the principle of light coherence. This system was developed to obtain three-dimensional high resolution images to examine coronary artery normal and/or pathological structure. This technique replaces the ultrasound used by its main alternative procedure, intravascular ultrasound, by a near-infrared light source. Acute coronary syndromes due to atherosclerotic vascular disease are the leading cause of mortality in developed and developing countries. As a consequence, intravascular imaging systems became an important area of research and 1991 marks the first use of OCT in coronary artery observations. Since its first appearance in invasive cardiology, OCT maintains a strong presence in the research environments for the identification of vulnerable plaques, as it is able to overcome difficulties presented by other techniques such as virtual intravascular ultrasound, near-infrared spectroscopy, and histology. Moreover, OCT is increasingly being used in the clinical practice as a guide during coronary interventions and in the assessment of vascular response after coronary stent implantation. This review focuses on the relevance of OCT in research and clinical applications in the field of invasive cardiology and discusses the future directions of the field.

Relevance of gender in patients with acute myocardial infarction undergoing coronary interventions.

Aims To evaluate whether gender differences in terms of up to 4-year outcome still persist within patients with acute myocardial infarction (AMI) who uniformly underwent coronary revascularization, we performed a gender comparison in a large contemporary multicentre percutaneous intervention (PCI) registry. Materials and methods We retrospectively analyzed data from 18 351 patients with AMI, who underwent percutaneous coronary interventions (5093 women and 13 258 men) in the Emilia Romagna region of Italy between July 2002 and December 2007. Median follow-up was 1174 days. Results After propensity score adjustment, differences in gender-related mortality were not temporarily homogeneous: 30-day adjusted mortality was higher in women than in men [hazard ratio (HR): 1.40, P < 0.0001], whereas thereafter female gender showed a significantly lower mortality risk (HR: 0.84, P = 0.01). Notably, younger women (<50 years old) both in the acute and postacute period had more than 3.6 higher risk of mortality when compared with men, whereas older women, particularly after the first 30-day post AMI, had similar (50–80 years old) or even better (≥80 years old) survival compared with men. Finally 1-month adjusted risk of heart failure and post PCI vascular complications requiring surgical treatment was higher in women while there was no detectable difference in terms of early and late AMI/unstable angina, stroke and angiographic stent thrombosis. Conclusion In a contemporary large real-world AMI population treated with PCI, we found gender-related temporal and age-dependent adjusted differences in mortality. Our data suggest the hypothesis that biological gender-related differences could, in part, explain these findings.

New-generation drug-eluting stents reduce stent thrombosis and myocardial infarction: A propensity-score-adjusted analysis from the multicenter REAL registry (REgistro Regionale AngiopLastiche Dell'Emilia-Romagna)

The aim of this study was to compare long‐term clinical outcomes in patients treated with new‐generation drug‐eluting stent (DES) or early‐generation DES in a real‐world registry.

Same-day transfer for the invasive strategy of patients with non-ST-segment elevation acute coronary syndrome admitted to spoke hospitals: Data from the Emilia-Romagna Regional Network

Background: The service strategy (same-day transfer between spoke hospital and hub centre with catheterisation laboratory (cath-lab) facility to perform invasive procedures) has been suggested to improve the management of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) admitted to spoke hospitals. We used data from a large prospective Italian registry to describe application, performance and outcome of the service strategy in the daily clinical practice. Methods: This study was based on an observational, post-hoc analysis of all consecutive NSTEACS patients admitted to spoke non-invasive hospitals of the Emilia-Romagna regional network and receiving coronary artery angiography (CAA)±percutaneous coronary intervention (PCI). We evaluated: application of service strategy, time to cath-lab access, hospital stay length, 30-days occurrence of adverse events. Results: From January 2011–December 2012, 2952 NSTEACS consecutive patients were admitted to spoke non-invasive hospitals and received CAA. Overall, 1765 (60%) patients were managed with a service strategy. After multivariable analysis, service strategy emerged as independent predictor of faster access to cath-lab (within 72 h: hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.9–2.7, p<0.0001; within 24 h: HR 2.8, 95% CI 2.2–3.3, p<0.0001, respectively). Service strategy significantly reduced hospital stay length (–5.5 days, p<0.0001). We estimated a mean of €1590 saved for each patient managed with service strategy. Thirty-day occurrence of adverse events did not differ between patients managed with or without a service strategy. Conclusions: In our daily clinical practice, a service strategy seems to be an effective approach to optimise the invasive management of NSTEACS patients admitted to spoke hospitals.

Association of bleeding, mortality and sex in acute coronary syndromes: the missing triangle.

Aims Percutaneous coronary intervention (PCI) and antithrombotic drugs are the standard therapy for patients with acute coronary syndromes (ACS), but their impact on bleeding and mortality in women has not been adequately investigated. Methods This was a prospective observational cohort study of ACS patients, who were referred to 6 of the 13 centres belonging to the REgistro regionale AngiopLastiche dell’Emilia-Romagna programme in Emilia-Romagna for coronary angiography and PCI between June 2010 and November 2011. The aim of the study was to verify whether the incidence of Global Registry of Acute Coronary Events-defined in-hospital bleeding after an ACS is significantly higher in women than in men, and to evaluate its impact on short and long-term mortality. Results The analysis involved a total of 1686 patients (511 women and 1175 men). The women were older and more frequently affected by hypertension, congestive heart failure and single-vessel disease; however, none of the clinical or procedural variables was significantly different between the sexes after statistical adjustment. There was a significantly higher rate of in-hospital bleeding among the women [8.6 vs. 5.8%; adjusted odds ratio 1.73, 95% confidence interval (CI) 1.19–2.52, P = 0.004], but the adjusted hazard ratio for short and long-term all-cause mortality was not significantly different. After optimal adjustment, bleeding, but not female sex, was identified as a predictor of short-term all-cause mortality (hazard ratio 2.68, 95% CI 1.21–5.93, P = 0.01), but this was not confirmed in the case of long-term mortality (hazard ratio 1.57, 95% CI 0.91–2.71, P = 0.10). Conclusion After optimal adjustment for baseline differences, the findings of this contemporary Italian PCI registry study showed that women experience bleeding more frequently, but do not have worse mortality outcomes than men. Bleeding was confirmed as an independent predictor of short-term mortality.

ALLiance for sEcondary PREvention after an acute coronary syndrome. The ALLEPRE trial: A multicenter fully nurse-coordinated intensive intervention program

Abstract The main objective of cardiovascular disease prevention is to reduce morbidity and mortality by promoting a healthy lifestyle, reducing risk factors, and improving adherence to medications. Secondary prevention after an acute coronary syndrome has proved to be effective in reducing new cardiovascular events, but its limited use in everyday clinical practice suggests that there is considerable room for improvement. The short-term results of evidence-based studies of nurse-coordinated secondary prevention programs have been positive, but there is a lack of long-term outcome data. The Alliance for the Secondary Prevention of Cardiovascular Disease in the Emilia-Romagna region (ALLEPRE) is a multicenter, randomized, controlled trial designed to compare the effects of a structured nurse-coordinated intensive intervention on long-term outcomes and risk profiles after an acute coronary syndrome with those of the standard of care. All of the patients randomized to the intervention group take part in 9 one-to-one sessions with an experienced nurse from the participating centers with the aim at promoting healthy lifestyles, reducing risk factors, and increasing adherence to medication over a mean period of 5 years. The primary clinical end point is the reduction in the risk of the 5-year occurrence of major adverse events (a composite of cardiovascular mortality, nonfatal reinfarction, and nonfatal stroke). The primary surrogate end point is the achievement of prespecified targets relating to classical risk factors, lifestyle modifications, and adherence to pharmacological therapy after 2 years of follow-up.