scholarly journals Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

2017 ◽  
Vol 21 (3) ◽  
pp. 76 ◽  
Author(s):  
A. A. Prokhorikhin ◽  
V. I. Baystrukov ◽  
I. O. Grazhdankin ◽  
D. N. Ponomarev ◽  
V. V. Verin ◽  
...  

<p><strong>Aim</strong>. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline) and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular) when used for treatment of ischemic heart disease patients.<br /><strong>Methods.</strong> The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline) (n = 407) or “XiencePrime” coronary stent (AbbottVascular) (n = 203). The follow-up period was 12 months. In order to detect restenosis (secondary endpoint), angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.<br /><strong>Results.</strong> In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017). Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable) was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p&gt;0.05). Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%), in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.<br /><strong>Conclusion.</strong> “Calypso” sirolimus eluting stent was not inferior to “XiencePrime” everolimus-eluting stent in treating patients with coronary heart disease.</p><p>Received 7 November 2017. Revised 13 November 2017. Accepted 20 November 2017.</p><p><strong>Funding:</strong> The study was funded by “Angioline Interventional Devices” (Novosibirsk, Russian Federation). The supporting source had no involvement in study design; collection, analysis and interpretation of data; writing of the report; and in the decision to submit the article for publication.</p><p><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p>

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Verdoia ◽  
H Suryapranata ◽  
S Damen ◽  
C Camaro ◽  
E Benit ◽  
...  

Abstract Background Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). Therefore, the impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) treated is still unclear and was therefore the aim of the present sub-study. Methods REDUCE is a prospective, multicenter, randomized, investigator-initiated study, designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a non-inferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleeding (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint. Results From June 2014 to May 2016 300 women and 1196 men were randomized in the trial. Among them 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, but of a lower rate of TIMI flow <3 (p<0.001) and lower systolic blood pressure (p<0.05) among women and a more advanced age (p=0.05) among men receiving a shorted DAPT. At 1 year follow-up, no difference in the primary endpoint was observed according to DAPT duration (females: 6.9% vs 5.9%, HR [95% CI]=1.19 [0.48–2.9], p=0.71; males: 8.2% vs 9%, HR [95% CI]=0.92 [0.63–1.35], p=0.67). Results were confirmed after correction for baseline differences (females: adjusted HR [95% CI]=1.12 [0.45–2.78], p=0.81; males: adjusted HR [95% CI]=0.90 [0.61–1.32], p=0.60). Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. Conclusions The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 1-year follow-up in both male and female gender. Acknowledgement/Funding None


2016 ◽  
Vol 20 (4) ◽  
pp. 96
Author(s):  
A. A. Prokhorikhin ◽  
V. V. Verin ◽  
A. G. Osiev ◽  
V. I. Ganyukov ◽  
A. V. Protopopov ◽  
...  

<p><strong>Aim.</strong> This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. <br /><strong>Methods.</strong> This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406) to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204) to receive coronary stent Xience Prime (Abbott). Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %). <br /><strong>Conclusion.</strong> A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.</p><p>Received 5 October 2016. Accepted 6 December 2016.</p><p><strong>Funding:</strong> This study was funded by “Angioline Interventional Devices”, 630090, 18 Inzhenernaya Street, Novosibirsk, Russian Federation. <br /><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p>


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.


VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.


2021 ◽  
Vol 8 ◽  
Author(s):  
Gang-Qiong Liu ◽  
Wen-Jing Zhang ◽  
Jia-Hong Shangguan ◽  
Xiao-Dan Zhu ◽  
Wei Wang ◽  
...  

Aims: The present study aimed to investigate the prognostic role of derived neutrophil-to-lymphocyte ratio (dNLR) in patients with coronary heart disease (CHD) after PCI.Methods: A total of 3,561 post-PCI patients with CHD were retrospectively enrolled in the CORFCHD-ZZ study from January 2013 to December 2017. The patients (3,462) were divided into three groups according to dNLR tertiles: the first tertile (dNLR &lt; 1.36; n = 1,139), second tertile (1.36 ≥ dNLR &lt; 1.96; n = 1,166), and third tertile(dNLR ≥ 1.96; n = 1,157). The mean follow-up time was 37.59 ± 22.24 months. The primary endpoint was defined as mortality (including all-cause death and cardiac death), and the secondary endpoint was major adverse cardiovascular events (MACEs) and major adverse cardiovascular and cerebrovascular events (MACCEs).Results: There were 2,644 patients with acute coronary syndrome (ACS) and 838 patients with chronic coronary syndrome (CCS) in the present study. In the total population, the all-cause mortality (ACM) and cardiac mortality (CM) incidence was significantly higher in the third tertile than in the first tertile [hazard risk (HR) = 1.8 (95% CI: 1.2–2.8), p = 0.006 and HR = 2.1 (95% CI: 1.23–3.8), p = 0.009, respectively]. Multivariate Cox regression analyses suggested that compared with the patients in the first tertile than those in the third tertile, the risk of ACM was increased 1.763 times (HR = 1.763, 95% CI: 1.133–2.743, p = 0.012), and the risk of CM was increased 1.763 times (HR = 1.961, 95% CI: 1.083–3.550, p = 0.026) in the higher dNLR group during the long-term follow-up. In both ACS patients and CCS patients, there were significant differences among the three groups in the incidence of ACM in univariate analysis. We also found that the incidence of CM was significantly different among the three groups in CCS patients in both univariate analysis (HR = 3.541, 95% CI: 1.154–10.863, p = 0.027) and multivariate analysis (HR = 3.136, 95% CI: 1.015–9.690, p = 0.047).Conclusion: The present study suggested that dNLR is an independent and novel predictor of mortality in CHD patients who underwent PCI.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
TOSHIAKI TOYOTA ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Takeshi Kimura

Background: We sought to compare the long-term clinical outcomes between everolimus-eluting stent (EES) and sirolimus-eluting stents (SES) with a meta-analysis method. The long-term clinical outcomes, especially stent thrombosis (ST), after EES versus SES implantation has not been clearly defined among trials directly comparing the 2 types of stents. Methods: We searched PubMed, Cochrane database, and ClinicalTrials.gov. for trials comparing outcomes between EES (Xience V/Promus) and SES (Cypher select/Cypher select plus) in patients with native coronary artery disease using randomized controlled trial (RCT) design. We selected the article reporting the longest follow-up outcomes from each RCT. The outcome measure was all-cause death, myocardial infarction (MI), definite ST, and target-lesion revascularization (TLR). ST was further classified as those occurring early (<=30 days), late (30-365 days), or very late (<365 days). Results: We identified 14 RCT comparing EES and SES including 2 trials reporting the longest follow-up outcomes as a pooled analysis. We analyzed 13,434 randomly assigned patients with the weighted follow-up period of 2.1 years (Follow-up <=1-year: 7 trials, and 3191 patients; >1-year: 7 trials, and 10243 patients). EES as compared to SES was associated with significantly lower risks for overall ST, and early ST (pooled odds ratio (OR) 0.49, 95% confidence interval (CI) 0.30-0.81, P=0.01, and OR 0.42, 95% CI 0.18-0.99, P=0.046, respectively), while there was no significant difference in the risk for late ST and very late ST (OR 0.49, 95% CI 0.17-1.43, P=0.19, and OR 0.66, 95% CI 0.23-1.85, P=0.43, respectively). EES as compared to SES was also associated with significantly lower risks for TLR (OR 0.84, 95% CI 0.71-0.99, P=0.04). There was no significant difference in the risk for all-cause death, and MI between EES and SES. (OR 0.91, 95% CI 0.78-1.07, P=0.11, and OR 0.92, 95% CI 0.75-1.13, P=0.44, respectively). Conclusions: In the current meta-analysis of 14 RCT directly comparing EES with SES, implantation of EES as compared to SES implantation was associated with significantly lower risk for definite ST and TLR.


2019 ◽  
Vol 13 ◽  
pp. 117954681985405 ◽  
Author(s):  
Alfredo E Rodriguez ◽  
Miguel Larribau ◽  
Carlos Fernandez-Pereira ◽  
Jorge Iravedra ◽  
Omar Santaera ◽  
...  

The aim of this study was to evaluate 1-year follow-up results in an all “comers” population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival ( P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.


2007 ◽  
Vol 46 (05) ◽  
pp. 185-191 ◽  
Author(s):  
T. Nusser ◽  
B. J. Krause ◽  
M. Kochs ◽  
T. Habig ◽  
F. M. Mottaghy ◽  
...  

SummaryAims: We compared the intracoronary β-brachytherapy using a liquid rhenium-188 filled balloon with the slow-release, polymer-based, paclitaxel-eluting Taxus-Express stent for treatment of in-stent restenoses. Patients, methods: During the same study period, patients with restenoses in bare-metal stents were either treated with Taxus- Express stents (n = 50) or β-brachytherapy after successful angioplasty (n = 51). For brachytherapy 30 Gy in 0.5 mm tissue depth were administered. The irradiated segment exceeded the traumatized segment 7.5 mm on both sides. Primary endpoint was the minimal lumen diameter (MLD) at the target lesion at six months follow-up. Angiographic follow-up was available in 78% (n = 79/101) and clinical follow-up in all patients. Results: Baseline parameters did not differ statistically. The Taxus-Express stent resulted in a significantly larger MLD and a significantly lower percent diameter stenosis post intervention compared to β-brachytherapy, which both maintained until angiographic follow-up (primary endpoint 2.44 ± 0.74 mm versus 1.73 ± 0.74 mm, p <0.0001). Therefore, Taxus- Express stents were associated with a lower angiographic restenosis rate compared with β-brachytherapy, both for the target lesion (6.1% versus 17.4%) and the total segment (9.1% versus 23.9%). Moreover, use of Taxus-stent was associated with a clinical benefit based on a significantly lower MACE rate compared with β-brachytherapy (p <0.05). Conclusions: Paclitaxel-eluting Taxus- Express stents resulted in superior clinical and angiographic outcomes compared to intracoronary β-brachytherapy with a liquid 188Re filled balloon for treatment of restenosis within a bare-metal stent.


2021 ◽  
Vol 16 (2) ◽  
pp. 225-233
Author(s):  
Eleonora DRĂGAN ◽  
◽  
Maria Suzana GUBERNA ◽  
Cătălina Liliana ANDREI ◽  
Crina-Julieta SINESCU ◽  
...  

Purpose. The study aims to determine the impact of dysthyroidism on the severity and type of coronary lesion, on vascular function, as well as on the morbidity and mortality of patients with acute coronary syndrome, by finding predictive markers that can be translated into preventive measures that contribute substantially to reduce the number of newly diagnosed patients with coronary heart disease. Methods. We introduced in the study 100 patients recently diagnosed with acute coronary syndrome, without history of ischemic heart disease or thyroid disease, hospitalized in the Cardiology Clinic of the “Bagdasar-Arseni“ Emergency Clinical Hospital Bucharest, for the interventional treatment of acute coronary syndrome. The studied patients were hospitalized between November 2014 and April 2015, with regular follow-up of up to 5 years (telephone or direct interview, conducted at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months), with an average period follow-up of 1006 days, evaluated clinically, bio-humorally, by echocardiography, explored with coronary angiography with the calculation of the SYNTAX score and with the performance of electrocardiogram and pulse wave. The obtained data were integrated in Excel sheets and statistically processed with the Python program. Results. The mortality rate in the patient group was 7% (7 deaths). Descriptively, of the deceased, 6 patients (86%) were male, and as thyroid status 1 hyperthyroid patient (14%), 3 hypothyroid patients (43%) and 3 patients (43%) normothyroid. There were 4 deaths (8%) in the group of patients with unstable angina and 3 deaths (8%) in the group of patients with myocardial infarction without ST-segment elevation. There were no deaths in the group of patients with acute myocardial infarction with ST-segment elevation. At follow-up, 41 patients (41%) were readmitted. Re-hospitalization was influenced by elevated values of mean blood pressure, diastolic blood pressure and C-reactive protein, unicoronary atherosclerotic disease and unstable angina at admission. At follow-up, the development of noncardiac events was noted in the evolution of patients, diabetes mellitus occurring in the majority, in almost a quarter of patients (22 patients, respectively 24% developed diabetes over time), 34% (19 patients) in euthyroidism and 8% (3 patients) dysthyroidism. Discussions. Predictive factors for the readmission of the patient with acute coronary syndrome are highlighted the following: increased level of C-reactive protein (p = 0.017), tricoronary vascular damage (p = 0.01), diastolic blood pressure greater than 80 mmHg (p = 0.025), and euthyroid status (p = 0.04). The probability of death for the patient with acute coronary syndrome rises to 66% in the presence of severe systolic dysfunction of the left ventricle (p = 0.006), and to 61% in the case of elevated values of hs troponin I (p = 0.008). In our study, the presence of dysthyroidism in the patient with acute coronary syndrome has a protective role in the development of diabetes in the first 5 years (p = 0.025). Conclusion. Dysthyroidism is associated with increased morbidity and mortality from cardiovascular disease.


2021 ◽  
Vol 2021 ◽  
pp. 1-4
Author(s):  
Fakilahyel S. Mshelbwala ◽  
Mir B. Basir ◽  
Brittany Fuller ◽  
Khaldoon Alaswad

The introduction of stents has led to significant improvement in the management of coronary artery disease. In-stent thrombosis, target lesion revascularization, and stent fracture (SF) have been identified as causes of in-stent restenosis. Peri-contrast staining (PSS) has been associated with in-stent restenosis, stent thrombosis, stent fracture, and the development of coronary aneurysm. As the frequency of patients with first generation sirolimus-eluting coronary stents becomes infrequent; PSS may go unrecognized. Herein, we present a patient with a decade of longitudinal follow-up, who developed PSS identified on coronary angiogram with recurrent stent failure.


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