Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: Final 5-year report of the LEADERS (limus eluted from a durable versus erodable stent coating) randomized, noninferiority trial
Serruys P.W.,Erasmus Medical Center |
Farooq V.,Erasmus Medical Center |
Kalesan B.,University of Bern |
De Vries T.,Cardialysis |
And 17 more authors.
JACC: Cardiovascular Interventions | Year: 2013
Objectives This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. Background The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. Methods The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. Results At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). Conclusions The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220) © 2013 by the American College of Cardiology Foundation.
PubMed | Institute Hospitalier Jacques Cartier, Imperial College London, American Heart of Poland, East Lancashire Hospitals NHS Trust and 11 more.
Type: Journal Article | Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions | Year: 2016
Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES=258; SES=239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P=0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P=0.0495), and CI TVR (12.0% vs. 19.2%, P=0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P=0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P=0.057).In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. 2015 Wiley Periodicals, Inc.
PubMed | University of Leipzig, American Heart of Poland, Baylor College of Medicine, University of Lübeck and 9 more.
Type: Journal Article | Journal: Kidney international | Year: 2016
Coronary atherosclerotic disease is highly prevalent in chronic kidney disease (CKD). Although revascularization improves outcomes, procedural risks are increased in CKD, and unbiased data comparing coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in CKD are sparse. To compare outcomes of CABG and PCI in stage 3 to 5 CKD, we identified randomized trials comparing these procedures. Investigators were contacted to obtain individual, patient-level data. Ten of 27 trials meeting inclusion criteria provided data. These trials enrolled 3993 patients encompassing 526 patients with stage 3 to 5 CKD of whom 137 were stage 3b-5 CKD. Among individuals with stage 3 to 5 CKD, survival through 5 years was not different after CABG compared with PCI (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.67-1.46) or stage 3b-5 CKD (HR 1.29, CI 0.68-2.46). However, CKD modified the impact on survival free of myocardial infarction: it was not different between CABG and PCI for individuals with preserved kidney function (HR 0.97, CI 0.80-1.17), but was significantly lower after CABG in stage 3-5 CKD (HR 0.49, CI 0.29-0.82) and stage 3b-5 CKD (HR 0.23, CI 0.09-0.58). Repeat revascularization was reduced after CABG compared with PCI regardless, of baseline kidney function. Results were limited by unavailability of data from several trials and paucity of enrolled patients with stage 4-5 CKD. Thus, our patient-level meta-analysis of individuals with CKD randomized to CABG versus PCI suggests that CABG significantly reduces the risk of subsequent myocardial infarction and revascularization without affecting survival in these patients.
Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial
PubMed | Cardiovascular Research Foundation, American Heart of Poland, Silesian Center for Heart Diseases and Melsungen AG
Type: Journal Article | Journal: Journal of interventional cardiology | Year: 2015
There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions.A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex+ PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients.The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 0.5 vs. 0.30 0.7 mm, respectively. P(non-inf) < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38).Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.
Smolka G.,University of Silesia |
Pysz P.,Medical University of Silesia, Katowice |
Jasinski M.,Medical University of Silesia, Katowice |
Gocol R.,Medical University of Silesia, Katowice |
And 5 more authors.
Journal of Invasive Cardiology | Year: 2013
Introduction: Paravalvular leak (PVL) may complicate cardiac valve replacement surgery. Radical treatment is required if a PVL produces heart failure (HF) symptoms or severe hemolysis. Even though transcatheter PVL closure (TPVLC) has become a valid alternative to reoperation, a number of anatomical conditions may prove technically challenging for transvascular access. We intended to verify the utility of transapical access in such settings. METHODS: We report a prospective series of 7 patients with mitral PVLs who underwent transapical TPVLC. The Heart Team made the choice of treatment and Amplatzer Vascular Plug III devices were used off-label as occluders. RESULTS: Transapical TPVLC enabled excellent sealing of mitral PVL in 6 cases. This resulted in HF symptom reduction and decreased NT-proBNP plasma concentration. No procedure-related complications occurred. CONCLUSIONS: Transapical access seems to be an efficient and safe alternative for transvascular approach for mitral TPVLC, but further technical development is still needed.
PubMed | DoNation, American Heart of Poland and University of Silesia
Type: | Journal: BioMed research international | Year: 2016
Purpose. Single nucleotide polymorphisms of the CYBA gene may modify the risk of coronary artery disease (CAD). The aim of the present study was to investigate whether the ()49A>G (rs7195830) polymorphism is associated with CAD. Materials and Methods. CYBA gene ()49A>G polymorphism was determined in 481 subjects: 242 patients with premature CAD and 239 age and sex matched controls using the fluorescently labeled allele-specific oligonucleotides method. Results. The frequency of the ()49G allele carrier state was significantly higher in patients than in controls (84.8% versus 76.6%, resp., P = 0.020), as well as the frequency of the ()49G allele (62.2% versus 54.0%, P = 0.009). Both factors were associated with CAD in the analyzed population (OR = 1.70, 95% CI: 1.04-2.76 for GG+AG versus AA and OR = 1.40, 95% CI: 1.08-1.83 for ()49G versus()49A). Carrier state of the ()49G allele was a stronger and independent risk factor for CAD among women (OR = 4.35, 95% CI: 1.50-13.20, P = 0.002), as well as the ()49G allele (OR = 2.25, 95% CI: 1.34-3.77, P = 0.001). The ()49G allele carrier state was also associated with left ventricular hypertrophy in patients with coronary artery disease (P = 0.015). Conclusion. The CYBA gene ()49A>G polymorphism modifies the risk of coronary artery disease.
PubMed | University of Silesia, American Heart of Poland, Medical University of Silesia, Katowice, Sharpe Strumia Research Foundation and University of Texas at San Antonio
Type: Journal Article | Journal: JACC. Cardiovascular interventions | Year: 2016
This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients.At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 8.3% vs. 49.8 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99).In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.
Vassilev D.,National Heart Hospital |
Gil R.,Polish Academy of Sciences |
Gil R.,Central Hospital of the Internal Affairs and Administration Ministry |
Milewski K.,American Heart of Poland
EuroIntervention | Year: 2011
Aims: The optimal treatment strategy for coronary bifurcation lesions is still unknown. The BiOSS Lim stents (Bifurcation Optimisation Stent System) is a novel dedicated bifurcation stent introduced over a single wire in to the main vessel, covered with biodegradable polymer and sirolimus. It has wider proximal and narrower distal parts. The aim of the study was to assess applicability of the the BiOSS Lim stent in a porcine coronary model. Methods and results: A total of 14 BiOSS Lims were implanted in normal non-atherosclerotic porcine coronary bifurcations of 14 animals (six stents for 28 days, eight stents for 90 days) using 1.1:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imagery (Faxitron Bioptics, LLC, IL, USA). Vascular effects were assessed based on angiographic and histological analysis. Analysis of Faxitron images revealed no major abnormalities except two struts fractures at the place of connection between the mid-portion and proximal wider part of the stent. Histomorphometry showed decreased area stenosis and intimal thickness at 90 days compared with the 28 days cohort. The inflammatory scores were low (<1) at both time points and struts endothelialisation was completed at 28 days. Conclusions: The novel BiOSS Lim stent demonstrates good short- and mid-term vascular effects in a porcine coronary bifurcation model. © Europa Edition 2011. All rights reserved.
PubMed | American Heart of Poland
Type: Journal Article | Journal: Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery | Year: 2016
Completeness of myocardial revascularization is essential in surgical treatment of coronary artery disease. The aim of this study is to determine the effectiveness of coronary endarterectomy as an adjunct to coronary artery bypass grafting (CABG) in the most difficult cases.Among 1559 patients who had CABG in our department, the cases of 17 who underwent an adjunct left anterior descending endarterectomy were analyzed. All procedures were performed with median sternotomy, extracorporeal circulation and in mild hypothermia (34C), by the same surgeon. No coronary artery endarterectomy was planned before surgery.There was no infarction or cardiac arrest during hospitalization. Only one patient required mechanical circulatory support (intra-aortic balloon counterpulsation). Each patient was contacted and investigation for major adverse cardiac and cerebrovascular events (MACCE) was performed. Eleven patients (65%) already underwent midterm clinical evaluation. There was no death, myocardial infarction or cerebrovascular incident during the entire period (mean follow-up at 15.3 months). One patient required urgent coronarography due to chest pain. No other patient had chest pain or significant deterioration of ventricular function in echocardiography.Outcomes and potential indications for performing left anterior descending coronary endarterectomy as an adjunct to CABG are discussed.
PubMed | American Heart of Poland
Type: Journal Article | Journal: Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery | Year: 2015
We present a case of a 64-year-old man with coronary artery disease, who underwent a percutaneous coronary intervention of the circumflex artery. As the guidewire was being withdrawn from the target vessel, it became entrapped by the structure of the previously implanted stent. Attempts to retrieve the foreign body were unsuccessful. Changes in electrocardiogram were observed during the procedure, and the level of cardiac biomarkers increased within the next 24-hours. The patient was admitted to the Cardiac Surgery Department. Remnants of the foreign body were removed under visual control using extracorporeal circulation, and coronary artery bypass grafting was performed. Treatment options and outcomes are discussed.