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Manipal lifestyle modification score to predict major adverse cardiac events in postcoronary angioplasty patients.
Devasia, T, Shetty, PN, Kareem, H, Karkala, YR, Singh, A
Indian heart journal. 2018;(Suppl 3):S353-S358
Abstract
BACKGROUND Lifestyle modification (LSM) such as prudent diet, physical activity, avoidance of smoking, and maintaining a healthy weight may considerably decrease the risk for coronary artery disease. OBJECTIVE The primary objective of this study was to develop a new LSM scoring system and investigate the correlation between adherence to LSM and incidence of major adverse cardiac events (MACEs) at 12-month follow-up. METHOD A total of 1000 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) were included in this prospective single-center study. Manipal lifestyle modification score (MLSMS) was developed by using five lifestyle-related factors. Adherence to LSM at the baseline and subsequent follow-ups was determined by using MLSMS. The MACE at 1-, 6-, and 12-month follow-up were analyzed. RESULTS There was a significant reduction in overall adherence to LSM (p < 0.001) at 12-month follow-up. Nonadherence to LSM [hazard ratio (HR) 0.575; 95% confidence interval (CI) 0.334-0.990; p < 0.046] and noncompliance to medication (HR 2.09; 95% CI 1.425-3.072; p < 0.001) were independent predictors of MACEs after PTCA. The cumulative MACE was 15.4%, which includes 4.9% of all-cause death, 5.2% of nonfatal myocardial infarction, 2.0% of target lesion revascularization, 1.8% of target vessel revascularization, and 1.3% of stroke at 12 months. The incidence of MACEs at 12 months was significantly (p = 0.03) higher in LSM nonadherent compared with LSM adherent patients. CONCLUSION There is an overall reduction in adherence to LSM on successive follow-ups and a significant association between the incidence of MACEs and the lack of adherence to LSM. MLSMS is a simple and effective evaluation tool in predicting MACEs in this group of patients.
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Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry.
Auffret, V, Berland, J, Barragan, P, Waliszewski, M, Bonello, L, Delarche, N, Furber, A, Albert, F, Carrié, D, Eltchaninoff, H, et al
International journal of cardiology. 2016;:690-6
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Abstract
BACKGROUND Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.
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Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study.
Ann, SH, Balbir Singh, G, Lim, KH, Koo, BK, Shin, ES
PloS one. 2016;(1):e0147057
Abstract
AIMS: To assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR). METHOD AND RESULTS This prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 ± 0.27 mm. Mean vessel and lumen areas showed increase at 9 months (12.0 ± 3.5 mm(2) to 13.2 ± 3.9 mm(2), p <0.001; and 5.4 ± 1.2 mm(2) to 6.5 ± 1.8 mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 ± 2.6 mm2 to 6.6 ± 2.4 mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 ± 7.9% to 49.5 ± 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 ± 0.13 pre-procedure, 0.87 ± 0.06 post-procedure and 0.84 ± 0.06 at follow-up. CONCLUSIONS De novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.
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Management of multivessel coronary disease after primary angioplasty: staged reintervention versus optimized clinical treatment and two-year follow-up.
Paula, JG, Godoy, MF, Santos, MA, Pivatelli, FC, Osti, AV, Trindade, LF, Novelli, D, Nakazone, MA
Revista brasileira de cirurgia cardiovascular : orgao oficial da Sociedade Brasileira de Cirurgia Cardiovascular. 2014;(2):177-85
Abstract
OBJECTIVE In the clinical scenario of ST-segment elevation acute myocardial infarction, several patients with multivessel coronary atherosclerotic disease are discharged without a defined strategy to monitor the residual atherosclerotic lesions. The clinical endpoints evaluated were cardiovascular death, symptoms of angina pectoris, rehospitalization for a new acute coronary syndrome, and the necessity of reintervention during the two-year follow-up. METHODS This observational, prospective, and historical study included multivessel coronary atherosclerotic disease patients who were admitted to a tertiary care university hospital with ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention with stent implantation only at the culprit lesion site; these patients were monitored in the outpatient clinic according to two treatments: the Clinical Group - CG (optimized pharmacological therapy associated with counseling for a healthy diet and cardiac rehabilitation) or the Intervention Group - IG (new staged percutaneous coronary intervention or surgical coronary artery bypass graft surgery combined with the previously prescribed treatment). RESULTS Of 143 patients consecutively admitted with ST-segment elevation acute myocardial infarction, 57 were eligible for the study (CG=44 and IG=13). Regarding the clinical endpoints, the cardiovascular death rate did not differ between the CG and IG. The symptom of angina pectoris and the rehospitalization rate for a new episode of acute coronary syndrome were accentuated in the CG (P=0.020 and P=0.049, respectively) mainly in individuals with evidence of ischemia evidenced by myocardial scintigraphy (P<0.001 and P=0.001, respectively) which culminated in an even greater need for reintervention (P=0.001) in this subgroup of patients. CONCLUSION The staged intervention was demonstrated to be safe and able to reduce angina pectoris and rehospitalization for a new episode of acute coronary syndrome. In addition, it decreases the likelihood of unplanned reinterventions of patients without ischemia evidenced by myocardial scintigraphy.
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Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry.
Toelg, R, Merkely, B, Erglis, A, Hoffman, S, Bruno, H, Kornowski, R, Slagboom, T, Naber, C, Witzenbichler, B, Graf, K, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2014;(5):591-9
Abstract
AIMS: Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients. METHODS AND RESULTS Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months. CONCLUSIONS Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).
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Comparison of the reperfusion efficacy of thrombus aspiration with and without distal protection during primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction.
Satoh, S, Inoue, H, Omura, S, Ejima, E, Shimozono, K, Hayashi, M, Mori, T, Takenaka, K, Kawamura, N, Numaguchi, K, et al
The American journal of cardiology. 2013;(11):1725-9
Abstract
We evaluated a hypothesis that thrombus aspiration with distal protection is superior to simple thrombus aspiration in patients treated with primary percutaneous coronary intervention (PCI). A total of 176 consecutive patients with ST-segment elevation myocardial infarction were enrolled in this study and assigned to either the thrombus aspiration group (A, n = 104) or the thrombus aspiration with distal protection group using a filter device system (A + DP, n = 72). We compared the angiographic reperfusion grade, left ventricular (LV) function, and clinical outcomes between the 2 groups. There were no significant differences in age, gender distribution, the onset-to-reperfusion time, the peak levels of creatine kinase, or 6-month mortality between the 2 groups. The rate of achieving a Thrombolysis In Myocardial Infarction flow grade of 3 and a myocardial blush grade of 3 was higher in the A + DP group than in the A group. Among the patients who underwent follow-up catheterization 6 months after PCI (A, n = 62; A + DP, n = 52), there were no significant differences in the LV end-diastolic volume index, LV end-systolic volume index, or LV ejection fraction between the 2 groups at the time of PCI or 6 months after PCI. In conclusion, thrombus aspiration with distal protection may be more effective in initially restoring the coronary blood flow than thrombus aspiration alone, although it may not be superior to thrombus aspiration in preventing LV remodeling or preserving the LV function in patients with ST-segment elevation myocardial infarction.