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Key Clinical Message: Situs inversus totalis is a rare diagnosis, but the likelihood of experiencing myocardial infarction is presumed to be comparable to the general population average. In individuals exhibiting situs inversus with suspected myocardial infarction, ECG recording, including right precordial leads, is crucial for diagnostic assessment. Coronary angiography and intervention should be performed with standard equipment using inverted maneuvers and radiographic projections. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the diagnostic value of contrast-enhanced magnetic resonance imaging (CMR) and single-photon emission computed tomography (SPECT) for detection of myocardial necrosis after acute myocardial infarction (AMI). Background: Single-photon emission computed tomography is widely accepted in the clinical setting for detection and estimation of myocardial infarction. Contrast-enhanced magnetic resonance imaging offers technical advantages and is therefore a promising new method for identification of infarcted tissue. Methods: Seventy-eight patients with AMI were examined by CMR and SPECT 7 days after percutaneous coronary intervention. Contrast-enhanced magnetic resonance imaging and SPECT images were scored for presence and location of infarction using a 17-segment model. Results were compared with the peak troponin T level, electrocardiographic, and angiographic findings. Results: Acute myocardial infarction was detected significantly more often by CMR than SPECT (overall sensitivity: 97% vs. 87%; p = 0.008). Sensitivity of CMR was superior to SPECT in detecting small infarction as assessed by the peak troponin T level <3.0 ng/ml (92 vs. 69%; p = 0.03), and infarction in non-anterior location (98% vs. 84%; p = 0.03). Non–Q-wave infarctions were more likely to be detected by CMR (sensitivity 85% vs. 46%; p = 0.06). While CMR offered high sensitivity for detection of AMI irrespective of the infarct-related artery, SPECT was less sensitive, particularly within the left circumflex artery territory. Conclusions: Contrast-enhanced magnetic resonance imaging is superior to SPECT in detecting myocardial necrosis after reperfused AMI because CMR detects small infarcts that were missed by SPECT independent of the infarct location. Thus, CMR is attractive for accurate detection and assessment of the myocardial infarct region in patients early after AMI. [Copyright &y& Elsevier]

Objectives: The aim of this research was to evaluate kinetics and extent of myocardial contrast enhancement (CE) in comparison with single-photon emission computed tomography (SPECT) early after acute myocardial infarction (AMI). Background: Quantification of infarct size serves as a surrogate end point in evaluating new therapies of AMI. Contrast-enhanced magnetic resonance imaging (CeMRI) of the myocardium is a promising new method for identification of irreversible tissue injury. Methods: A total of 33 patients were examined by CeMRI and SPECT 7 ± 2 days after AMI and successful coronary intervention. After gadolinium-diethylenetraimine pentaacetic acid injection (0.2 mmol/kg), continuous short-axis slices of the left ventricle (LV) were acquired every 7 min up to 42 min using different inversion times (TI). Myocardial CE at each imaging time point was quantified and compared with corresponding SPECT perfusion defect. Results: All patients showed myocardial CE in the infarct region. A constant TI for CeMRI resulted in a decrease of signal intensity and extent of CE on late acquisitions. With TI adjustment, infarct image intensity peaked at 21 min with a contrast of 478% of remote myocardium and remained at this level up to 42 min after contrast injection (437%); CE extent was stable over time and agreed well with SPECT within an average difference of 3% of the LV myocardium, yielding the best correlation at 28 min (r = 0.86). Conclusions: In patients after AMI and successful reperfusion, CE is stable over time and matches well with SPECT perfusion defect; CeMRI under standardized conditions can accurately assess myocardial infarct size in vivo and may be attractive for serving as a surrogate end point early after AMI. [Copyright &y& Elsevier]

: ObjectivesThe study compared flow reserve indices by magnetic resonance imaging (MRI) with quantitative measures of coronary angiography and positron emission tomography (PET).: BackgroundThe noninvasive evaluation of myocardial flow by MRI has recently been introduced. However, a comparison to quantitative flow measurement as assessed by PET has not been reported in patients with coronary artery disease (CAD).: MethodsTwo groups of healthy volunteers and 25 patients with angiographically documented CAD were examined by MRI and PET at rest and during adenosine stress. Dynamic MRI was performed using a multi-slice ultra-fast hybrid sequence and a rapid gadolinium-diethylenetriaminepenta-acetic acid bolus injection (0.05 mmol/l). Upslope and peak-intensity indices were regionally determined from first-pass signal intensity curves and compared to N-13 ammonia PET flow reserve measurements.: ResultsIn healthy volunteers, the upslope analysis showed a stress/rest index of 2.1 ± 0.6, which was higher than peak intensity (1.5 ± 0.3), but lower than flow reserve by PET (3.9 ± 1.1). Localization of coronary artery stenoses (>75%, MRI <1.2), based on the upslope index, yielded sensitivity, specificity and diagnostic accuracy of 69%, 89% and 79%, respectively. Upslope index correlated with PET flow reserve (r = 0.70). A reduced coronary flow reserve (PET <2.0, MRI <1.3) was detected by the upslope index with sensitivity, specificity and diagnostic accuracy of 86%, 84% and 85%, respectively.: ConclusionsMagnetic resonance imaging first-pass perfusion measurements underestimate flow reserve values, but may represent a promising semi-quantitative technique for detection and severity assessment of regional CAD. [Copyright &y& Elsevier]

Introduction: Mechanical circulatory support (MCS) devices are increasingly used as a treatment option in resuscitation or in patients with cardiogenic shock (CS). Prophylactic implantation in high‐risk percutaneous coronary interventions (HRPCI) is another upcoming indication. The i‐cor ECG‐synchronized cardiac assist device combines the hemodynamic support of a veno‐arterial extracorporeal membrane oxygenation (VA‐ECMO) with the ability to generate a pulsatile flow and thus decreasing adverse effects of VA‐ECMO on myocardial function. Aim of this study was to obtain data concerning feasibility, safety and outcomes in both indications. Methods: A total of 47 patients (34 HRPCI, 13 CS) were included in nine German centers and participated in this study. Demographic and clinical parameters, procedural as well as follow‐up data were prospectively recorded and analyzed. Results: Device implantation and initiation of ECG‐synchronized cardiac assist was technical successful in all cases and no failures of the consoles or disposable parts were observed. Furthermore, intended percutaneous coronary interventions and successful weaning from cardiac assist was achieved in 97.1% of HRPCI patients. We observed a 30d‐survival of 94.1% in the HRPCI group and 69.2% in the CS group. Main complications in both groups were bleeding events (14.7% HRPCI, 23.1% CS) and critical limb ischemia (2.9% HRPCI, 38.5% CS). Conclusion: The i‐cor ECG‐synchronized cardiac assist device appears safe and feasible showing clinical outcomes comparable to existing data in the setting of high‐risk percutaneous coronary interventions and acute cardiogenic shock. Further prospective trials are warranted to identify optimal patient and interventional characteristics that will benefit most of this novel kind of mechanical circulatory support. [ABSTRACT FROM AUTHOR]

An abstract of the conference paper "Gender differences in contrast-enhanced magnetic resonance imaging after acute myocardial infarction," by Birgit Langhans and colleagues is presented.

An abstract of the paper "Temporal Changes of Microvascular Obstruction and Infarct Border Zone After Acute Myocardial Infarction Assessed by Contrast Enhanced Magnetic Resonance Imaging," by Birgit Langhans and colleagues is presented.

The efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with acute coronary syndromes (ACS) are not known. We assessed the efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with ACS undergoing invasive management. This pre-specified analysis of the ISAR-REACT 5 trial included 1349 smokers and 2652 nonsmokers randomized to receive ticagrelor or prasugrel. The primary endpoint was the incidence of death, myocardial infarction, or stroke; the secondary endpoint was the incidence of Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding (both endpoints assessed at 12 months). There was no significant treatment arm-by-smoking status interaction regarding the efficacy outcome. The primary endpoint occurred in 47 patients (7.0%) in the ticagrelor group and 41 patients (6.2%) in the prasugrel group in smokers (hazard ratio [HR] = 1.15; 95% confidence interval [CI] 0.76–1.75; P = 0.510) and in 133 patients (10.2%) in the ticagrelor group and 94 patients (7.2%) in the prasugrel group in nonsmokers (HR = 1.44 [1.10–1.87]; P = 0.007; P for interaction = 0.378). The secondary endpoint occurred in 27 patients (4.6%) in the ticagrelor group and 33 patients (5.6%) in the prasugrel group in smokers (HR = 0.81 [0.49–1.35]; P = 0.412) and in 66 patients (6.0%) in the ticagrelor group and 46 patients (4.4%) in the prasugrel group in nonsmokers (HR = 1.38 [0.94–2.01]; P = 0.097). In patients with ACS undergoing an invasive management strategy, the smoking status did not significantly interact with the relative treatment effect of ticagrelor vs. prasugrel. NCT01944800 • In ACS patients, ticagrelor and prasugrel showed similar efficacy regardless of smoking status. • Bleeding risk was comparable between ticagrelor and prasugrel in smokers and nonsmokers. • Smoking status does not interfere with the relative treatment effect of ticagrelor vs. prasugrel. [ABSTRACT FROM AUTHOR]

The extent of the involvement of platelets in venous thromboembolisms (VTE) is still not fully understood. Immature platelets are large, RNA-rich, prothrombotic platelets. They are involved in arterial thromboembolisms and are associated with adverse cardiovascular events. Their role in VTE has not been investigated before. The aim of this study was to assess different platelet parameters including immature platelet fraction (IPF), immature platelet count (IPC), absolute platelet count and platelet aggregation (PA) over time in patients with VTE at time of diagnosis, as well as at 3–10 days and at 90–110 days after diagnosis. 50 healthy volunteers similar in age and sex to patients served as controls at diagnosis. IPF was measured by the Sysmex XE-5000 analyzer, PA was assessed using the Multiplate analyzer. Diagnosis of VTE had no relevant effect on IPF and IPC whereas absolute platelet count and PA were significantly decreased compared to controls. In the course of VTE, IPF decreased significantly, whereas IPC, absolute platelet count and PA increased. In conclusion, VTE was associated with relevant changes of the absolute platelet count and PA at diagnosis, as well as changes in IPF and IPC over time reflecting a relevant and measurable platelet consumption in VTEs. [ABSTRACT FROM AUTHOR]

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome. [ABSTRACT FROM AUTHOR]

Background: Since the outbreak of the COVID-19 pandemic, a number of risk factors for a poor outcome have been identified. Thereby, cardiovascular comorbidity has a major impact on mortality. We investigated whether coronary calcification as a marker for coronary artery disease (CAD) is appropriate for risk prediction in COVID-19. Methods: Hospitalized patients with COVID-19 (n = 109) were analyzed regarding clinical outcome after native computed tomography (CT) imaging for COVID-19 screening. CAC (coronary calcium score) and clinical outcome (need for intensive care treatment or death) data were calculated following a standardized protocol. We defined three endpoints: critical COVID-19 and transfer to ICU, fatal COVID-19 and death, composite endpoint critical and fatal COVID-19, a composite of ICU treatment and death. We evaluated the association of clinical outcome with the CAC. Patients were dichotomized by the median of CAC. Hazard ratios and odds ratios were calculated for the events death or ICU or a composite of death and ICU. Results: We observed significantly more events for patients with CAC above the group's median of 31 for critical outcome (HR: 1.97[1.09,3.57], p = 0.026), for fatal outcome (HR: 4.95[1.07,22.9], p = 0.041) and the composite endpoint (HR: 2.31[1.28,4.17], p = 0.0056. Also, odds ratio was significantly increased for critical outcome (OR: 3.01 [1.37, 6.61], p = 0.01) and for fatal outcome (OR: 5.3 [1.09, 25.8], p = 0.02). Conclusion: The results indicate a significant association between CAC and clinical outcome in COVID-19. Our data therefore suggest that CAC might be useful in risk prediction in patients with COVID-19. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate myocardial viability assessment with hybrid 2-deoxy-2-[18F]fluoro-d-glucose positron emission tomography/magnetic resonance imaging ([18F]FDG-PET/MR) in predicting left ventricular (LV) wall motion recovery after percutaneous revascularisation of coronary chronic total occlusion (CTO). Methods and results: Forty-nine patients with CTO and corresponding wall motion abnormality (WMA) underwent [18F]FDG-PET/MR imaging for viability assessment prior to percutaneous revascularisation. After 3–6 months, 23 patients underwent follow-up MR to evaluate wall motion recovery. In total, 124 segments were assigned to the CTO territories, while 80 segments displayed impaired wall motion. Of these, 68% (54) were concordantly viable in PET and MR; conversely, only 2 segments (2%) were assessed non-viable by both modalities. However, 30% showed a discordant viability pattern, either PET non-viable/MR viable (3 segments, 4%) or PET viable/MR non-viable (21 segments, 26%), and the latter revealed a significant wall motion improvement at follow-up (p = 0.033). Combined imaging by [18F]FDG-PET/MR showed a fair accuracy in predicting myocardial recovery after CTO revascularisation (PET/MR area under ROC curve (AUC) = 0.72, p = 0.002), which was superior to LGE-MR (AUC = 0.66) and [18F]FDG-PET (AUC = 0.58) alone. Conclusion: Hybrid PET/MR imaging prior to CTO revascularisation predicts more accurately the recovery of dysfunctional myocardium than PET or MR alone. Its complementary information may identify regions of viable myocardium with increased potential for functional recovery. [ABSTRACT FROM AUTHOR]

Background: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.Objectives: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.Methods: A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.Results: The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).Conclusions: At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533). [ABSTRACT FROM AUTHOR]

Disturbed wound healing (DWH) following elective foot and ankle surgery is associated with a number of known risk factors. The purpose of this study was to determine if peripheral artery disease (PAD) is a potential risk factor that contributes to an increase in postoperative DWH. In a case–control study, we analyzed all patients undergoing elective foot and ankle surgery between January 1, 2014 and December 31, 2017 at two institutions and identified 51 patients with postoperative DWH. After matching with 51 control patients without DWH, all 102 patients were evaluated for PAD. The prevalence of PAD was significantly higher in the DWH group compared to the control group (41.2% vs 19.6%, p < 0.01). This difference was even more distinctive for patients with any abnormal ankle–brachial index (ABI) (51.0% vs 19.6%, p < 0.001). After adjustment for diabetes, hypertension, hypercholesterolemia, and smoking, any abnormal ABI or a history of PAD remained an independent risk factor for DWH (odds ratio 3.28; 95% CI 1.24–8.71). In this dual-center study, postoperative DWH was associated with significantly higher rates of PAD. These findings suggest that preoperative evaluation for PAD could be a helpful tool to identify patients at high risk for postoperative wound complications undergoing foot and ankle surgery. This trial is registered with drks.de, number DRKS00012580. [ABSTRACT FROM AUTHOR]

The local inflammatory response following acute myocardial infarction (AMI) is increasingly being recognized as a central factor determining infarct healing. Myocardial inflammation can be visualized in patients using fasting 18F-FDG PET/MRI. Although this novel biosignal correlates with long-term functional outcome, the corresponding cellular substrate is not well understood. Here we present a retrospective analysis of 29 patients with AMI who underwent revascularization, suggesting a connection between post infarction myocardial fasting 18F-FDG uptake, monocyte platelet aggregates (MPA), and P2Y 12 inhibition. In detail, patients with high MPA percentages of CD14highCD16+ and CD14lowCD16+ monocytes had significantly higher local 18F-FDG uptake (SUV mean) in the infarcted myocardium than patients with low MPA (p < 0.05). Furthermore, there was an association of high MPA percentage in all monocyte subpopulations with deteriorating ΔLV-EF after 6 months (p < 0.01), which was confirmed in an extended analysis with additional 29 patients without PET/MRI data available. In this analysis, administration of Ticagrelor was associated with lower MPA percentage of CD14high monocyte subpopulations than Clopidogrel (p < 0.01) or Prasugrel (p < 0.05). Taken together, the findings from this analysis suggest that platelet aggregability may affect monocyte extravasation into the infarcted myocardium and influence long-term functional outcome. P2Y 12 inhibition may intervene in this pathophysiologic process. Prospective studies are needed to further examine this important relationship. • High relative levels of monocyte-platelet aggregates are associated with strong myocardial inflammation in patients with AMI. • P2Y12 inhibitor choice may affect MPA formation, with ticagrelor showing the lowest relative MPA levels. • The relationship between platelet inhibition, myocardial inflammation, and cardiac remodeling may represent an axis of therapeutic relevance. [ABSTRACT FROM AUTHOR]

Background: New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up.Methods: Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients.Results: The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES.Conclusions: In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676. [ABSTRACT FROM AUTHOR]

Background: In the ISAR-CABG (Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?) trial, clinical outcomes at 1 year in patients undergoing treatment of saphenous vein graft lesions were superior with drug-eluting stents (DES) versus bare-metal stents.Objectives: The authors compared outcomes between treatment groups at 5 years.Methods: Patients were randomized (1:1:1:3) to receive DES (either permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. The primary endpoint was the combined incidence of death, myocardial infarction (MI), or target lesion revascularization (TLR). Secondary endpoints were the composite of death or MI and TLR.Results: A total of 610 patients were allocated to treatment with DES (n = 303) or bare-metal stents (n = 307). At 5 years, the primary endpoint occurred in 159 (55.5%) versus 157 (53.6%) patients in the DES and bare-metal stent groups, respectively (hazard ratio [HR]: 0.98; 95% confidence interval [CI]: 0.79 to 1.23; p = 0.89). There was interaction between treatment effect and time (pinteraction = 0.005), with a lower event rate in the DES group at 1 year (HR: 0.64; 95% CI: 0.44 to 0.94; p = 0.02) but a numerically higher rate between 1 and 5 years (HR: 1.24; 95% CI: 0.94 to 1.63; p = 0.13). Death or MI occurred in 93 (32.8%) versus 108 (36.6%) patients, respectively (HR: 0.85; 95% CI: 0.64 to 1.12; p = 0.24), without significant interaction between treatment effect and time (pinteraction = 0.57). TLR occurred in 84 (33.1%) versus 69 (25.5%) patients in the DES and bare-metal stent groups, respectively (HR: 1.20; 95% CI: 0.87 to 1.64; p = 0.27). There was interaction between treatment effect and time (pinteraction <0.001): TLR was significantly lower in the DES group at 1 year (HR: 0.49; 95% CI: 0.28 to 0.86; p = 0.01) but significantly higher thereafter (HR: 2.02; 95% CI: 1.32 to 3.08; p = 0.001).Conclusions: In patients undergoing treatment of saphenous vein graft lesions, the advantage of DES over bare-metal stents demonstrated at 1 year was lost at 5 years due to higher attrition of efficacy in the DES group. (Efficacy Study of Drug-Eluting and Bare Metal Stents in Bypass Graft Lesions [ISAR-CABG]; NCT00611910). [ABSTRACT FROM AUTHOR]

We evaluated safety and long-term outcome of endovascular therapy for steno-occlusive iliac artery disease. All endovascular procedures of iliac artery lesions performed at our institution between 2001 and 2014 (n = 676) were retrospectively analyzed. The overall technical success rate was 99% and yielded 100% for stenoses (n = 596) and 95% for chronic total occlusions (n = 80). Lesion complexity defined by the Trans-Atlantic Inter-Society Consensus (TASC) II classification had no impact on success rates (TASC A + B vs C + D; 99.5% vs 98.6%, P = .359). During a median follow-up of 11 months, the overall rate of restenosis was 9.4%. After 1 and 3 years, the primary patency rates were 94% and 86% and the secondary patency rate was 100%, respectively. The TASC II classification had no impact on long-term patency rates (TASC A þ B vs C þ D; 86% vs 81%). In a multivariable analysis, stent diameter remained the only significant predictor for restenosis (hazard ratio: 0.58; 95% confidence interval: 0.41%-0.81%; P = .002). In this single-center retrospective study, endovascular therapy for steno-occlusive iliac artery disease was associated with high technical and clinical success rates as well as an excellent long-term patency rate irrespective of lesion complexity. [ABSTRACT FROM AUTHOR]

Background The incidence of pulmonary vein stenosis (PVS) as complication after pulmonary vein isolation (PVI) for atrial fibrillation (AF) has decreased in the last decade. However, as PVI for AF is becoming more prevalent, the incidence remains considerable in absolute terms. The purpose of this meta-analysis is to investigate the optimal approach for management of PVS after PVI for AF. Methods and results We searched electronic scientific databases for studies comparing plain balloon angioplasty (BA) versus stenting for PVS after PVI for AF. Aggregate data were pooled to perform a meta-analysis. The primary and secondary outcomes were restenosis requiring repeated intervention and procedure-related complications, respectively. A total of 4 studies, treating 315 PVS in 188 patients (BA, n = 171 versus stent, n = 144 PVS) were considered. After a median follow-up of 32 months, the overall incidence of restenosis was 46%. A percutaneous therapy with BA was associated with a higher risk for restenosis requiring repeat intervention compared to stent (risk ratio — RR, 95% confidence interval [95% CI] = 2.18 [1.64–2.89], p < 0.001). Procedure-related complications were comparable between BA and stent (RR [95% CI] = 0.96 [0.19–4.96], p = 0.96). The time to diagnosis of PVS after PVI for AF did not modify the treatment effect for the primary outcome with BA versus stent ( p for interaction = 0.16). Conclusions In patients presenting PVS after PVI for AF, a percutaneous therapy with BA is associated with higher risk for restenosis requiring repeat intervention as compared to stent. These percutaneous therapies display comparable safety. [ABSTRACT FROM AUTHOR]

Background Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR. Methods We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6–8 month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1 year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups. Results In total, 264 patients were treated with BTHC-PCB ( n = 127) or iopromide-PCB ( n = 137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P = 0.001). At 6–8 month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively ( P = 0.16, P adjusted = 0.32). At 1 year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62–1.70], P = 0.91, P adjusted = 0.96). Conclusions In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1 year compared with iopromide-PCB. [ABSTRACT FROM AUTHOR]

Background: Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain.Methods: One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months.Results: Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P=0.009) or DA (55±29%, P=0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation.Conclusions: Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752. [ABSTRACT FROM AUTHOR]

Background: Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial. Methods: In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models. Results: A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52). Conclusions: In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. [ABSTRACT FROM AUTHOR]

Objectives Studies addressing optimal postprocedural pharmacological management after endovascular stenting of iliofemoral post-thrombotic venous obstruction are lacking. We report our early clinical experience with a combination of rivaroxaban and clopidogrel in patients after iliofemoral post-thrombotic venous obstruction stenting. Methods Demographic, procedural, and follow-up data of nine patients (seven women; mean age of 32 ± 11 years) undergoing 10 procedures for iliofemoral post-thrombotic venous obstruction performed between August 2012 and January 2014 were retrospectively reviewed. After endovascular intervention, all patients were administered 20 mg rivaroxaban once daily (s.i.d.) and 75 mg clopidogrel s.i.d. or every second day depending on the individual drug responsiveness for at least six months. The adenosine diphosphate-induced platelet aggregation (platelet aggregation, in aggregation units × min) was assessed on a Multiplate analyzer. Patency was verified venographically at procedure end and was evaluated with duplex ultrasound in regular follow-ups. Results Iliofemoral venous flow was successfully re-established by percutaneous endovascular angioplasty and stent implantation in nine left-sided and one bilateral iliofemoral post-thrombotic venous obstruction. Under dual treatment strategy of rivaroxaban and clopidogrel with platelet aggregation control (median (range): 285 aggregation units × min (192; 402)), none of the patients experienced restenosis or stent thrombosis, respectively. After a median follow-up of 14 months (range: 6–26 months), the primary patency rate was 100% and no in-stent restenosis, stent occlusion or relevant minor or major bleeding occurred. Conclusion Combined factor Xa inhibition and tailored antiplatelet therapy after stenting of iliofemoral post-thrombotic venous obstruction were safe and performed favorably in terms of vessel patency. [ABSTRACT FROM AUTHOR]

Background Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel. Such triple therapy confers an elevated bleeding risk, and its optimal duration is not known. Objectives The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC. Methods In this randomized, open-label trial, we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013. A total of 614 patients receiving concomitant aspirin and OAC were randomized to either 6-week clopidogrel therapy (n = 307) or 6-month clopidogrel therapy (n = 307). The primary endpoint was a composite of death, myocardial infarction (MI), definite stent thrombosis, stroke, or Thrombolysis In Myocardial Infarction (TIMI) major bleeding at 9 months. Results The primary endpoint occurred in 30 patients (9.8%) in the 6-week group compared with 27 patients (8.8%) in the 6-month group (hazard ratio [HR]: 1.14; 95% CI: 0.68 to 1.91; p = 0.63). There were no significant differences for the secondary combined ischemic endpoint of cardiac death, MI, definite stent thrombosis, and ischemic stroke (12 [4.0%] vs. 13 [4.3%]; HR: 0.93; 95% CI: 0.43 to 2.05; p = 0.87) or the secondary bleeding endpoint of TIMI major bleeding (16 [5.3%] vs. 12 [4.0%]; HR: 1.35; 95% CI: 0.64 to 2.84; p = 0.44). Conclusions Six weeks of triple therapy was not superior to 6 months with respect to net clinical outcomes. These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy. (Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation [ISAR-TRIPLE]; NCT00776633 ) [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to systematically evaluate the spatial distribution of image quality improvement with dual-source radiofrequency (RF) transmission in cardiac steady-state free precession sequences at 3.0 T. Imaging with and without dual-source RF transmission was performed in 30 patients. Contrast-to-noise ratio for the left ventricular myocardium was significantly higher using dual-source RF transmission, but improvement was not uniformly distributed. The posterior myocardium showed significantly less contrast-to-noise ratio gain than all other cardiac regions. Signal-to-noise ratio increase was higher in the right than in the left ventricle. Subjective image quality was significantly enhanced by parallel RF transmission. [ABSTRACT FROM AUTHOR]

Importance: The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial.Objective: To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications. A secondary objective was the comparison of the 2 types of VCD.Design, Setting, and Participants: Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014.Interventions: After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio.Main Outcomes and Measures: Primary end point: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons.Results: Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, -1.0% [1-sided 97.5% CI, 0.7%]; P for noninferiority<.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001).Conclusions and Relevance: In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis.Trial Registration: clinicaltrials.gov Identifier: NCT01389375. [ABSTRACT FROM AUTHOR]

IMPORTANCE The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial. OBJECTIVE To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access--a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access--site complications. A secondary objective was the comparison of the 2 types of VCD. DESIGN, SETTING, AND PARTICIPANTS Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014. INTERVENTIONS After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio. MAIN OUTCOMES AND MEASURES Primary end point: the composite of access site--related vascular complications at 30 days after randomization with a 2%noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons. RESULTS Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, --1.0% [1-sided 97.5%CI, 0.7%]; P for noninferiority <.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001). CONCLUSIONS AND RELEVANCE In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis. [ABSTRACT FROM AUTHOR]

Objective Systematic investigation of restenosis after percutaneous coronary intervention (PCI) with bare metal stents (BMS) or first or second generation drug eluting stents (DES) in large scale, broadly inclusive patient populations undergoing follow-up angiography represents a gap in our scientific knowledge. We investigated the incidence of angiographically proven restenosis and its predictors in patients undergoing PCI with stents. Methods All patients undergoing successful implantation of coronary stents for de novo lesions from 1998 to 2009 and follow-up angiography at 6-8 months at two centres in Munich, Germany were eligible for inclusion. Patients with cardiogenic shock, dialysis dependent renal insufficiency or previous cardiac transplantation were excluded. Data were prospectively collected. The incidence of restenosis, defined as diameter stenosis ≥50% in the in-segment area at follow-up angiography, and its predictors were evaluated. Results A total of 12 094 patients met inclusion criteria. Angiographic follow-up was available for 10 004 patients (77.5%) with 15 004 treated lesions. Binary restenosis was detected in 2643 (26.4%) patients. Use of first generation DES versus BMS (OR 0.35, 95% CI 0.31 to 0.39) and second generation DES versus first generation DES (OR 0.67, 95% CI 0.58 to 0.77) were independent predictors of lower rates of restenosis. At multivariate analysis, smaller vessel size (OR 1.59, 95% CI 1.52 to 1.68, for each 0.5 mm decrease), total stented length (OR 1.27, 95% CI 1.21 to 1.33, for each 10 mm increase), complex lesion morphology (OR 1.35, 95% 1.21 to 1.51), presence of diabetes mellitus (OR 1.32, 95% 1.19 to 1.46), and history of bypass surgery (OR 1.38, 95% CI 1.20 to 1.58) were independently associated with restenosis and were similar across the spectrum of stent devices. Conclusions In this large cohort of patients with angiographic surveillance we demonstrated the impact of device development on antirestenotic efficacy, with sequentially improved efficacy from BMS to first generation DES to second generation DES. Predictors of restenosis were small vessel size, increased stented length, complex lesion morphology, diabetes mellitus, and prior bypass surgery. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to compare the safety and efficacy of the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES) for treatment of unprotected left main coronary artery (uLMCA) disease. Background: The second-generation ZES and EES have reduced the risk of restenosis in large patient cohorts. However, their comparative performance in uLMCA lesions is not known. Methods: In this study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either a ZES (n = 324) or an EES (n = 326). The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularization at 1 year. Secondary endpoints were definite or probable stent thrombosis at 1 year and angiographic restenosis based on analysis of the left main coronary artery area at follow-up angiography. Results: At 1 year, the cumulative incidence of the primary endpoint was 17.5% in the ZES group and 14.3% in the EES group (relative risk: 1.26; 95% confidence interval [CI]: 0.85 to 1.85; p = 0.25). Three patients in the ZES group (0.9%) and 2 patients in the EES group (0.6%) experienced definite or probable stent thrombosis (p > 0.99). All-cause mortality at 1 year was equal in the 2 groups (5.6%; relative risk: 1.00; 95% CI: 0.52 to 1.93; p = 0.98). Angiographic restenosis occurred in 21.5% of patients in the ZES group and 16.8% in the EES group (relative risk: 1.28; 95% CI: 0.86 to 1.92; p = 0.24). Conclusions: Within the statistical limitations of the present study, treatment of uLMCA lesions with a ZES or an EES provided comparable clinical and angiographic outcomes at 1-year follow-up. (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions [ISAR-LEFT MAIN-2]; NCT00598637) [Copyright &y& Elsevier]

The article presents the study which examined the effectiveness of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES) and balloon angioplasty in patients who previously received a drug-eluting stent (DES). The randomised, open-label trial was conducted in Germany. Based on the results, PEB could be an effective treatment for patients with restenosis following the implantation of a DES.

An abstract of the conference paper "Comparison between magnetic resonance imaging and single-photon emission tomography for the assessment of myocardial salvage after coronary revascularization in acute myocardial infarction," by Tareq Ibrahim and colleagues is presented.

Background: Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results. Methods and Results: In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, P(noninferiority)=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; P(superiority)=0.74). The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46). Conclusion: In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier NCT 00598533. [ABSTRACT FROM AUTHOR]

Background-Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results. Methods and Results-In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, Pnoninferiority=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; Psuperiority=0.74). The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46). Conclusion-In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months. [ABSTRACT FROM AUTHOR]

This study was an initial phase II trial in humans of molecular magnetic resonance (MR) imaging for improved visualization of thrombi in vessel territories potentially responsible for stroke using a new fibrin-specific contrast agent (EP-2104R). Eleven patients with thrombus in the left ventricle (n = 2), left or right atrium (n = 4), thoracic aorta (n = 4) or carotid artery (n = 1) as verified by an index examination (ultrasound, computed tomograpy, or conventional MR) were enrolled. All MR imaging was performed on 1.5 T whole-body MR-system using an inversion-recovery black-blood gradient-echo sequence. The same sequence was performed before and 2-6 h after low-dose intravenous administration of 4 mumol/kg EP-2104R. Two investigators assessed image quality and signal amplification. Furthermore, contrast-to-noise ratios (CNR) between the clot and the blood pool/surrounding soft tissue before and after administration of the contrast agent were compared using Student's t-test. MR imaging and data analysis were successfully completed in 10 patients. No major adverse effects occurred. On enhanced images, thrombi demonstrated high signal amplification, typically at the clot surface, with a significantly increased contrast in comparison to the surrounding blood pool and soft tissue (CNR for clot vs. blood pool, unenhanced and enhanced: 6 +/- 8 and 29 +/- 14; CNR for clot vs. soft tissue, unenhanced and enhanced: 0 +/- 4 and 21 +/- 13; P < 0.01 for both comparisons). EP-2104R allows for molecular MR imaging of thrombi potentially responsible for stroke. High contrast between thrombus and surrounding blood and soft tissues can be achieved with enhanced imaging. [ABSTRACT FROM AUTHOR]

Context Experimental studies and early phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived stem cells may improve cardiac regeneration and neovascularization after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells. Objective To assess the value of stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction. Design, Setting, and Patients Randomized, double-blind, placebo-controlled trial of patients diagnosed with ST-segment elevation acute myocardial infarction who had successful reperfusion by percutaneous coronary intervention within 12 hours after onset of symptoms in Germany between February 24, 2004, and February 2, 2005. Interventions Patients were randomly assigned to receive subcutaneously either a daily dose of 10 μg/kg of G-CSF or placebo for 5 days. Main Outcome Measures The primary end point was reduction of left ventricular infarct size according to technetium Tc 99m sestamibi scintigraphy performed at baseline and at 4 to 6 months after randomization. Secondary end points included improvement of left ventricular ejection fraction measured by magnetic resonance imaging and the incidence of angiographic restenosis. Results Of the 114 patients, 56 were assigned to receive treatment with G-CSF and 58 were assigned to receive placebo. Treatment with G-CSF produced a significant mobilization of stem cells. Between baseline and follow-up, left ventricular infarct size according to scintigraphy was reduced by a mean (SD) of 6.2% (9.1%) in the G-CSF group and 4.9% (8.9%) in the placebo group (P = .56) and left ventricular ejection fraction was improved by 0.5% (3.8%) in the G-CSF group and 2.0% (4.9%) in the placebo group (P = .14). Angiographic restenosis occurred in 19 (35.2%) of 54 patients in the G-CSF group and in 17 (30.9%) of 55 patients in the placebo group (P = .79). The most common adverse event among patients assigned to G-CSF was mild to moderate bone pain and muscle discomfort. Conclusion Stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction and successful mechanical reperfusion has no influence on infarct size, left ventricular function, or coronary restenosis. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this research was to evaluate kinetics and extent of myocardial contrast enhancement (CE) in comparison with single-photon emission computed tomography (SPECT) early after acute myocardial infarction (AMI). Background: Quantification of infarct size serves as a surrogate end point in evaluating new therapies of AMI. Contrast-enhanced magnetic resonance imaging (CeMRI) of the myocardium is a promising new method for identification of irreversible tissue injury. Methods: A total of 33 patients were examined by CeMRI and SPECT 7 +/- 2 days after AMI and successful coronary intervention. After gadolinium-diethylenetraimine pentaacetic acid injection (0.2 mmol/kg), continuous short-axis slices of the left ventricle (LV) were acquired every 7 min up to 42 min using different inversion times (TI). Myocardial CE at each imaging time point was quantified and compared with corresponding SPECT perfusion defect. Results: All patients showed myocardial CE in the infarct region. A constant TI for CeMRI resulted in a decrease of signal intensity and extent of CE on late acquisitions. With TI adjustment, infarct image intensity peaked at 21 min with a contrast of 478% of remote myocardium and remained at this level up to 42 min after contrast injection (437%); CE extent was stable over time and agreed well with SPECT within an average difference of 3% of the LV myocardium, yielding the best correlation at 28 min (r = 0.86). Conclusions: In patients after AMI and successful reperfusion, CE is stable over time and matches well with SPECT perfusion defect; CeMRI under standardized conditions can accurately assess myocardial infarct size in vivo and may be attractive for serving as a surrogate end point early after AMI. [ABSTRACT FROM AUTHOR]

Background: Characterization of tissue integrity and inflammatory processes after acute myocardial infarction (AMI) using non-invasive imaging is predictive of patient outcome. Quantitative cardiovascular magnetic resonance (CMR) techniques such as native T1 and extracellular volume (ECV) mapping as well as 18F-FDG positron emission tomography (PET) imaging targeting inflammatory cell populations are gaining acceptance, but are often applied without assessing their quantitative potential. Using simultaneously acquired PET/CMR data from patients early after AMI, this study quantitatively compares these three imaging markers and investigates links to blood markers of myocardial injury and systemic inflammatory activity. Methods: A total of 25 patients without microvascular obstruction were retrospectively recruited. All imaging was simultaneously performed 5 ± 1 days after revascularization following AMI on an integrated 3T PET/MRI scanner. Native and post-contrast T1 data were acquired using a modified Look-Locker inversion recovery (MOLLI) sequence, ECV maps were calculated using individually sampled hematocrit. 18F-FDG PET was executed after 1 day of dietary preparation, 12 h of fasting, and administration of heparin. ECV, 18F-FDG and native T1 data were compared mutually as well as to peak counts of peripheral blood markers (creatine kinase, creatine kinase-MB, troponin, leukocytes, monocytes) and infarct size. Results: High intra-patient correlations of relative ECV, 18F-FDG PET and native T1 signal increases were observed in combination with no inter-patient correlation of maximum absolute values at the infarct center, suggesting well-colocalized but physiologically diverse processes begetting the respective image signals. Comparison of maximum image signals to markers of myocardial damage and systemic inflammation yielded highly significant correlations of ECV to peak creatine kinase-MB and overall infarct size as well as between native T1 and peak monocyte counts. Conclusions: Absolute native T1 values at the infarct core early after AMI can be linked to the systemic inflammatory response independent of infarct size. Absolute ECV at the infarct core is related to both infarct size and blood markers of myocardial damage. [ABSTRACT FROM AUTHOR]

The article discusses the case of a 21-year-old male patient with chest pain who was diagnosed with acute inflammatory myocarditis caused by Epstein Barr virus infection. The details of the medical conditions of the patient are presented. It discusses the advantages of the F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) imaging systems in detecting myocarditis.