Abstract
| Original language | English |
|---|---|
| Article number | 100441 |
| Number of pages | 8 |
| Journal | Journal of the Society for Cardiovascular Angiography and Interventions |
| Volume | 1 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 1 Sept 2022 |
Keywords
- diabetes mellitus
- high bleeding risk
- percutaneous coronary intervention
- zotarolimus-eluting stent
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- 10.1016/j.jscai.2022.100441Licence: CC BY
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In: Journal of the Society for Cardiovascular Angiography and Interventions, Vol. 1, No. 5, 100441, 01.09.2022.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy
T2 - Onyx ONE Clear Results
AU - Kedhi, Elvin
AU - Windecker, Stephan
AU - Latib, Azeem
AU - Kirtane, Ajay J.
AU - Kandzari, David
AU - Mehran, Roxana
AU - Price, Matthew J.
AU - Abizaid, Alexandre
AU - Simon, Daniel I.
AU - Zaman, Azfar
AU - Fabbiocchini, Franco
AU - Tie, Charlies
AU - van ‘t Hof, Arnoud
AU - de la Torre Hernandez, Jose M.
AU - Hammett, Christopher J.
AU - McLaurin, Brent
AU - Potluri, Srinivasa
AU - Smith, Timothy
AU - Waksman, Ron
AU - Ragosta, Michael
AU - Parke, Maria
AU - Lung, Te Hsin
AU - Stone, Gregg W.
N1 - Funding Information: Dr Kedhi holds speaker honoraria from Medtronic, Abbott, and AORTICLAB and has received institutional grants from Abbott and Medtronic. Dr Windecker reports research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Johnson & Johnson, Medicare, Medtronic, Novartis, Polares, OrPha Swiss, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and member of the steering/executive committee group of several investigator-initiated trials that receive funding from industry without effect on his personal remuneration. Dr Latib receives consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. Dr Kirtane reports institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, and Neurotronic. In addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; receives consulting fees from IMDS and travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari report institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions and personal consulting honoraria from Ablative Solutions, Cardiovascular Systems Inc, Magenta Medical, Medtronic, and Terumo. Dr Mehran report institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, CardiaWave, Chiesi, Cine-Med Research, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; and consultant (spouse) from Abiomed, The Medicines Company, Merck; equity <1% from Claret Medical, Elixir Medical, Applied Therapeutics, STEL; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals Ltd, Regeneron Pharmaceuticals; and Associate Editor for ACC and AMA. Dr Price reports consulting fees and speaker’s honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Medtronic and consulting fees from Acutus, Baylis Medical, and W.L. Gore. Dr Simon reports compensation for the course director (<$10,000) from Medtronic. Dr Zaman report consulting fees from Abbott, Boston Scientific, Medtronic, Meril, SMT and Terumo. Dr Tie discloses speaker honoraria from Boehringer Ingelheim. Dr Hof disclose speaker fee from AstraZeneca and unrestricted grants from Medtronic, Boehringer Ing, Abbott, Sanofi, and Amgen not related to this work. Dr Hernandez receives grants and research support from Abbott Medical, Biosensors, Bristol Myers Squibb, and Amgen and receives honoraria or consultation fees from Boston Scientific, Medtronic, Biotronik, AstraZeneca, and Daiichi Sankyo. Dr Hammett reports research support and compensation or is an advisory board member for Amgen, Aspen Pharmacare, AstraZeneca, Bayer, Boehringer Ingelheim, CSL Behring, Eli Lilly, Janssen, The Medicines Company, Medtronic, Merck Sharp and Dohme, Novartis, and Pfizer/BMS. Dr Potluri receives consulting honoraria and speaker bureau fees from AstraZeneca, Boston Scientific, Abbot, Cordis, and Terumo. Dr Smith receives consultant and/or honoraria fees from Abiomed, Boston Scientific, and Macquet. Dr Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; having received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; serving on the speaker bureau of AstraZeneca; and an investor in MedAlliance and Transmural Systems Inc. Dr Ragosta discloses that he is an advisory board member for Cohre Health Inc not related to this work. Dr Parke is an employee and shareholder in Medtronic. Dr Lung is an employee and shareholder at Medtronic. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, and Amgen; and has equity/options from Ancora, Agent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Venter. Dr. Stone’s daughter is an employee at Medtronic. Institutional disclosure: Dr. Stone’s employer, Mount Sinai Hospital, received research support from Abbott, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, and V-Wave. Drs Abizaid, Fabbiocchini, and McLaurin reported no financial interests. Funding Information: The authors thank Benjamin Woods, PhD, and Beth Ferri, PhD, CMPP, of Medtronic for providing medical writing and editorial support. Dr Kedhi holds speaker honoraria from Medtronic, Abbott, and AORTICLAB and has received institutional grants from Abbott and Medtronic. Dr Windecker reports research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Johnson & Johnson, Medicare, Medtronic, Novartis, Polares, OrPha Swiss, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; and member of the steering/executive committee group of several investigator-initiated trials that receive funding from industry without effect on his personal remuneration. Dr Latib receives consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. Dr Kirtane reports institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, and Neurotronic. In addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; receives consulting fees from IMDS and travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari report institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions and personal consulting honoraria from Ablative Solutions, Cardiovascular Systems Inc, Magenta Medical, Medtronic, and Terumo. Dr Mehran report institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, CardiaWave, Chiesi, Cine-Med Research, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, and Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories and Bristol Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; and consultant (spouse) from Abiomed, The Medicines Company, Merck; equity <1% from Claret Medical, Elixir Medical, Applied Therapeutics, STEL; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals Ltd, Regeneron Pharmaceuticals; and Associate Editor for ACC and AMA. Dr Price reports consulting fees and speaker's honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Medtronic and consulting fees from Acutus, Baylis Medical, and W.L. Gore. Dr Simon reports compensation for the course director (<$10,000) from Medtronic. Dr Zaman report consulting fees from Abbott, Boston Scientific, Medtronic, Meril, SMT and Terumo. Dr Tie discloses speaker honoraria from Boehringer Ingelheim. Dr Hof disclose speaker fee from AstraZeneca and unrestricted grants from Medtronic, Boehringer Ing, Abbott, Sanofi, and Amgen not related to this work. Dr Hernandez receives grants and research support from Abbott Medical, Biosensors, Bristol Myers Squibb, and Amgen and receives honoraria or consultation fees from Boston Scientific, Medtronic, Biotronik, AstraZeneca, and Daiichi Sankyo. Dr Hammett reports research support and compensation or is an advisory board member for Amgen, Aspen Pharmacare, AstraZeneca, Bayer, Boehringer Ingelheim, CSL Behring, Eli Lilly, Janssen, The Medicines Company, Medtronic, Merck Sharp and Dohme, Novartis, and Pfizer/BMS. Dr Potluri receives consulting honoraria and speaker bureau fees from AstraZeneca, Boston Scientific, Abbot, Cordis, and Terumo. Dr Smith receives consultant and/or honoraria fees from Abiomed, Boston Scientific, and Macquet. Dr Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; having received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; serving on the speaker bureau of AstraZeneca; and an investor in MedAlliance and Transmural Systems Inc. Dr Ragosta discloses that he is an advisory board member for Cohre Health Inc not related to this work. Dr Parke is an employee and shareholder in Medtronic. Dr Lung is an employee and shareholder at Medtronic. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, and Amgen; and has equity/options from Ancora, Agent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Venter. Dr. Stone's daughter is an employee at Medtronic. Institutional disclosure: Dr. Stone's employer, Mount Sinai Hospital, received research support from Abbott, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, and V-Wave. Drs Abizaid, Fabbiocchini, and McLaurin reported no financial interests. This research was funded by Medtronic. The Onyx ONE Clear study was conducted in accordance with the tenets of the Declaration of Helsinki and was approved by the institutional review board or ethics committee at each enrollment center. All patiens provided informed signed consent. Publisher Copyright: © 2022 Medtronic
PY - 2022/9/1
Y1 - 2022/9/1
N2 - Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan–Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P =.122, unadjusted P =.010) and target lesion failure (10.2% vs 7.7%; P =.294, unadjusted P =.056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.
AB - Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan–Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P =.122, unadjusted P =.010) and target lesion failure (10.2% vs 7.7%; P =.294, unadjusted P =.056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.
KW - diabetes mellitus
KW - high bleeding risk
KW - percutaneous coronary intervention
KW - zotarolimus-eluting stent
U2 - 10.1016/j.jscai.2022.100441
DO - 10.1016/j.jscai.2022.100441
M3 - Article
SN - 2772-9303
VL - 1
JO - Journal of the Society for Cardiovascular Angiography and Interventions
JF - Journal of the Society for Cardiovascular Angiography and Interventions
IS - 5
M1 - 100441
ER -