The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Peter J. Fitzgerald - One of the best experts on this subject based on the ideXlab platform.
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desyne novolimus eluting coronary stent is superior to endeavor Zotarolimus eluting coronary stent at five year follow up final results of the multicentre excella ii randomised controlled trial
Eurointervention, 2016Co-Authors: Javaid Iqbal, Lynn Morrison, Sara Toyloy, John A Ormiston, Peter J. Fitzgerald, Alexandre Abizaid, Stefan Verheye, Stephan Windecker, Ton De Vries, Patrick W SerruysAbstract:Aims: Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have Zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a Zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). Methods and results: EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up. Conclusions: At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted. Trial Registration: ClinicalTrials.gov number NCT00792753.
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relative dose and vascular response after drug eluting stent implantation a dosimetric 3d intravascular ultrasound study
International Journal of Cardiology, 2016Co-Authors: Hideki Kitahara, Peter J. Fitzgerald, Katsuhisa Waseda, Kenji Sakamoto, Paul G. Yock, Ryotaro Yamada, Yasuhiro HondaAbstract:Abstract Background In drug-eluting stents (DESs), the theoretical drug dose exposed to the vessel wall per stent surface area may vary due to the fixed loading dose and differences in the stent surface area once expanded in varying vessel sizes. The aim of this study was to evaluate the potential effects of different dose intensities, as estimated by 3D-IVUS dosimetry, on vascular response after DES implantation. Methods Follow-up (6–9months) 3D-IVUS was performed in 840 coronary lesions treated with a single DES of the following types: sirolimus (SES, n=148), paclitaxel (PES, n=162), Endeavor Zotarolimus (E-ZES, n=233), Resolute Zotarolimus (R-ZES, n=147), and everolimus (EES, n=150). Volume index (volume/length, mm 3 /mm) was obtained for vessel, lumen, plaque, stent, and neointima. In each lesion, exposed dose intensity was calculated as known loading dose divided by measured luminal surface area of the stented segment. Lesions were divided into tertiles based on the exposed dose intensity: high, medium, and low dose groups. Results The exposed dose intensity ranged 0.74–1.76μg/mm 2 for SES, 0.41–1.18μg/mm 2 for PES, 0.71–1.57μg/mm 2 for E-ZES, 0.72–1.63μg/mm 2 for R-ZES, and 0.40–0.99μg/mm 2 for EES. All types of DES showed no significant difference in neointimal hyperplasia among the 3 groups, except that E-ZES showed significantly less neointimal hyperplasia in the high dose group. Conclusions Detailed 3D-IVUS revealed significant lesion-to-lesion variability in dose intensity exposed to the vessel wall following DES implantation. However, the major types of DES appear to yield equally effective neointimal suppression, despite the varying dose intensity, except for E-ZES.
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abstract 13724 intravascular ultrasound and angiographic predictors for 5 year target lesion revascularization after second generation drug eluting stent implantation
Circulation, 2015Co-Authors: Hideki Kitahara, Peter J. Fitzgerald, Yuhei Kobayashi, Kenji Sakamoto, Paul G. Yock, Kozo Okada, Takumi Kimura, Alan C Yeung, Yasuhiro HondaAbstract:Background: Late target lesion revascularization (TLR) remains an unresolved problem in drug-eluting stents (DES). This study aimed to evaluate whether angiography and IVUS at mid-term can predict late-TLR in lesions treated with 2nd generation DES. Methods: Clinical outcomes were followed for 5 years in 1265 lesions with no TLR within the 1st year after Endeavor Zotarolimus- (E-ZES, n=748), Resolute Zotarolimus- (R-ZES, n=195), and everolimus-eluting stent (EES, n=322) implantation. Quantitative coronary angiography (QCA) and IVUS were performed at baseline and mid-term (8-12 months) follow-up. Results: During 1 to 5 years, R-ZES and EES showed equivalent late-TLR rates, while E-ZES demonstrated significantly less late-TLR than other stents (4.6%, 4.3% and 1.5%, respectively. Log Rank p=0.002). In E-ZES, no QCA or IVUS variables predicted late-TLR. In contrast, the late-TLR group in R-ZES and EES had smaller minimum lumen diameter (MLD), greater neointima and more late-acquired incomplete stent appositio...
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tct 568 multi center randomized evaluation of the elixir desyne novolimus eluting coronary stent system with biodegradable polymer compared to a Zotarolimus eluting coronary stent system 4 year results from the excella bd study
Journal of the American College of Cardiology, 2015Co-Authors: Stefan Verheye, Roberto Botelho, Luiz Fernando Tanajura, Lynn Morrison, Sara Toyloy, Peter J. Fitzgerald, Alexandre Abizaid, Katsuhisa Waseda, Ricardo Costa, Joachim SchoferAbstract:A non-inferiority study evaluating the long-term safety and effectiveness of the Elixir DESyne® BD Novolimus Eluting Coronary Stent System (NECSS), a Co-Cr stent with a biodegradable polymer compared to the control Endeavor Zotarolimus Eluting Coronary Stent System (ZECSS) (Medtronic, Santa Rosa,
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tct 460 multi center randomized evaluation of the elixir desyne novolimus eluting coronary stent system with biodegradable polymer compared to a Zotarolimus eluting coronary stent system final 5 year results from the excella bd study
Journal of the American College of Cardiology, 2015Co-Authors: Stefan Verheye, Roberto Botelho, Luiz Fernando Tanajura, Lynn Morrison, Sara Toyloy, Ricardo A. Costa, Peter J. Fitzgerald, Alexandre Abizaid, Katsuhisa Waseda, Joachim SchoferAbstract:A non-inferiority study evaluating the long-term safety and effectiveness of the Elixir DESyne® BD Novolimus Eluting Coronary Stent System (NECSS), a Co-Cr stent with a biodegradable polymer compared to the control Endeavor Zotarolimus Eluting Coronary Stent System (ZECSS) (Medtronic, Santa Rosa,
Martin B Leon - One of the best experts on this subject based on the ideXlab platform.
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outcomes among diabetic patients undergoing percutaneous coronary intervention with contemporary drug eluting stents analysis from the bionics randomized trial
Jacc-cardiovascular Interventions, 2018Co-Authors: Maayan Konigstein, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Martin B LeonAbstract:Abstract Objectives The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. Background Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). Methods A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus Zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. Results The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent– and Zotarolimus-eluting stent–treated patients. Conclusions Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.
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tct 199 comparison of ridaforolimus eluting and Zotarolimus eluting coronary stents in patients with long lesions 1 year outcomes from the randomized bionics trial
Journal of the American College of Cardiology, 2018Co-Authors: David E Kandzari, Martin B Leon, Maayan Konigstein, Pieter C. Smits, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Ozgu M Ozan, Gregg W StoneAbstract:The BIONICS trial was an international, randomized study demonstrating the safety and efficacy of a novel cobalt alloy-based coronary stent with durable elastomeric polymer and antiproliferative agent ridaforolimus (RES; EluNIR, Medinol, Israel) compared with Zotarolimus-eluting stents (ZES;
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tct 92 randomized comparison of ridaforolimus and Zotarolimus eluting coronary stents 2 year clinical outcomes of the pooled bionics and nireus trials
Journal of the American College of Cardiology, 2018Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Mengdan Liu, Ori Benyehuda, Ozgu M Ozan, Gregg W Stone, Yoram Richter, David E KandzariAbstract:In the BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis (BIONICS) and the NIREUS trials, the safety and efficacy of the novel ridaforolimus-eluting stent (RES) was evaluated, demonstrating the noninferiority of this stent in comparison to Zotarolimus-eluting stent (ZES), in
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performance of the resolute Zotarolimus eluting stent in small vessels
Catheterization and Cardiovascular Interventions, 2014Co-Authors: Ronald P Caputo, Sigmund Silber, Stephan Windecker, Martin B Leon, Alan C Yeung, Patrick W Serruys, Franzjosef Neumann, Ian T Meredith, Jorge A Belardi, Petr WidimskyAbstract:BACKGROUND Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute Zotarolimus-eluting stent (R-ZES) in small vessels was examined. METHODS Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. RESULTS Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). CONCLUSION When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.
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three vs twelve months of dual antiplatelet therapy after Zotarolimus eluting stents the optimize randomized trial
JAMA, 2013Co-Authors: Fausto Feres, Roberto Botelho, Ricardo A. Costa, Alexandre Abizaid, Martin B Leon, Minglei Liu, Antonio J Marinneto, Spencer B King, Manuela Negoita, Eduardo J T De PaulaAbstract:Importance The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. Objective To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with Zotarolimus-eluting stents. Design, Setting, and Patients The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with Zotarolimus-eluting stents. Interventions After PCI with Zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. Main Outcomes and Measures The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. Results NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, −1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). Conclusions and Relevance In patients with stable coronary artery disease or low-risk ACS treated with Zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. Trial Registration clinicaltrials.gov Identifier:NCT01113372
Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.
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five year clinical outcomes of Zotarolimus eluting stents in coronary total occlusions
Eurointervention, 2021Co-Authors: Henning Kelbæk, Stephan Windecker, Patrick W Serruys, Thomas Engstrom, Robert W Yeh, Franzjosef Neumann, Shubin Qiao, Jorge A Belardi, Minglei LiuAbstract:AIMS Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the Zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions. METHODS AND RESULTS Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11). CONCLUSIONS In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.
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desyne novolimus eluting coronary stent is superior to endeavor Zotarolimus eluting coronary stent at five year follow up final results of the multicentre excella ii randomised controlled trial
Eurointervention, 2016Co-Authors: Javaid Iqbal, Lynn Morrison, Sara Toyloy, John A Ormiston, Peter J. Fitzgerald, Alexandre Abizaid, Stefan Verheye, Stephan Windecker, Ton De Vries, Patrick W SerruysAbstract:Aims: Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have Zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a Zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). Methods and results: EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up. Conclusions: At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted. Trial Registration: ClinicalTrials.gov number NCT00792753.
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comparison of Zotarolimus and everolimus eluting coronary stents final 5 year report of the resolute all comers trial
Circulation-cardiovascular Interventions, 2015Co-Authors: Javaid Iqbal, Gert Richardt, Henning Kelbæk, Sigmund Silber, Patrick W Serruys, Pawel Buszman, Manuela Negoita, Marieangele Morel, Stephan WindeckerAbstract:Background— Newer-generation drug-eluting stents that release Zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of Zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial. Methods and Results— RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P =0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P =0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P =0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P =0.12). Conclusions— At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria. Clinical Trial Registration— URL: . Unique identifier: [NCT00617084][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00617084&atom=%2Fcirccvint%2F8%2F6%2Fe002230.atom
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clinical results with the resolute Zotarolimus eluting stent in total coronary occlusions
Eurointervention, 2015Co-Authors: Henning Kelbæk, Gert Richardt, Stephan Windecker, Patrick W Serruys, Franzjosef Neumann, Pawel Buszman, Lene Holmvang, Franz R Eberli, Pieter R Stella, Petr WidimskyAbstract:Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® Zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods and results: Patients were divided into three groups: chronic TO (CTO; n=256), non-chronic TO (n=292), and no occlusion (n=2,941). Clinical and safety outcomes assessed through two years included target lesion failure (TLF: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events. Conclusions: Apart from a higher rate of stent thrombosis in patients with TO, patients with totally occluded coronary arteries who receive revascularisation with an R-ZES have clinical outcomes comparable to those who receive a similar stent in non-occluded lesions.
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performance of the resolute Zotarolimus eluting stent in small vessels
Catheterization and Cardiovascular Interventions, 2014Co-Authors: Ronald P Caputo, Sigmund Silber, Stephan Windecker, Martin B Leon, Alan C Yeung, Patrick W Serruys, Franzjosef Neumann, Ian T Meredith, Jorge A Belardi, Petr WidimskyAbstract:BACKGROUND Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute Zotarolimus-eluting stent (R-ZES) in small vessels was examined. METHODS Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. RESULTS Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). CONCLUSION When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.
David E Kandzari - One of the best experts on this subject based on the ideXlab platform.
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incidence and predictors of target lesion failure in patients with lesions in small vessels undergoing pci with contemporary drug eluting stents insights from the bionics study
Cardiovascular Revascularization Medicine, 2020Co-Authors: Haim D Danenberg, David E Kandzari, Maayan Konigstein, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y PerlmanAbstract:Abstract Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI).We aimed to evaluate the outcomes of patients undergoing small-vessel PCI in the BIONICS trial and to identify predictors of stent failure. 1910 patients were randomized to treatment with the EluNIR™ ridaforolimus-eluting stent (RES) or Resolute™ Zotarolimus-eluting stent (ZES). Small vessels were defined as reference vessel diameters (RVD) ≤2.5 mm. A Cox proportional hazards model was used to identify predictors of target lesion failure (TLF) through 2 years. Patients undergoing small vessel disease PCI had a higher frequency of diabetes, prior myocardial infarction (MI), and prior PCI. 2 year TLF was higher among patients with small vessels (9.7% vs. 5.9%, HR 1.7 [95% CI 1.22–2.37], p
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tct 199 comparison of ridaforolimus eluting and Zotarolimus eluting coronary stents in patients with long lesions 1 year outcomes from the randomized bionics trial
Journal of the American College of Cardiology, 2018Co-Authors: David E Kandzari, Martin B Leon, Maayan Konigstein, Pieter C. Smits, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Ozgu M Ozan, Gregg W StoneAbstract:The BIONICS trial was an international, randomized study demonstrating the safety and efficacy of a novel cobalt alloy-based coronary stent with durable elastomeric polymer and antiproliferative agent ridaforolimus (RES; EluNIR, Medinol, Israel) compared with Zotarolimus-eluting stents (ZES;
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tct 92 randomized comparison of ridaforolimus and Zotarolimus eluting coronary stents 2 year clinical outcomes of the pooled bionics and nireus trials
Journal of the American College of Cardiology, 2018Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Mengdan Liu, Ori Benyehuda, Ozgu M Ozan, Gregg W Stone, Yoram Richter, David E KandzariAbstract:In the BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis (BIONICS) and the NIREUS trials, the safety and efficacy of the novel ridaforolimus-eluting stent (RES) was evaluated, demonstrating the noninferiority of this stent in comparison to Zotarolimus-eluting stent (ZES), in
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biodegradable polymer drug eluting stents vs bare metal stents vs durable polymer drug eluting stents a systematic review and bayesian approach network meta analysis
European Heart Journal, 2014Co-Authors: Si Hyuk Kang, David J. Cohen, Do Yoon Kang, Hyunjae Kang, David E Kandzari, Kyung-taek Park, Kyung Woo Park, Byunghee Oh, Young Bae Park, Seung Sik HwangAbstract:Background The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. Methods and results Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor Zotarolimus-eluting (ZES-E), cobalt–chromium everolimus-eluting (CoCr-EES), platinium–chromium everolimus-eluting (PtCr-EES), resolute Zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year. Results Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33–0.90], SES (OR, 0.53; 95% CrI, 0.38–0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23–0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10–0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt–chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04–2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS. Conclusions All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt–chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.
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Zotarolimus eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase 5 inhibitors
Journal of the American College of Cardiology, 2012Co-Authors: Jason H Rogers, David E Kandzari, Jeffrey J Popma, Irwin Goldstein, Tobias S Kohler, Curtiss T Stinis, Paula J Wagner, Michael R Jaff, Krishna J RochasinghAbstract:Objectives: This study sought to evaluate the safety and feasibility of Zotarolimus-eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries among men with erec...
Laura Mauri - One of the best experts on this subject based on the ideXlab platform.
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5 year safety and efficacy of resolute Zotarolimus eluting stent the resolute global clinical trial program
Jacc-cardiovascular Interventions, 2017Co-Authors: Robert W Yeh, Sigmund Silber, Shigeru Saito, Lianglong Chen, Shaoliang Chen, Shirish Hiremath, Franzjosef Neumann, Shubin Qiao, Yuejin Yang, Laura MauriAbstract:AbstractObjectives: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute Zotarolimus-eluting stent (R-ZES) implantation.Background: Individual trials ar...
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comparison of short and long term cardiac mortality in early versus late stent thrombosis from pooled protect trials
American Journal of Cardiology, 2015Co-Authors: Eugene P Mcfadden, Robert W Yeh, Eric A Secemsky, Alexis Matteau, Philippe Gabriel Steg, Edoardo Camenzind, William Wijns, Laura MauriAbstract:Studies have indicated varying mortality risks with timing of stent thrombosis (ST), but few have been adequately powered with prospective late follow-up. PROTECT randomized 8,709 subjects to either Endeavor Zotarolimus-eluting or Cypher sirolimus-eluting stents. PROTECT Continued Access enrolled 1,018 patients treated with Endeavor Zotarolimus-eluting stents. Subjects completed at least 4 and 3 years of follow-up, respectively. ARC-defined definite and probable ST events were stratified by time from index procedure: early (≤30 days), late (>30 and ≤360 days), and very late (>360 days). Rates of death and myocardial infarction were analyzed by ST timing. Median follow-up was 4.1 years. There were 184 ST events (1.9%): 61 early, 27 late, and 96 very late. Patient and procedural characteristics were similar between timing groups. There was no difference in dual-antiplatelet therapy use at discharge (97%) or 1 year (84%). Cardiac death in patients with ST at 4 years occurred in 32.1% compared with 2.5% in patients without ST (p ClinicalTrials.gov , number NCT00476957 .)
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dual antiplatelet therapy duration and clinical outcomes following treatment with Zotarolimus eluting stents
Jacc-cardiovascular Interventions, 2011Co-Authors: David E Kandzari, Laura Mauri, Martin B Leon, William Wijns, Jean Fajadet, Colin S Barker, Roxana MehranAbstract:Objectives We sought to evaluate differences in late safety outcomes relative to dual antiplatelet therapy (DAPT) duration in patients treated with Zotarolimus-eluting stents (ZES). Background Despite treatment recommendations for at least 12 months of DAPT following drug-eluting stent revascularization, device-specific outcomes relative to DAPT duration are absent. Methods Among 2,032 patients undergoing percutaneous coronary revascularization with ZES in 5 trials, late safety events were compared relative to DAPT duration for patients with ≥6 months DAPT adherence and survival free of major ischemic and bleeding events. Results A total of 1,414 event-free patients on DAPT at 6 months were identified. Patient group comparisons relative to DAPT included: 6 months versus ≥12 months, and 6 months versus ≥24 months. Through 3 years, risk-adjusted ischemic event rates did not significantly differ between groups: 6 versus ≥12 months: death (2.7% vs. 2.2%), myocardial infarction (MI, 0.3% vs. 1.1%), and definite/probable stent thrombosis (ST, 0.3% vs. 0%); 6 versus ≥24 months: death (1.6% vs. 1.6%), MI (0.4% vs. 1.2%), and definite/probable ST (0.1% vs. 0.2%). Composite events also did not statistically vary between DAPT durations. In multivariable analysis, 6-month versus longer DAPT duration was not associated with increased likelihood of thrombotic events at 3-year follow-up. Major bleeding was negligible across groups. Conclusions Among patients treated with ZES, late-term events of death, MI, stroke, and ST do not significantly differ between patients taking 6 months DAPT compared with continuation beyond 1 year. These findings merit further study to identify the appropriate duration of DAPT according to specific drug-eluting stents.
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rationale and design of the clinical evaluation of the resolute Zotarolimus eluting coronary stent system in the treatment of de novo lesions in native coronary arteries the resolute us clinical trial
American Heart Journal, 2011Co-Authors: Laura Mauri, Martin B Leon, Alan C Yeung, Manuela Negoita, Michelle J Keyes, Joseph M MassaroAbstract:Background Drug-eluting stents (DES) are commonly used to treat obstructive coronary disease and avoid restenosis. Newer DES have been developed to improve effectiveness and safety. We describe a clinical trial to evaluate a DES with a novel polymer that may improve the antirestenosis effectiveness while maintaining the safety standards of currently Food and Drug Administration–approved DES. Methods The RESOLUTE US Trial is a multicenter, nonrandomized trial prospectively designed to compare the Resolute Zotarolimus-eluting stent (R-ZES) to the Food and Drug Administration–approved Endeavor ZES using patient-level historical control data, adjusting for baseline covariates through propensity score. The stents differ primarily in the polymer, which, in the R-ZES, is designed to elute Zotarolimus over a longer period. The study will enroll up to 1,574 patients with ischemic heart disease due to de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. The primary end point is target lesion failure at 12 months postprocedure, defined as the composite of cardiac death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization by percutaneous or surgical methods. Secondary end points include device, lesion and procedural success, death, MI, cardiac death and MI, composites of these clinical events, and stent thrombosis at each follow-up assessment up to 5 years postprocedure. Conclusions The RESOLUTE US Trial (ClinicalTrials.gov #NCT00726453) is a prospective, multicenter, observational study with a patient-level historical control designed to assess the safety and efficacy of the R-ZES for the treatment of de novo lesions in native coronary arteries.
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long term clinical outcomes with Zotarolimus eluting versus bare metal coronary stents
Jacc-cardiovascular Interventions, 2010Co-Authors: David E Kandzari, Laura Mauri, Martin B Leon, Joseph M Massaro, William Wijns, Jean Fajadet, Ian T Meredith, Songtao Jiang, Donald E CutlipAbstract:Objectives This study sought to evaluate the long-term safety of the Zotarolimus-eluting stent (ZES) using a pooled analysis of pivotal trials. Background Drug-eluting stents, compared with bare-metal stents (BMS), have reduced restenosis; however, individual trials of these stents have not had sufficient power to ascertain long-term safety. Methods We combined patient level data from 6 prospective randomized single-arm multicenter trials involving 2,132 patients treated with ZES and 596 patients treated with a BMS control. The median follow-up was 4.1 years, with 5-year follow-up completed in 1,256 patients (97% of those eligible). The recommended minimum duration of dual antiplatelet therapy in these studies was 3 to 6 months regardless of stent type. An independent events committee adjudicated all events. The 2 treatment groups were compared after adjustment for between trial variation and for individual patient clinical and angiographic characteristics by propensity score. Results The cumulative incidence of adverse events at 5 years for ZES and BMS were: death: 5.9% versus 7.6% (adjusted hazard ratio: 0.81, p = 0.34), cardiac death: 2.4 versus 3.7% (0.83, p = 0.57), myocardial infarction: 3.4 versus 4.8% (0.77, p = 0.37), target lesion revascularization: 7.0% vs. 16.5% (0.42, p Conclusions Over 5 years, there was no increased risk of death, myocardial infarction, or stent thrombosis, and there was a benefit of prevention of repeat revascularization procedures in ZES compared with BMS. (The ENDEAVOR Pharmacokinetic [PK] Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System [ENDEAVOR PK]; NCT00314275 ) (The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions [ENDEAVOR II]; NCT00614848 ) (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256 ) (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions [ENDEAVOR IV]; NCT00217269 )
