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Safety and efficacy of extracorporeal shock wave myocardial revascularization therapy for refractory angina pectoris.
Cassar, A, Prasad, M, Rodriguez-Porcel, M, Reeder, GS, Karia, D, DeMaria, AN, Lerman, A
Mayo Clinic proceedings. 2014;(3):346-54
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Abstract
OBJECTIVE To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. PATIENTS AND METHODS A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires. RESULTS Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10). CONCLUSION In this multicenter feasibility study, ESMR seems to be a safe and efficacious treatment for patients with refractory angina pectoris. However, larger sham-controlled trials will be required to confirm these findings.
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Prediction of enzymatic infarct size in ST-segment elevation myocardial infarction.
Mills, JS, Mahaffey, KW, Lokhnygina, Y, Nicolau, JC, Ruzyllo, W, Adams, PX, Todaro, TG, Armstrong, PW, Granger, CB, ,
Coronary artery disease. 2012;(2):118-25
Abstract
OBJECTIVES Predictors of adverse outcomes following myocardial infarction (MI) are well established; however, little is known about what predicts enzymatically estimated infarct size in patients with acute ST-elevation MI. The Complement And Reduction of INfarct size after Angioplasty or Lytics trials of pexelizumab used creatine kinase (CK)-MB area under the curve to determine infarct size in patients treated with primary percutaneous coronary intervention (PCI) or fibrinolysis. METHODS Prediction of infarct size was carried out by measuring CK-MB area under the curve in patients with ST-segment elevation MI treated with reperfusion therapy from January 2000 to April 2002. Infarct size was calculated in 1622 patients (PCI=817; fibrinolysis=805). Logistic regression was used to examine the relationship between baseline demographics, total ST-segment elevation, index angiographic findings (PCI group), and binary outcome of CK-MB area under the curve greater than 3000 ng/ml. RESULTS Large infarcts occurred in 63% (515) of the PCI group and 69% (554) of the fibrinolysis group. Independent predictors of large infarcts differed depending on mode of reperfusion. In PCI, male sex, no prior coronary revascularization and diabetes, decreased systolic blood pressure, sum of ST-segment elevation, total (angiographic) occlusion, and nonright coronary artery culprit artery were independent predictors of larger infarcts (C index=0.73). In fibrinolysis, younger age, decreased heart rate, white race, no history of arrhythmia, increased time to fibrinolytic therapy in patients treated up to 2 h after symptom onset, and sum of ST-segment elevation were independently associated with a larger infarct size (C index=0.68). CONCLUSION Clinical and patient data can be used to predict larger infarcts on the basis of CK-MB quantification. These models may be helpful in designing future trials and in guiding the use of novel pharmacotherapies aimed at limiting infarct size in clinical practice.
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SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease.
Nikolsky, E, Lansky, AJ, Sudhir, K, Doostzadeh, J, Cutlip, DE, Piana, R, Su, X, White, R, Simonton, CA, Stone, GW
American heart journal. 2009;(4):520-526.e2
Abstract
BACKGROUND In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points). However, neither trial was powered for superiority for clinical end points, and the routine performance of angiographic follow-up may have artificially exaggerated the absolute benefits of EES. The relative efficacy of these 2 stents in patients with diabetes mellitus also remains controversial. We therefore designed a large-scale randomized trial without angiographic follow-up to further assess the differences between these 2 stent platforms. STUDY DESIGN SPIRIT IV is an ongoing prospective, active-controlled, single-blinded, multicenter clinical trial in which 3690 patients with native coronary artery disease have been randomized 2:1 to EES versus PES. Patients with up to 3 de novo native coronary artery lesions (maximum 2 lesions per epicardial vessel) with length or=2.5 to SUMMARY SPIRIT IV is the largest randomized comparison of 2 DES with completed enrollment. The absence of routine angiographic follow-up will allow an accurate assessment of the absolute differences in the clinical safety and efficacy profile between these devices. The magnitude of the study will also permit significant insights to be gained into the relative performance of the 2 stents in important subgroups, including patients with diabetes mellitus.
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One-year outcomes from the TAXUS express stent versus cypher stent.
Mayor, M, Malik, AZ, Minor, RJ, Deshpande, MC, Strauss, WE, Maloney, TH, Baim, DS, O'Neill, W, Kandzari, DE
The American journal of cardiology. 2009;(7):930-6
Abstract
We compared 1-year outcomes in patients treated with paclitaxel-eluting stents (PESs) or sirolimus-eluting stents (SESs) in "real-world" clinical practice. Clinical outcomes were evaluated in 1,558 consecutive, unselected, retrospectively collected patients treated with drug-eluting stents (DESs; PES = 816, SES = 742) at 19 United States centers. The primary end point was 1-year target vessel revascularization (TVR). The study included a prespecified diabetic cohort (PES = 289, SES = 247), for which efficacy comparisons between DESs were analyzed according to vessel diameter and presence of chronic kidney disease. Baseline demographic, angiographic, and procedural characteristics were similar between patients treated with PESs and those treated with SESs. At 1 year, there were no overall statistical differences in death, myocardial infarction, TVR, or stent thrombosis. In the diabetic cohort, however, the cumulative incidence of TVR was significantly lower for patients treated with PESs (3%) compared with SESs (9%, p <0.01), which persisted after adjustment for baseline differences (hazard ratio 0.29, 95% confidence interval 0.12 to 0.67). This decrease in TVR with PES was similar in insulin- and noninsulin-requiring diabetic patients. In multivariate analysis, independent predictors of TVR included diabetes, bifurcation stenting, and overlapping stents; in the diabetic cohort, treatment with SESs was also a multivariate predictor of TVR. In conclusion, in this observational, retrospective analysis of DES-treated patients, PESs and SESs demonstrated similar overall safety and efficacy, but PESs were associated with a significant decrease in 1-year TVR rates in diabetic patients.
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[Use of a potassium and magnesium asparaginate solution to maintain the balance of potassium and magnesium during cardiosurgical interventions under extracorporeal circulation].
Trekova, NA, Andrianova, MIu, Tolstova, IA, Aksel'rod, BA, Zaĭtseva, SV, Morozov, IuA
Anesteziologiia i reanimatologiia. 2008;(5):17-21
Abstract
The study included 42 patients with coronary heart disease operated on the coronary arteries. A potassium and magnesium asparaginate (PMA) solution, 450-1000 ml, was injected in 30 patients for 5-7 hours; other crystalloid solutions was used in a control group (n = 12). The concentrations of potassium and magnesium were measured prior to surgery, following initial anesthesia, before and after extracorporeal circulation (EC). The measurements suggested a significant potassium and magnesium intake at surgery under EC. The use of PMA solution showed its advantage in stabilizing the study electrolytes at the main surgical stages. Inclusion of PMA into infusion therapy considerably reduced a need for an additional use of concentrated KCl solution to maintain potassium at the preoperative level. Of particular importance was the use of PMA to maintain magnesium that was held in the upper normal range throughout the operation, as shown by both the median values and an individual analysis. When PLA was not administered, the mean concentration of magnesium was consistent with that in the lower normal electrolyte range and 50% patients developed hypomagnesemia. The comparative analysis of the clinical course after EC in both groups of patients with different levels of magnesium was indicative of the better status of some hemostatic parameters with the level of magnesium being maintained in the upper normal range.
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[Effect of rosuvastatin therapy and myocardial revascularization on angiogenesis in coronary artery disease patients].
Semenova, AE, Sergienko, IV, Masenko, VP, Gabrusenko, SA, Kukharchuk, VV, Belenkov, IuN
Kardiologiia. 2007;(11):4-8
Abstract
We studied the influence of rosuvastatin therapy and myocardial revascularization on angiogenic growth factors in coronary artery disease (CAD) patients. Two main groups were examined: the first one consisted of patients passed through successful percutaneous coronary intervention (PCI), the second one consisted of patients on 3 months rosuvastatin therapy. Vascular endothelial growth factor (VEGF), VEGF receptor Flt-1 (sVEGF-Rl) and transforming growth factor-beta (TGF-bl) levels were measured in healthy volunteers and CAD patients before and 6 days after myocardial revascularization by PCI. VEGF and basic fibroblast growth factor (bFGF) levels were measured before and 3 month after rosuvastatin therapy, as well as total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDLC), C-reactive protein (CRP), interleukin 6 (IL-6) and endothelium dependent vasodilation. VEGF levels did not differ, but TGF - b levels were significantly lower in CAD patients compared to healthy subjects (11.0 +/- 4.9 pg/ml and 120.0 +/- 32.4 pg/ml, respectively, p < 0.000l). Myocardial revascularization caused changes in VEGF levels from 192.4 +/- 166.1 pg/ml to 264.7 +/- 226.6 pg/ml (p=0.0066) without significant influence on TGF and VEGF-R1 levels in 6 days. There were positive changes in lipid levels, lowering of CRP and IL-6 concentrations, improvement of endothelial function and decrease of VEGF levels from 382 +/- 249 pg/ml to 297 +/- 220 pg/ml (p=0.006) 3 month after start of rosuvastatin treatment (no changes in bFGF levels were observed). Chronic insufficient myocardial blood supply leads to decreasing of TGF - b levels. The elevation of VEGF after myocardial revascularization reflects transient ischemia and potentially may provoke hemodynamic instability, caused by atherosclerotic plaque neovascularization. Strengthening of statin therapy early after myocardial revascularization may allow to stabilize the atherosclerotic plaque condition, also by means of VEGF lowering.
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Impact of platelet glycoprotein IIb/IIIa Inhibition on the paclitaxel-eluting stent in patients with stable or unstable angina pectoris or provocable myocardial ischemia (a TAXUS IV substudy).
Teirstein, PS, Kao, J, Watkins, M, Tannenbaum, MA, Laufer, N, Chang, M, Mehran, R, Dangas, G, Russell, ME, Ellis, SG, et al
The American journal of cardiology. 2005;(4):500-5
Abstract
Whether the benefits that glycoprotein IIb/IIIa inhibitors confer in patients who undergo bare metal stent implantation extend to drug-eluting stents is unknown. We performed a prespecified subgroup analysis of the TAXUS IV study population to examine the effect of procedural glycoprotein IIb/IIIa inhibition during paclitaxel-eluting stent implantation on periprocedural creatine kinase-MB (CK-MB) levels. Glycoprotein (GP) IIb/IIIa inhibitors were administered to 57.7% of patients who had been randomized to receive the TAXUS stent and to 56.7% of those who had been randomized to receive the control stent. Among patients who received the TAXUS stent, the rate of CK-MB increases of >3 times the normal level was 2.6-fold higher in those who received a GP IIb/IIIa inhibitor than in those who did not (11.4% vs 4.4%, p = 0.0015). Composite rates of major adverse cardiac events and target vessel failure were also higher at 1 month in the GP IIb/IIIa group. By multivariate analysis, use of GP IIb/IIIa inhibitors during stenting with the TAXUS stent was an independent predictor of CK-MB increases >3 times the normal level. Further studies are warranted.
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Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomised controlled trial [ISRCTN72884263].
Jolly, K, Lip, GY, Sandercock, J, Greenfield, SM, Raftery, JP, Mant, J, Taylor, R, Lane, D, Lee, KW, Stevens, AJ
BMC cardiovascular disorders. 2003;:10
Abstract
BACKGROUND Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. METHODS/DESIGN A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. PATIENTS We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. MAIN OUTCOME MEASURES Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity.In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. DISCUSSION More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the Birmingham Rehabilitation Uptake Maximisation Study (BRUM) study and has implications for the clinical management of these patients. A novel feature of this study is the inclusion of non-English Punjabi speakers.
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Simvastatin attenuates leucocyte-endothelial interactions after coronary revascularisation with cardiopulmonary bypass.
Chello, M, Mastroroberto, P, Patti, G, D'Ambrosio, A, Morichetti, MC, Di Sciascio, G, Covino, E
Heart (British Cardiac Society). 2003;(5):538-43
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Abstract
OBJECTIVE To investigate the effects of preoperative simvastatin treatment on leucocyte-endothelial interactions following coronary artery bypass surgery with cardiopulmonary bypass. DESIGN Double blind crossover study. Experiments on polymorphonuclear cells (neutrophils) were done at the end of cardiopulmonary bypass and one hour postoperatively. Endothelial P-selectin expression and neutrophil/endothelial adhesion were evaluated under either normoxic or hypoxic conditions. SETTING University hospital (tertiary referral centre). PATIENTS Three groups of patients undergoing coronary bypass surgery: 20 patients taking simvastatin for cholesterol control, 16 patients not responsive to simvastatin, and 20 controls. MAIN OUTCOME MEASURES Expression of neutrophil CD11b and endothelial P-selectin; adhesion of neutrophils to endothelium. RESULTS Cardiopulmonary bypass resulted in a significant increase in neutrophil CD11b expression in all groups. Similarly, the exposure of saphenous vein to hypoxia/reoxygenation induced an augmentation of endothelial P-selectin. However, both neutrophil CD11b expression and endothelial P-selectin exocytosis were less in the simvastatin groups than in the controls. Cardiopulmonary bypass and controlled hypoxia/reoxygenation stimulated neutrophil/endothelial adhesion, but the number of adhering cells was less in the simvastatin groups than in the controls, irrespective of the cholesterol concentration. Treatment of endothelial cells with L-NAME completely reversed the effects of simvastatin. CONCLUSIONS Pretreatment with simvastatin reduces neutrophil adhesion to the venous endothelium in patients undergoing coronary surgery, irrespective of its efficacy at lowering cholesterol concentration.
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Prospective analysis of creatine kinase muscle-brain fraction and comparison with troponin T to predict cardiac risk and benefit of an invasive strategy in patients with non-ST-elevation acute coronary syndromes.
Kleiman, NS, Lakkis, N, Cannon, CP, Murphy, SA, DiBattiste, PM, Demopoulos, LA, Weintraub, WS, Braunwald, E, ,
Journal of the American College of Cardiology. 2002;(6):1044-50
Abstract
OBJECTIVE We sought to determine whether elevation of plasma creatine kinase muscle-brain fraction (CK-MB) would be useful to triage patients with acute coronary syndromes (ACS) to early angiography/revascularization. BACKGROUND It is unknown whether the measurement of CK-MB is effective for triage to an aggressive management strategy. METHOD Patients in the Treat Angina With Aggrastat and Determine Cost of Therapy With an Invasive or Conservative Strategy (TACTICS-TIMI) 18 study received aspirin, heparin, and tirofiban for treatment of ACS, were randomized to an invasive or a conservative strategy (angiography/revascularization between 4 and 48 h), and were followed up for a composite end point of death, myocardial infarction, or rehospitalization for ACS. Of 2,220 patients, CK-MB was elevated in 826 (37%). Of the patients with negative CK-MB, troponin T was elevated in 361 (31.2%). Event rates at 30 and 180 days were twice as high in patients with elevated CK-MB than in patients without elevated CK-MB. Both groups had similar benefit from an invasive strategy; there was no evidence of interaction between CK-MB elevation and strategy on the composite end point at 30 or 180 days. When patients were stratified according to both CK-MB and troponin status, there was evidence of a benefit in the invasive strategy among patients who were CK-negative but troponin-positive (odds ratios [95% confidence interval]: 0.13 [0.04 to 0.39] at 30 days and 0.29 [0.16 to 0.52] at 180 days). CONCLUSION Patients with minimal amounts of recent onset myonecrosis but elevated risk as indicated by CK-MB and troponin, respectively, benefit most from invasive management. Determination of troponin levels yielded significant information regarding triage to an invasive strategy, particularly in CK-MB-negative patients.