Zotarolimus-eluting Stent Group Research Articles

Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial.

Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. URL: https://www. gov; Unique identifier: NCT04137510.

Comparison of long-term clinical outcomes among zotarolimus-, everolimus-, and biolimus-eluting stents in acute myocardial infarction patients with renal impairment.

It is important to determine the best drug-eluting stent (DES) for acute myocardial infarction (AMI) in patients with renal impairment. In this studythe outcomes of everolimus-eluting stents (EESs), zotarolimus-eluting stents (ZESs) and biolimus-eluting stents (BESs) were evaluated. From the Korea Acute Myocardial Infarction-National Institutes of Health registry, a total of 1,470 AMI patients with renal impairment undergoing percutaneous coronary intervention (PCI) were enrolled (816 with EES, 345 with ZES, and 309 with BES). Renal impairment was defined as creatinine clearance < 60 mL/min/1.73 m² estimated by the Cockcroft-Gault method. Major adverse cardiac and cerebrovascular events were determined as the composite of all-cause death, non-fatal myocardial infarction (MI), cerebrovascular accident, any revascularization, rehospitalization and stent thrombosis. All clinical outcomes were analyzed. The baseline characteristics of the patients revealed no significant difference between the three groups, except for Killip classification > 2, beta-blockers, lesion type, vascular approach, staged PCI, left main coronary artery (LMCA) complex lesions, LMCA PCI, and the number and length of implanted stents. In the Kaplan-Meier analysis, similar clinical outcomes were derived from the unadjusted data between the three DES groups. However, after the inverse probability of treatment weighting, a statistically significant difference was found in non-fatal MI, which implied a higher incidence of non-fatal MI in the ZES group than in the other two DES groups. In AMI patients with renal impairment, there was no significant difference between the three stent groups in terms of long-term clinical outcomes, except for non-fatal MI.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. This study reports the final 2-year results of the randomized Onyx ONE trial. The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95%CI: -3.1% to 4.2%; P=0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95%CI: -2.5% to 4.8%; P=0.54). Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

Comparison of two iterations of the zotarolimus-eluting stents: an analysis of all-comer patients from two consecutive randomised clinical trials

Abstract Background The newest iteration of the durable polymer zotarolimus-eluting stents (ZES) is designed with thin swaged shape composite-wire struts (inner platinum–iridium core and outer cobalt–chromium layer). It is of interest to compare the clinical performance of this novel device with its predecessor in all-comers. Purpose The purpose of the present study is to assess 2-year clinical outcome in all-comer patients who were treated with the novel ZES versus the previous iteration ZES. Methods We did a post-hoc analysis of clinical outcome data of 2374 patients who were treated with the novel or the previous generation ZES (only nominal stent diameters that were available for both devices) in two consecutive large-scale randomised all-comer trials. A total of 1201 trial participants were treated with the novel ZES, and 1173 were treated with the previous generation ZES. The main outcome parameter target vessel failure is a composite of safety (cardiac death, target vessel myocardial infarction) and efficacy (target vessel revascularisation). Clinical outcome data were analysed with Kaplan-Meier methods and hazard ratios were computed with Cox regression analysis. An additional analysis was done in a subgroup of patients who presented with chronic coronary syndromes. Results The mean age of the study population was 63.9±10.9 years, 611 (25.7%) were female and 1669 (70.3%) presented with acute coronary syndromes. Two-year follow-up was available in 2346 (98.8%) participants. After 2 years, there was no significant difference between stent-groups in the rates of target vessel failure (7.2% vs. 8.3%, HR 0.85, 95% CI 0.64–1.14, p-logrank = 0.28; Figure 1) or its individual components. Peri-procedural myocardial infarction occurred less often in patients treated with the novel ZES (0.7% vs. 2.1%, p-logrank &amp;lt;0.01), and definite-or-probable stent thrombosis rates were low in both ZES groups (0.3% vs. 0.8%, p-logrank = 0.15). In a subgroup of 705 patients with chronic coronary syndromes, the rate of target vessel myocardial infarction tended to be lower with novel ZES (1.8% vs. 4.2%, p-logrank = 0.05). Conclusions The novel ZES showed similar 2-year clinical outcomes as compared to its predecessor. Furthermore, there was a positive safety signal regarding the incidence of target vessel myocardial infarction and a particularly low stent thrombosis rates with the novel ZES. Figure 1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Other. Main funding source(s): Thoraxcentrum Twente has received institutional research grants provided by Abbott Vascular, Biotronik, Boston Scientific and Medtronic. The present analysis received no funding.

Onyx ONE: outcomes in patients with acute coronary syndrome

Abstract Background/Introduction The Onyx ONE Global Study (Onyx ONE), a randomized, single-blind, international trial, demonstrated non-inferiority of a zotarolimus-eluting stent (ZES) to a polymer-free drug-coated stent (DCS) in high-bleeding risk patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT). More than half of the Onyx ONE patients presented with an acute coronary syndrome (ACS). The safety and effectiveness of ZES and DCS in ACS patients treated with SAPT after 30 days remains unknown. Purpose To evaluate the safety and effectiveness outcomes for ZES and DCS in Onyx ONE patients presenting with ACS. Methods The primary outcome of the trial was a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year. To align with the time that DAPT is interrupted, we also evaluated the primary endpoint between the 2 stent groups in a landmark analysis between 30 days and 1 year. All analyses were performed in ACS patients (includes unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction). Results Among the 1996 patients randomized in Onyx ONE, 982/1902 (51.6%) presented with ACS, of which 511/982 (52.0%) and 471/982 (48.0%) were treated with ZES and DCS respectively. In a pre-defined subgroup analysis in ACS patients, the event rates between the two stent groups regarding the primary outcome at one year were similar (18.5% ZES; 20.8% DCS; HR: 0.91; 95% CI [0.68, 1.22]; p=0.523). In the landmark analysis beyond day 30, the primary outcome rate tended to be lower among those treated with the ZES (8.4%) compared with the DCS (12.1%) [HR: 0.66 (95% CI: 0.43, 1.01), p=0.055] (Figure). This was primarily driven by lower rates of myocardial infarction with ZES (6.5% ZES; 10.2% DCS; [HR: 0.58 (95% CI: 0.36, 0.93); p=0.025], while other components were similar: cardiac death, 2.6% ZES vs. 2.8% DCS [HR: 1.00 (95% CI: 0.44, 2.27); p&amp;gt;0.99) and stent thrombosis, 1.4% ZES vs. 1.4% DCS [HR: 0.93 (95% CI: 0.27, 3.21); p=0.91]. Conclusions In Onyx ONE, high-bleeding risk patients presenting with ACS had similar safety and efficacy at 1 year in both the ZES and DCS stent groups. However, a trend was present for greater safety with the ZES with SAPT treatment beyond 30 days driven by lower myocardial infarction rates in that time period thus warranting additional confirmatory studies. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic sponsored the Onyx ONE Global Study

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk

BackgroundPolymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.MethodsIn an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus–coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.ResultsA total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P=0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P=0.007 for noninferiority).ConclusionsAmong patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)

Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry.

Objective In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, Conclusions In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial

ObjectivesThe study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts). BackgroundThe DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices. MethodsIn total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated. ResultsFive-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83). ConclusionsAt 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487.

2925Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: insights from the DUTCH PEERS trial

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Abstract 148: Difference in Neointimal Coverage Pattern Between Zotarolimus Eluting Stents and Everolimus Eluting Stents Using Optical Coherence Tomography: A Meta-Analysis

Background: Late stent thrombosis in drug eluting stents (DES) is attributed to poor endothelialization of struts. Second generation DES have shown superior safety profile and efficacy in comparison to first generation DES. We conducted a meta-analysis to compare the neointimal coverage patterns between Zotarolimus eluting stents (ZES) and Everolimus eluting stents (EES) using optical coherence tomography (OCT). Methods: We searched online databases for studies comparing the neointimal thickness (NIT), %malapposed strut per stent (MSS) or % uncovered strut per stent (USS) between ZES and EES using OCT. Studies included inte mmeta-analysis, OCT was performed &gt;6 months after stent deployment. A calculation of weighted standardized mean difference (SMD) in NIT, MSS and USS between ZES and EES groups was calculated. Residual maximum likelihood (REML) metaregression was performed on smokers, diabetes mellitus (DM), hypertension, (HTN) dyslipidemia (DLD), and age and sex covariates. Results: A total of 6 studies enrolling 327 patients which met inclusion criteria were included in the meta-analysis. 400 stents including 184 ZES and 216 EES were analyzed by OCT. The median of mean age in years, male sex, smokers, DM, HTN and DLD in the ZES group was 60.7(59.5 - 60.9), 76.7% (71.4 - 77.3), 38.7% (18.2 - 45.8), 36.4% (23.3 - 37.5), 63.6% (60 - 66.6), 66.7% (47.9 - 68.4) versus 62.6(59.8 - 65.3), 63.9% (63.6 - 82.1), 30% (17.2 - 47.2), 31.8% (25 - 36.1), 69.4% (59.1 - 75.9), 70% (48.9 - 70.7) in the EES group respectively. The unweighted median NIT, MSS and USS in the ZES group are 127.5 μm (108.8 - 152.2), 0.7% (0.7 - 0.9), 1.8% (0.2 - 3.5) vs 117.4 μm (108.5 - 128.5), 0.3% (0.2 - 1.3), 2.3% (0.9 - 3.5) in the EES group respectively. The weighted SMD of NIT, MSS and USS in the ZES vs EES groups are -0.22 (95%CI -1.12; 0.67) P = 0.63, -0.51(95% CI -1.78; 0.77), P = 0.44, -1.26 (95%CI -2.83; 0.31). None of the above mentioned covariates accounted for statistical insignificance except age for NIT. As age increases, the SMD increases for NIT and was not significant for MSS and USS. Conclusion: No significant difference was noted in the NIT, MSS and USS between both groups. This suggests that the neointimal coverage patterns are similar in ZES and EES groups.

Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial).

At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients. Patients were eligible for this study if they were between 40 and 75 years old with in-stent restenosis >50% by quantitative coronary angiographic analysis in DES or within 5 mm of the stent edges with signs of ischaemia. Eligible patients (n = 304, 146 women and 158 men) were randomly assigned to receive either EES (158 patients) or ZES (146 patients). The primary endpoint of the study was to compare neointima volume between the EES and ZES groups at the 9-month follow-up IVUS. MACEs, including death, non-fatal MI, stent thrombosis and the need for repeated TLR within 3 years, were noted. The 9-month angiographic and IVUS follow-up showed no significant differences in late lumen loss (0.40 ± 0.56 vs. 0.45 ± 0.61 mm, P = 0.57, respectively) and neointima volume (0.51 ± 0.48 vs. 0.56 ± 0.54 mm3/1 mm, P = 0.47, respectively) in the EES and the ZES groups. Composite MACEs such as death, MI, stent thrombosis and TLR during 3-year follow-up were comparable between the two groups [15.8% (n = 25) in the EES group and 22.6% (n = 33) in the ZES group, P = 0.276], independent of de novo DES type, sex, age, body mass index, presence of diabetes, hypertension and dyslipidaemia. Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.

Zotarolimus-Eluting Versus Bare-Metal Stents in Uncertain Drug-Eluting Stent Candidates

BackgroundThe use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. ObjectivesThis study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). MethodsWe randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). ResultsMedian DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). ConclusionsCompared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)

Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents

Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents Introduction: Restenosis after stent implantation is one of the major limitations of percutaneous coronary intervention (PCI). Compared to bare metal stents (BMS), drug-eluting stents (DES) have a reduced incidence of restenosis. However, the temporal pattern of restenosis development in patients implanted with DES has not been clearly defined. Aim: This study aims to compare the efficacy of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), and everolimus eluting stents (EES) via sequential angiographic follow-up and to reveal the development of restenosis over time. Material and methods: Patients were randomized to receive SES, PES, ZES, or EES, and follow-up angiography was performed at 6, 12 and 24months after percutaneous coronary intervention. We analyzed late loss (LL) at each time point and defined 2 time periods: “early” (within first year of follow-up) and “late” (after the first year). Results: In all groups, mean minimal lumen diameter decreased slightly during the 2-year period after the procedure. Compared with the SES group, the PES and the ZES groups showed significantly greater late loss (LL) within 1 year. However, the SES group showed significantly greater LL compared with the other drug-eluting stents (DES) between 1 and 2 years. Conclusions: Serial angiographic analysis revealed differences in the rate of restenosis development over time for various DES. Of the studied DES, EES showed the best results in both early and late LL.

Abstract 12801: Angled Lesions Have Higher Incidence of Vascular Injury and Incomplete Stent Apposition, as Compared to Non-Angled Lesions, Following Stenting: An Optical Coherence Tomography Study

Backgrounds: Angled lesions are reported to be associated with worse procedural and clinical outcomes. Recent ex vivo studies have demonstrated that an angled arterial wall is exposed to imbalanced mechanical stress, which can cause vessel injuries and incomplete stent apposition (ISA) following stent implantation. Hypothesis: We tested the hypothesis that the angled coronary lesions, compared to non-angled lesions, would have higher incidence of vascular complications and ISA following stent implantation using optical coherence tomography (OCT) in patients. Methods: A total of 245 lesions treated with a single DES [95 zotarolimus-eluting stent (ZES) and 150 everolimus-eluting stent (EES)] were analyzed using OCT. An angled lesion was defined as a lesion on a curve ≥45° (n=59) on an angiogram and non-angled lesion on a curve &lt;45° (n=186). The frequency was expressed as the percentage of stents with at least one type of injury or strut malapposition. Vessel injury included edge dissection, in-stent dissection, thrombus, and tissue protrusion. ISA was defined when the distance between the center of strut and the vessel wall was &gt;100μm in ZES and &gt;90um in EES. Results: The incidence of edge dissection and tissue protrusion was not significantly different between the groups. However, the incidence of in-stent dissection (84.7% vs 63.4%, P&lt;0.01), thrombus (55.9% vs 35.5%, P&lt;0.01) and ISA (76.3% vs 44.6%, P&lt;0.001) was significantly higher in the angled group. The multivariate analysis demonstrated that the lesion on angle ≥60° was the independent predictor for in-stent dissection [Odds ratio (OR) 4.37, P=0.03] and ISA [OR 7.37, P&lt;0.01], and that the angle ≥45° was the independent predictor for thrombus [OR 2.94, P=0.01]. There was no difference in the OCT findings between the ZES and EES groups. Conclusion: Angled coronary lesions had higher incidence of in-stent dissection, thrombus and ISA compared with non-angled lesions following DES implantation as assessed by OCT.

Abstract 11491: Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents

Objective: This study aims to compare the efficacy of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), and everolimus eluting stents (EES) via sequential angiographic follow-up and to reveal the development of restenosis over time. Methods: Patients were randomized to receive SES, PES, ZES, or EES, and follow-up angiography was performed at 6, 12 and 24months after percutaneous coronary intervention. Results: The baseline clinical characteristics of the patients and the coronary lesions are shown in (Table 1). In all groups, mean minimal lumen diameter decreased slightly during the 2-year period after the procedure (Figure 1). Compared with the SES group, the PES and the ZES groups showed greater late loss (LL) within 1 year. However, the SES group showed significantly greater LL compared with the other drug-eluting stents (DES) between 1 and 2 years (Figure 2). Conclusion: Serial angiographic analysis revealed differences in the rate of restenosis development over time for various DES. As DES are comprised of many components (metallic platform, alloy, drug and polymer), the progression of LL can be complex and affected by different factors.

Comparison of frequency and severity of longitudinal stent deformation among various drug-eluting stents: An intravascular ultrasound study

BackgroundLongitudinal stent deformation (LSD) in drug-eluting stents (DES) has been described as a disruption of stent structure. This study aimed to compare first- versus second-generation DES with respect to their actual stent length post deployment. MethodsA total of 617 DES for de novo coronary lesions in 552 patients were analyzed. Intravascular ultrasound (IVUS) was utilized to compare the degree and rate of LSD among six different DES types. IVUS-measured stent length was compared to the labeled length for calculation of absolute difference in stent length and relative absolute difference (absolute difference divided by the labeled length). ResultsThe baseline characteristics were comparable between groups, except for higher calcification in the sirolimus-eluting stent (SES) group (p=0.037). The absolute and relative difference in length showed the lowest degree in the SES group and the highest degree in the Endeavor zotarolimus-eluting stent group (p=0.085 and 0.078, respectively). The percentage of more than 5% relative absolute difference was the lowest in the SES group compared to the other groups (p=0.018). However, the percentage of significant (>15%) relative absolute difference was similar among groups (p=0.99). In multivariate linear regression analysis, labeled stent length and stent diameter, but not stent type, were identified as independent correlates to the absolute and relative difference in the actual stent length post-deployment. ConclusionThis IVUS analysis confirms that among second-generation DES, there is overall similar frequency and severity of LSD when deploying in common coronary lesions.

Everolimus-Eluting Xience V/Promus Versus Zotarolimus-Eluting Resolute Stents in Patients With Diabetes Mellitus

This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial

In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents. We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478. We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period. The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation. Cordis and Medtronic.