Abstract 16775: Efficacy and Safety of a Thinner-strut Silicon Carbide-coated Cobalt Chromium Bare-metal Stent Compared to a Thin-strut Uncoated Cobalt Chromium Bare-metal Stent in Large Vessel Stenting: Insights From Two Prospective Randomised All-comers Trials

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Kim W Hansen ◽  
Rikke Sørensen ◽  
Raban Jeger ◽  
Christoph Kaiser ◽  
Matthias Pfisterer ◽  
...  
Keyword(s):  
Silicon Carbide ◽  
Cardiac Death ◽  
Bare Metal Stent ◽  
Bare Metal ◽  
Target Vessel ◽  
Efficacy And Safety ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Target Vessel Revascularization ◽  
New Generation

Introduction: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest reduced efficacy with higher rates of symptomatic restenosis in patients receiving the newer generation BMS. Objective: We investigated the efficacy and safety of a new generation thinner-strut SiC coated CoCr BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0mm) and thus at low risk of restenosis. Methods: We included all patients randomized to SCC- (n=761) or UC-BMS (n=765) in the BASKET-PROVE II and I trials, respectively. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis were also assessed. We used Cox proportional hazards regressions to estimate relative hazards adjusting for known confounders. Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. Rates of the primary endpoint were 10.4% in the SCC-BMS group and 8.4% among patients receiving UC-BMS yielding an adjusted relative hazard (HR) of 1.46 ([1.03-2.07], p=0.032). Estimates for the safety endpoints were: cardiac death (1.8% vs. 2.4% ; HR 0.77 [0.36-1.59], p=0.46), non-fatal MI (3.2% vs. 2.5% ; HR 1.68 [0.88-3.21], p=0.11), and definite/probable stent thrombosis (0.8% vs. 1.0% ; HR 0.97 [0.32-3.00], p=0.96). We detected no particular subgroups driving the increased risk of target-vessel revascularization in the SCC-BMS group. Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of symptomatic restenosis despite less complex procedures compared to the UC-BMS with no signs of an offsetting safety benefit.

scholarly journals Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

BMJ ◽  
2014 ◽  
Vol 349 (nov04 12) ◽  
pp. g6427-g6427 ◽  
Author(s):  
M. Valgimigli ◽  
M. Sabate ◽  
C. Kaiser ◽  
S. Brugaletta ◽  
J. M. de la Torre Hernandez ◽  
...  
Keyword(s):  
Cardiovascular Events ◽  
Meta Analysis ◽  
Bare Metal Stent ◽  
Bare Metal ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Patient Level

scholarly journals Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Eline H. Ploumen ◽  
Tineke H. Pinxterhuis ◽  
Paolo Zocca ◽  
Ariel Roguin ◽  
Rutger L. Anthonio ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Major Bleeding ◽  
Cardiac Death ◽  
Drug Eluting Stents ◽  
High Risk Population ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
New Generation

Abstract Background Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. Methods For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38–2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85–2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49–5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29–2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03–2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23–2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. Conclusions Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. Trial registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

scholarly journals CRT-700.07 Nine-Month RESULTS Of The BIOHELIX-I Clinical Trial Study: Evaluation Of The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent

2017 ◽  
Vol 10 (3) ◽  
pp. S59
Author(s):  
Tesfaldet Michael ◽  
Gert Richardt ◽  
Alexandra Lansky ◽  
Robert J. Carney ◽  
Muhammed Akram Khan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kinetic Energy ◽  
Bare Metal Stent ◽  
Bare Metal ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Study Evaluation

scholarly journals Do ultrathin strut bare-metal stents with passive coating improve efficacy in large coronary arteries? Insights from the randomized, multicenter BASKET-PROVE trials

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Kim Wadt Hansen ◽  
Raban Jeger ◽  
Rikke Sørensen ◽  
Christoph Kaiser ◽  
Matthias Pfisterer ◽  
...  
Keyword(s):  
Silicon Carbide ◽  
Coronary Arteries ◽  
Cardiac Death ◽  
Proportional Hazards ◽  
Bare Metal Stents ◽  
Metal Stents ◽  
Bare Metal ◽  
Cobalt Chromium ◽  
Stent Type ◽  
Large Coronary Arteries

Abstract Background The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest higher rates of symptomatic restenosis in patients receiving the newer generation BMS. We investigated the efficacy of a newer generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0 mm). Methods All patients randomized to SCC- (n = 761) or UC-BMS (n = 765) in the two BASKET-PROVE trials were included. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST) were also assessed. We used inverse probability weighted proportional hazards Cox regressions adjusting for known confounders. Results Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. The risk for clinically driven TVR was increased om the SCC-BMS group compared to the UC-BMS group (cumulative incidence, 10.6% vs. 8.4%; adjusted relative hazard [HR], 1.49 [95% CI, 1.05–2.10]). No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30–1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83–2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39–3.50]). Differences in strut thickness between the two stents did not explain the association between stent type and clinically driven TVR. Conclusions In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of clinically driven repeat revascularization compared to the UC-BMS with no signs of an offsetting safety benefit.

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