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Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes Following Percutaneous Coronary Intervention: A Subgroup Analysis of the PRESERVE Trial.
Garcia, S, Bhatt, DL, Gallagher, M, Jneid, H, Kaufman, J, Palevsky, PM, Wu, H, Weisbord, SD, ,
JACC. Cardiovascular interventions. 2018;(22):2254-2261
Abstract
OBJECTIVES The aim of this study was to compare intravenous (IV) sodium bicarbonate with IV sodium chloride and oral acetylcysteine with placebo for the prevention of contrast-associated acute kidney injury (CAAKI) and intermediate-term adverse outcomes. BACKGROUND Data are conflicting on the optimal strategy to reduce CAAKI and related complications after percutaneous coronary intervention (PCI). METHODS The PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial used a 2 × 2 factorial design to randomize 5,177 patients with stage III or IV chronic kidney disease undergoing angiography to IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and 5 days of oral acetylcysteine or placebo. A subgroup analysis was conducted of the efficacy of these interventions in patients who underwent PCI during the study angiographic examination. The primary endpoint was a composite of death, need for dialysis, or persistent kidney impairment at 90 days; CAAKI was a secondary endpoint. RESULTS A total of 1,161 PRESERVE patients (mean age 69 ± 8 years) underwent PCI. The median estimated glomerular filtration rate was 50.7 ml/min/1.73 m2 (interquartile range: 41.7 to 60.1 ml/min/1.73 m2), and 952 patients (82%) had diabetes mellitus. The primary endpoint occurred in 15 of 568 patients (2.6%) in the IV sodium bicarbonate group and 24 of 593 patients (4.0%) in the IV sodium chloride group (odds ratio: 0.64; 95% confidence interval: 0.33 to 1.24; p for interaction = 0.41) and in 23 of 598 patients (3.8%) in the acetylcysteine group and 16 of 563 patients (2.8%) in the placebo group (odds ratio: 1.37; 95% confidence interval: 0.71 to 2.62; p for interaction = 0.29). There were no significant between-group differences in the rates of CAAKI. CONCLUSIONS Among patients with CKD undergoing PCI, there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of CAAKI or intermediate-term adverse outcomes.
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Culprit Plaque Characteristics in Patients With Sleep-Disordered Breathing Undergoing Percutaneous Coronary Intervention: An Intravascular Ultrasound Study.
Wada, H, Dohi, T, Kasai, T, Yatsu, S, Naito, R, Kato, Y, Okai, I, Iwata, H, Isoda, K, Okazaki, S, et al
Journal of the American Heart Association. 2018;(19):e009826
Abstract
Background Sleep-disordered breathing ( SDB ) is a novel cardiovascular risk factor. However, the coronary plaque characteristics of patients with SDB with coronary artery disease are still unclear. Methods and Results This study included 289 consecutive patients with coronary artery disease undergoing percutaneous coronary intervention. Plaque characteristics of the culprit lesion were assessed by preintervention intravascular ultrasound. The presence of SDB was defined as a 3% oxygen desaturation index of ≥15 events per hour measured by nocturnal pulse oximetry. Of 289 patients, the median 3% oxygen desaturation index was 9.6 (interquartile range, 5.1-16.6), and 88 patients (30.4%) were defined as having SDB . Compared with the no- SDB group, the SDB group had a larger total atheroma volume of the culprit lesion (224.5 mm3 versus 190.8 mm3, P=0.05). The median maximum attenuation and calcification angle were 140° and 130°, respectively. Attenuated plaque with a maximum attenuation angle >140° was more frequently observed in the SDB group compared with the no- SDB group (34.9% versus 22.6%; P=0.03). However, there were no statistically significant differences between groups in the maximum calcium angle and the frequency of calcific plaques with a maximum calcium angle >130°. Multivariable logistic regression analysis showed that the presence of SDB was a significant predictor of a greater ultrasound attenuation angle (>140°) (odds ratio, 1.86; 95% confidence interval, 1.02-3.39; P=0.04). Conclusions SDB was associated with larger atheroma plaque volume and a greater ultrasound attenuation, which are discriminators of plaque vulnerability. Further studies are needed to clarify the effects of SDB treatment on coronary plaque lesions.
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The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial.
Moretti, C, Cerrato, E, Cavallero, E, Lin, S, Rossi, ML, Picchi, A, Sanguineti, F, Ugo, F, Palazzuoli, A, Bertaina, M, et al
International journal of cardiology. 2018;:1-6
Abstract
BACKGROUND The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.
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A randomized study of prourokinase during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction.
Geng, W, Zhang, Q, Liu, J, Tian, X, Zhen, L, Song, D, Yang, Y, Meng, H, Wang, Y, Chen, J
Journal of interventional cardiology. 2018;(2):136-143
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Abstract
OBJECTIVES To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). METHODS Acute STEMI patients underwent primary PCI were randomly divided into two groups: intracoronary prourokinase (IP) group (n = 118) and control group (n = 112). During primary PCI, prourokinase or saline were injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and MACE occurred in the 6-months follow up were recorded. RESULTS No significant differences were observed between two groups with respect to baseline demographic, clinical, and angiographic characteristics (P > 0.05). In IP group, more patients had complete ST segment resolution (>70%) compared with control group (P < 0.05). Patients in IP group showed lower levels of serum CK, CK-MB and TnI, and a much higher myocardial blood flow (MBF) than those in control group (P < 0.05). No significant differences of TIMI major or minor bleeding complications were observed between the two groups (P > 0.05). At 6-months follow-up, there was a trend that patients in the IP group had a less chance to have MACE, though it was not statistically different (8.5% vs 12.5%, P > 0.05). CONCLUSIONS Intracoronary administration of prourokinase via balloon catheter during primary PCI effectively improved myocardial perfusion in STEMI patients.
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Remote Ischemic Postconditioning (RIPC) of the Upper Arm Results in Protection from Cardiac Ischemia-Reperfusion Injury Following Primary Percutaneous Coronary Intervention (PCI) for Acute ST-Segment Elevation Myocardial Infarction (STEMI).
Cao, B, Wang, H, Zhang, C, Xia, M, Yang, X
Medical science monitor : international medical journal of experimental and clinical research. 2018;:1017-1026
Abstract
BACKGROUND The aim of this study was to evaluate the role of remote ischemic postconditioning (RIPC) of the upper arm on protection from cardiac ischemia-reperfusion injury following primary percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). MATERIAL AND METHODS Eighty patients with STEMI were randomized into two groups: primary PCI (N=44) and primary PCI+RIPC (N=36). RIPC consisted of four cycles of 5 minutes of occlusion and five minutes of reperfusion by cuff inflation and deflation of the upper arm, commencing within one minute of the first PCI balloon dilatation. Peripheral venous blood samples were collected before PCI and at 0.5, 8, 24, 48, and 72 hours after PCI. Levels of creatine kinase-MB (CK-MB), serum creatinine (Cr), nitric oxide (NO), and stromal cell-derived factor-1α (SDF-1α) were measured. The rates of acute kidney injury (AKI) and the estimated glomerular filtration rate (eGFR) were calculated. RESULTS Patients in the primary PCI+RIPC group, compared with the primary PCI group, had significantly lower peak CK-MB concentrations (P<0.01), a significantly increased left ventricular ejection fraction (LVEF) (P=0.01), a significantly lower rate of AKI (P<0.01) a significantly increased eGFR (P<0.01), and decreased area under the curve (AUC) of CK-MB, NO and SDF-1α. CONCLUSIONS RIPC of the upper arm following primary PCI in patients with acute STEMI might provide cardiac and renal protection from ischemia-reperfusion injury via the actions of SDF-1α, and NO.
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Adjunctive laser-stimulated stem-cells therapy to primary reperfusion in acute myocardial infarction in humans: Safety and feasibility study.
Elbaz-Greener, G, Sud, M, Tzuman, O, Leitman, M, Vered, Z, Ben-Dov, N, Oron, U, Blatt, A
Journal of interventional cardiology. 2018;(6):711-716
Abstract
BACKGROUND Low-level laser therapy (LLLT) has photobiostimulatory effects on stem cells and may offer cardioprotection. This cell-based therapy may compliment primary percutaneous coronary intervention (PPCI) in patients with ST-segment elevation myocardial infarction (STEMI). OBJECTIVE In this randomized control trial, our primary objective was to determine the safety and feasibility of LLLT application to the bone marrow in patients with STEMI undergoing PPCI. METHODS We randomly assigned patients undergoing PPCI to LLLT or non-laser therapy (NLT). In the LLLT group, 100 s of laser therapy was applied to the tibia bone prior to PPCI, as well as 24 and 72 h post-PPCI. In the control group, the power source was turned off. The primary outcome was the difference in door-to-balloon (D2B) time, and additional outcomes included differences in circulating cell counts, cardiac enzymes, and left-ventricular ejection fraction (LVEF) at pre-specified intervals post-PPCI. RESULTS Twenty-four patients were randomized to LLLT (N = 12) or NLT (N = 12). No adverse effects of the treatment were detected. The D2B time was not significantly different between the groups (41 ± 8 vs 48 ± 1 min; P = 0.73). Creatinine Phosphokinase area under the curve, was lower after LLLT (22 ± 10) compared to NLT (49 ± 12), but this was not statistically significant (P = 0.08). Troponin-T was significantly lower after LLLT (2.7 ± 1.4 ng/mL) in comparison to NLT (5.2 ± 1.8 ng/mL. P < 0.05). At 9 months, LVEF improved in both groups without a significant difference between LLLT (55 ± 9%) and NLT (52 ± 9%; P = 0.90). CONCLUSION LLLT is a safe and feasible adjunctive cell-based therapy to PPCI that may benefit ischemic myocardium.
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Different postconditioning cycles affect prognosis of aged patients undergoing primary percutaneous coronary intervention.
Zhang, J, Zhang, X, Cui, Y, Ferdous, M, Cui, L, Zhao, P
Cardiology journal. 2018;(6):666-673
Abstract
BACKGROUND Postconditioning can affect the infarct size in acute myocardial infarction (AMI). How-ever, few studies show an effect of different postconditioning cycles on AMI aged patients. This study sought to assess the effect of different postconditioning cycles on prognosis in aged patients with AMI who underwent primary percutaneous coronary intervention (PCI). METHODS Seventy four aged patients were randomly assigned to three groups. Control group; PC-1 group accepted postconditioning 4 cycles of 30 s inflation and 30 s deflation; PC-2 group accepted postconditioning 4 cycles of 60 s. Creatine kinase MB (CK-MB), troponin I (cTnI), high-sensitive C-reactive protein (hs-CRP) and corrected Thrombolysis in Myocardial Infarction (TIMI) frame counts (CTFC) were analyzed before and after treatment. All patients received an echocardiographic examina-tion for whole heart function, wall motion score index (WMSI) and single-photon emission computed tomography (SPECT) examination at 7 days and 6 months after treatment. RESULTS The peak of CK-MB, postoperative 72 h cTnI and CTFC were significantly attenuated by postconditioning when compared with the control group. The hs-CRP of the postconditioning group was lower than the control group 24 h postoperative. No difference was observed between PC-1 and PC-2 group about the effect described above. At 7 days, heart function in the postconditioning group was im-proved when compared with the control group. At 6 months, the WMSI and SPECT score significantly reduced in the PC-2 group compared with the control and PC-1 groups, but there was no difference among the three groups about echo data except the left ventricular end-systolic diameter. CONCLUSIONS Postconditioning is significantly beneficial to prognosis in aged patients with AMI. The cardiac protective effect of 4 cycles of 60 s procedure was observed in WMSI and SPECT. It is favorable to implement this procedure in aged patients with AMI in clinic.
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Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial.
Ye, Z, Lu, H, Su, Q, Long, M, Li, L
Drug design, development and therapy. 2018;:2591-2599
Abstract
BACKGROUND Previous studies have indicated that nicorandil can reduce perioperative myocardial injury (PMI) in patients undergoing elective percutaneous coronary intervention (ePCI), but this conclusion is still controversial. Additionally, studies reporting on the safety of nicorandil are lacking. Therefore, we performed this prospective study to evaluate the efficacy and safety of nicorandil on PMI in patients undergoing ePCI. METHODS One hundred and forty-six patients with coronary heart disease (CHD) scheduled to undergo ePCI were randomly assigned to the nicorandil group (n=74) or control group (n=72). The primary outcomes were the change in cardiac troponin T (cTnT) and creatine kinase-MB (CK-MB) at 12 and 24 hours after surgery. The secondary outcome was the incidence of major adverse cardiac events (MACE), which was a composite of cardiac death, nonfatal myocardial infarction, new heart failure or coronary revascularization. RESULTS There was no difference in age (54.76±5.93 vs 56.35±5.22) between the nicorandil group and the control group. In addition, no differences were observed in the cTnT and CK-MB levels between the two groups at admission (all P⩾0.05). Compared with those in the control group, the cTnT (0.15±0.12 vs 0.12±0.10 at 12 hours and 0.17±0.12 vs 0.13±0.10 at 24 hours) and CK-MB (15.35±8.23 vs 12.31±7.93 at 12 hours and 13.63±8.87 vs 11.13±5.71 at 24 hours) levels in the nicorandil group were significantly decreased after surgery (all P⩽0.05). Furthermore, nicorandil did not increase the incidence of MACE in the nicorandil group compared with the control group (12.16% vs 12.50%). CONCLUSIONS Nicorandil can reduce PMI in patients undergoing ePCI and does not increase the incidence of MACE. CLINICAL TRIAL REGISTRATION URL: http://www.chictr.org.cn/. Unique Identifier: ChiCTR-IOR-17012056.
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Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-α1RT Study.
Abouzaki, NA, Christopher, S, Trankle, C, Van Tassell, BW, Carbone, S, Mauro, AG, Buckley, L, Toldo, S, Abbate, A
Journal of cardiovascular pharmacology. 2018;(6):375-379
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Abstract
BACKGROUND Despite the benefits of reperfusion in limiting myocardial injury, the infarct size continues to expand after reperfusion because of secondary inflammatory injury. Plasma-derived alpha-1 antitrypsin (AAT) inhibits the inflammatory injury in myocardial ischemia and reperfusion. To explore the effects of plasma-derived AAT on the inflammatory response to ischemia-reperfusion injury, we analyzed time-to-reperfusion and enzymatic infarct size estimates in a post hoc analysis of the VCU-α1RT clinical trial (clinicaltrials.gov NCT01936896). METHODS Ten patients with ST-segment elevation acute myocardial infarction (STEMI) were enrolled in an open-label, single-arm treatment study of Prolastin C, plasma-derived AAT, at 60 mg/kg infused intravenously within 12 hours of reperfusion. Biomarkers were measured serially over the first 72 hours, and patients were followed clinically for the occurrence of new-onset heart failure, recurrent MI, or death. Twenty patients with STEMI who had been enrolled in previous randomized trials with identical inclusion/exclusion criteria and had been assigned to placebo served as historical controls. RESULTS Time to percutaneous coronary intervention and time to drug did not significantly differ between groups. AAT-treated patients had a significantly shorter time-to-peak creatine kinase myocardial band (CK-MB) values (525 [480-735] vs. 789 [664-959] minute, P = 0.005) and CK-MB area under the curve (from 1204 [758-2728] vs. 2418 [1551-4289] U·day, P = 0.035), despite no differences in peak CK-MB (123 [30-196] vs. 123 [71-213] U/mL, P = 0.71). CONCLUSIONS A single administration of Prolastin C given hours after reperfusion in patients with STEMI led to a significant shorter time to peak and area under the curve for CK-MB, despite similar peak CK-MB values. These preliminary data support the hypothesis that Prolastin C shortens the duration of the ischemia-reperfusion injury in patients with STEMI.
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Efficacy of alprostadil in preventing contrast-induced nephropathy in patients undergoing percutaneous coronary intervention: A multicenter prospective randomized controlled trial.
Liang, M, Yang, S, Fu, N, Lu, C, Tian, F, Xing, X, Lin, W, Liu, J
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2018;(4):742-750
Abstract
BACKGROUND The role of alprostadil on the prevention of contrast-induced nephropathy (CIN) still remains controversial. The purpose of this study was to examine the effects of short-term alprostadil on the incidence of CIN in patients undergoing elective percutaneous coronary intervention (PCI). METHODS A total of 480 patients with coronary heart disease undergoing PCI were enrolled in our study and randomly assigned to two groups. The control group (n = 240) was given only hydration therapy and the alprostadil group (n = 240) received intravenous administration of 20 ug/day (diluted with 100 ml normal saline) from 0.5∼1 hr before to 3 days after operation on the basis of hydration. The primary endpoint of the study was the incidence of CIN, which was defined as an increase in SCr concentration ≥ 44.2 umol/l or ≥25% above baseline within 48 hr∼72 hr after exposure of contrast media. RESULTS The incidence of CIN was significantly lower in the alprostadil group than that in the control group (6.25% vs 11.67%, P = 0.038). Multivariate logistic regression analysis showed that alprostadil was the protective factor of CIN (OR = 0.699, 95% CI 0.542-0.902, P = 0.006). The benefits against CIN were consistent in prespecified high-risk patients with diabetes mellitus (P = 0.003). In addition, we also found that hs-CRP and blood homocysteine values after PCI were significantly lower in the alprostadil group than those in the control group. CONCLUSION Prophylactic administration of alprostadil may prevent against CIN in coronary heart disease patients undergoing elective PCI, particularly in high-risk patients with diabetes mellitus.