B-25 | Two-Year Outcomes in Patients with Bifurcation Lesions treated with Resolute ONYX ZES: Final Results from the RESOLUTE ONYX Bifurcation Study

BackgroundBifurcations are a challenging lesion subset for percutaneous coronary intervention. In the RESOLUTE ONYX Bifurcation study, we evaluated the 2-year clinical outcomes of patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES).MethodsThis was a prospective, observational study that enrolled patients with a single bifurcation target lesion undergoing planned treatment with the provisional stenting technique at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) between 2.25 and 5.0mm, lesion length ≤35mm, side branch ≥2.0mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Baseline angiograms were evaluated by an independent core laboratory.ResultsA total of 205 patients with 267 total lesions and 209 bifurcation lesions were enrolled. Mean patient age was 67±11 years, 21% were female, and diabetes was present in 30%. According to core lab analysis, 33% of lesions were classified as 1.1.1, 1.0.1 or 0.1.1 per Medina classification. Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. Provisional stenting was performed in 96.2% of patients. The rate of TVF at 2 years was 9.0%. Other outcomes are shown in the Figure.ConclusionsDisclosuresM. J. Price: Abbott: Consulting and Speaker Bureau; Boston Scientific Corp.: Consulting and Speaker Bureau; Medtronic: Consulting and Speaker Bureau; AstraZeneca: Consulting and Speaker Bureau; Actus: Consulting; Baylis Medical: Consulting; W.L. Gore: Consulting; A. J. Kirtane: Medtronic: institutional funding; Boston Scientific Corp.: institutional funding; Abbott: institutional funding; Abiomed: institutional funding; Cardiovascular Systems, Inc.: institutional funding; CathWorks: institutional funding; Siemens: institutional funding; Philips: institutional funding; ReCor Medical: institutional funding; Neurotonic: Consulting; Medtronic: travel expenses/meals; Boston Scientific Corp.: travel expenses/meals; Abbott: travel expenses/meals; Abiomed: travel expenses/meals; Cardiovascular Systems, Inc.: travel expenses/meals; CathWorks: travel expenses/meals; Siemens: travel expenses/meals; Philips: travel expenses/meals; ReCor Medical: travel expenses/meals; Chiesi: travel expenses/meals; OpSens: travel expenses/meals; Zoll: travel expenses/meals; Regeneron: travel expenses/meals; P. Hu: Abiomed: Proctor and Speaker Bureau; Cardiovascular Systems, Inc.: Proctor and Speaker Bureau; Y. S. Chatzizisis: Boston Scientific Corp.: Advisory Board/Board Member, Consulting, Principal Investigator for a Research Study and Speaker Bureau; Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Comkardia inc.: Patent Holder/Intellectual Property Rights; R. P. Caputo: Medtronic: Consulting; Merit Medical: Consulting; Cordis: Consulting; Transluminal Technologies: Ownership Interests: Stocks, Stock Options; M. Dauler: Medtronic: Employed or Salary; S. Ibrahim: Medtronic: Employed or Salary; T. H. Lung: Medtronic: Employed or Salary; R. Mehran: Abbott: institutional research payments; Abiomed: institutional research payments; Alleviant Medical: institutional research payments; AM-Pharma: institutional research payments; Applied Therapeutics: institutional research payments and Ownership Interests: Stocks, Stock Options; Arena: institutional research payments; AstraZeneca: institutional research payments; BAIM: institutional research payments; Bayer: institutional research payments; Beth Israel Deaconness: institutional research payments; Biosensors: institutional research payments; Biotronik: institutional research payments; Boston Scientific Corp.: institutional research payments; Bristol-Myers Squibb: institutional research payments; CardiaWave: institutional research payments; CellAegis: institutional research payments; CeloNova: institutional research payments; CERC: institutional research payments; Chiesi: institutional research payments; Concept Medical: institutional research payments; CSL Behring: institutional research payments; DSI: institutional research payments; Duke University: institutional research payments; Element Science: institutional research payments; Humacyte: institutional research payments; Insel Gruppe AG: institutional research payments; Janssen: Consulting and institutional research payments; Magenta: institutional research payments; Medtronic: institutional research payments; Novartis: institutional research payments; OrbusNeich: institutional research payments; Philips: institutional research payments; Vivasure: institutional research payments; Zoll: institutional research payments; Boston Scientific Corp.: Consulting; California Institute for Regenerative Medicine (CIRM): Consulting; Cine-Med Research: Consulting; WebMD: Consulting; Idorsia Pharmaceuticals: consulting fees paid to institution; L. S. Boutis Nothing to disclose. S. J. Chetcuti Nothing to disclose. P. Poliačiková Nothing to disclose. J. Dens Nothing to disclose. M. Attubato Nothing to disclose. Y. L. Wang Nothing to disclose. D. J. Spriggs Nothing to disclose. J. Krasnow Nothing to disclose. A. Aminian Nothing to disclose. A. R. Shah Nothing to disclose. BackgroundBifurcations are a challenging lesion subset for percutaneous coronary intervention. In the RESOLUTE ONYX Bifurcation study, we evaluated the 2-year clinical outcomes of patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES). Bifurcations are a challenging lesion subset for percutaneous coronary intervention. In the RESOLUTE ONYX Bifurcation study, we evaluated the 2-year clinical outcomes of patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES). MethodsThis was a prospective, observational study that enrolled patients with a single bifurcation target lesion undergoing planned treatment with the provisional stenting technique at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) between 2.25 and 5.0mm, lesion length ≤35mm, side branch ≥2.0mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Baseline angiograms were evaluated by an independent core laboratory. This was a prospective, observational study that enrolled patients with a single bifurcation target lesion undergoing planned treatment with the provisional stenting technique at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) between 2.25 and 5.0mm, lesion length ≤35mm, side branch ≥2.0mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Baseline angiograms were evaluated by an independent core laboratory. ResultsA total of 205 patients with 267 total lesions and 209 bifurcation lesions were enrolled. Mean patient age was 67±11 years, 21% were female, and diabetes was present in 30%. According to core lab analysis, 33% of lesions were classified as 1.1.1, 1.0.1 or 0.1.1 per Medina classification. Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. Provisional stenting was performed in 96.2% of patients. The rate of TVF at 2 years was 9.0%. Other outcomes are shown in the Figure. A total of 205 patients with 267 total lesions and 209 bifurcation lesions were enrolled. Mean patient age was 67±11 years, 21% were female, and diabetes was present in 30%. According to core lab analysis, 33% of lesions were classified as 1.1.1, 1.0.1 or 0.1.1 per Medina classification. Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. Provisional stenting was performed in 96.2% of patients. The rate of TVF at 2 years was 9.0%. Other outcomes are shown in the Figure. Conclusions DisclosuresM. J. Price: Abbott: Consulting and Speaker Bureau; Boston Scientific Corp.: Consulting and Speaker Bureau; Medtronic: Consulting and Speaker Bureau; AstraZeneca: Consulting and Speaker Bureau; Actus: Consulting; Baylis Medical: Consulting; W.L. Gore: Consulting; A. J. Kirtane: Medtronic: institutional funding; Boston Scientific Corp.: institutional funding; Abbott: institutional funding; Abiomed: institutional funding; Cardiovascular Systems, Inc.: institutional funding; CathWorks: institutional funding; Siemens: institutional funding; Philips: institutional funding; ReCor Medical: institutional funding; Neurotonic: Consulting; Medtronic: travel expenses/meals; Boston Scientific Corp.: travel expenses/meals; Abbott: travel expenses/meals; Abiomed: travel expenses/meals; Cardiovascular Systems, Inc.: travel expenses/meals; CathWorks: travel expenses/meals; Siemens: travel expenses/meals; Philips: travel expenses/meals; ReCor Medical: travel expenses/meals; Chiesi: travel expenses/meals; OpSens: travel expenses/meals; Zoll: travel expenses/meals; Regeneron: travel expenses/meals; P. Hu: Abiomed: Proctor and Speaker Bureau; Cardiovascular Systems, Inc.: Proctor and Speaker Bureau; Y. S. Chatzizisis: Boston Scientific Corp.: Advisory Board/Board Member, Consulting, Principal Investigator for a Research Study and Speaker Bureau; Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Comkardia inc.: Patent Holder/Intellectual Property Rights; R. P. Caputo: Medtronic: Consulting; Merit Medical: Consulting; Cordis: Consulting; Transluminal Technologies: Ownership Interests: Stocks, Stock Options; M. Dauler: Medtronic: Employed or Salary; S. Ibrahim: Medtronic: Employed or Salary; T. H. Lung: Medtronic: Employed or Salary; R. Mehran: Abbott: institutional research payments; Abiomed: institutional research payments; Alleviant Medical: institutional research payments; AM-Pharma: institutional research payments; Applied Therapeutics: institutional research payments and Ownership Interests: Stocks, Stock Options; Arena: institutional research payments; AstraZeneca: institutional research payments; BAIM: institutional research payments; Bayer: institutional research payments; Beth Israel Deaconness: institutional research payments; Biosensors: institutional research payments; Biotronik: institutional research payments; Boston Scientific Corp.: institutional research payments; Bristol-Myers Squibb: institutional research payments; CardiaWave: institutional research payments; CellAegis: institutional research payments; CeloNova: institutional research payments; CERC: institutional research payments; Chiesi: institutional research payments; Concept Medical: institutional research payments; CSL Behring: institutional research payments; DSI: institutional research payments; Duke University: institutional research payments; Element Science: institutional research payments; Humacyte: institutional research payments; Insel Gruppe AG: institutional research payments; Janssen: Consulting and institutional research payments; Magenta: institutional research payments; Medtronic: institutional research payments; Novartis: institutional research payments; OrbusNeich: institutional research payments; Philips: institutional research payments; Vivasure: institutional research payments; Zoll: institutional research payments; Boston Scientific Corp.: Consulting; California Institute for Regenerative Medicine (CIRM): Consulting; Cine-Med Research: Consulting; WebMD: Consulting; Idorsia Pharmaceuticals: consulting fees paid to institution; L. S. Boutis Nothing to disclose. S. J. Chetcuti Nothing to disclose. P. Poliačiková Nothing to disclose. J. Dens Nothing to disclose. M. Attubato Nothing to disclose. Y. L. Wang Nothing to disclose. D. J. Spriggs Nothing to disclose. J. Krasnow Nothing to disclose. A. Aminian Nothing to disclose. A. R. Shah Nothing to disclose. M. J. Price: Abbott: Consulting and Speaker Bureau; Boston Scientific Corp.: Consulting and Speaker Bureau; Medtronic: Consulting and Speaker Bureau; AstraZeneca: Consulting and Speaker Bureau; Actus: Consulting; Baylis Medical: Consulting; W.L. Gore: Consulting; A. J. Kirtane: Medtronic: institutional funding; Boston Scientific Corp.: institutional funding; Abbott: institutional funding; Abiomed: institutional funding; Cardiovascular Systems, Inc.: institutional funding; CathWorks: institutional funding; Siemens: institutional funding; Philips: institutional funding; ReCor Medical: institutional funding; Neurotonic: Consulting; Medtronic: travel expenses/meals; Boston Scientific Corp.: travel expenses/meals; Abbott: travel expenses/meals; Abiomed: travel expenses/meals; Cardiovascular Systems, Inc.: travel expenses/meals; CathWorks: travel expenses/meals; Siemens: travel expenses/meals; Philips: travel expenses/meals; ReCor Medical: travel expenses/meals; Chiesi: travel expenses/meals; OpSens: travel expenses/meals; Zoll: travel expenses/meals; Regeneron: travel expenses/meals; P. Hu: Abiomed: Proctor and Speaker Bureau; Cardiovascular Systems, Inc.: Proctor and Speaker Bureau; Y. S. Chatzizisis: Boston Scientific Corp.: Advisory Board/Board Member, Consulting, Principal Investigator for a Research Study and Speaker Bureau; Medtronic: Advisory Board/Board Member, Consulting and Principal Investigator for a Research Study; Comkardia inc.: Patent Holder/Intellectual Property Rights; R. P. Caputo: Medtronic: Consulting; Merit Medical: Consulting; Cordis: Consulting; Transluminal Technologies: Ownership Interests: Stocks, Stock Options; M. Dauler: Medtronic: Employed or Salary; S. Ibrahim: Medtronic: Employed or Salary; T. H. Lung: Medtronic: Employed or Salary; R. Mehran: Abbott: institutional research payments; Abiomed: institutional research payments; Alleviant Medical: institutional research payments; AM-Pharma: institutional research payments; Applied Therapeutics: institutional research payments and Ownership Interests: Stocks, Stock Options; Arena: institutional research payments; AstraZeneca: institutional research payments; BAIM: institutional research payments; Bayer: institutional research payments; Beth Israel Deaconness: institutional research payments; Biosensors: institutional research payments; Biotronik: institutional research payments; Boston Scientific Corp.: institutional research payments; Bristol-Myers Squibb: institutional research payments; CardiaWave: institutional research payments; CellAegis: institutional research payments; CeloNova: institutional research payments; CERC: institutional research payments; Chiesi: institutional research payments; Concept Medical: institutional research payments; CSL Behring: institutional research payments; DSI: institutional research payments; Duke University: institutional research payments; Element Science: institutional research payments; Humacyte: institutional research payments; Insel Gruppe AG: institutional research payments; Janssen: Consulting and institutional research payments; Magenta: institutional research payments; Medtronic: institutional research payments; Novartis: institutional research payments; OrbusNeich: institutional research payments; Philips: institutional research payments; Vivasure: institutional research payments; Zoll: institutional research payments; Boston Scientific Corp.: Consulting; California Institute for Regenerative Medicine (CIRM): Consulting; Cine-Med Research: Consulting; WebMD: Consulting; Idorsia Pharmaceuticals: consulting fees paid to institution; L. S. Boutis Nothing to disclose. S. J. Chetcuti Nothing to disclose. P. Poliačiková Nothing to disclose. J. Dens Nothing to disclose. M. Attubato Nothing to disclose. Y. L. Wang Nothing to disclose. D. J. Spriggs Nothing to disclose. J. Krasnow Nothing to disclose. A. Aminian Nothing to disclose. A. R. Shah Nothing to disclose.