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Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry.
Tamburino, C, Capodanno, D, Di Salvo, ME, Sanfilippo, A, Cascone, I, Incardona, V, Longo, G, Giacoppo, D, Capranzano, P, Sgroi, C, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2012;(9):1062-8
Abstract
AIMS: The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Cataniaâ„¢ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario. METHODS AND RESULTS The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year. CONCLUSIONS The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.
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Cardiovascular risk assessment and treatment to target low density lipoprotein levels in hospitalized ischemic heart disease patients: results of the HOLEM study.
Harats, D, Leibovitz, E, Maislos, M, Wolfovitz, E, Chajek-Shaul, T, Leitersdorf, E, Gavish, D, Gerber, Y, Goldbourt, U, ,
The Israel Medical Association journal : IMAJ. 2005;(6):355-9
Abstract
BACKGROUND Hypercholesterolemia control status is lacking throughout the western world. OBJECTIVES To examine whether the treatment recommendations given to ischemic heart disease patients at hospital discharge are compatible with the guidelines of the Israeli medical societies and the U.S. National Cholesterol Education Program for coronary artery disease prevention; and to study the effects of brief educational sessions on the adherence of physicians with the guidelines. METHODS We included consecutive IHD patients admitted to four central hospitals in Israel between 1998 and 2000. The study was conducted in two phases. In phase 1, we reviewed discharge letters to document treatment recommendations given to each patient. In phase 2 we educated the practitioners by reviewing the Israeli medical societies and the NCEP guidelines and the quality of their recommendations in phase 1, after which we reevaluated the discharge letters. RESULTS The study included 2,994 patients: 627 in phase 1 and 2,367 in phase 2. Of the patients who needed cholesterol-lowering according to their low density lipoprotein levels, 37.4% were not prescribed such drugs at discharge (under-treatment group). This proportion was reduced by education to 26.6% (P < 0.001) in phase 2. Of the treated patients, 65.6% did not reach the target LDLgoal in phase 1 (under-dosage group) as compared to 60.2% in phase 2 (P = 0.23). In phase 2 there was an increase in the percent of patients reaching LDL levels <130 mg/day (69.3% vs. 63.8% of patients prescribed medication, P = 0.01), but the percent of patients reaching' LDL levels <100 was not different in phase 2 after adjusting for age and gender (the odds ratio for reaching target LDL was 1.16, with 95% confidence interval of 0.95-1.43). CONCLUSIONS Physician recommendations to IHD patients discharged from hospital were suboptimal. We documented a high proportion of under-treated and under-dosaged patients. Brief educational sessions have a beneficial effect on the usage of statins; however, additional effort in guideline implementations is needed.
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Myocardial ischemia induced by nebulized fenoterol for severe childhood asthma.
Zanoni, LZ, Palhares, DB, Consolo, LC
Indian pediatrics. 2005;(10):1013-8
Abstract
We examined for myocardial ischemia induced by continuous inhalation of fenoterol in children with severe acute asthma. Thirty children with severe acute asthma were evaluated for signs of myocardial ischemia when treated with 0.5 mg kg dose (maximum 15 mg) of inhaled fenoterol for one hour. The heart rate was measured before and after inhalation. Cardiac enzymes (creatine kinase, creatine kinase MB fraction and troponin levels) were measured at admission and 12 hours later. An EKG was recorded before inhalation was started and immediately after its completion to detect the presence of any evidence of myocardial ischemia. All patients developed significant increase in heart rate. Six patients showed EKG changes compatible with myocardial ischemia, despite normal enzyme levels. Patients with severe acute asthma show tachycardia and may show EKG changes of myocardial ischemia.
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Testosterone replacement in hypogonadal men with angina improves ischaemic threshold and quality of life.
Malkin, CJ, Pugh, PJ, Morris, PD, Kerry, KE, Jones, RD, Jones, TH, Channer, KS
Heart (British Cardiac Society). 2004;(8):871-6
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Abstract
BACKGROUND Low serum testosterone is associated with several cardiovascular risk factors including dyslipidaemia, adverse clotting profiles, obesity, and insulin resistance. Testosterone has been reported to improve symptoms of angina and delay time to ischaemic threshold in unselected men with coronary disease. OBJECTIVE This randomised single blind placebo controlled crossover study compared testosterone replacement therapy (Sustanon 100) with placebo in 10 men with ischaemic heart disease and hypogonadism. RESULTS Baseline total testosterone and bioavailable testosterone were respectively 4.2 (0.5) nmol/l and 1.7 (0.4) nmol/l. After a month of testosterone, delta value analysis between testosterone and placebo phase showed that mean (SD) trough testosterone concentrations increased significantly by 4.8 (6.6) nmol/l (total testosterone) (p = 0.05) and 3.8 (4.5) nmol/l (bioavailable testosterone) (p = 0.025), time to 1 mm ST segment depression assessed by Bruce protocol exercise treadmill testing increased by 74 (54) seconds (p = 0.002), and mood scores assessed with validated questionnaires all improved. Compared with placebo, testosterone therapy was also associated with a significant reduction of total cholesterol and serum tumour necrosis factor alpha with delta values of -0.41 (0.54) mmol/l (p = 0.04) and -1.8 (2.4) pg/ml (p = 0.05) respectively. CONCLUSION Testosterone replacement therapy in hypogonadal men delays time to ischaemia, improves mood, and is associated with potentially beneficial reductions of total cholesterol and serum tumour necrosis factor alpha.
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Nicorandil infusion leads to good recovery from ischemia of left ventricular regional work in comparison with nitroglycerin.
Isobe, N, Oshima, S, Taniguchi, K, Hoshizaki, H, Adachi, H, Toyama, T, Naito, S, Nogami, A, Sugawara, M
Circulation journal : official journal of the Japanese Circulation Society. 2002;(10):943-8
Abstract
Nicorandil is an antianginal drug that exerts both a conventional nitrate effect and an independent ATP-dependent potassium channel-opening effect. The present study examined the effects of nicorandil on left ventricular regional work (RW) during coronary angioplasty in 22 patients with angina pectoris who were scheduled for angioplasty to the left anterior descending artery. The patients were randomly assigned to receive either nitroglycerin (group NG, n=12, 0.5 microg x kg(-1) min(-1)) or nicorandil (group NR, n = 10, 1.5 microg x kg(-1) min(-1)). Inflation was performed for 60 s and the data were collected every 10 s. The RW was derived from the relation between mean wall stress and area strain. The RW of the interventricular septum decreased after balloon inflation and was at its minimum after the 60s inflation (group NR: 1.24 +/- 0.72mJ/cm3, group NG: 0.63 +/- 0.25mJ/cm3). After balloon deflation, the septal RW of both groups increased, and recovered to the baseline condition at about 30s. At 20 s after deflation, the septal RW in group NR (3.58 +/- 1.17 mJ/cm3) was significantly higher than that in group NG (2.25 +/- 0.59mJ/cm3) (p < 0.05). An intravenous infusion of nicorandil led to good recovery of RW from ischemia compared with that obtained with nitroglycerin.
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Medical treatment of myocardial ischemia in coronary artery disease: effect of drug regime and irregular dosing in the CAPE II trial.
Deanfield, JE, Detry, JM, Sellier, P, Lichtlen, PR, Thaulow, E, Bultas, J, Brennan, C, Young, ST, Beckerman, B, ,
Journal of the American College of Cardiology. 2002;(5):917-25
Abstract
OBJECTIVES The Circadian Anti-ischemia Program in Europe (CAPE II) compared the efficacy of amlodipine and diltiazem (Adizem XL) and the combination of amlodipine/atenolol and diltiazem (Adizem XL)/isosorbide 5-mononitrate on exercise and ambulatory myocardial ischemia during regular therapy and after omission of medication. BACKGROUND The optimal medical therapy for ischemia suppression and the impact of irregular dosing using agents with different pharmacologic properties has not been established in patients with coronary disease. METHODS Patients with > or = 4 ischemic episodes or > or = 20 min of ST segment depression on 72-h electrocardiogram were randomized to amlodipine 10 mg once daily or diltiazem (Adizem XL) 300 mg once daily in a 14-week double-blind randomized multicountry study. In the second phase, atenolol 100 mg was added to amlodipine and isosorbide 5-mononitrate 100 mg to diltiazem (Adizem XL). Ambulatory monitoring (72 h) and exercise testing were repeated after both phases, on treatment and after a 24-h drug-free interval. RESULTS Both monotherapy with amlodipine and diltiazem (Adizem XL) were effective on symptoms and ambulatory and exercise ischemia. Combination therapy reduced ischemia further, with amlodipine/atenolol superior to diltiazem (Adizem XL)/isosorbide 5-mononitrate. Amlodipine/atenolol was significantly superior during the drug-free interval with maintenance of ischemia reduction. CONCLUSIONS Amlodipine, with its intrinsically long half-life alone or together with beta-blocker, is likely to produce superior ischemia reduction in clinical practice when patients frequently forget to take medication or dose irregularly.
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Nicorandil enhances myocardial tolerance to ischemia without progressive collateral recruitment during coronary angioplasty.
Sakai, K, Yamagata, T, Teragawa, H, Matsuura, H, Chayama, K
Circulation journal : official journal of the Japanese Circulation Society. 2002;(4):317-22
Abstract
Nicorandil, a hybrid nitrate and ATP-sensitive potassium channel opener, has had a preconditioning effect in some coronary angioplasty studies. The present study investigated whether the cardioprotective effects of nicorandil involve coronary collateral function. Thirty-two patients with stable angina pectoris were randomized to receive a 1-min intravenous infusion of nicorandil (100 microg/kg) or normal saline. Five minutes later they underwent three 2-min balloon inflations 5-min apart. The maximum ST-segment elevation (deltaSTmax), the sum of ST-segment elevations in all leads (sigmaST), and the chest pain score were determined at the end of each balloon inflation. The collateral flow index (CFI) was derived from simultaneous measurement of the mean aortic pressure and the coronary wedge pressure obtained from a pressure guidewire during balloon inflation. The deltaSTmax, sigmaST, and chest pain score decreased progressively during the 3 sequential balloon inflations in both groups, and the deltaSTmax and sigmaST were less in the nicorandil group than in the control group during each inflation. The CFI did not change during the 3 inflations in either group and was similar in the 2 groups during each inflation. In conclusion, pretreatment with intravenous nicorandil enhances myocardial tolerance to ischemia without progressive collateral recruitment during coronary angioplasty.
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Dose-dependent prophylactic effect of nicorandil, an ATP-sensitive potassium channel opener, on intra-operative myocardial ischaemia in patients undergoing major abdominal surgery.
Kaneko, T, Saito, Y, Hikawa, Y, Yasuda, K, Makita, K
British journal of anaesthesia. 2001;(3):332-7
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Abstract
Nicorandil, a nicotinamide nitrate derivative, relaxes vascular smooth muscle and reduces cardiac muscle contractility by increasing membrane potassium conductance, probably by activating ATP-sensitive potassium channels. In this prospective, randomized, double-blind, placebo-controlled clinical study, we examined the dose-dependent prophylactic effect of nicorandil on intra-operative myocardial ischaemia in 248 patients who had pre-operative risk factors for ischaemic heart disease and were undergoing major abdominal surgery. Patients in group HD (n=81) received a bolus dose of nicorandil 0.08 mg kg(-1) and a continuous infusion of 0.08 mg kg(-1) h(-1). Patients in group LD (n=87) received nicorandil 0.04 mg kg(-1) and 0.04 mg kg(-1) h(-1). Patients in the placebo (P) group (n=80) received the same volumes of saline. The patients were monitored with a three-lead clinical ECG monitor with an ST trending device from arrival in the operating theatre to the end of anaesthesia. Intra-operative myocardial ischaemia occurred significantly less frequently in the HD group (one patient, 1.2%) than in the LD (11 patients, 12.6%) and P groups (21 patients, 26.3%) (P<0.01), and in group LD significantly less than in group P (P<0.05). Administration of nicorandil had little effect on the patients' heart rate or arterial pressure. Three patients in group P and none in either treatment group developed myocardial infarction after surgery.