TY - JOUR
T1 - Clinical outcomes according to lesion complexity in high bleeding risk patients treated with 1-month dual antiplatelet therapy following PCI
T2 - Analysis from the Onyx ONE clear study
AU - Kandzari, David E.
AU - Kirtane, Ajay J.
AU - Mehran, Roxana
AU - Price, Matthew J.
AU - Simon, Daniel I.
AU - Latib, Azeem
AU - Kedhi, Elvin
AU - Abizaid, Alexandre
AU - Worthley, Stephen G.
AU - Zaman, Azfar
AU - Hudec, Martin
AU - Stoler, Robert
AU - Choi, James W.
AU - Kanitkar, Mihir
AU - Conradie, Andre
AU - Tam, Chor Cheung Frankie
AU - Walton, Antony
AU - Gruberg, Luis
AU - Ando, Kenji
AU - Lee, Lilian C.
AU - Lung, Te Hsin
AU - Windecker, Stephan
AU - Stone, Gregg W.
N1 - Funding Information:
Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., Orbus Neich, Medtronic and Ablative Solutions; and personal consulting honoraria from Cardiovascular Systems, Inc., Magenta Medical and Medtronic. Dr Kirtane reports Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting. Personal: Consulting: Neurotronic; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Mehran reports 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, 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, Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories, Bristol‐Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; 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; Associate Editor for ACC, 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 honoraria from Medtronic. Dr. Latib reports consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. Dr. Kedhi reports speaker's honoraria and institutional grants from Medtronic and Abbott Vascular. Dr. Abizaid has nothing to report. Dr. Worthley reports research grants for Abbott and Biotronik. Dr. Zaman reports consulting fees from Abbott, Boston Scientific, Medtronic, Meril, SMT and Terumo. Dr. Hudec has nothing to disclose. Dr. Stoler reports fees for medical advisory board participation from Medtronic and Boston Scientific. Dr. Choi reports fees for medical advisory board participation from Medtronic. Dr. Kanitkar has nothing to disclose. Dr. Conradie has nothing to disclose. Dr. Tam has nothing to disclose. Dr. Walton reports grant support from Medtronic, Abbott, and Edwards; proctor fees from Medtronic and Abbott; fees for medical advisory board participation for Medtronic. Dr. Gruberg has nothing to disclose. Dr. Ando reports speaker fees from Medtronic Japan. Dr. Lee is an employee and shareholder of Medtronic. Dr. Lung is an employee and shareholder of Medtronic. Dr. Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, Sinomed; unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, 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; member of the steering/excecutive committee group of several investigated‐initiated trials that receive funding by industry without impact on his personal remuneration; unpaid member of the Pfizer Research Award selection committee in Switzerland. Dr. Stone has received speaker or other honoraria from Cook, Terumo, QOOL Therapeutics and Orchestra Biomed; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V‐Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix.
Publisher Copyright:
© 2021 Wiley Periodicals LLC.
PY - 2022/2/15
Y1 - 2022/2/15
N2 - Objectives: To compare clinical outcomes in high bleeding risk (HBR) patients with and without complex percutaneous coronary intervention (PCI) treated with Resolute Onyx zotarolimus-eluting stents (ZES) after 1-month dual antiplatelet therapy (DAPT). Background: PCI with 1-month DAPT has been demonstrated to be safe in HBR patients treated with Resolute Onyx ZES. Whether these outcomes are consistent in patients with complex lesions is uncertain. Methods: Among HBR patients who were event-free 1 month after PCI with ZES and treated thereafter with single antiplatelet therapy (SAPT), the clinical outcomes between 1 month and 1 year were compared after complex PCI (3 vessels treated, ≥ 3 lesions treated, total stent length > 60 mm, bifurcation with ≥ 2 stents implanted, atherectomy, or left main, surgical bypass graft or chronic total occlusion PCI) versus noncomplex PCI. Propensity score adjustment was performed to adjust for baseline differences among complex and noncomplex patients. Results: Complex patients (N = 401, 26.6% of total) had a higher prevalence of hyperlipidemia, diabetes mellitus and previous myocardial infarction (MI). Between 1 month and 1 year, rates of MI (7.1% vs. 4.0%, p = 0.02) and cardiac death/MI (9.3% vs. 6.1%, p = 0.04) were higher among complex versus noncomplex patients, although stent thrombosis rates were similar. After adjustment for baseline characteristics, differences in outcomes were no longer significant between groups. Conclusions: Higher rates of ischemic outcomes in complex PCI patients were largely explained by baseline clinical differences, rather than lesion complexity, among HBR patients treated with 1-month DAPT following PCI with Resolute Onyx ZES.
AB - Objectives: To compare clinical outcomes in high bleeding risk (HBR) patients with and without complex percutaneous coronary intervention (PCI) treated with Resolute Onyx zotarolimus-eluting stents (ZES) after 1-month dual antiplatelet therapy (DAPT). Background: PCI with 1-month DAPT has been demonstrated to be safe in HBR patients treated with Resolute Onyx ZES. Whether these outcomes are consistent in patients with complex lesions is uncertain. Methods: Among HBR patients who were event-free 1 month after PCI with ZES and treated thereafter with single antiplatelet therapy (SAPT), the clinical outcomes between 1 month and 1 year were compared after complex PCI (3 vessels treated, ≥ 3 lesions treated, total stent length > 60 mm, bifurcation with ≥ 2 stents implanted, atherectomy, or left main, surgical bypass graft or chronic total occlusion PCI) versus noncomplex PCI. Propensity score adjustment was performed to adjust for baseline differences among complex and noncomplex patients. Results: Complex patients (N = 401, 26.6% of total) had a higher prevalence of hyperlipidemia, diabetes mellitus and previous myocardial infarction (MI). Between 1 month and 1 year, rates of MI (7.1% vs. 4.0%, p = 0.02) and cardiac death/MI (9.3% vs. 6.1%, p = 0.04) were higher among complex versus noncomplex patients, although stent thrombosis rates were similar. After adjustment for baseline characteristics, differences in outcomes were no longer significant between groups. Conclusions: Higher rates of ischemic outcomes in complex PCI patients were largely explained by baseline clinical differences, rather than lesion complexity, among HBR patients treated with 1-month DAPT following PCI with Resolute Onyx ZES.
KW - antiplatelet therapy
KW - complex percutaneous coronary intervention
KW - coronary artery disease
KW - drug-eluting stents
UR - http://www.scopus.com/inward/record.url?scp=85114504207&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114504207&partnerID=8YFLogxK
U2 - 10.1002/ccd.29939
DO - 10.1002/ccd.29939
M3 - Article
C2 - 34478233
AN - SCOPUS:85114504207
SN - 1522-1946
VL - 99
SP - 583
EP - 592
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 3
ER -
