A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

BACKGROUND: MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. METHODS: We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. FINDINGS: Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. INTERPRETATION: The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. FUNDING: The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

Early Cardiac Rehabilitation Improves Carotid Arterial Stiffness in Patients with Myocardial Infarction.

Background: Little is known about the effect of cardiac rehabilitation (CR) on carotid arterial stiffness (CAS) in patients with myocardial infarction (MI). Patients and Methods: Rehabilitation group (B) included 90 patients with MI subjected to CR, control group (K) consisted of 30 patients with MI not participating in CR, and healthy group comprised 38 persons without cardiovascular risk factors. CAS was determined using echo-tracking before and after CR. Results: At baseline, patients with MI (B+K) presented with significantly higher mean values of CAS parameters: beta-stiffness index (7.1 vs 6.4, p = 0.004), Peterson's elastic modulus (96 kPa vs 77 kPa, p < 0.001) and PWV-beta (6.1 m/s vs 5.2 m/s, p < 0.001) than healthy persons. Age (beta: r = 0.242, p = 0.008; EP: r = 0.250, p = 0.006; PWV-beta: r = 0.224, p = 0.014) and blood pressure: SBP (EP: r = 0.388, PWV-beta: r = 0.360), DBP (AC: r = 0.225) and PP (PWV-beta: r = 0.221) correlated positively with the initial parameters of CAS. Beta-stiffness index (Rho=-0.26, p = 0.04) and PWV-beta (Rho = 0.29, p = 0.03) correlated inversely with peak exercise capacity expressed in METs. After CR, mean values of beta-stiffness index (6.2 vs 7.1, p = 0.016), EP (78 kPa vs 101 kPa, p = 0.001) and PWV-beta (5.4 m/s vs 6.2 m/s, p = 0.001) in group B were significantly lower than in group K. In group B, CAS parameters decreased significantly after CR. Univariate analysis demonstrated that the likelihood of an improvement in CAS after CR was significantly higher in patients with baseline systolic blood pressure <120 mm Hg (OR = 2.74, p = 0.009) and left ventricular ejection fraction <43% (OR = 5.05, p = 0.005). Conclusion: In patients with MI, CR exerted a beneficial effect on CAS parameters. The improvement in CAS was predicted by lower SBP and LVEF at baseline.

Influence of the Apelinergic System on Conduction Disorders in Patients after Myocardial Infarction.

BACKGROUND: There is a growing body of evidence for an important role of the apelinergic system in the modulation of cardiovascular homeostasis. The aim of our study was to (1) examine the relationship between apelin serum concentration at index myocardial infarction (MI) and atrioventricular conduction disorders (AVCDs) at 12-month follow-up, and (2) investigate the association between initial apelin concentration and the novel marker of post-MI scar (Q/QRS ratio) at follow-up. METHODS: In 84 patients with MI with complete revascularization, apelin peptide serum concentrations for apelin-13, apelin-17, elabela (ELA) and apelin receptor (APJ) were measured on day one of hospitalization; at 12-month follow-up, 54 of them underwent thorough examination that included 12-lead electrocardiography (ECG), Holter ECG monitoring and echocardiography. RESULTS: The mean age was 58.9 years. At 12-month follow-up, AVCDs were diagnosed in 21.4% of subjects, with AV first-degree block in 16.7% and sinoatrial arrest in 3.7%. ELA serum concentration at index MI correlated positively with the occurrence of AVCD (p = 0.003) and heart rate (p = 0.005) at 12-month follow-up. The apelin-13 serum concentration at index MI correlated negatively with the Q/QRS ratio. CONCLUSIONS: The apelin peptide concentration during an acute phase of MI impacts the development of AVCD and the value of Q/QRS ratio in MI survivors.

Mobilization of CD34+CXCR4+ stem/progenitor cells and the parameters of left ventricular function and remodeling in 1-year follow-up of patients with acute myocardial infarction.

Mobilization of stem cells in acute MI might signify the reparatory response. Aim of the Study. Prospective evaluation of correlation between CD34+CXCR4+ cell mobilization and improvement of LVEF and remodeling in patients with acute MI in 1-year followup. Methods. 50 patients with MI, 28 with stable angina (SAP), and 20 individuals with no CAD (CTRL). CD34+CXCR4+ cells, SDF-1, G-CSF, troponin I (TnI) and NT-proBNP were measured on admission and 1 year after MI. Echocardiography and ergospirometry were carried out after 1 year. Results. Number of CD34+CXCR4+ cells in acute MI was significantly higher in comparison with SAP and CTRL, but lower in patients with decreased LVEF ≤40%. In patients who had significant LVEF increase ≥5% in 1 year FU the number of cells in acute MI was significantly higher versus patients with no LVEF improvement. Number of cells was positively correlated (r = 0,41, P = 0,031) with absolute LVEF change and inversely with absolute change of ESD and EDD in 1-year FU. Mobilization of CD34+CXCR4+ cells in acute MI was negatively correlated with maximum TnI and NT-proBNP levels. Conclusion. Mobilization of CD34+CXCR4+ cells in acute MI shows significant positive correlation with improvement of LVEF after 1 year.

Plasma Levels of Apelinergic System Components in Patients with Chronic and Acute Coronary Syndromes-A Pilot Study.

The effects of the apelinergic system components apelin (AP) and elabela (ELA) in the regulation of human cardiovascular homeostasis, and data concerning the relationship between ELA and AP and coronary artery disease (CAD) are yet unknown. The aim of the study was the evaluation of AP, ELA and APJ-receptor levels in the plasma of patients with chronic coronary syndromes (CCS) and acute coronary syndromes (ACS). The study group consisted of 114 patients with CAD and 33 healthy controls. Patients were divided into two groups: with CCS (n = 30) and ACS (n = 84). Routine laboratory tests and plasma ELA, AP-17, AP-13 and APJ receptor levels were measured. Echocardiographic data were analyzed in all patients. Levels of AP-17 and ELA were significantly lower in CCS than in healthy controls and ACS patients. We demonstrated significant increase of levels of plasma apelinergic system peptides, especially ELA and AP-17 in ACS patients compared with healthy controls and CCS, suggestive of compensating up-regulation mechanisms. There is a relationship between circulating ELA and AP-17 levels and classical, biochemical markers of ischemia and left ventricular ejection faction as well.

Perforation of saphenous vein graft with mediastinal haemorrhage leading to near closure of distal graft segment.

Perforations of saphenous venous grafts during coronary angioplasty are rare and potentially lethal. The objective of this clinical case report is to highlight this unusual complication and necessary treatment. A 76-year-old woman, 3 months after coronary artery bypass grafting (left internal mammary artery to left anterior descendant artery, saphenous vein graft to obtuse marginal, saphenous vein graft to right coronary artery), demonstrated typical signs of acute coronary syndrome. Coronary angiogram revealed, inter alia, two critical lesions in saphenous vein graft to right coronary artery. Percutaneous coronary intervention was performed with placement of two drug-eluting stents, complicated by a vessel rupture and heavy extravasation of contrast. A polyurethane-covered stent was then deployed and successfully sealed the vascular wall. In a computed tomography of the chest, a mediastinal haematoma near the heart base and right heart margin was found. Subsequently, this intrathoracic bleeding caused external impression on saphenous vein graft to right coronary artery, leading to near occlusion of the vessel with recurrence of chest pain and ST-segment elevation in inferior wall electrocardiogram leads. Immediate coronary angiography and drug-eluting stent implantation was performed. During, further, in-hospital follow-up, patient was free of chest pain; computed tomography scan performed after 10 days revealed regression of haematoma. Clinicians must remain alert to the potential of life-threatening complications associated with saphenous venous graft angioplasty, as their recognition is critical to institution of prompt, appropriate therapy.

A 64-year-old man suffering from ST-elevation myocardial infarction and severe thrombocytopenia: Procedures in the case of a patient not fitting the guidelines.

The objective of this case report is to present how the chronic condition significantly complicates life-saving procedures and influences further treatment decisions. A 64-year-old man suffering from arterial hypertension and immune thrombocytopenic purpura presented to the Emergency Department with anterior ST-elevation myocardial infarction. An immediate coronary angiography was performed where critical stenosis of the proximal left anterior descending was found. It was followed by primary percutaneous intervention with bare metal stent. In first laboratory results, extremely low platelet count was found (13 × 109/L). Consulting haematologist advised the use of single antiplatelet therapy and from the second day of hospitalisation only clopidogrel was prescribed. On the sixth day of hospital stay, patient presented acute chest pain with ST elevation in anterior leads. Emergency coronary angiography confirmed acute stent thrombosis and aspiration thrombectomy was performed. It was therefore agreed to continue dual antiplatelet therapy for 4 weeks. As there are no clinical trials where patients with low platelet count are included, all therapeutic decisions must be made based on clinician's experience and experts' consensus. Both the risk of haemorrhagic complications and increased risk of thrombosis must be taken into consideration when deciding on patient's treatment.

[Massive pulmonary embolism mimicking ST-elevation acute coronary syndrome successfully treated with hybrid therapy in a trauma patient receiving nadroparin: diagnostic and therapeutic dilemmas]. / Masywny zator tetnicy plucnej imitujacy ostry zespól wiencowy z uniesieniem odcinka ST skutecznie leczony terapia hybrydowa u chorej po zlozonym urazie ortopedycznym otrzymujacej nadroparyne

A case of a 48-year-old woman with a comminuted fracture of the left tibia and receiving prophylactic doses of nadroparin, with massive pulmonary embolism mimicking ST-elevation acute coronary syndrome and complicated by cardiogenic shock and cardiac arrest, is presented. Pulmonary angiography showed total right pulmonary artery occlusion. Intraarterial thrombolysis with reduced dose of alteplase (50 mg), platelet GP IIb/IIIa blockade with eptifibatide, endovascular embolus fragmentation with a pigtail rotation catheter, and rescue pulmonary balloon angioplasty were performed, after which complete recovery was achieved. On day 4 of hospitalisation the patient was transferred to the orthopaedic ward where she underwent uneventful tibial surgery.

Mobilization of CD34/CXCR4+, CD34/CD117+, c-met+ stem cells, and mononuclear cells expressing early cardiac, muscle, and endothelial markers into peripheral blood in patients with acute myocardial infarction.

BACKGROUND: Adult stem cells can contribute to myocardial regeneration after ischemic injury. Bone marrow and skeletal muscles contain a population of CXCR4+ cells expressing genes specific for muscle progenitor cells that can be mobilized into the peripheral blood. The aims of the study were (1) to confirm the presence of early tissue-committed cells expressing cardiac, muscle, and endothelial markers in populations of mononuclear cells in peripheral blood and (2) to assess the dynamics and magnitude of the mobilization of CD34+, CD117+, CXCR4+, c-met+, CD34/CD117+, and CD34/CXCR4+ stem cells into peripheral blood in relation to inflammatory and hematopoietic cytokines in patients with ST-segment-elevation acute myocardial infarction (STEMI). METHODS AND RESULTS: Fifty-six patients with STEMI (<12 hours), 39 with stable angina, and 20 healthy control subjects were enrolled. Real-time reverse transcription-polymerase chain reaction (RT-PCR) was used for detection of tissue-specific markers. The number of the cells was assessed by use of a flow cytometer on admission, after 24 hours, and after 7 days. RT-PCR revealed increased expression of mRNA (up to 3.5-fold increase) for specific cardiac (GATA4, MEF2C, Nkx2.5/Csx), muscle (Myf5, Myogenin, MyoD), and endothelial (VE-cadherin, von Willebrand factor) markers in peripheral blood mononuclear cells. The number of CD34/CXCR4+ and CD34/CD117+ and c-met+ stem cells in peripheral blood was significantly higher in STEMI patients than in stable angina and healthy subjects, peaking on admission, without further significant increase after 24 hours and 7 days. CONCLUSIONS: The study demonstrates in the setting of STEMI a marked mobilization of mononuclear cells expressing specific cardiac, muscle, and endothelial markers as well as CD34/CXCR4+ and CD34/CD117+ and c-met+ stem cells and shows that stromal cell-derived factor-1 is an important factor influencing the mobilization.

The pro- and anti-inflammatory markers in patients with acute myocardial infarction and chronic stable angina.

The aim of this study was to assess the plasma levels of VEGF and interleukin-10 in patients with acute myocardial infarction (AMI) and stable chronic angina (SA) and correlate the values with traditional CHD risk factors, left ventricular ejection fraction (LVEF) and established inflammatory marker hsCRP. Fifty patients with AMI and 30 with SA were enrolled. IL-10 levels in AMI patients were lower than in SA patients (9.81 +/- 5.0 versus 22.63 +/- 8.38 pg/ml, p < 0.00001). IL-10 levels were lower in AMI and SA patients with multiple CHD risk factors than in patients < or = 2 risk factors (SA: 19.48 +/- 2.94 versus 23.77 +/- 2.94 pg/ml; p < 0.005; AMI: 8.64 +/- 4.43 versus 11.85 +/- 4.09 pg/ml; p < 0.05) and patients with AMI and single-vessel than with multi-vessel disease (8.45 +/- 3.86 versus 10.72 +/- 3.95 pg/ml; p < 0.05). VEGF levels in AMI patients were higher than in SA patients (312.0 +/- 67.0 versus 221.0 + /- 50 pg/ml; p < 0.005). VEGF levels were higher in AMI patients with multi-vessel disease than in patients with single-vessel disease (348.74 +/- 45.23 versus 252.05 +/- 21.12 pg/ml; p < 0.005), with LVEF <40% and Killip class III-IV than in patients with LVEF >40% and Killip class I-II (338.8 +/- 51.59 versus 271.8 +/- 50.51 pg/ml; p < 0.005 and 340.71 +/- 52.94 versus 275.45 +/- 49.48 pg/ml; p < 0.05, respectively) and with chest pain > 6 h versus < 6 h (330.03 +/- 58.58 versus 292 +/- 57.53 pg/ml; p < 0.05). HsCRP concentrations in AMI patients were higher than in SA (1.24 +/- 0.47 versus 0.42 +/- 0.14; p < 0.0001). HsCRP was correlated with IL-10 (r = -0.413; p < 0.05) and VEGF (r = 0.319; p < 0.05). Acute myocardial infarction is associated with elevated VEGF levels and decreased concentration of IL-10. There is a significant correlation between levels of inflamatory markers and CHD risk factors and the function of the left ventricle on admission.

Mobilization of CD34(+), CD117(+), CXCR4(+), c-met(+) stem cells is correlated with left ventricular ejection fraction and plasma NT-proBNP levels in patients with acute myocardial infarction.

AIMS: The aim of the study was to assess the correlation between the number of CD34(+), CD117(+), c-met(+), CXCR4(+) stem cells mobilized into peripheral blood, left ventricular ejection fraction (LVEF), NT-proBNP levels, and myocardial necrosis markers in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: 43 patients with STEMI were enrolled. Stem cells number was measured using flow-cytometer and concentrations of NT-proBNP, SDF-1, G-CSF, VEGF, IL-6, and HGF were measured using ELISA kits. The number of stem cells mobilized early (<12 h) in AMI was significantly, positively correlated with LVEF: r=0.49 (P=0.0012) for CD34(+) cells, r=0.48 (P=0.0018) for CXCR4(+) cells, r=0.45 (P=0.0043) for CD117(+) cells, and r=0.41 (P=0.01) for c-met(+) cells and negatively correlated with NT-proBNP levels on admission r=-0.35 (P=0.024) for CD34(+) cells, r=-0.42 (P=0.007) for CXCR4(+) cells, r=-0.33 (P=0.04). In patients with LVEF 40%. The number of CXCR4(+) cells on admission and after 24 h was negatively correlated with respective cardiac Troponin I levels (r=-0.37; P=0.029 and r=-0.45, P=0.02) and maximum activity of CK-MB (r=-0.37; P=0.021). No significant correlations between levels of haematopoietic cytokines and LVEF were found. CONCLUSION: The mobilization of CD34(+), CD117(+), CXCR4(+), c-met(+) stem cells into peripheral blood early in STEMI is positively correlated with LVEF and negatively correlated with NT-proBNP levels and myocardial necrosis markers.