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1.
Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept Study.
Yu, L, Huang, B, Po, SS, Tan, T, Wang, M, Zhou, L, Meng, G, Yuan, S, Zhou, X, Li, X, et al
JACC. Cardiovascular interventions. 2017;(15):1511-1520
Abstract
OBJECTIVES The aim of this study was to investigate whether low-level tragus stimulation (LL-TS) treatment could reduce myocardial ischemia-reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND The authors' previous studies suggested that LL-TS could reduce the size of myocardial injury induced by ischemia. METHODS Patients who presented with STEMI within 12 h of symptom onset, treated with primary percutaneous coronary intervention, were randomized to the LL-TS group (n = 47) or the control group (with sham stimulation [n = 48]). LL-TS, 50% lower than the electric current that slowed the sinus rate, was delivered to the right tragus once the patients arrived in the catheterization room and lasted for 2 h after balloon dilatation (reperfusion). All patients were followed for 7 days. The occurrence of reperfusion-related arrhythmia, blood levels of creatine kinase-MB, myoglobin, N-terminal pro-B-type natriuretic peptide and inflammatory markers, and echocardiographic characteristics were evaluated. RESULTS The incidence of reperfusion-related ventricular arrhythmia during the first 24 h was significantly attenuated by LL-TS. In addition, the area under the curve for creatine kinase-MB and myoglobin over 72 h was smaller in the LL-TS group than the control group. Furthermore, blood levels of inflammatory markers were decreased by LL-TS. Cardiac function, as demonstrated by the level of N-terminal pro-B-type natriuretic peptide, the left ventricular ejection fraction, and the wall motion index, was markedly improved by LL-TS. CONCLUSIONS LL-TS reduces myocardial ischemia-reperfusion injury in patients with STEMI. This proof-of-concept study raises the possibility that this noninvasive strategy may be used to treat patients with STEMI undergoing primary percutaneous coronary intervention.
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2.
Left ventricular remodeling and 1-year clinical follow-up of the REOPEN-AMI trial.
Niccoli, G, Spaziani, C, Crea, F, ,
Journal of the American College of Cardiology. 2014;(14):1454-5
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3.
Prospective 'real world' registry for the use of the 'PCB only' strategy in small vessel de novo lesions.
Zeymer, U, Waliszewski, M, Spiecker, M, Gastmann, O, Faurie, B, Ferrari, M, Alidoosti, M, Palmieri, C, Heang, TN, Ong, PJ, et al
Heart (British Cardiac Society). 2014;(4):311-6
Abstract
BACKGROUND This prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting. The use of PCBs in small vessels seems to be associated with favourable outcomes; however, prospective data for the use of PCBs without stenting are limited. METHODS The SeQuent Please Small Vessel 'PCB only' Registry was an international, prospective, multicentre registry enrolling patients with de novo lesions of small reference diameters (≥ 2.0 mm, ≤ 2.75 mm). The primary end point was clinically driven target lesion revascularisation (TLR) at 9 months. Secondary end points were acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) (death, myocardial infarction, or TLR), and the occurrence of definite lesion and vessel thrombosis. RESULTS A total of 479 patients (66.1 ± 10.9 years, 36.7% diabetics) were enrolled, 105 (23.5%) with an acute coronary syndrome, 41 (9.2%) with ST elevation myocardial infarction (STEMI), and 60 (14.8%) with non-STEMI. The initial procedural success rate was 99.0%; 27 patients (6%) needed additional bare metal stent implantation. TLR at 9.4±1.7 months occurred in 14 patients (3.6%), while three patients (0.6%) had vessel thrombosis in non-target lesions. There was no cardiac death or coronary artery bypass graft surgery. CONCLUSIONS To date, this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients. Rates of TLR and MACE were low, suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels.
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4.
Effect of adenosine intracoronary bolus on myonecrosis occurrence in elective PCI (RACE trial).
Sardella, G, Lucisano, L, Mancone, M, Canali, E, De Carlo, C, Stio, RE, Calcagno, S, Brasolin, B, Fedele, F
International journal of cardiology. 2012;(3):456-9
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5.
Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial).
Bolognese, L, Falsini, G, Schwenke, C, Grotti, S, Limbruno, U, Liistro, F, Carrera, A, Angioli, P, Picchi, A, Ducci, K, et al
The American journal of cardiology. 2012;(1):67-74
Abstract
Conflicting data have been reported on the effects of low-osmolar and iso-osmolar contrast media on contrast-induced acute kidney injury (CI-AKI). In particular, no clinical trial has yet focused on the effect of contemporary contrast media on CI-AKI, epicardial flow, and microcirculatory function in patients with ST-segment elevation acute myocardial infarction who undergo primary percutaneous coronary intervention. The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty for Acute Myocardial Infarction (CONTRAST-AMI) trial is a prospective, randomized, single-blind, parallel-group, noninferiority study aiming to evaluate the effects of the low-osmolar contrast medium iopromide compared to the iso-osmolar agent iodixanol on CI-AKI and tissue-level perfusion in patients with ST-segment elevation acute myocardial infarction. Four hundred seventy-five consecutive, unselected patients who underwent primary percutaneous coronary intervention were randomized to iopromide (n = 239) or iodixanol (n = 236). All patients received high-dose N-acetylcysteine and hydration. The primary end point was the proportion of patients with serum creatinine (sCr) increases ≥25% from baseline to 72 hours. Secondary end points were Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade, increase in sCr ≥50%, increase in sCr ≥0.5 or ≥1 mg/dl, and 1-month major adverse cardiac events. The primary end point occurred in 10% of the iopromide group and in 13% of the iodixanol group (95% confidence interval -9% to 3%, p for noninferiority = 0.0002). A TIMI myocardial perfusion grade of 0 or 1 was present in 14% of patients in the 2 groups. No differences between the 2 groups were found in any of the secondary analyses of sCr increase. No significant difference in 1-month major adverse cardiac events was found (8% vs 6%, p = 0.37). In conclusion, in a population of unselected patients with ST-segment elevation acute myocardial infarction who underwent primary percutaneous coronary intervention, iopromide was not inferior to iodixanol in the occurrence of CI-AKI; no significant differences were found in terms of tissue-level reperfusion and major adverse cardiac events between the 2 contrast agents.
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6.
Outcomes of patients treated with triple antithrombotic therapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] trial).
Nikolsky, E, Mehran, R, Dangas, GD, Yu, J, Parise, H, Xu, K, Pocock, SJ, Stone, GW
The American journal of cardiology. 2012;(6):831-8
Abstract
In the setting of ST-segment elevation myocardial infarction (STEMI), patients at high risk of systemic emboli who undergo primary percutaneous coronary intervention (PCI) using stents might require triple antithrombotic therapy (a combination of aspirin, thienopyridine, and vitamin K antagonist [VKA]). The risks and benefits of such therapy in the setting of STEMI have been incompletely characterized. We, therefore, assessed the outcomes of patients who received triple therapy after primary PCI in the large-scale, contemporary Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] trial. Among the 3,320 patients triaged to primary PCI, 126 (3.8%) were prescribed triple therapy and 3,194 (96.2%) were prescribed dual antiplatelet therapy. The most frequent indications for VKA treatment were a severely reduced left ventricular ejection fraction with a large akinetic area, atrial fibrillation (23.8% each), and mural thrombus (23.0%). The assignment to triple therapy was associated with older age, female gender, rhythm disturbances, Killip class > 1 on admission, lower left ventricular ejection fraction, left anterior descending artery territory infarcts, and Final Thrombolysis In Myocardial Infarction flow grade < 3. Patients treated with triple versus dual therapy had comparable short- and long-term ischemic outcomes but had significantly increased rates of major bleeding during the index hospitalization (17.1% vs 6.5%, p < 0.0001), resulting in premature VKA discontinuation in 14.3% of those patients. In conclusion, in the setting of STEMI treated with primary PCI, the combination of aspirin, thienopyridine, and VKA results in an excess of bleeding complications and premature discontinuation of VKA. The risk of adding oral anticoagulation to patients admitted for STEMI should be carefully considered before choosing drug-eluting or bare metal stents.
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7.
Impact of routine angiographic follow-up after percutaneous coronary intervention with drug-eluting stents in the SPIRIT III randomized trial at three years.
Lansky, AJ, Brar, SS, Yaqub, M, Sood, P, Applegate, RJ, Lazar, D, Jankovic, I, Hermiller, JB, Koo, K, Sudhir, K, et al
The American journal of cardiology. 2012;(1):21-9
Abstract
Routine angiographic follow-up after bare-metal stent implantation has been associated with an increase in coronary revascularization. The impact of angiographic follow-up after drug-eluting stent placement remains poorly characterized. The prospective, randomized, single-blinded SPIRIT III trial assigned patients to the everolimus-eluting stent or the paclitaxel-eluting stent (PES). Major adverse cardiovascular events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization [ID-TLR]) at 3 years were assessed by angiographic versus clinical-only follow-up at 8 months ± 28 days and a landmark survival analysis from 9 months to 3 years. Of 1,002 patients, 564 patients were assigned to angiographic follow-up at 8 months ± 28 days and 438 patients underwent clinical follow-up alone. Three-year major adverse cardiovascular event rates were 10.6% in the angiographic group and 12.0% in the clinical follow-up group (p = 0.64). Ischemia-driven revascularization increased twofold at 9 months, but no difference was noted in ID-TLR for either device. Non-ID-TLR was significantly higher in patients in the angiographic group (4.5% vs 1.0%, p = 0.002), a difference resulting from PES (9.1% vs 0.7%, p = 0.0007) rather than everolimus-eluting stent (2.2% vs 1.1%, p = 0.36) treatment. The landmark analysis showed no significant differences between the angiographic and clinical follow-up groups from 9 months to 3 years of major clinical outcomes. In conclusion, routine angiographic follow-up in SPIRIT III did not increase rates of ID-TLR compared to clinical follow-up alone. Despite higher nonischemia-driven revascularization rates with angiographic follow-up of patients with PESs, none of the safety end points were adversely affected.
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8.
A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions.
Carrié, D, Berland, J, Verheye, S, Hauptmann, KE, Vrolix, M, Violini, R, Dibie, A, Berti, S, Maupas, E, Antoniucci, D, et al
Journal of the American College of Cardiology. 2012;(15):1371-6
Abstract
OBJECTIVES This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention. BACKGROUND Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain. METHODS Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté stents. Primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound was performed in 20% of the patients. All patients will be clinically followed up to 5 years. RESULTS Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberté stents. In-stent LLL was significantly lower in Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority <0.0001, p superiority <0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups. CONCLUSIONS The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus Carbostent and Taxus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions [NEXT]; NCT01373502).
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9.
Inhibition of sPLA2 and endothelial function: a substudy of the SPIDER-PCI trial.
Lavi, S, Thorpe, K, Luca, MC, Liuni, A, Floras, J, Horlick, EM, Ing, D, Osten, MD, Overgaard, CB, Lan, J, et al
The Canadian journal of cardiology. 2012;(2):215-21
Abstract
BACKGROUND Inflammation plays an important role in the pathophysiology of atherosclerosis and endothelial dysfunction, and occurs after percutaneous coronary intervention (PCI). We evaluated whether endothelial function is attenuated after PCI and if inhibition of secretory phospholipase A2 (sPLA2) activity augments endothelial function and coronary flow reserve (CFR) in these patients. METHODS In the sPLA2 Inhibition to Decrease Enzyme Release After Percutaneous Coronary Intervention (SPIDER-PCI) study, patients undergoing elective PCI were randomized to receive Varespladib (Anthera Pharmaceuticals Inc, San Mateo, CA), an inhibitor of sPLA2, or placebo 3-5 days prior to PCI and for 5 days after PCI. In this substudy, endothelial function was assessed in 31 patients by flow-mediated dilation (FMD) before treatment and on the day after PCI, while taking study medication. During the PCI procedure, CFR was assessed using a Doppler guide wire. RESULTS Baseline and procedural characteristics were comparable in both groups and sPLA2 activity was similar at baseline. After PCI, sPLA2 activity decreased only in the Varespladib group (2.9 ± 0.9 to 0.5 ± 0.4 ng/mL), and high-sensitivity C-reactive protein (hsCRP) increased by more than 100% in both groups. FMD at baseline was 3.66 ± 2.45% (Varespladib) and 3.37 ± 1.73% (placebo) with nonsignificant increase in both groups after PCI. The effect of Varespladib on FMD, adjusted for pre-PCI FMD by linear regression, was -1.16 ± 1.68%; P = 0.5. CFR was 2.45 ± 0.66 and 2.77 ± 0.85 in the Varespladib and placebo groups, respectively (P = 0.36). CONCLUSIONS Systemic endothelial function is not reduced after elective PCI despite eliciting acute inflammatory response. Acute inhibition of sPLA2 activity with Varespladib does not affect endothelial or microvascular function after PCI.
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10.
A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study.
Rittger, H, Brachmann, J, Sinha, AM, Waliszewski, M, Ohlow, M, Brugger, A, Thiele, H, Birkemeyer, R, Kurowski, V, Breithardt, OA, et al
Journal of the American College of Cardiology. 2012;(15):1377-82
Abstract
OBJECTIVES This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone. BACKGROUND Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis. METHODS In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization. RESULTS There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91%. Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1% to 17.2% (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0% to 16.7% (p < 0.001), respectively. CONCLUSIONS Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; NCT00998439).