Abstract 2562: Two-Year Clinical Follow-Up of COREA-TAXUS Trial: Long-Term Safety And Efficacy of Celecoxib for 6 Months After Paclitaxel-Eluting Stents Implantation

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Jin-Wook Chung ◽  
Han-Mo Yang ◽  
Dong-A Kwon ◽  
Jung-Won Suh ◽  
Kyung-Woo Park ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Target Lesion ◽  
Controlled Study ◽  
Control Group ◽  
Cardiac Events ◽  
Open Label ◽  
Adverse Cardiac Events ◽  
Fatal Myocardial Infarction

Background: The effect of celecoxib on restenosis after angioplasty with a Taxus stent (COREA-TAXUS) trial is an open-label randomized controlled study, where we reported celecoxib was effective in reducing 6months late loss of Taxus stent. With this cohort, we analyzed long-term clinical outcomes. Method: Two hundred sixty seven patients underwent successful paclitaxel-eluting stents implantation for native coronary lesions. Patients were randomized to receive celecoxib (400 mg before the intervention, and 200 mg twice daily for 6 months after the procedure) or not. Clinical endpoints were cardiac death, non-fatal myocardial infarction, and revascularization of the target lesion. Results: At 6 months, frequency of adverse cardiac events was significantly lower in the celecoxib group (5.3% versus 16.2%, P=0.005), mainly because of reduced need for revascularization of the target lesion (5.3% versus 15.4%, P=0.009). Between 6 and 24 months, frequency of adverse cardiac events was not different between the celecoxib group and the control group (1.6% versus 4.4%, P=NS: 0% versus 0% for cardiac death; 0.8% versus 0.9% for non-fatal myocardial infarction; 0.8% versus 3.5% for revascularization of target lesion, P=all NS). At 2 years, frequency of adverse cardiac events was still significantly lower in the celecoxib group (6.9% versus 19.9%, P=0.002) Conclusion: In the COREA-TAXUS trial, the adjunctive use of celecoxib for 6 months after Taxus stent implantation was safe and clinically effective for 2 years.

Abstract 18600: Very Long-term Clinical Outcome After Sirolimus-eluting Stent Implantation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shoichi Kuramitsu ◽  
Hiroaki Matsuda ◽  
Hiroyuki Jinnouchi ◽  
Takashi Hiromasa ◽  
Takenori Domei ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Cumulative Incidence ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Cardiac Events ◽  
Important Concern ◽  
Adverse Cardiac Events ◽  
Sirolimus Eluting Stent

Background: Late adverse events such as stent thrombosis (ST) or late target-lesion revascularization (TLR) after sirolimus-eluting stents (SES) implantation remain an important concern. However, there is little data regarding clinical outcome beyond 5 years after SES implantation. We sought to assess very long-term clinical outcome after SES implantation. Methods: Between April 2004 and December 2006, a total of 686 patients with 894 lesions underwent percutaneous coronary intervention only with SES. We assessed the major adverse cardiac events (MACE), defined as a composite of cardiac death, TLR, definite ST. Results: At 10 years, cumulative incidence of MACE and cardiac death were 50.8% and 8.2%, respectively. Cumulative incidence of TLR within 1 year was 12.6%. However, late TLR beyond 1 year continued to occur without attenuation up to 10 years (2.3%/year) (5 years, 22.8%; 10 years, 33.3%). Cumulative incidence of definite ST was low (30 days, 0.3%; 1 year, 0.9%; 5 years, 1.8%; and 10 years, 3.3%), whereas definite ST also continued to occur without attenuation (0.27%/year). The predictors of MACE were hemodialysis (hazard ratio [HR] 2.87, 95% confidence intervals [CI]:1.76-4.53, p <0.001) and age ≥75 years (HR 1.72, 95% CI: 1.31-2.26, p <0.001). Conclusions: Late catch-up phenomenon regarding ST and TLR continued up to 10 years without attenuation. Careful clinical follow-up is required in patients treated with SES beyond 5 years.

Abstract 20675: Longest Available Follow-Up of Drug-Eluting Stents in Real World Practice - Outcomes up to 12 Years From the DESIRE Registry

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ricardo A Costa ◽  
Amanda Sousa ◽  
Adriana Moreira ◽  
Adriana Moreira ◽  
J. Ribamar Costa ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Stent Thrombosis ◽  
Cardiac Death ◽  
Cardiac Events ◽  
Residual Stenosis ◽  
Adverse Cardiac Events ◽  
Drug Eluting ◽  
Event Rates

Background: Despite the marked efficacy demonstrated by drug-eluting stents (DES) in reducing neointimal proliferation, and therefore, the need for target lesion revascularization (TLR), persistent concerns regarding long-term safety and efficacy, especially in more complex subset, are still. Methods: The DESIRE Registry is a large, prospective, non-randomized, single center study assessing the late outcomes of unselected pts treated with DES. Overall, 5,541 pts were consecutively enrolled from May/02-Jun/14. Clinical follow-up (FU) (97%) was performed yearly up to 12 yrs (median 4.9 yrs). Stent thrombosis (ST) was defined according to the ARC. Results: Mean age was 65 yrs, 31% had diabetes, 29% current smokers, 42% presented with ACS (17% recent myocardial infarction, MI), and the majority of lesions were highly complex (67% type B2/C). Overall, there were 8,919 lesions treated with 9,537 DES, and angiographic success was 99%. During the FU period, cumulative event rates were major adverse cardiac events (cardiac death, myocardial infarction, or TLR) 32%, myocardial infarction 8%, TLR 21%, and cardiac death 6%. As for stent thrombosis, overal rate was 2.4%, given that 95% of patients were free from this event up to 12 years. In the multivariate model, independent predictors of major adverse cardiac events were: prior revascularization by percutaneous intervention (HR 1.21, p=0.03) or surgery (HR 1.53, p<0.001), dyslipidemia (HR 1.20, p=0.03), renal insufficiency (HR 1.41, p<0.001), peripheral vascular disease (HR 2.06, p<0.001), long lesions (HR 1.38, p<0.001), acute coronary syndrome (HR 1.39, p<0.001), and residual stenosis (HR 1.02, p<0.001). As for stent thrombosis, predictors were: recent myocardial infarction (HR 2.66, p=0.001), multiple stents implanted (HR 1.89, p=0.002), saphenous vein graft (HR 2.21, p=0.004), and residual stenosis (HR 1.03, p=0.03). Conclusions: At very long-term follow-up (up to 12 years) in a large cohort of patients from the real world practice, cumulative event rates included TLR in 21% and stent thrombosis in 2.4%. Overall, there were no safety concers, given that 95% of patients were free from stent thrombosis up to 12 years.

scholarly journals Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

2017 ◽  
Vol 21 (1) ◽  
pp. 44 ◽  
Author(s):  
V. L. Vorobev ◽  
A. A. Semenihin ◽  
N. I. Grachev ◽  
V. V. Verin
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Conflict Of Interest ◽  
Cardiac Death ◽  
Target Lesion ◽  
Major Adverse Cardiac Events ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Adverse Cardiac Events ◽  
One Year

<p><strong>Aim</strong>. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA).<br /><strong>Methods.</strong> The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS) for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated), major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated). <br /><strong>Results.</strong> In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. <br /><strong>Conclusion.</strong> The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.</p><p>Received 31 January 2017. Accepted 17 March 2017.</p><p><strong>Financing:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p>

5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Cardiac Death ◽  
Target Lesion ◽  
Funding Source ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Stable Cad

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland

scholarly journals Circulating Platelet-Derived Microparticles Associated with Postdischarge Major Adverse Cardiac Events in ST-Elevation Acute Myocardial Infarction

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Anggoro Budi Hartopo ◽  
Dyah Samti Mayasari ◽  
Ira Puspitawati ◽  
Hasanah Mumpuni
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Major Adverse Cardiac Events ◽  
Cardiac Events ◽  
Prognostic Implication ◽  
Adverse Cardiac Events ◽  
St Elevation ◽  
Elevation Acute Myocardial Infarction

Introduction. Platelet-derived microparticles (PDMPs) measurement adds prognostic implication for ST-elevation acute myocardial infarction (STEMI). The long-term implication of PDMPs in STEMI needs to be corroborated. Methods. The research design was a cohort study. Subjects were STEMI patients and were enrolled consecutively. The PDMPs were defined as microparticles bearing CD41(+) and CD62P(+) markers detected with flow cytometry. The PDMPs were measured on hospital admission and 30 days after discharge. The outcomes were major adverse cardiac events (MACE), i.e., a composite of cardiac death, heart failure, cardiogenic shock, reinfarction, and resuscitated ventricular arrhythmia, occurring from hospitalization until 1 year after discharge. Results. We enrolled 101 subjects with STEMI. During hospitalization, 17 subjects (16.8%) developed MACE. The PDMPs were not different between subjects with MACE and those without (median (IQR): 3305.0/μL (2370.0–14690.5/μL) vs. 4452.0/μL (2024.3–14396.8/μL), p=0.874). Forty-five subjects had increased PDMPs in 30 days after discharge as compared with on-admission measurement. Subjects with increased PDMPs had significantly higher 30-day MACE as compared to subjects with decreased PDMPs 17 (37.8%) vs. 6 (16.7%, p=0.036). There was a trend toward higher MACE in subjects with increased PDMPs as compared to those with decreased PDMPs in 90 days after discharge (48.9% vs. 30.6%, p=0.095) and 1 year after discharge (48.9% vs. 36.1%, p=0.249). Conclusion. The PDMPs level was increased from the day of admission to 30 days after discharge in patients with STEMI. The persistent increase in the PDMPs level in 30 days after the STEMI event was associated with the 30-day postdischarge MACE and trended toward increased MACE during the 90-day and 1-year follow-up.

Abstract 4910: Integrated Approach By Using Coronary Flow Velocity Reserve And Coronary Flow Velocity Patterns In Predicting Long-term Adverse Cardiac Events In Acute Myocardial Infarction

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Myeong Ho Yoon ◽  
Seung-Jea Tahk ◽  
Hong-Seok Lim ◽  
Jin-Sun Park ◽  
Hyeong-Mo Yang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Flow Velocity ◽  
Coronary Flow ◽  
Integrated Approach ◽  
Left Ventricular ◽  
Cardiac Events ◽  
Coronary Flow Velocity ◽  
Adverse Cardiac Events

Background: The microvascular function was known to be an useful predictor of left ventricular functional changes and clinical outcomes in ST-segment elevation myocardial infarction (STEMI). We evaluated the usefulness of integrated approach by using coronary flow velocity reserve (CFR) and diastolic deceleration time (DDT) in the prediction of long-term major adverse cardiac events in STEMI. Methods and Results: Using an intracoronary Doppler wire, CFR, DDT and hyperemic microvascular resistance index (MVRI) were evaluated in 202 patients with first STEMI received reperfusion therapy within 24 hours after onset of symptoms. Major adverse cardiac events were the composite of cardiac death, recurrent myocardial infarction, congestive heart failure and stroke during an average follow-up period of 60 ± 39 months. Follow-up echocardiography was performed at 12 ± 9 months. CFR, DDT and MVRI had significant correlations with left ventricular regional wall motion score index at follow-up echocardiography (r =−0.441, p<0.001; r = 0.413, p<0.001; r =−0.485, p<0.001, respectively). Using receiver-operating characteristics analysis, CFR ≤1.3 (sensitivity: 51%, specificity: 78%), DDT ≤577 ms (sensitivity: 72%, specificity: 62%) and MVRI >2.7 (sensitivity: 68%, specificity: 67%) were the best cutoff values in the prediction of occurring the adverse cardiac events. In patients with CFR ≤1.3, DDT ≤577 ms, cardiac events were occurred in 18 patients (40.0 %) of 45 patients, whereas cardiac events were occurred in 12 patients (20.3%) of 59 patients with CFR >1.3 and DDT ≤577 ms or CFR ≤1.3 and DDT >577 ms (p= 0.048), 9 patients (9.1%) of 99 patients with CFR>1.3 and DDT >577 ms (p<0.001). Ejection fraction at admission (p=0.009), MVRI (p =0.002) and DDT (p=0.023) were independent predictors in the prediction of long-term adverse cardiac outcomes during follow-up. Conclusions: Integrated approach by using CFR and DDT was useful in the prediction of long-term adverse cardiac events. MVRI and DDT were strong independent predictors of long-term adverse cardiac events in STEMI patients.

scholarly journals Microvascular integrity indexes were predictor of long-term adverse cardiac events in acute myocardial infarction

2013 ◽  
Vol 34 (suppl 1) ◽  
pp. P450-P450
Author(s):  
M. H. Yoon ◽  
S. J. Tahk ◽  
H. S. Lim ◽  
J. S. Park ◽  
H. M. Yang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Events ◽  
Adverse Cardiac Events

PD65 The Acquisition Of Eculizumab By Judicial Proceeding In Brazil

2018 ◽  
Vol 34 (S1) ◽  
pp. 153-154
Author(s):  
Flavia Salomon ◽  
Eliete Simabuku ◽  
Jose Beutel ◽  
Eduardo De Oliveira ◽  
Roberta Rabelo ◽  
...  
Keyword(s):  
Atypical Hemolytic Uremic Syndrome ◽  
The United States ◽  
Cochrane Library ◽  
Controlled Study ◽  
European Medicines Agency ◽  
Control Group ◽  
Open Label ◽  
Expensive Drug ◽  
Judicial Proceedings

Introduction:Eculizumab is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or with atypical hemolytic uremic syndrome (aHUS). In Brazil in recent years eculizumab was the most expensive drug requested through court orders, obliging public health managers to import it from the USA. From 2012 to 2016, approximately BRL 424 million (USD 112 million) was spent on eculizumab. The purpose of this study was to assess the regulatory situation and the scientific evidence on the safety and efficacy of eculizumab.Methods:A literature search was conducted in PubMed, The Cochrane Library, and the Centre for Reviews and Dissemination databases on September 2017. The websites of regulatory agencies were also searched.Results:In 2007, the use of eculizumab was approved by the United States Food and Drug Administration and the European Medicines Agency. In Brazil, despite the provision of eculizumab through judicial proceedings since 2009, the manufacturer of eculizumab only requested a licence for it in 2017, after several meetings with the government when the company agreed to provide the drug at approximately half the price of the imported product. The efficacy of eculizumab in PNH patients was assessed in one randomized, placebo controlled study, one single arm study, and one long-term extension study. The drug reduced hemolysis and the need for transfusion, although the studies had methodological problems. The efficacy of eculizumab in the treatment of aHUS was assessed in four prospective, controlled open-label studies, two long-term extension studies, and one retrospective study. Eculizumab normalized platelet counts and reduced the need for plasmapheresis, although the studies had no control group. Eculizumab was well tolerated, with no meningococcal infections occurring after patients were immunized.Conclusions:Some companies have no interest in licensing their products in Brazil because their provision by judicial proceedings is more lucrative. This situation promotes litigation and irrational prescription of drugs, and also obligates the Brazilian government to import expensive health products.

scholarly journals Tirofiban hydrochloride sodium chloride injection combined with cardiovascular intervention in the treatment of Acute Myocardial Infarction

2019 ◽  
Vol 36 (1) ◽  
Author(s):  
Yongxuan Liu ◽  
Lingling Zhang ◽  
Yanyan Yang
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Sodium Chloride ◽  
Treatment Group ◽  
Interventional Therapy ◽  
Good Effect ◽  
Control Group ◽  
Cardiac Events ◽  
Adverse Cardiac Events ◽  
Cardiovascular Intervention

Objective: To investigate the therapeutic effect of tirofiban hydrochloride sodium chloride injection combined with cardiovascular intervention on acute myocardial infarction. Methods: Eighty-four patients with acute myocardial infarction who were treated in our hospital from April 2017 to May 2018 were divided into a control group and a treatment group using random number table method; there were 42 patients in each group. Both groups were given conventional treatment and were treated with aspirin and clopidogrel before and after operation. Moreover, the control group was treated with cardiovascular interventional therapy, while the treatment group was treated with tirofiban hydrochloride on the basis of cardiovascular interventional therapy. The patients were followed up to observe and compare the treatment condition and adverse reactions of the two groups. Results: After percutaneous coronary intervention, the normal rate of myocardial perfusion in the treatment group was 92.86%, which was higher than 69.05% in the control group (P<0.05). After PCI, there were significant differences of thrombolysis in myocardial infarction (TIMI) flow Grade- 2 and 3 between the two groups (P<0.05). The improvement of platelet activation function in the treatment group was better than that in the control group (P<0.05). The incidence of adverse cardiac events in the treatment group was significantly lower than that in the control group (P<0.05). Conclusion: Tirofiban hydrochloride sodium chloride injection combined with cardiovascular intervention has a significant clinical effect in the treatment of acute myocardial infarction. It can effectively improve the blood perfusion and reduce the incidence of adverse cardiac events, suggesting a good effect on the prognosis of patients and high application value. doi: https://doi.org/10.12669/pjms.36.1.1005 How to cite this:Liu Y, Zhang L, Yang Y. Tirofiban hydrochloride sodium chloride injection combined with cardiovascular intervention in the treatment of Acute Myocardial Infarction. Pak J Med Sci. 2020;36(1):---------. doi: https://doi.org/10.12669/pjms.36.1.1005 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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