Undesired Outcomes of the Catania Stent Compared to the Xience Stent in Patients Undergoing Angioplasty: A Double-Blind Randomized Controlled Trial
Masoud Pourmoghaddas1, Hamid Reza Rohani1, Hamid Sanei2, Afshin Amirpour1
1 Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
|Date of Web Publication||30-Nov-2017|
Dr. Hamid Reza Rohani
Fellowship for Cardiology, Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan
Source of Support: None, Conflict of Interest: None
Background: The present study tries to compare the unintended outcomes of the Catania stent versus Xience stent in patients undergoing angioplasty. Materials and Methods: In a three month, follow-up, double-blinded, randomized controlled trial, 83 patients undergoing angioplasty, who met the inclusion criteria were entered into the study. After randomization 43 patients were treated with the Xience stent and 40 patients with the Catania stent. Stent-related outcomes such as Cardiac and Non-Cardiovascular Death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR), Stent Thrombosis (ST), Coronary Artery Bypass Grafting (CABG), Peripheral vasculopathy, and Cerebral Vascular Accident (CVA) were compared between the groups. Results: There was no statistically significant difference in the incidence rate of complications and clinical outcomes between the two treatment groups (P > 0.05). The incidence of MI, TLR, CABG operation, peripheral vasculopathy, or CVA was not observed in any patient and there was no statistically difference in mortality (4.7% vs. 2.5%; P = 0.527) and stent thrombosis (2.3% vs. 2.5%; P = 0.735). Conclusion: All in all, the present study could not find the significant differences between the Catania stent and Xience stent in terms of clinical outcomes during the follow-up period.
Keywords: Angioplasty, Catania stent, clinical outcome, stent thrombosis, Xience stent
|How to cite this article:|
Pourmoghaddas M, Rohani HR, Sanei H, Amirpour A. Undesired Outcomes of the Catania Stent Compared to the Xience Stent in Patients Undergoing Angioplasty: A Double-Blind Randomized Controlled Trial. Adv Biomed Res 2017;6:154
|How to cite this URL:|
Pourmoghaddas M, Rohani HR, Sanei H, Amirpour A. Undesired Outcomes of the Catania Stent Compared to the Xience Stent in Patients Undergoing Angioplasty: A Double-Blind Randomized Controlled Trial. Adv Biomed Res [serial online] 2017 [cited 2018 May 21];6:154. Available from: http://www.advbiores.net/text.asp?2017/6/1/154/219419
| Introduction|| |
The outreach of stents has made remarkable progress in the remedy of obstructive coronary artery disease since the introduction of balloon angioplasty. Two broad categories of stents are available: Bare metal stents (BMS) and drug-eluting stents (DES). The unexpected gelation of vessels owing to subacute stent thrombosis (SAT) and late in-stent restenosis (ISR) are two significant complications that are faced with the extensive use of BMS., However, DES is more effective than BMS in reducing restenosis and the need to target vessel revascularization (TVR).,,, Introduction of DES was a major achievement in interventional cardiology. Several studies using DES have shown a substantial reduction in angiographic restenosis and target vessel revascularization in comparison to bare metal stents.,,, DES has now become the mainstream therapy for coronary artery stenosis due to the very low rate expected for in-stent restenosis. Xience V (an everolimus-eluting stent) is one of the second-generation DES that has been newly approved in the US; in 2007. This stent is designed from a cobalt-chromium alloy and is thinner and more flexible than the first-generation ones., The Xience V stent has a superior anti-restenotic efficiency as well as long-term safety. Moreover, the Xience stent is based on the multi-link platform and delivery system., In an investigation, patients treated with the Xience stent were compared with patients treated in the past with BMS, sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES). In this assessment, the efficacy of the Xience was found to be superior to BMS, had clinical outcomes similar to SES, was also as safe as PES, and was maybe more effective than PES. In a recent investigation, the safety and efficacy of the Everolimus-eluting Xience V stent (EES) was compared with the Zotarolimus-eluting resolute stent (ZES-R). Both stents showed comparable safety and efficacy at a one-year follow-up. Also excellent safety and efficacy of both types of second-generation drug-eluting stents was suggested. Comparison of the everolimus eluting XIENCE V stent with the paclitaxel eluting TAXUS LIBERTE stent indicated that the EES had a substantial clinical benefit over the PES with regard to the measures of both safety and efficacy that were maintained at the two-year of follow-up. The assessments prepared by the SPIRIT program in several studies indicated that Xience V reduced late loss compared to the Bare and Taxus stents.,,, Although DES was shown to reduce the restenosis rates, there were some concerns about the safety, due to reports of increased risk of late and very late stent thrombosis.,
Catania (CeloNova BioSciences) is another stent that has recently been used. The Catania stent is flexible, made of a cobalt-chromium alloy, is balloon-expandable, and its surface is treated with Polyzene-F. Its application in a first-in-man assessment has shown a great safety profile and high efficacy in the treatment of de novo coronary lesions (5). Another study has evaluated the 12-month safety and efficacy of the Catania stent and confirmed the positive results of the former study. It seems that comparative studies assessing the value of the Catania stent over the currently used drug-eluting stents like Xience, are needed. The present survey in a double-blind, randomized controlled trial, which tries to compare the unintended outcomes of the Catania and Xience stents in patients undergoing angioplasty.
| Materials and Methods|| |
This double-blind, randomized controlled trial was conducted on 83 patients undergoing angioplasty in the Chamran Hospital, Isfahan, Iran, between June 2012 and March 2013. Determination of the sample size was done using the Krejcie and Morgan's table.
The non-probability consecutive sampling method was used. After enrollment, all the patients were randomly divided into one of the two groups (group 1: Patients received the Xience stent and group 2: Patients received the Catania stent) by the Random Allocation Software.
The inclusion criteria were, age between 30 and 75 years, stable or unstable angina, and/or documentation of myocardial ischemia, attributable to native coronary artery stenosis. Written informed consent was obtained from all the participants, as approved by the Ethics Committee of the Isfahan University of Medical Sciences.
The exclusion criteria were chronic renal failure (serum creatinine >2.5 mg/dl), ongoing acute myocardial infarction or myocardial infarction within the last 48 hours, left ventricular ejection fraction <30%, cardiogenic shock, and documented or suspected systemic and/or infectious disease. In such cases the patients were not acceptable candidates for emergent coronary artery bypass graft, planned two-stent implantation (except bail-out), other types of stent implantation, diffuse/severe coronary calcifications, extreme vessel tortuosity, unprotected left main stenosis, and saphenous vein graft and arterial bypass (internal mammary artery).
The endpoint of the study was to define the rate of all deaths (Cardiac Death and Non-Cardiovascular Death), Myocardial Infarction (MI), Target Lesion Revascularization (TLR), Stent Thrombosis (Definite, Probable, Possible), Coronary Artery Bypass Grafting (CABG), Peripheral Vasculopathy and Cerebral Vascular Accident (CVA), during follow-up.
To assess the incidence rate of Stent Thrombosis, depending upon 'event certainty' and 'time frame', the Academic Research Consortium (ARC) classification was used.
Data are presented as Mean ± 1 SD or Median (twenty-fifth and seventy-fifth percentile) for continuous variables and Number (Percent) for categorical ones. As the number of patients in each group was smaller than 50, the Shapiro–Wilk test was used for normality testing. Statistical differences among the studied groups were assessed by the Independent-Samples T-test, Mann-Whitney, Chi-square, and Fisher's Exact test.
On account of the statistically significant differences between the two groups, in terms of variables such as 'hypertension' and 'history of myocardial infarction' and also due to the control of the effect of potential confounders on the relationship between the occurrence of the main outcome and type of stent (group), we used the multivariate regression models.
All analyses were done using the Statistical Package for Social Sciences Version 20 (SPSS Inc., Chicago, IL, USA) and p-values less than 0.05 were considered significant.
| Results|| |
[Figure 1] shows the flow chart of the study. This figure shows the number of patients who entered the study, were assigned to the study groups, and analyzed. On the basis of the eligibility criteria, a total of 89 patients were randomly divided, six of whom did not enter the analyses (because of not consenting to participate in the trial).
Eighty-three patients (43 men and 40 women) entered the study. Their ages ranged from 37 to 75 years, with a mean age of 60.7 ± 9.4 years and a median age of 60 years. Other demographic and clinical features of the study population categorized by the group are shown in detail in [Table 1]. As shown by the analysis of the statistics, the age and sex structure of the studied groups is well-distributed. There were no statistically significant differences between the two groups with respect to the mean of weight, height, body mass index (BMI), and frequencies of smoking, diabetes mellitus, history of coronary artery disease (CAD), hyperlipidemia, and vessel place (P > 0.05).
|Table 1: The comparison of demographic, laboratory, and clinical patterns of 83 patients under angioplasty by the studied groups|
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There was no statistically significant difference in the incidence of complications and clinical outcomes between the two treatment groups (P > 0.05). The incidence of MI, TLR, CABG operation, peripheral vasculopathy, and CVA were not observed in any of the patients. Furthermore, there was no statistically significant difference in mortality (4.7% vs. 2.5%; P = 0.527) and stent thrombosis (2.3% vs. 2.5%; P = 0.735) [Table 2].
|Table 2: The comparison of clinical outcomes between the studied groups during three months follow-up after intervention|
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After performing a univariate analysis, the clinical outcomes and some other independent variables such as, hypertension (HTN) and history of MI (based on the univariate analysis, at significance levels of 0.05) were included in the multiple logistic regression analysis. All variables were entered simultaneously ('Enter' method).
Even after adjusting for the potential confounders, there were no statistically significant differences between the Xience and Catania stents in terms of any outcome variables during the follow-up period.
| Discussion|| |
The present study as a double-blind, randomized controlled trial, compares the unintended outcomes of the Catania stent versus the Xience stent in patients undergoing angioplasty during three months of follow-up.
As our results indicate, there are no statistically significant differences between the Catania Polyzene-F coated stent and Xience stent with regard to all the unintended clinical outcomes during the follow-up period.
The first-in-man study of the Catania stent from May 2007 through August 2007, as a nonrandomized, single-arm study, on 55 patients with coronary artery diseases, showed superb safety and high-level efficacy in the treatment of de novo coronary artery lesions. In this survey it was suggested that the Catania stent could be an alternative to both BMS and DES, which could lessen the late loss, restenosis, and target lesion revascularization, with no long-term dual antiplatelet therapy. Also, in a six-month clinical outcome assessment, in the comparison between patients treated with Xience stent and patients who were treated in the past with BMS, paclitaxel-eluting stents, and sirolimus-eluting stents, in 2007, Xience was better than BMS for target vessel revascularization and major adverse cardiac events (MACE), with clinical outcomes equal to SES. Our results are in-keeping with their findings.
In a recently published study the safety and efficacy of the Xience everolimus-eluting stent (EES) were compared with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) in a huge real-world registry (3056 patients treated with Xience and 1998 patients treated with zotarolimus-eluting stent). It was suggested that these two drug-eluting stents had excellent safety and efficacy.
Although drug-eluting stents were found to lessen restenosis and the need for revascularization, several studies showed that they did not reduce the total mortality and were also associated with increased rates of stent thrombosis.,,, Nordmann et al., in a meta-analysis study compared the effect of DES versus BMS among studies, between 1980 up to 2006. They suggested that with regard to treatment of coronary artery disease, drug-eluting stents did not reduce the total mortality in comparison to bare metal stents. They also expressed that long-term follow-up and evaluation of cause-specific deaths in patients receiving DES was compulsory to specify the long-term safety of these stents.
The seconder study for evaluating the Catania Polyzene-F coated stent's safety and efficacy at a 12-month clinical follow-up, confirmed the first-in-man study of the Catania stent. In this survey, 300 patients were evaluated between May 2007 and March 2008, in a prospective, non-randomized, single-arm study. The most important limitation of their study was the lack of randomized comparison with a different stent, and we have considered this limitation in our survey. According to the aforesaid studies and taking into account our findings, the Catania stent, as a biodegradable and polymer-free DES, could be effective for preventing unintended and late and very late outcomes.
The major limitation of our study was the lack of a follow-up period, which should be considered in future studies. Follow-up was only reported through three months, which was too short for describing the conclusions concerning stent thrombosis and matters related to safety. Also more randomized controlled trial studies should be carried out with different DESs and BMSs to evaluate the exact position of the Catania stents.
According to the increased concerns about the safety of DESs, due to the reports of the rising risk of late and very late stent thrombosis, the Catania stent, because of its safety profile, could be suggested as an alternative stent for patients who did not qualify for a long-term drug regimen. All in all, we could not find any significant difference between the Catania Polyzene-F coated stent and Xience stent.
The authors appreciate the financial support of the Vice Chancellor for Research (School of Medicine, Isfahan University of Medical Sciences, Isfahan, IRAN) [Project number: 392134].
Financial support and sponsorship
Isfahan University of Medical sciences.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Htay T, Liu MW. Drug-eluting stent: A review and update. Vasc Health Risk Manag 2005;1:263-76.
Kirchner RM, Abbott JD. Update on the everolimus-eluting coronary stent system: Results and implications from the SPIRIT clinical trial program. Vasc Health Risk Manag 2009;5:1089-97.
Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al
. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N
Engl J Med 2004;350:221-31.
Htay T, Liu MW. Drug-eluting stent: A review and update. Vasc Health Risk Manag 2005;1:263-76.
Tamburino C, La Manna A, Di Salvo ME, Sacchetta G, Capodanno D, Mehran R, et al
. First-in-man 1-year clinical outcomes of the Catania Coronary Stent System with Nanothin Polyzene-F in de novo
native coronary artery lesions: The ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) trial. JACC Cardiovasc Interv 2009;2:197-204.
Capodanno D, Dipasqua F, Tamburino C. Novel drug-eluting stents in the treatment of de novo
coronary lesions. Vasc Health Risk Manag 2011;7:103-18.
Waksman R. Late stent thrombosis--the “vulnerable” stent. Catheter Cardiovasc Interv 2007;70:54-6.
Moussa I, Leon MB, Baim DS, O'Neill WW, Popma JJ, Buchbinder M, et al
. Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients A SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo
coronary artery lesions) Substudy. Circulation 2004;109:2273-8.
Capodanno D, Di Salvo ME, Palmerini T, Sheiban I, Margheri M, Vecchi G, et al
. Long-term clinical benefit of drug-eluting stents over bare-metal stents in diabetic patients with de novo
left main coronary artery disease: Results from a real-world multicenter registry. Catheter Cardiovasc Interv 2009;73:310-6.
Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, et al
. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease. JAMA 2005;294:1215-23.
Sheiban I, Villata G, Bollati M, Sillano D, Lotrionte M, Biondi-Zoccai G. Next-generation drug-eluting stents in coronary artery disease: Focus on everolimus-eluting stent (Xience V). Vasc Health Risk Manag 2008;4:31-8.
Onuma Y, Kukreja N, Piazza N, Eindhoven J, Girasis C, Schenkeveld L, et al
. The everolimus-eluting stent in real-world patients 6-month follow-up of the X-SEARCH (Xience V) stent evaluated at Rotterdam Cardiac Hospital registry. J Am Coll Cardiol 2009;54:269-76.
Park KW, Lee JM, Kang SH, Ahn HS, Yang HM, Lee HY, et al
. Safety and Efficacy of Second-Generation Everolimus-Eluting Xience V Stents Versus Zotarolimus-Eluting Resolute Stents in Real-World PracticePatient-Related and Stent-Related Outcomes From the Multicenter Prospective EXCELLENT AND RESOLUTE-Korea Registries. J Am Coll Cardiol 2013;61:536-44.
Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga TA, et al
. 2-Year Follow-Up of a Randomized Controlled Trial of Everolimus-and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice COMPARE (Comparison of the everolimus eluting Xience-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: A randomized open label trial). J Am Coll Cardiol 2011;58:11-8.
Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, et al
. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: The SPIRIT II trial. EuroIntervention 2006;2:286-94.
Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, et al
. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The Spirit first trial. EuroIntervention 2005;1:58-65.
Iakovou I. Do the New Data on Second-Generation drug eluting stents provide reassurance on safety, Efficacy, Even for Off-Label Use? Hosp Chron 2010;5:141-4.
Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, et al
. Comparison of in vivo
acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: Insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 2007;70:515-23.
Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: A meta-analysis. Eur Heart J 2006;27:2784-814.
Tamburino C, Capodanno D, Di Salvo ME, Sanfilippo A, Cascone I, Incardona V, et al
. Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the Atlanta 2 registry. EuroIntervention 2012;7:1062-8.
Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol 2004;4:26.
Gupta S, Gupta MM. Stent thrombosis. J Assoc Physicians India 2008;56:969-79.
Jeremias A, Sylvia B, Bridges J, Kirtane AJ, Bigelow B, Pinto DS, et al
. Stent thrombosis after successful sirolimus-eluting stent implantation. Circulation 2004;109:1930-2.
Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al
. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent should we be cautious? Circulation 2004;109:701-5.
[Table 1], [Table 2]