The Experts below are selected from a list of 300 Experts worldwide ranked by ideXlab platform
David E Kandzari - One of the best experts on this subject based on the ideXlab platform.
-
Ridaforolimus eluting stent for the treatment of japanese patients with coronary disease 1 year outcomes of the jnir study
Cardiovascular Intervention and Therapeutics, 2021Co-Authors: Shigeru Saito, David E Kandzari, Melek Ozgu Ozan, Seiji Yamazaki, Satoru Otsuji, Shigeru Nakamura, Akihiko Takahashi, Tomohiro Kawasaki, Kotaro Hasegawa, Mengdan LiuAbstract:Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the Ridaforolimus-eluting EluNIR stent in Japanese patients are unknown. This was a multi-center trial in Japanese patients undergoing PCI with the Ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%, p < 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%, p = 0.03), target vessel MI (0% vs. 3.7%, p = 0.04), MACE (1.0% vs. 6.2%, p = 0.03) and TVF (1.0% vs. 6.9%, p = 0.02) were all significantly lower among Japanese patients. Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.
-
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
-
outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1 stent treatment from the bionics trial
American Journal of Cardiology, 2020Co-Authors: Maayan Konigstein, David E Kandzari, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori BenyehudaAbstract:Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of Ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.
-
randomized comparison of Ridaforolimus eluting and zotarolimus eluting coronary stents 2 year clinical outcomes from the bionics and nireus trials
Jacc-cardiovascular Interventions, 2020Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Mbchb Michael P Love, David E KandzariAbstract:Abstract Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up. Background The safety and efficacy of a Ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
-
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;
Pieter C. Smits - One of the best experts on this subject based on the ideXlab platform.
-
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
-
outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1 stent treatment from the bionics trial
American Journal of Cardiology, 2020Co-Authors: Maayan Konigstein, David E Kandzari, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori BenyehudaAbstract:Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of Ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.
-
randomized comparison of Ridaforolimus eluting and zotarolimus eluting coronary stents 2 year clinical outcomes from the bionics and nireus trials
Jacc-cardiovascular Interventions, 2020Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Mbchb Michael P Love, David E KandzariAbstract:Abstract Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up. Background The safety and efficacy of a Ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
-
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.
-
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;
Ori Benyehuda - One of the best experts on this subject based on the ideXlab platform.
-
outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1 stent treatment from the bionics trial
American Journal of Cardiology, 2020Co-Authors: Maayan Konigstein, David E Kandzari, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori BenyehudaAbstract:Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of Ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.
-
randomized comparison of Ridaforolimus eluting and zotarolimus eluting coronary stents 2 year clinical outcomes from the bionics and nireus trials
Jacc-cardiovascular Interventions, 2020Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Mbchb Michael P Love, David E KandzariAbstract:Abstract Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up. Background The safety and efficacy of a Ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
-
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.
-
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;
-
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
Maayan Konigstein - One of the best experts on this subject based on the ideXlab platform.
-
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
-
outcomes of patients with coronary arterial bifurcation narrowings undergoing provisional 1 stent treatment from the bionics trial
American Journal of Cardiology, 2020Co-Authors: Maayan Konigstein, David E Kandzari, Pieter C. Smits, Mordechai Golomb, Michael P Love, Shmuel Banai, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori BenyehudaAbstract:Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of Ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.
-
randomized comparison of Ridaforolimus eluting and zotarolimus eluting coronary stents 2 year clinical outcomes from the bionics and nireus trials
Jacc-cardiovascular Interventions, 2020Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Mbchb Michael P Love, David E KandzariAbstract:Abstract Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up. Background The safety and efficacy of a Ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
-
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.
-
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;
Gregg W Stone - One of the best experts on this subject based on the ideXlab platform.
-
randomized comparison of Ridaforolimus eluting and zotarolimus eluting coronary stents 2 year clinical outcomes from the bionics and nireus trials
Jacc-cardiovascular Interventions, 2020Co-Authors: Maayan Konigstein, Martin B Leon, Pieter C. Smits, Melek Ozgu Ozan, Mengdan Liu, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Mbchb Michael P Love, David E KandzariAbstract:Abstract Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up. Background The safety and efficacy of a Ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
-
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;
-
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
-
a prospective randomised trial comparing the novel Ridaforolimus eluting bionir stent to the zotarolimus eluting resolute stent six month angiographic and one year clinical results of the nireus trial
Eurointervention, 2018Co-Authors: Valeria Paradies, David E Kandzari, Shmuel Banai, Gidon Y Perlman, Ori Benyehuda, Gregg W Stone, Michael Jonas, Andres Iniguez, Pieter C. SmitsAbstract:AIMS The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. METHODS AND RESULTS This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45). CONCLUSIONS The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.
-
outcomes of patients with small vessels undergoing pci with contemporary drug eluting stents a sub analysis from the bionics study
Journal of the American College of Cardiology, 2018Co-Authors: Maayan Konigstein, David E Kandzari, Martin B Leon, Pieter C. Smits, Michael P Love, Shmuel Banai, Gidon Y Perlman, Gregg W Stone, Ozan Melek Ozgu, Ori BenyehudaAbstract:Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after PCI. We sought to compare the clinical and angiographic outcomes of patients with vs. without small-vessel PCI with contemporary DES in the BioNIR Ridaforolimus-eluting coronary
