One-year results from the Assessing MICRO-vascular resistances via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoing primary PCI (AMICRO) trial.

Background: In ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary angioplasty (PPCI) the index of microcirculatory resistance (IMR) correlates to the extent of myocardial damage and left ventricular (LV) function recovery. Data on the IMR time-course and impact on clinical outcome in STEMI patients with multi-vessel disease (MVD) are scarce. Aims: We designed a prospective, multicenter clinical trial to assess the infarct-related artery (IRA)-IMR in STEMI patients with MVD undergoing PPCI and to explore its potential in relationship with outcome and LV remodeling. Methods: The study enrolled 242 STEMI patients with MVD. Both fractional flow reserve (FFR) and IMR of the IRA were assessed after successful PPCI. Then, FFR/IMR measurements were repeated in the IRA at a staged angiography, and FFR-guided angioplasty was performed in non-IRA lesions. The primary endpoint was the composite of cardiovascular death, re-infarction, re-hospitalization for heart failure, resuscitation or appropriate ICD shock at 1-year follow-up. Results: A significant improvement of IRA-IMR values (from 47.9 to 34.2, p < 0.0001) was observed early after PPCI. Staged FFR-guided angioplasty was performed in 102 non-IRA lesions. We failed to find a correlation between IRA-IMR, clinical events and LV remodeling. Notwithstanding, in patients with anterior STEMI an inverse correlation between initial IMR values and LV function at follow-up was observed. Conclusion: After successful PPCI, a significant proportion of patients with STEMI and MVD had coronary microvascular dysfunction as assessed by IMR that recovered early after reperfusion. Higher IMR values predicted lack of improvement of LV function only in anterior STEMI. Clinical trial registration: https://clinicaltrials.gov/, identifier [NCT02325973].

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

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. Coronary heart disease is a chronic degenerative disease, and patients who recover from an acute coronary syndrome (ACS) are at high risk of developing recurrent events.1 Although secondary prevention measures have proved to be effective and are strongly recommended by all of the international guidelines,2., 3. the 4 EUROASPIRE surveys4., 5., 6., 7., 8. showed that there was still a high prevalence of conventional risk factors, that secondary prevention measures were inadequately implemented, and that their main goals were often not reached. In addition, there were considerable discrepancy in secondary prevention practices between centers and countries, and a widespread underuse of cardiac prevention and rehabilitation programs despite their demonstrated effectiveness in reducing cardiovascular risk over time.9., 10. Over the last 10 years, nurses have been increasingly involved in successful cardiovascular risk management,11., 12., 13. but although this has improved levels of cardiovascular risk, no clear reduction in hard end points such as major cardiovascular adverse events and mortality has been demonstrated.10 The aim of the ALLEPRE trial is to evaluate the benefit of a homogeneous, structured, secondary prevention intervention program, fully coordinated by nurses from in- and outpatient clinics, in terms of cardiovascular risk profiles and major clinical events in ACS patients living in the large Emilia-Romagna region of Italy.

Assessing MICRO-vascular resistances via IMR to predict outcome in STEMI patients with multivessel disease undergoing primary PCI (AMICRO): Rationale and design of a prospective multicenter clinical trial.

BACKGROUND: In STEMI patients treated with primary percutaneous coronary angioplasty (PPCI) the evaluation of coronary microcirculatory resistance index (IMR) predict the extent of microvascular damage and left ventricular (LV) remodeling. However, the impact of IMR on the clinical outcome after PPCI in patients with multivessel disease (MVD) remains unsettled. AIM: We designed a prospective multicenter controlled clinical trial to evaluate the prognostic value of IMR in terms of clinical outcome and left ventricular remodeling in STEMI patients with MVD undergoing PPCI. METHODS AND DESIGN: The study will involve 242 patients with MVD defines as the presence of at least a non-culprit lesion of >50% stenosis at index coronary angiography. Both fractional flow reserve (FFR) and IMR will be measured in the infarct-related artery (IRA) after successful PPCI. Measurements of FFR and IMR will be repeated in the IRA and performed in the non-culprit vessels at staged angiography. The non-culprit vessel lesions will be treated only in the presence of a FFR<0.75. A 2D echocardiographic evaluation of the left ventricular (LV) volumes and ejection fraction will be performed before hospital discharge and at 1-year follow-up. The primary end-point of the study will be the composite of cardiovascular death, re-hospitalization for heart failure and resuscitation or appropriate ICD shock during 1-year of follow-up. Secondary end-points will be the impact of IMR in predicting LV remodeling during follow-up and correlations between IMR and ST-segment resolution. Other secondary endpoints will be need for new revascularization, stent thrombosis and re-infarction of the non-culprit vessels territory. IMPLICATIONS: If IMR significantly correlates with differences in outcome and LV remodeling, it will emerge as a potential prognostic index after PPCI in patients with MVD.

Fractional Flow Reserve Evaluation and Chronic Kidney Disease: Analysis From a Multicenter Italian Registry (the FREAK Study).

OBJECTIVES: To establish if the presence of chronic kidney disease (CKD) influences fractional flow reserve (FFR) value in patients with intermediate coronary stenosis. BACKGROUND: FFR-guided coronary revascularization reduces cardiac adverse events in patients with coronary artery disease. CKD impairs microcirculation and increases cardiovascular risk. Whether CKD presence may limit FFR accuracy is unknown. METHODS: We used data from a multicenter prospective registry enrolling 1.004 patients undergoing FFR evaluation for intermediate stenosis. We assessed the relationship between clinical and angiographic variables and FFR measurement. CKD was defined as CrCl value ≤45 ml/min. FFR value was considered potentially flow-limiting, and therefore positive, if ≤0.80. The index of microcirculatory resistance (IMR) was calculated in 20 patients stratified according CrCl value (single-center substudy). RESULTS: FFR measurement was positive in 395 (39%) patients. Overall, 131 (13%) patients had CKD. Patients with CrCl ≤45 ml/min showed significantly higher FFR values as compared to the others (0.84 ± 0.07 vs. 0.81 ± 0.08, p < 0.001). Positive FFR occurrence was lower in patients with CrCl ≤45 ml/min (27% vs. 41%, p < 0.01). After multivariable analysis, diabetes (HR 1.07, 95%CI 1.008-1.13, p = 0.03), left anterior descending (HR 1.35, 95%CI 1.27-1.43, p < 0.001) and CrCl ≤45 ml/min (HR 0.92, 95%CI 0.87-0.97, p = 0.005) emerged as independent predictors of FFR measurement. Accordingly, IMR values were higher in patients with CrCl ≤45 ml/min (32 U [28245] vs. 16 U [11220], p < 0.01). CONCLUSIONS: FFR and IMR measurements differ between CKD patients and those with normal renal function. Flow-limiting FFR is less frequent in patients with CrCl ≤45 ml/min. © 2015 Wiley Periodicals, Inc.

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.

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).

OBJECTIVES: 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. BACKGROUND: New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification. METHODS: A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up. RESULTS: At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR]=0.65, 95% confidence interval [CI]=0.51-0.82, P=0.0004) and angiographic ST (0.5% vs. 1.1%, HR=0.35, 95% CI 0.17-0.72, P=0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84-1.16, P=0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR=0.94, 95% CI=0.83-1.07, P=0.35). CONCLUSIONS: Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI.

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.

Coronary artery surgery versus percutaneous coronary intervention in octogenarians: long-term results.

BACKGROUND: The aim of this study was to compare 7-year rates of all-cause death, cardiac death, myocardial infarction, target vessel revascularization, and stroke in a large cohort of octogenarians with left main coronary artery or multivessel disease, treated with coronary artery bypass grafting or percutaneous coronary intervention. METHODS: Two propensity score-matched cohorts of patients undergoing revascularization procedures at regional public and private centers of Emilia-Romagna, Italy, from July 2002 to December 2008 were used to compare long-term outcomes of percutaneous coronary intervention (947 patients) and coronary artery bypass grafting (441 patients). RESULTS: There were no significant differences between groups in 30-day mortality. In the follow-up the overall and the matched percutaneous coronary intervention population experienced significantly worse outcomes in terms of cardiac mortality, myocardial infarction, and target vessel revascularization. No difference was found for stroke between treatment groups. Percutaneous coronary intervention was an independent predictor of increased death at long-term follow-up. The subgroups in which coronary artery bypass grafting reduced more clearly the risk of death were age 80 to 85 years, previous myocardial infarction, history of cardiac heart failure, chronic renal failure, peripheral vascular disease, and patients with three-vessel disease associated with the left main coronary artery. CONCLUSIONS: In this real-world setting, surgical coronary revascularization remains the standard of care for patients with left main or multivessel disease. The long-term outcomes of current percutaneous coronary intervention technology in octogenarians are yet to be determined with adequately powered prospective randomized studies.

Implantable cardioverter defibrillator system with floating atrial sensing dipole: a single-center experience.

BACKGROUND: The concept of a single-lead dual-chamber implantable cardioverter defibrillator (ICD) with floating sensing atrial dipole has been proven safe and functional. We report a single-center experience with this ICD system; the major focus of the work is on the recorded atrial activation and its stability on a medium term follow-up. METHODS: Thirteen patients received a DX ICD (BIOTRONIK SE & Co, Berlin, Germany) with the Linox Smart S DX(ProMRI) ICD lead; the implantation data were reported. Daily P- and R-wave sensing amplitude was collected and followed up during 200 days; their coefficient of variance (CV) was calculated. In addition, all the atrial and ventricular high-rate episodes were analyzed. RESULTS: The total x-ray exposure time was 3.9 ± 1.8 minutes. The overall mean sensing was 4.2 ± 1.9 mV for P wave and 12.9 ± 4.5 mV for R wave. The CV was significantly higher for the P-wave amplitude than for the R-wave one (0.25 ± 0.11 vs 0.08 ± 0.06; P < 0.001). A total of 27 high ventricular rate episodes were recorded and correctly discriminated by the device. Fifty-six high atrial rate episodes were recorded, 49 were true arrhythmic events. CONCLUSIONS: The single-lead ICD system with floating atrial dipole provides reliable atrial sensing amplitude over time. The physician, without the implantation of an additional lead, has the atrial information that may be used for the discrimination of supraventricular tachyarrhythmia/ventricular tachycardia, for the early detection of atrial fibrillation episodes and for the evaluation of changes in the patient's heart status.

Acute kidney injury after primary angioplasty: effect of different hydration treatments.

AIMS: We evaluated the effect of different dose hydration protocols, with normal saline or bicarbonate, on the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). METHODS: We considered 592 STEMI patients treated with PPCI in 5 Italian centers. Patients were randomized to receive standard or high-dose infusions of normal saline or sodium bicarbonate started immediately before contrast medium administration and continued for the following 12 h. RESULTS: The cumulative incidence of CI-AKI was 18.1% without any difference among treatment groups. Shock, age, ejection fraction 35% or less, and basal serum creatinine were significantly associated with an increased risk of CI-AKI. Follow-up at 12 months was complete in 573 patients. Overall, 25 out of 573 patients died (4.3%). We observed higher short-term mortality rates in patients receiving high-volume hydration. Otherwise, only age, shock and CI-AKI were significantly associated with 1-year mortality. CONCLUSION: In patients with STEMI undergoing PPCI, high-volume hydration with normal saline or sodium bicarbonate administrated at the time of contrast media administration was not associated with any significant advantage in terms of CI-AKI prevention.

Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: Insights from the REAL registry.

OBJECTIVES: To examine the differences in cardiac outcomes for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) as a function of whether they underwent culprit-only primary percutaneous coronary intervention (PPCI) or multivessel PCI, either during PPCI or as a staged procedure. BACKGROUND: MVD occurs in about 40% of patients presenting with STEMI, and it has been associated with a worse outcome compared to single-vessel disease. The most favorable PCI strategy for dealing with significant nonculprit lesions has to be established. METHODS: A total of 2061 STEMI patients with MVD undergoing PPCI, prospectively enrolled in the REAL Registry between July 2002 and December 2010, were considered: 706 underwent culprit-only PPCI; 367 multivessel PCI during the index procedure; 988 had a staged PCI within 60 days. Mortality and outcomes were calculated at 30 days and 2 years. RESULTS: At multivariate analysis, culprit-only PPCI was associated with higher rates of cardiac outcomes as compared to staged multivessel PCI, taken as reference [Hazard Ratio (HR): 2.81, 95% confidence interval (CI): 1.34-5.89, P = 0.006 for 30-day mortality, and HR: 1.93, 95% CI: 1.35-2.74, P = 0.0002 for 2-year mortality, respectively]. Short-term mortality rates were higher in multivessel PCI group as compared to staged PCI group (HR: 2.58, 95% CI: 1.06-6.26, P = 0.03); no differences were observed at 2-year follow-up (HR: 1.08, 95% CI: 0.64-1.82, P = 0.76). CONCLUSIONS: Our findings support the current guidelines recommendation to perform culprit-only PPCI in STEMI patients with MVD without hemodynamic compromise, followed by a staged PCI of noninfarct-related significant lesions.

Incidence and outcome of high on-treatment platelet reactivity in patients with non-ST elevation acute coronary syndromes undergoing percutaneous coronary intervention (from the VIP [VerifyNow and Inhibition of Platelet Reactivity] study).

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y12 reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y12 reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y12 reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.

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.

Five-year outcomes of surgical or percutaneous myocardial revascularization in diabetic patients.

BACKGROUND: The study compares five-year clinical outcomes of CABG vs PCI in a real world population of diabetic patients with multivessel coronary disease since it is not clear whether to prefer surgical or percutaneous revascularization. METHODS: Between July 2002 and December 2008, 2885 multivessel coronary diabetic patients underwent revascularization (1466 CABG and 1419 PCI) at hospitals in Emilia-Romagna Region, Italy and were followed for 1827 ± 617 days by record linkage of two clinical registries with the regional administrative database of hospital admissions and the mortality registry. Five-year incidences of MACCE (mortality, acute myocardial infarction [AMI], stroke, and repeat revascularization [TVR]) were assessed with Kaplan-Meier estimates, Cox proportional hazards regression and cumulative incidence functions of death and TVR, to evaluate the competing risk of AMI on death and TVR. The same analyses were applied to the propensity score matched subgroup of patients undergoing CABG or PCI with DES and with complete revascularization. RESULTS: PCI had higher mortality for all causes (HR: 1.8, 95% CI 1.4-2.2 p<0.0001), AMI (HR: 3.3, 95% CI 2.4-4.6 p<0.0001) and TVR (HR: 4.5, 95% CI 3.4-6.1 p<0.0001). No significant differences emerged for stroke (HR: 0.8, 95% CI 0.5-1.2 p=0.26). The higher incidence of AMI caused higher mortality in PCI group. Results did not change comparing CABG with PCI patients receiving complete revascularization or DES only. CONCLUSIONS: Diabetics show a higher incidence of MACCE with PCI than with CABG: thus diabetes and its degree of control should be considered when choosing the type of revascularization.

Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis.

Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting.Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used.Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial.

OBJECTIVES: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. METHODS: A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. RESULTS: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). CONCLUSIONS: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

Coronary stenting using the radial approach in two women with situs viscerum inversus and acute myocardial infarction.

A situs inversus with dextrocardia (DC) is a rare condition in adults. Usually, patients have structurally normal hearts and normal life expectancy. The incidence of coronary artery disease in this setting is similar to that in the general population. Coronary revascularization may present potential difficulties related to the unusual anatomy. Although the radial artery is a safe and effective site of access for coronary interventions, some anatomical variations may make this procedure more complicated. We describe two cases of patients with situs viscerum inversus and acute myocardial infarction who underwent successful transradial percutaneous coronary intervention (PCI). We will show that coronary angioplasty with stent application via the radial approach in patients with DC is feasible and effective also in emergency and urgent care.

Antithrombotic management and 1-year outcome of patients on oral anticoagulation undergoing coronary stent implantation (from the Registro Regionale Angioplastiche Emilia-Romagna Registry).

Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients.

Transradial versus transfemoral intervention for acute myocardial infarction: a propensity score-adjusted and -matched analysis from the REAL (REgistro regionale AngiopLastiche dell'Emilia-Romagna) multicenter registry.

OBJECTIVES: This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach. BACKGROUND: Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty. METHODS: We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching. RESULTS: A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052). CONCLUSIONS: In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

Timing of events in STEMI patients treated with immediate PCI or standard medical therapy: implications on optimisation of timing of treatment from the CARESS-in-AMI trial.

OBJECTIVES: Early angioplasty after thrombolysis is now recommended for ST-elevation myocardial infarction, but the current guidelines propose a wide time-window ranging between 3 and 24h after lytic administration. To identify the optimal timing for PCI after thrombolysis, we analyzed frequency and time course of the adverse events in patients randomized in the multicenter CARESS-in-AMI trial. METHODS: 598 high-risk patients with STEMI recruited in the CARESS-in-AMI study, were divided into the Immediate PCI group (IMM, n=298), Rescue PCI group (RES, n=107) and Standard Treatment Arm without rescue PCI (STA, n=193). RESULTS: RES patients had worse pre-procedural TIMI flow and post-procedural blush grade. At 30 days, there were 23 deaths: 11 (10.3%) in RES, 9 (3%) in IMM and 3 (1.6%) in STA (p<0.001). There were 22 episodes of refractory ischemia or re-infarction: 17 (8.8%) in the STA group, 4 (1.6%) in IMM and 1 (0.9%) in RES (p<0.001). In the RES group 10/11 (90.9%) deaths occurred before day 5. In the STA group, all deaths and the majority of ischemic events occurred after day 3. A reduction of risk of death was observed if PCI after thrombolysis was performed within 3.35 h from initial hospitalization. CONCLUSIONS: The mortality benefit of immediate referral to PCI after pharmacological treatment for STEMI derives from a reduction in the time to reperfusion of patients with failed thrombolysis in need of rescue PCI. In patients with evidence of successful reperfusion, "elective" PCI within 3 days may be sufficient to reduce the recurrent ischemic events.