Percutaneous artErial closure devices and ultrasound-guided Trans-femoRal puncture ObservatioNal InvestigatiOn: Insights from the PETRONIO registry.

OBJECTIVE: To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. BACKGROUND: U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. METHODS: All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (a) control period with F and M mainly performed; (b) phase out period where U and P were introduced; (c) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). RESULTS: Four hundred eighteen procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; p = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; p = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. CONCLUSIONS: The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleedings with a progressive improvement after the first 6 months learning period.

Combined use of intra-aortic balloon pump and impella in cardiogenic shock: A systematic review.

BACKGROUND: Use of Intra-Aortic Balloon Pump (IABP) in combination with Impella has been described as an alternative strategy for mechanical circulatory support (MCS) in patients with cardiogenic shock (CS). We provide a systematic review aimed to explore the effectiveness of this paired MCS approach. METHODS: We conducted a comprehensive systematic search in MEDLINE, Scopus, and Cochrane databases to identify all studies that investigated dual MCS with IABP and Impella. RESULTS: Our search strategy identified 12 articles, including 1 randomized controlled trial, 1 retrospective study, 1 case series, 7 case report and 2 animal studies. Rationale for this combined MCS strategy stems from an observed reduction in myocardial oxygen demand/supply ratio compared to the use of each device alone, without determining significant variations in left ventricular work. Nonetheless, this combined approach also leads to a 30-40 % decline in Impella flow, increasing the risk of bleeding, Impella displacement, as well as triggering positioning and pressure alarms. Additionally, hemolytic risk data yielded inconclusive results. Importantly, there were no notable disparities in mortality rates when comparing the combined strategy to the use of each device individually. CONCLUSION: At the current state-of-the-art, there are no conclusive data demonstrating net clinical benefits of combining Impella with IABP. Considering the substantial risks of morbidity associated, we recommend against its use in clinical practice.

Efficacy and safety of a minimalistic balloon aortic valvuloplasty strategy in a centre without heart surgery.

Background: Balloon aortic valvuloplasty (BAV) is a palliative tool for patients with symptomatic severe aortic stenosis (AS) at prohibitive risk for surgery or as a bridge to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). BAV is traditionally performed in hospitals with onsite cardiac surgery due to its potential complications. Aims: The aim of this study was to evaluate the safety of BAV procedures performed by trained high-volume operators in a centre without onsite surgery and to assess the effect of a minimalistic approach to reduce periprocedural complications. Methods: From 2016 to 2021, 187 BAV procedures were performed in 174 patients. Patients were elderly (mean age: 85.0±5.4 years) and had high-risk (mean European System for Cardiac Operative Risk Evaluation score [EuroSCORE] II: 10.1±9.9) features. According to the indications, 4 cohorts were identified: 1) bridge to TAVR (n=98; 56%); 2) bridge to SAVR (n=8; 5%); 3) cardiogenic shock (n=11; 6%); and 4) palliation (n=57; 33%). BAV procedures were performed using the standard retrograde technique via femoral access in 165 patients (95%), although radial access was used in 9 patients (5%). Ultrasound-guided vascular puncture was performed in 118 patients (72%) and left ventricular pacing was administered through a stiff guidewire in 105 cases (60%). Results: BAV safety was confirmed by 1 periprocedural death (0.6%), 1 intraprocedural stroke (0.6%), 2 major vascular complications (1%) and 9 minor vascular complications (5%). Nine cases of in-hospital mortality occurred (5%), predominantly in patients with cardiogenic shock. Conclusions: BAV is a safe procedure that can be performed in centres without onsite cardiac surgery using a minimalistic approach that can reduce periprocedural complications.

Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.

Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.

Health-Status Outcomes in Older Patients With Myocardial Infarction: Physiology-Guided Complete Revascularization Versus Culprit-Only Strategy.

BACKGROUND: The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) enrolled 1445 older (aged ≥75 years) patients with myocardial infarction and multivessel disease in Italy, Spain, and Poland. Patients were randomized to physiology-guided complete revascularization or treatment of the only culprit lesion. Physiology-guided complete revascularization significantly reduced ischemic adverse events at 1 year. This prespecified analysis investigated the changes between the 2 study groups in angina status, quality of life, physical performance, and frailty. METHODS: Patients underwent validated scales at hospital discharge (baseline) and 1 year later. Angina status was evaluated using the Seattle Angina Questionnaire, health-related quality of life by EQ visual analog scale, physical performance by short physical performance battery, and frailty by the clinical frailty scale. Mixed models for repeated measures analysis were used to study the association between the treatment arms, time, and scales. RESULTS: Baseline and 1-year Seattle Angina Questionnaire, EQ visual analog scale, short physical performance battery, and clinical frailty scale were collected in around two-thirds of the entire FIRE study population. The mean age was 80.9±4.6 years (female sex, 35.9%). Overall, 35.3% were admitted for ST-segment-elevation myocardial infarction, whereas the others were admitted for non-ST-segment-elevation myocardial infarction. Physiology-guided complete revascularization, compared with culprit-only revascularization, was associated with greater improvement in terms of angina status (Seattle Angina Questionnaire summary score, 7.3 [95% CI, 6.1-8.6] points), health-related quality of life (EQ visual analog scale, 6.2 [95% CI, 4.4-8.1] points), and physical performance (short physical performance battery, 1.1 [95% CI, 0.9-1.3] points). After 1 year, patients randomized to culprit-only revascularization experienced a deterioration in frailty status (clinical frailty scale, 0.2 [95% CI, 0.1-0.3] points), which was not observed in patients randomized to physiology-guided complete revascularization. CONCLUSIONS: The present analysis suggested that a physiology-guided complete revascularization is associated with consistent benefits in terms of angina status, quality of life, physical performance, and the absence of further deterioration of the frailty status. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03772743.

Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study.

BACKGROUND: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. METHODS: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. CONCLUSIONS: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.

[Is it time to implement Cardiac Arrest Centers in Italy? The integrated experience in the decade 2009-2019 between metropolitan area and Maggiore Hospital of Bologna]. / È il momento per implementare i Centri per l'Arresto Cardiaco in Italia? L'esperienza integrata nel decennio 2009-2019 tra area metropolitana ed Ospedale Maggiore di Bologna.

Cardiac arrest (CA) is the third cause of death in Europe. This paper highlights the various treatments for the prevention and early management of CA and provides an overview of available evidence on the CA center concept. The experience of Maggiore Hospital of Bologna, Italy over the last 11 years is also outlined along with the treatments applied to patients with CA and their impact on improving outcomes. The new concept of the "Systems Saving Lives" approach is presented as a potential way for implementing Italian healthcare systems involved in the management of CA patients. Finally, the future perspective of implementation of CA centers in Italy is also described encouraging the healthcare professionals involved in the treatment of CA patients to consider a multidisciplinary approach (including a cardiologist, emergency physician, neurologist, physiatrist, radiologist, and intensivist).

[Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry]. / Gestione periprocedurale della terapia anticoagulante ed esiti intraospedalieri nei pazienti con indicazione a warfarin sottoposti ad angioplastica coronarica. Informazioni dal registro WAR-STENT.

BACKGROUND: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. METHODS: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. RESULTS: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route. CONCLUSIONS: In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.

Risk for contrast nephropathy in patients undergoing coronarography.

Among the causes of in-hospital acute renal failure, contrast-induced nephropathy ranks third in prevalence. Although it represents a condition of renal impairment with spontaneous recovery, contrast nephropathy should always be considered, because it prolongs hospitalization and it may become a severe complication requiring dialysis. The purposes of this study are: (i) to determine if the application of the most effective contrast-induced nephropathy prevention strategies in the Cardiology Intensive Care Unit can prove to be successful in reducing nephropathy risk; and (ii) to identify which of the involved risk factors persist after the preventive treatment. We examined the patients who had a coronarography at the Bentivoglio hospital from April 2007 to April 2008 who required at least 3 days of permanence in hospital due to the presence of potential risk factors; 136 out of 784 patients were included. Among the selected patients, 21 (15.44%) developed a renal impairment compatible with contrast-induced nephropathy. The risk factors that seemed to display the best correlation with risk of contrast nephropathy were advanced age and an ventricular failure (ejection fraction <40%); however, the critical condition did not appear to be due to a single risk factor, but it resulted from the association of more contextual risk factors. Particularly, the concomitant presence of ventricular failure, anemia, diabetes, previous myocardial infarction and advanced age (>70 years) determined a threefold increased risk of contrast nephropathy. Our data suggest that the development of contrast nephropathy following coronarography is associated with worse renal function during hospitalization and at discharge.

Periprocedural management and in-hospital outcome of patients with indication for oral anticoagulation undergoing coronary artery stenting.

PURPOSE: In patients on oral anticoagulation (OAC) undergoing coronary stenting (PCI-S), procedural management and in-hospital outcome have never been specifically and prospectively investigated. Also, the contribution of early bleeding to the relevant hemorrhagic rate reported at follow-up with triple therapy of OAC, aspirin, and clopidogrel is largely unknown. METHODS: Consecutive patients with indication for OAC undergoing PCI-S at 5 centers were enrolled and prospectively evaluated. RESULTS: Out of 3410 patients undergoing PCI-S in the study period, indication for OAC was present in 4.8%. Femoral approach and bare metal stents were the most frequently used. During PCI-S, OAC was continued in about 30% of patients, whereas in about 20% heparin bridging was carried out. Glycoprotein IIb/IIIa inhibitors were rarely used (11%), whereas a standard bolus of unfractionated heparin was given in 93% of cases. Major adverse cardiovascular events (MACE) occurred in 4.8% of patients and major bleeding in 4.3%. No predictors of MACE or bleeding were identified, although the femoral approach was of borderline significance for major bleeding (OR 4.6, 95% CI 1.0-20.8; P = 0.05). A history of previous hemorrhage (OR 5.3, 95% CI 1.6-18.1; P = 0.007) predicted Carbofilm-coated stent implantation. CONCLUSIONS: A limited, albeit clinically relevant, proportion of patients undergoing PCI-S has indication for OAC. Procedural management appears not substantially different from that of common patients. In-hospital major bleeding is relevant and should be taken into account when evaluating the overall hemorrhagic rate at a medium- to long-term follow-up.

[ANMCO Position paper: From acute to chronic disease: the needs of complex cardiac patients]. / Position paper ANMCO: Bisogni assistenziali del malato cardiopatico complesso: dalla fase acuta alla fase cronica.

Managing a patient suffering from a chronic disease requires a multidisciplinary team that can take care of them beyond the simple coordination of various specialties. In this context, a central role in the treatment of chronic heart disease is the continuity of care that should promote organic integration among different hospital departments, hospital and community. This position paper of the Italian Association of Hospital Cardiologists (ANMCO) aims at defining the general principles to inspire care for complex cardiac patients at different phases of the disease. A multidisciplinary integrated holistic approach uses analytical tools able to understand the elements that characterize complexity and therefore suggest appropriate management strategies: (i) care pathways aimed at optimizing treatments; (ii) care pathways in intensive care and ward in a multidisciplinary perspective; (iii) integration of social and health needs; (iv) nursing role in the context of continuity of outpatient, community and home care; (v) promotion of educational interventions.

Post-coronarography application of continuous veno-venous hemofiltration in the prevention of contrast nephropathy in patients with complex multisystem deficiency.

BACKGROUND: An increased admission of high-risk patients to diagnostic and interventional radiological procedures with contrast medium has resulted in an increase of contrast-induced nephropathy, which now represents the third main cause of hospital-acquired acute renal failure. The pathogenic mechanism of contrast-induced nephropathy (CN) is unclear, but there is much evidence which indicated an interaction between direct tubular cytotoxicity and osmotic/hemodynamic effects. Continuous veno-venous hemofiltration (CVVH) has shown possible benefits in preventing CN. It is not understood when and how prophylactic strategies should be used either in pharmacological therapies or in continous renal replacement therapy (CRRT) approaches. The aim of this study was to evaluate the efficiency of the CVVH technique in preventing CN secondary to emergency radiological procedures in very high-risk patients. PATIENTS AND METHODS: Twelve patients with severe chronic renal impairment (serum creatinine concentration >2 mg/dl with an estimated glomerular filtration rate (eGFR) <40 ml/min) in association with at least two severe comorbidities (such as previous acute myocardial infarction in hypertensive or diabetic patients obesity, cardiac failure with ejection fraction <40%, severe hypotension) were treated with CVVH after coronarography using an iso-osmolar contrast medium (Visipaque, Iodixanol), with or without percutaneous transluminal coronary angioplasty. Adverse events and their association with the interventional radiological procedure were investigated after hemofiltration. RESULTS: Statistically significant differences were observed for both eGFR and serum creatinine at different time points (pre-, post- and 7 days after the procedure) at p<0.05. Statistical analysis of all the variables related to the radiological procedure and the hemofiltration technique did not cause any modification of renal function between the pre- and post-procedure values. No patient showed signs of cardiovascular instability, nor were any episodes of marked hypotension reported during the dialysis session. No patient showed any adverse effects related to the interventional radiological procedure or to the CVVH technique. Renal function, according to serum creatinine concentration and the e-GFR calculation (Cockcroft), did not worsen but had improved when the patients left hospital, with function rates statistically significantly better compared to that on hospital admission, even 7 days after the radiological procedure. CONCLUSION: The present study suggests the efficiency of the CVVH technique in preventing CN in high-risk patients who need to undergo interventional radiological cardiovascular procedures involving the administration of an iodine-based contrast medium.

Value of baseline left lateral wall postsystolic displacement assessed by M-mode to predict reverse remodeling by cardiac resynchronization therapy.

Although left ventricular (LV) dyssynchrony assessed by ultrasound is emerging as superior to QRS duration in predicting response to cardiac resynchronization therapy (CRT), the role of conventional echocardiographic parameters of dyssynchrony is still debated. Forty-eight patients with heart failure in New York Heart Association classes III to IV, LV ejection fraction < or =35%, and QRS duration > or =120 ms were studied. LV dyssynchrony was evaluated by M-mode as septal-to-posterior wall motion delay and left lateral wall postsystolic displacement (LWPSD). Interventricular dyssynchrony was defined as the difference between the LV and right ventricular preejection periods measured by standard Doppler. Reverse remodeling was defined as an LV end-systolic volume decrease > or =15% after 6 months of CRT. Thirty-one patients (65%) were considered responders to CRT. At baseline responders differed from nonresponders by having less severe New York Heart Association class (p = 0.006), lower percentage of ischemic cause (p = 0.006), longer PR interval (p = 0.013), shorter LV diastolic filling time corrected for heart rate (p = 0.005), and presence of LWPSD (p = 0.003). At multivariate analysis, predictors of CRT response were LWPSD (odds ratio [OR] 1.045, 95% confidence interval [CI] 1.001 to 1.091; p = 0.043), LV diastolic filling time corrected for heart rate (OR 0.855, 95% CI 0.744 to 0.981, p = 0.026), and nonischemic cause (OR 0.109, 95% CI 0.018 to 0.657, p = 0.016). In conclusion, preimplantation assessment of cardiac dyssynchrony based on M-mode LWPSD may predict LV reverse remodeling after CRT, especially in patients with nonischemic cause and shorter diastolic filling time. This suggests the potential role of baseline postsystolic mechanical phenomena in determining response to CRT independently of QRS duration.

Low-molecular-weight heparins in conjunction with thrombolysis for ST-elevation acute myocardial infarction. A critical review of the literature.

BACKGROUND: Intravenous unfractionated heparin (UFH) is recommended in ST-elevation acute myocardial infarction (STEMI), following thrombolysis with fibrin-specific agents. Subcutaneous low-molecular-weight heparins (LMWH), previously proven effective in non-ST-elevation acute coronary syndromes, have been recently investigated in the setting of STEMI. We aimed at evaluating the current level of evidence supporting the use of LMWH in STEMI. METHODS: A Medline search of the English language literature between January 1995 and December 2005 was performed and randomized clinical trials comparing LMWH to either placebo or UFH in conjunction with thrombolysis were selected. RESULTS: About 26,800 patients treated with various thrombolytic regimens were included in 12 randomized clinical trials. Dalteparin was superior to placebo on left ventricular thrombosis/arterial thromboembolism, with no significant effect on the early patency rate of the infarct-related artery (IRA). Compared to UFH, dalteparin had no significant effect on clinical events and on the IRA late patency, although less thrombus was present. Enoxaparin was superior to placebo on the medium-term death/reinfarction/angina rate and late IRA patency, and superior also to UFH on in-hospital and medium-term occurrence of death/reinfarction/angina. The effect of enoxaparin on IRA patency rate was not univocal. Compared to placebo, reviparin significantly reduced early and medium-term mortality and reinfarction rates, without a substantial increase in overall stroke rate. As regards safety, bleedings were more frequent than placebo and comparable to UFH in LMWH groups, with the exception of the pre-hospital ASSENT-3 PLUS trial, where in elderly patients, enoxaparin had an incidence of intracranial hemorrhage twice higher than UFH. CONCLUSIONS: In-hospital subcutaneous administration of dalteparin, enoxaparin or reviparin, as an adjunct to various thrombolytics in STEMI, appears feasible and at least as effective and safe as intravenous UFH. Before LMWH might be recommended, however, some yet unresolved issues (i.e. use in elderly patients, in severe renal insufficiency, in association with glycoprotein IIb/IIIa inhibitors and during interventional procedures), need to be addressed.

Utilizing enoxaparin in the management of STEMI.

The use of enoxaparin in conjunction with thrombolysis in ST-elevation acute myocardial infarction (STEMI), has been recently investigated in several clinical trials. In 8 published open-label studies including about 10,000 patients, in which enoxaparin was compared to either placebo or unfractionated heparin (UFH), a general superiority of enoxaparin on both reinfarction/recurrent angina and patency of the infarct-related artery, was observed. Overall, bleeding rate with enoxaparin was higher than with placebo and comparable to UFH, with the exception of one study where pre-hospital administration induced a doubled incidence of intracranial bleeding in patients older than 75 years. In a recent double-blind, randomized, mega-trial including over 20,000 patients, the superior efficacy on in-hospital and 30-day adverse cardiac events (namely reinfarction), and comparable safety on intracranial bleedings of enoxaparin compared to UFH, was definitively proven. In conclusion, initial intravenous bolus of enoxaparin followed by twice daily subcutaneous administration for about 1 week should be considered instead of intravenous UFH for the treatment of patients with STEMI receiving thrombolysis. Along with its easiness of use, not requiring laboratory monitoring, the subcutaneous administration of enoxaparin allows extended antithrombotic treatment, while permitting early mobilization (and rehabilitation) of patients.

In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.