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Background It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI). Objectives The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial. Methods Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr). Results AKI occurred in 634 patients (15.4%) with RA and 712 patients (17.4%) with FA (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.77 to 0.98; p = 0.0181). A >25% sCr increase was noted in 633 patients (15.4%) with RA and 710 patients (17.3%) with FA (OR: 0.87; 95% CI: 0.77 to 0.98; p = 0.0195), whereas a >0.5 mg/dl absolute sCr increase occurred in 175 patients (4.3%) with RA versus 223 patients (5.4%) with FA (OR: 0.77; 95% CI: 0.63 to 0.95; p = 0.0131). By implementing the Kidney Disease Improving Global Outcomes criteria, AKI was 3-fold less prevalent and trended lower with RA (OR: 0.85; 95% CI: 0.70 to 1.03; p = 0.090), with stage 3 AKI occurring in 28 patients (0.68%) with RA versus 46 patients (1.12%) with FA (p = 0.0367). Post-intervention dialysis was needed in 6 patients (0.15%) with RA and 14 patients (0.34%) with FA (p = 0.0814). Stratified analyses suggested greater benefit with RA than FA in patients at greater risk for AKI. Conclusions In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627 )

AIMS To evaluate the prognostic implications of baseline cardiac troponin (cTn) values in the normal range in stable coronary artery disease (CAD) patients successfully treated with percutaneous coronary intervention (PCI). METHODS AND RESULTS We investigated the correlation between pre-procedural cTnI levels and major clinical adverse events at three years of follow-up in 1,063 consecutive stable CAD patients with normal baseline cTnI levels, successfully treated with PCI. Patients with pre-procedural cTnI levels in the upper tertile showed an increased long-term risk of overall death (HR 3.17, 95% CI: 1.62 to 6.21; p=0.0001), cardiac death (HR 5.09, 95% CI: 2.30 to 11.25; p=0.002), myocardial infarction (MI) (HR 2.34, 95% CI: 1.45 to 3.76; p=0.003) and target vessel failure (TVF) (HR 1.91, 95% CI: 1.28 to 2.84; p=0.006). Pre-procedural cTnI levels remained significantly correlated after adjustment for clinical and angiographic findings. Analysis of pre-PCI values eliminated any association of post-PCI values with prognosis. CONCLUSIONS In stable CAD patients successfully treated with PCI, pre-procedural cTnI levels, in the upper limits of the normal range, are associated with hard cardiac endpoints.

BACKGROUND Intracoronary Abciximab administration during primary percutaneous coronary intervention (pPCI) could offer theoretical advantages over the intravenous route. Besides antiplatelet effects, Abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of our study was to assess whether the Abciximab administration route could influence its anti-inflammatory effects. METHODS Eighty-nine consecutive ST elevation myocardial infarction patient candidates for pPCI were randomized to intracoronary (Group A-47 patients) or intravenous (Group B-42 patients) Abciximab bolus administration. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), vascular cell adhesion molecule 1 (VCAM-1) and inter-cellular adhesion molecule 1 (ICAM-1) levels. This study is registered with ClinicalTrials.gov, NCT01757457. RESULTS Data are expressed in medians (interquartiles). In both groups, troponin levels were similar [baseline: 0.12 (0.03-0.94) vs. 0.27 (0.07-1.24) ng/ml, P = 0.73; postprocedural: 22.00 (14.75-69.43) vs. 31.96 (8.23-7.20) ng/ml, P = 0.83]. Both groups also showed similar baseline [0.31 (0.14-0.69) vs. 0.22 (0.09-0.59) mg/ml, P = 0.80] and postprocedural CRP levels [2.28 (1.37-4.23) vs. 2.16 (1.15-3.22) mg/dl, P = 0.69], similar baseline [272.5 (224.7-340.8) vs. 262.2 (221.2-306.4) ng/ml, P = 0.33] and postprocedural soluble ICAM-1 levels [281.5 (244.6-337.4) vs. 287.2 (226.9-359.2) ng/ml P = 0.71], and similar baseline [771.6 (620.9-971.0) vs. 748.6 (592.2-838.8) ng/ml, P = 0.30] and postprocedural soluble VCAM-1 levels [785.2 (671.6-947.1) vs. 745.9 (641.1-841.9) ng/ml, P = 0.17]. In-hospital and 6-month event rates were similar in the two groups. CONCLUSIONS Our study suggests that Abciximab has similar anti-inflammatory effects irrespective of the administration route. It is unlikely that the potential clinical benefits of intracoronary Abciximab can be related to modulation of integrin receptors.

Coronary artery disease is the major cause of mortality and morbidity in the industrialized countries; in the United States of America and in Europe, it is responsible for one of every six deaths per year. In the setting of ischemic heart disease, angina pectoris and chest pain, in particular, are the major causes of emergency department accesses. Angina pectoris is a clinical syndrome characterized by discomfort typically in the chest, neck, chin and left arm induced by physical exertion, emotional stress and cold and is relieved by rest or by taking of nitrates. The main targets of treatment of angina pectoris are to improve quality of life by reducing the frequency and the severity of symptoms, to increase functional capacity and to improve prognosis. Ranolazine is a recent antianginal drug with unique methods of action. It was approved by the US Food and Drug Administration in 2006 as add-on therapy in patients symptomatic for stable angina. With the inhibition of the late sodium current, Ranolazine protects against ion deregulation, prevents cellular calcium overload and the subsequent increase in diastolic tension without impacting heart rate and blood pressure. Short term clinical trials and patent research show that add on therapy with Ranolazine in patients with chronic stable angina significantly improves exercise duration, exercise time to angina and reduces the use of nitro glycerine. Long term clinical trials showed no significant differences in the rate of cardiovascular death and myocardial infarction in patients with non-ST segment elevation acute coronary syndromes but a reduction in terms of recurrent ischemia. Ranolazine is generally well tolerated and even if it increases the duration of QTc interval it is not associated with atrial and ventricular arrhythmias. Therefore Ranolazine represents a good therapeutic approach in patients with chronic stable angina still symptomatic, while on optimal anti-ischemic therapy, or intolerant to traditional anti-ischemic drugs.

Objectives To perform an updated meta-analysis comparing biodegradable polymer drug eluting stents (BP-DES) and durable polymer drug eluting stents (DP-DES). Background BP-DES have been suggested to reduce late stent thrombosis (LST) rates as compared to first generation DP-DES. Recently, second generation DP-DES have replaced older DES, but comparison of these stents with BP-DES has not yielded consistent results. Methods Medline/Web databases were searched for studies comparing BP-DES and DP-DES, and reporting rates of overall/cardiac mortality, myocardial infarction (MI), LST, target lesion revascularization (TLR) and target vessel revascularization (TVR) and late lumen loss (LLL), with a follow-up ≥6 months. Results Twenty studies (20,005 patients) were included in the meta-analysis. Median follow-up time was 1 year. Compared with DP-DES, BP-DES showed lower LLL (in stent: weighted mean difference WMD −0.45 mm, 95% CI −0.66 to −0.24 mm, P = 0.00001; in segment: WMD −0.15 mm, 95% CI = −0.24 to −0.06 mm, P = 0.001) and lower rates of LST (OR 0.51, 95% CI = 0.30 to 0.86, P = 0.01), although they did not improve mortality, MI, TLR, and TVR rates. BP-DES coated with sirolimus or novolimus, in comparison with biolimus or paclitaxel, were associated with reduced LLL (P

Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting stents (DES), but clinic results of various DEB studies are still not consistent. Thus, we performed a meta-analysis to compare outcomes of DEB and DES for the treatment of coronary artery disease (CAD).Medline/Web databases were searched for studies comparing DEB and DES for obstructive CAD, reporting late lumen loss (LLL) and rates for overall mortality, myocardial infarction (MI), stent thrombosis (ST) and target lesion revascularization (TLR).8 studies (1462 patients) were included in the meta-analysis. Compared with DES, DEB treated patients showed non-significantly higher LLL (weighted mean difference [WMD] 0.32, 95% confidence interval [CI] -0.15 to 0.78, P=0.18) and non-significantly higher rate of binary restenosis (odds ratio [OR] 1.40 [0.68-2.48], P=0.36). Mortality (OR 1.13[0.54-2.37], P=0.74), MI (OR 0.95, [0.50-1.80], P=0.87), ST (OR 1.12, [0.34-4.19], P=0.77) and TLR rates (OR 1.19[0.60-2.38], P=0.61) were similar between the 2 treatments. A pre-specified meta-regression analysis showed that LLL WMD and TLR OR were inversely correlated to the prevalence of diabetes (P0.0001) and directly correlated to reference coronary diameters (P0.001).The present meta-analysis showed that compared to DES, DEB use resulted in similar clinical efficacy and safety. Thus DEB could be considered a reasonable alternative to DES for the treatment of CAD in selected clinical settings (Clinicaltrials.gov identifier: NCT01760200).

The direct thrombin inhibitor bivalirudin has gained popularity in cardiovascular medicine over the past decade because, in comparison with unfractionated heparin, it guarantees a predictable dose-related degree of anticoagulation with a low immunogenic profile and, possibly, with reduced rates of major bleeding complications. In the past bivalirudin has been frequently employed in the management of patients with heparin-induced thrombocytopenia. The REPLACE-2, ACUITY and ISAR-REACT4 studies demonstrated bivalirudin non-inferiority in comparison with unfractionated heparin in terms of ischemic end-points with a reduction of the bleeding rate also in patients acute coronary syndrome without ST elevation. Finally the results of the HORIZONS-AMI study positioned this drug as a first choice anticoagulant during percutaneous coronary interventions in patients with ST-elevation myocardial infarction. In fact the bivalirudin alone regimen, compared to unfractionated heparin plus GP2b3a inhibitors, decreased inhospital bleeding rates and short and long term mortality. Given the body of clinical evidence, bivalirudin is likely to contend to GP2b3a inhibitors the leading place among the proposed anticoagulation strategies in the setting of acute coronary syndromes. The duration of the bivalirudin infusion after PCI and the optimal oral antiplatelet regimen associated to bivalirudin are important issues to be solved in future randomized controlled studies.

Background Pre-hospital ticagrelor, given less than 1 h before coronary intervention (PCI), failed to improve coronary reperfusion in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. It is unknown whether a longer interval from ticagrelor administration to primary PCI might reveal any improvement of coronary reperfusion. Methods We retrospectively compared 143 patients, pre-treated in spoke centers or ambulance with ticagrelor at least 1.5 h before PCI (Pre-treatment Group), with 143 propensity score-matched controls treated with ticagrelor in the hub before primary PCI (Control Group) extracted from RENOVAMI, a large observational Italian registry of more than 1400 STEMI patients enrolled from Jan. 2012 to Oct. 2015 ( ClinicalTrials.gov id: NCT01347580 ). The median time from ticagrelor administration and PCI was 2.08 h (95% CI 1.66–2.84) in the Pre-treatment Group and 0.56 h (95% CI 0.33–0.76) in the Control Group. TIMI flow grade before primary PCI in the infarct related artery was the primary endpoint. Results The primary endpoint, baseline TIMI flow grade, was significantly higher in Pre-treatment Group (0.88 ± 1.14 vs 0.53 ± 0.86, P = 0.02). However in-hospital mortality, in-hospital stent thrombosis, bleeding rates and other clinical and angiographic outcomes were similar in the two groups. Conclusions In a real world STEMI network, pre-treatment with ticagrelor in spoke hospitals or in ambulance loading at least 1.5 h before primary PCI is safe and might improve pre-PCI coronary reperfusion, in comparison with ticagrelor administration immediately before PCI.

Background: Atrial fibrillation (AF) is a common complication of coronary artery bypass grafting (CABG). However, limited information is available about the role of preoperative echocardiographic left atrial evaluation to predict AF occurrence after CABG. Thus, we prospectively compared the ability of echocardiographic measurements of left atrial volume to predict AF in this setting. Methods: From January to December 2009, 220 patients (75% males, 66.8 ± 10.0 years) met the inclusion criteria of our study (isolated and elective CABG, no valve surgery, no permanent AF, or other chronic atrial arrhythmias). The day before CABG a complete echocardiographic evaluation was performed with left atrial volume measurements. The primary endpoint of the study was postoperative AF (POAF) lasting >30 seconds. Results: POAF was observed in 61 patients (27.7%). POAF patients showed increased left atrial M-mode anteroposterior dimension (41.2 ± 6.4 mm vs. 43.6 ± 7.3 mm; p = 0.020) and increased left atrial volume (59.0 ± 18.3 mL vs. 70.6 ± 28.1 mL; p = 0.0004). Left atrial volume was an independent risk factor for POAF (OR 10.03; 95% CI 10.01 to 10.05; p = 0.01), along with postoperative bleeding with hemoglobin levels below 8 g/dL (OR 20.84; 95% CI 10.12 to 70.19; p = 0.03) and preoperative left ventricular ejection fraction below 40% (OR 10.08; 95% CI 10.01 to 10.15; p = 0.02). Conversely, preoperative statin therapy exerted a protective role (OR 0.30; 95% CI 0.12 to 0.74; p = 0.009). Conclusion: Preoperative echocardiographic evaluation of patients with isolated CABG demonstrated that left atrium volume measurements were independently correlated to the occurrence of POAF. Further investigations should focus on the opportunity to target prophylactic antiarrhythmic treatments to patients with large left atrial volumes. (J Card Surg 2012;27:128–135)

Plasma fibrinogen levels influence restenosis following elective percutaneous coronary intervention (PCI) for stable angina. It is unknown whether the same is true in the setting of primary PCI. The aim of the study was therefore to assess whether fibrinogen levels were associated to 6-month in-stent restenosis (ISR) in STEMI patients undergoing successful primary PCI. From January 2003 to October 2004, 267 patients were admitted to our Institution for STEMI and treated by primary PCI. Of these, 171 patients met the inclusion criteria and were enrolled in our study. Fibrinogen levels were assessed at admission, 12 h, 24 h, 48 h, 72 h following PCI and at discharge. Six-month angiographic follow-up was 100% complete. Subjects with 6-month ISR showed higher fibrinogen levels than patients without ISR. Patients in the upper fibrinogen tertile showed a higher 6-month incidence of symptoms and/or inducible myocardial ischemia (27.1% vs. 7.1%, P = 0.006) and a larger late lumen loss (1.3 ± 0.8 vs. 1.0 ± 0.9 mm, P = 0.049). Logistic regression analysis demonstrated a significant and independent association between fibrinogen levels and ISR. Our study suggests that increased plasma fibrinogen levels are related to ISR in STEMI patients undergoing primary PCI. Larger studies are warranted to assess the prognostic value of fibrinogen over harder end-points.

Coronary artery diseases continue to be the most common causes of mortality and morbidity in the industrialized world, especially in the setting of acute myocardial infarction. Platelets play a crucial role in thrombosis and haemostasis, which can be either beneficial or deleterious, depending on the circumstances. Platelet hyperreactivity is a multifactor process depending on genetic polymorphism, pathological state and lifestyle; it contributes to the activation of the thrombotic cascade. Under pathophysiological conditions platelets activation plays a critical role in arterial thrombosis including platelets aggregation, the basis of destabilization of coronary plaque. Despite the benefits observed in outcome when primary angioplasty is compared with thrombolysis for the treatment of acute myocardial infarction there is still some room for improvement; unfortunately the restoration of an “optimal” epicardial flow is not always related to an “optimal” myocardial reperfusion. In the recent, past several studies have shown significant benefits with the administration of glycoprotein IIb/IIIa inhibitors. Thus, the aim of the present review is to perform an update on factors associated with platelets hyperactivity and on adjunctive glycoprotein IIb – IIIa inhibitors in primary angioplasty.

Background: Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease. Methods and Results: Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P

Transradial percutaneous coronary interventions (PCIs) have gained popularity because of reduced vascular complications and increased patient acceptability. However, safety and efficacy of transradial PCI in ST elevation myocardial infarction has been questioned. Anomalous radial artery anatomy is a relatively common cause of transradial PCI failure. The authors describe a case of a primary PCI performed by transradial approach through a very small caliper and tortuous superficial brachioradial artery (a rare variant). The use of miniaturized and hydrophilic apparels allowed procedure success without significant delay. To the authors’ knowledge, this is the first report of a primary PCI performed through an abnormal superficial brachioradial artery with final success.

Longitudinal deformation has been described as a new complication affecting new-generation thin-strut coronary stents. Benchmark tests have suggested that the platinum-chromium (PtCr) Element coronary stent platform (Boston Scientific) might present increased susceptibility to this complication. Our study assessed the incidence of longitudinal stent deformation in a large single-center study population.A total of 337 consecutive Promus Element PtCr stents deployed in an all-comer population underwent quantitative coronary angiography (QCA) analysis. Postdeployment QCA measured/nominal stent length ratio (SLR) was considered as a surrogate estimate of longitudinal stent deformation and averaged 0.95 ± 0.04 in the entire population. This small postdeployment reduction of stent length had no clinical relevance, leading to 3 cases (0.9%) of trivial geographical miss, which did not require further interventions. Plaque prolapse through the stent struts was observed in 19 cases (5.6%). Only 1 case of typical "concertina" effect (0.3%) complicated an ostial stenosis treatment requiring deployment of a second stent, while in 3 cases (0.9%), stent struts adapted to severely tortuous and calcified vessels mimicked longitudinal stent deformation, without further complications. Multiple regression analysis demonstrated a significant correlation between need for predilation and lower SLR values, while postdilation independently predicted higher SLR.Systematic QCA analysis of a large single-center all-comers PCI population treated with PtCr stents failed to detect any clinically relevant longitudinal stent deformation. Complex lesions needing predilation were associated with a reduced SLR; conversely, postdilation was associated with QCA stent measures close to nominal. Clinicaltrials.gov ID: NCT01759719.

To perform an updated meta-analysis comparing biodegradable polymer drug eluting stents (BP-DES) and durable polymer drug eluting stents (DP-DES).BP-DES have been suggested to reduce late stent thrombosis (LST) rates as compared to first generation DP-DES. Recently, second generation DP-DES have replaced older DES, but comparison of these stents with BP-DES has not yielded consistent results.Medline/Web databases were searched for studies comparing BP-DES and DP-DES, and reporting rates of overall/cardiac mortality, myocardial infarction (MI), LST, target lesion revascularization (TLR) and target vessel revascularization (TVR) and late lumen loss (LLL), with a follow-up ≥6 months.Twenty studies (20,005 patients) were included in the meta-analysis. Median follow-up time was 1 year. Compared with DP-DES, BP-DES showed lower LLL (in stent: weighted mean difference WMD -0.45 mm, 95% CI -0.66 to -0.24 mm, P = 0.00001; in segment: WMD -0.15 mm, 95% CI = -0.24 to -0.06 mm, P = 0.001) and lower rates of LST (OR 0.51, 95% CI = 0.30 to 0.86, P = 0.01), although they did not improve mortality, MI, TLR, and TVR rates. BP-DES coated with sirolimus or novolimus, in comparison with biolimus or paclitaxel, were associated with reduced LLL (P 0.0001 for subgroups).In comparison with DP-DES, BP-DES significantly reduce LLL and LST rates, without clear benefits on harder endpoints. The efficacy of BP-DES in preserving lumen patency seems larger for sirolimus and novolimus DES.

Coronary artery disease is the major cause of mortality and morbidity in the industrialized countries; in the United States of America and in Europe, it is responsible for one of every six deaths per year. In the setting of ischemic heart disease, angina pectoris and chest pain, in particular, are the major causes of emergency department accesses. Angina pectoris is a clinical syndrome characterized by discomfort typically in the chest, neck, chin and left arm induced by physical exertion, emotional stress and cold and is relieved by rest or by taking of nitrates. The main targets of treatment of angina pectoris are to improve quality of life by reducing the frequency and the severity of symptoms, to increase functional capacity and to improve prognosis. Ranolazine is a recent antianginal drug with unique methods of action. It was approved by the US Food and Drug Administration in 2006 as add-on therapy in patients symptomatic for stable angina. With the inhibition of the late sodium current, Ranolazine protects against ion deregulation, prevents cellular calcium overload and the subsequent increase in diastolic tension without impacting heart rate and blood pressure. Short term clinical trials and patent research show that add on therapy with Ranolazine in patients with chronic stable angina significantly improves exercise duration, exercise time to angina and reduces the use of nitro glycerine. Long term clinical trials showed no significant differences in the rate of cardiovascular death and myocardial infarction in patients with non-ST segment elevation acute coronary syndromes but a reduction in terms of recurrent ischemia. Ranolazine is generally well tolerated and even if it increases the duration of QTc interval it is not associated with atrial and ventricular arrhythmias. Therefore Ranolazine represents a good therapeutic approach in patients with chronic stable angina still symptomatic, while on optimal anti-ischemic therapy, or intolerant to traditional anti-ischemic drugs.

Intracoronary thrombi are a common finding in the setting of acute coronary syndromes and correlate with intraprocedural complications, adverse prognosis and unpredictable response to standard pharmacological and interventional treatment. Interventional cardiologists have learned to fear the so-called hostile thrombus, with its aggressive and unstable behavior often leading to abrupt and refractory vessel closure. Here we report a case series of intracoronary bivalirudin administration to treat massive intracoronary thrombi, leading to rapid clot disappearance and coronary blood flow restoration. Interventional cardiologists might consider intracoronary bivalirudin administration as a bailout strategy during unusual critical situations.

Aims: Recent reports have described cases of longitudinal deformation in new generation thin-strut coronary stents and biomechanical analyses have suggested increased susceptibility for such a complication for the novel platinum chromium (PtCr) "Elements™" coronary stent platform. The present study assesses the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population. Methods and results: Quantitative angiographic analysis (QCA) of 337 PtCr stents deployed in 253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 was performed. QCA: nominal stent length ratio (QCA:NSLR) was considered as surrogate estimate of longitudinal stent deformation. The risk profile of the studied population was high, with 265 lesion (75.3%) classified as ACC/AHA type B2/C. QCA:NSLR averaged 0.95±0.04 in the whole population. The small post-deployment reduction of stent length had no clinical relevance, with only 3 cases (0.9%) of trivial geographical miss which did not required further interventions. Plaque prolapsed, usually small and focal, through the stent struts was observed in 19 cases (5.6%). No case of typical "concertina effect" was observed, while in 3 cases (0.9%) a large prolapsed plaque mimicked longitudinal stent deformation. Minor grades of stent deformation were more common and correlated with tortuous and calcified lesions, as expression of great stent conformability. Actually blinded a posteriori re-examination of the angiograms corresponding to the 20 lowest and highest ratios did not identify any cases of severe stent deformation. Logistic regression analysis identified a significant correlation between the need for predilation and lower QCA:NSLR values, while postdilation independently predicted higher QCA:NSLRs. Conclusions: Systematic QCA analysis of a large single centre population of all-comer PCI patients treated with PtCr stents failed to detect clinically relevant longitudinal stent deformations. Need for predilation was associated with a reduced stent length ratio, even if this did not substantially influenced PCI outcomes. Conversely postdilation was associated with QCA stent measures closest to nominal. (Clinicaltrials.gov ID: [NCT01759719][1]) [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01759719&atom=%2Fehj%2F34%2Fsuppl_1%2FP3017.atom

Biodegradable polymer drug eluting stents (BP-DES) have been developed to overcome the limitations of first generation durable polymer DES (DP-DES) but the clinical results of different BP-DES are not consistent. We performed a meta-analysis to compare the outcomes of BP-DES and DP-DES in the treatment of coronary artery disease (CAD).Online databases including MEDLINE were searched for studies comparing BP-DES and DP-DES for obstructive CAD that reported rates for overall mortality, myocardial infarction (MI), late stent thrombosis (LST), target lesion revascularization (TLR) and late lumen loss (LLL) with a follow-up of ≥ 6 months. Ten studies (5834 patients) with a 1-year median follow-up were included in the meta-analysis. When comparing patients treated with DP-DES and BP-DES those treated with BP-DES had lower LLL (in-stent: weighted mean difference (WMD) -0.10 mm, 95% CI = -0.17 to -0.03 mm, p = 0.004; in-segment: WMD -0.06 mm, 95% CI = -0.10 to -0.01 mm, p = 0.01) with lower TLR rates (OR 0.67, 95% CI = 0.47 to 0.98, p = 0.04). However, BP-DES did not improve mortality (OR 0.97, 95% CI = 0.73 to 1.29, p = 0.83), MI (OR 1.13, 95% CI = 0.87 to 1.46, p = 0.36) or LST rates (OR 0.64, 95% CI = 0.36 to 1.16, p = 0.14). A pre-specified subgroup analysis of Biolimus BP-DES confirmed significant LLL reduction without differences in other clinical endpoints. Meta-regression analysis demonstrated a strong significant inverse correlation between LLL and reference coronary diameter (p 0.001).Our present meta-analysis showed that BP-DES when compared with DP-DES significantly reduced LLL and TVR but without clear benefits on mortality, MI and LST rates. (Clinicaltrials.gov identifier: NCT01466634).

Reported complication rates after vascular closure device deployment or femoral manual compression (MC) are similar. However, the features and severity of such complications have never been thoroughly evaluated.A consecutive series of 1241 patients treated from 2008 to 2010 with Angio-Seal (AS) was prospectively evaluated for vascular complications (VC). As control group, we used a consecutive series of 672 patients treated with MC in the 7 months preceding AS adoption at our institution. VC were observed in 88 patients, 55 with AS and 33 with MC (relative risk, 0.90; 95% confidence interval, 0.59-1.38; P=.63). The clinical profile of complications observed in the 2 groups was different. Groin hematomas were more frequent with MC (100% vs 65.5%; P=.0005) and retroperitoneal bleedings were more common with AS (41.8% vs 6.1%; P=.0005). AS complications required more frequently transfusions (49.1% vs 18.2%; P=.006), while MC complications significantly delayed hospital discharge, in comparison to AS (4.3 ± 4.0 days vs 2.7 ± 1.9 days; P=.01). Differences in groin hematoma and retroperitoneal bleeding rates were confirmed after propensity score matching. Finally, a different allocation of diagnostic/therapeutic resources was observed in the 2 groups.AS and MC were associated with similar incidences of VC, with a higher prevalence of severe complications (retroperitoneal hemorrhages and transfusions) after using AS. However, complications after MC were associated with significantly prolonged hospital stay. Comparison between different hemostatic strategies should consider the logistic burden imposed by different vascular complications.

The Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce the individual skills needed for deployment. A clinical comparison of ASE with manual femoral compression (MC) has never been reported.A total of 451 consecutive patients treated by ASE following cardiac catheterization were compared with 451 propensity-score matched controls treated by MC. Early failure of ASE and in-hospital major vascular complications (any retroperitoneal hemorrhage, limb-threatening ischemia or surgical repair) and minor vascular complications (any groin hematoma ≥ 5 cm or pseudoaneurysm) following ASE deployment were prospectively assessed. Early failure of ASE was rare (1.8%). In the two groups, the major vascular complication rate was similar [odds ratio (OR), 2.5; 95% confidence interval (CI), 0.5-13.0; p = NS]. However, patients treated by ASE showed a significantly higher risk for minor vascular complications (OR, 2.2; 95% CI, 1.1-4.3; p = 0.029). In comparison to successful deployment, early ASE failure was associated with a very high risk for both major (OR, 15.7; 95% CI, 1.56-158.7; p = 0.002) and minor (OR, 6.1; 95% CI, 1.2-31.8; p = 0.015) vascular complications.In a large, single-center experience, early ASE failure was rare and the rate of major vascular complications following ASE deployment was similar to controls. However, an excess of minor vascular complications (generally large groin hematomas) was observed in patients treated by ASE. Our study confirms that early ASE failure is an important risk factor for severe vascular complications.

Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease.Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes.The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data.

Levosimendan is one of the documented pharmacological agents used in the management and treatment of acute and chronic heart failure; it is a novel inodilator agent which enhanced myocardial performance without changes in oxygen consumption. The combination of positive inotropic and vasodilator effects of levosimendan relates to its Ca(2+) - sensitizing and K(+) channels opening effects. Levosimendan has been proposed, in the recent past, to be non-inferior and may have some advantages to standard inotropes; further possible indications for levosimendan have been described, in some observational studies, such as a perioperative use, cardioprotection, cardiogenic shock, sepsis and right ventricular dysfunction. The ability of levosimendan to improve myocardial function without substantially increasing oxygen consumption may appear paradoxical but is possible via improved efficacy not only with regard to the effects on the contractile apparatus of the cardiomyocytes. The aim of this review is to describe the pharmacological characteristics of levosimendan and its clinical applications. The patent review data regarding the use of levosimendan are also discussed in this review article.

Experimental clinical observations suggest that fibrinolysis (FL) in acute myocardial infarction, even though reducing global mortality, is associated with an increasing incidence of death in the first 24-48 h. The responsible mechanism is not yet known, although available evidence supports heart rupture as the possible cause.We studied 154 patients at autopsy who died of cardiac causes from January 1, 1994 to December 31, 2005 among a cohort of 2260 patients who were admitted for ST-elevation myocardial infarction. They were divided into three therapeutic groups-- FL, coronary angioplasty (PTCA) and conventional therapy (CT)--in order to assess the incidence of cardiac rupture and compare it with the other causes of cardiac death.Of the 896 patients (39.7%) who were treated with FL, 57 (6.4%) died; of the 804 (35.6%) treated with PTCA, 40 (5.05%) died, and of the 560 (24.7%) treated with CT, 57 (10.2%) died (p0.05 in the two first groups vs CT). We studied at autopsy 154 patients (mortality 6.7%). The mean admission delay was 5.05 h in the FL group, 7.04 h in the PTCA group, and 7.05 h in the CT group. Cardiac death occurred on average after 13 h in the FL group, after 15 h in the PTCA group, and after 19 h in the CT group. The cause of death was due to cardiac rupture in 56 patients (36.5%), to shock in 55 patients (35.7%), to electromechanical dissociation in 29 patients (18.8%), and to cardiac failure in 14 patients (9%). In the FL and PTCA groups, cardiac rupture was the major, and also the earliest (10 e 12 h, respectively), cause of death, whereas in the CT group cardiac shock (13 h) was the major cause of death. Anterior myocardial infarction (n = 104, 65%) was more prevalent in deceased patients, whereas inferior myocardial infarction was found in the other 50 cases (35%). Cardiac rupture was more prevalent in anterior myocardial infarction. In the FL and PTCA groups, histological examination showed unusual hemorrhagic infiltration in the necrotic areas with presence of leukocytes.Our study shows that cardiac rupture is the major cause of death in patients with ST-elevation myocardial infarction treated with FL and PTCA, suggesting that mechanical and lythic reperfusion injury, in coagulative necrosis, may represent a further cause of cardiac rupture that occurs early or within the first hours.