31 research outputs found
TCT-819 Prediabetes and its Impact on 1-Year Clinical Outcome After Treatment with Newer-Generation Drug-eluting Stents in 2,986 All-Comer Patients
BACKGROUND Prediabetes (Pre-DM) is a risk factor state for developing diabetes mellitus (DM). Yet it is unclear whether detection of Pre-DM by routine assessment of glycated haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) among patients undergoing percutaneous coronary intervention (PCI) may help identify subjects with increased event risk. We assessed in all-comers who underwent PCI with contemporary drug-eluting stents (DES) the relation between glycaemia status and 1-year clinical outcome. METHODS HbA1c and FPG was determined in 2,362 non-DM participants in the multicenter, randomized, investigator-initiated TWENTE III trial, in order to identify Pre-DM (HbA1c 42-47mmol/mol; FPG 6.1- 6.9 mmol/L) and DM (HbA1c>=48mmol/mol; FPG >7 mmol/L). Another 624 patients had medically treated DM. The main clinical outcome parameter was a composite endpoint consisting of death, myocardial infarction, or revascularisation. RESULTS Glycaemic state was known in 2,986 trial participants: Pre- DM was present in 324 (11%), DM in 793 (27%), and normoglycaemia in 1,869 (63%) patients. Patients with Pre-DM and DM differed from normoglycemic patients in cardiovascular risk factors. The composite clinical endpoint in Pre-DM occurred in 11.1%, in DM in 10.5%, and in normoglycemic patients in 5.7% (
Bifurcation treatment with novel, highly flexible drug-eluting coronary stents in all-comers: 2-year outcome in patients of the DUTCH PEERS trial
Background: Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce.Methods: We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization.Results: Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71â2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002).Conclusion: All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions
TCT-588 2-Year Clinical Outcome of the Randomized, Multicenter DUTCH PEERS (TWENTE II) Trial, Comparing Cobalt-Chromium Zotarolimus-Eluting Resolute Integrity Stents and Platinum-Chromium Everolimus-Eluting Promus Element Stents in âAll-Comerâ Patients
Background: The multicenter, prospective, randomized, single-blinded, investigator-initiated DUTCH PEERS (TWENTE II) âAll Comersâ Trial demonstrated at 1-year follow-up the non-inferiority of third-generation Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, CA) versus Promus Element everolimus-eluting stents (Boston Scientific, Natick, MA), based on a similar incidence of the primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel revascularization (TVR), or myocardial infarction (MI). No other follow-up data beyond 12 months have been published from a randomized head-to-head comparison of both stents. Methods: In 4 study centers in the Netherlands, 1,811 patients were 1:1 randomly assigned to treatment with one of both stents. Patients with any clinical syndrome, any lesion type, and any number of lesions or vessels to be treated were included. Study monitoring and clinical event adjudication were performed by two independent Dutch contract research organizations (Diagram, Zwolle, and Cardialysis, Rotterdam, respectively). Results: DUTCH PEERS examines an all-comer patient population that included 59% of patients with acute coronary syndromes (20% of all patients presented with an acute STEMI) and 66% of patients with complex target lesions. We will compare for both stent groups the 2-year incidence of TVF (primary endpoint) and various secondary endpoints, including individual components of the primary endpoint, the incidence of stent thrombosis, and other composite endpoints, such as target lesion failure, major adverse cardiac events, and the patient-oriented composite endpoint. In addition, we will report the outcome of patients with longitudinal stent deformation after discontinuation of dual anti-platelet therapy. Conclusions: Clinical outcome of the DUTCH PEERS trial at 2-year follow-up will be presented
Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers
BACKGROUND: In a previous trial, higher 5âyear mortality was observed following treatment with biodegradable polymer Orsiro sirolimusâeluting stents (SES). We assessed 5âyear safety and efficacy of allâcomers as well as patients with diabetes treated with SES or Synergy everolimusâeluting stents (EES) versus durable polymer Resolute Integrity zotarolimusâeluting stents (ZES). METHODS AND RESULTS: The randomized BIOâRESORT (Comparison of Biodegradable Polymer and Durable Polymer DrugâEluting Stents in an All Comers Population) trial enrolled 3514 allâcomer patients at 4 Dutch cardiac centers. Patients aged â„18âyears who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Fiveâyear followâup was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71â1.12], P (logârank)=0.31; and HR, 0.82 [95% CI, 0.65â1.04], P (logârank)=0.10, respectively). Individual components of target vessel failure showed no significant betweenâstent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stentâgroups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [P (logârank)=0.69 and P (logârank)=0.63]). CONCLUSIONS: Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5âyear outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5âyear clinical outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803
Resultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: anĂĄlisis del ensayo aleatorizado DUTCH PEERS (TWENTE II)
Introduction and objectives In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. Methods The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or nonâST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. Results Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P =.45), target lesion revascularization (3.1% vs 2.8%; P =.79), and definite stent thrombosis (1.0% vs 0.5%; P =.69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF: 5.1% vs 4.9%; P =.81) and 447 patients with nonâST-segment elevation MI (TVF: 9.0% vs 7.5%; P =.56). Conclusions Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting. Full English text available from: www.revespcardiol.org/e
Proximal LAD Treated With Thin-Strut New-Generation Drug-Eluting Stents: A Patient-Level Pooled Analysis of TWENTE I-III
Objectives: This study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treated in proximal left anterior descending artery (P-LAD) versus nonâP-LAD lesions. Background: In current revascularization guidelines, P-LAD coronary artery stenosis is discussed separately, mainly because of a higher adverse event risk and benefits of bypass surgery. Methods: The study included 6,037 patients without previous bypass surgery or left main stem involvement from the TWENTE I, II, and III randomized trials. A total of 1,607 (26.6%) patients had at least 1 DES implanted in P-LAD and were compared with 4,430 (73.4%) patients who were exclusively treated in other (nonâP-LAD) segments. Results: Two-year follow-up was available in 5,995 (99.3%) patients. At baseline, P-LAD patients had more multivessel treatment and longer total stent length. The rate of the patient-oriented composite clinical endpoint (any death, any myocardial infarction, or any revascularization) was similar in P-LAD versus nonâP-LAD patients (11.4% vs. 11.6%; p = 0.87). In P-LAD patients, the rate of the device-oriented composite clinical endpoint (cardiac death, target vessel myocardial infarction, or target lesion revascularization) was higher (7.6% vs. 6.0%; p = 0.020), driven by a higher rate of target vessel myocardial infarction (4.1% vs. 2.6%; p = 0.002). However, multivariate analysis showed no independent association between stenting P-LAD lesions and clinical endpoints. Conclusions: In this patient-level pooled analysis of 3 large-scale contemporary DES trials, treatment of P-LAD lesions was not independently associated with higher 2-year adverse clinical event rates. These results imply that separate consideration in future revascularization guidelines may not be mandatory any longer
Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial
Introduction and objectives: In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. Methods: The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or nonâST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. Results: Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with nonâST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). Conclusions: Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting
Resultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: anĂĄlisis del ensayo aleatorizado DUTCH PEERS (TWENTE II)
Introduction and objectives: In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. Methods: The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or nonâST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. Results: Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P =.45), target lesion revascularization (3.1% vs 2.8%; P =.79), and definite stent thrombosis (1.0% vs 0.5%; P =.69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF: 5.1% vs 4.9%; P =.81) and 447 patients with nonâST-segment elevation MI (TVF: 9.0% vs 7.5%; P =.56). Conclusions: Â Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting. Full English text available from: www.revespcardiol.org/e
Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions The PRISON IV Trial
OBJECTIVES: The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BACKGROUND: The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. METHODS: In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. RESULTS: Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion â„3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. CONCLUSIONS: This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.publisher: Elsevier
articletitle: Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions
journaltitle: JACC: Cardiovascular Interventions
articlelink: http://dx.doi.org/10.1016/j.jcin.2016.10.017
content_type: article
copyright: © 2017 by the American College of Cardiology Foundation. Published by Elsevier.status: publishe