Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents

One-year results from the XIENCE V USA study

Authors

  • Krishnankutty Sudhir MD, PhD, FACC,

    Corresponding author
    1. Abbott Vascular, Santa Clara, California
    • Center for Cardiovascular Technology, Stanford University, Palo Alto, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • James B. Hermiller MD, FACC,

    1. The Care Group, LLC, St. Vincent Heart Center of Indiana, Indiana
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Srihari S. Naidu MD, FACC,

    1. Cardiac Catheterization Laboratory, Winthrop University Hospital, Mineola, New York
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Timothy D. Henry MD, FACC,

    1. Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Vivian W. Mao MD,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Weiying Zhao MD, PhD,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Joanne M. Ferguson RN,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Jin Wang PhD,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Lalitha Jonnavithula MBA,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Charles A. Simonton MD, FACC,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • David R. Rutledge PharmD, FAHA,

    1. Abbott Vascular, Santa Clara, California
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • Mitchell W. Krucoff MD, FACC,

    1. Department of Cardiology, Duke University Medical Center, Durham, NC
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    • Disclosures: James B Hermiller: Research consultant for Abbott Vascular. Consultant for St. Jude Medical and Boston Scientific. Speaker bureau for Eli Lilly and Company. Mitchell W Krucoff: Research grant from Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella. Research consultant/advisory board and speakers bureau for Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella. Srihari S. Naidu: Consultant for Abbott Vascular, Abiomed, and Cordis Corporation. Timothy D. Henry: Member, Medical Advisory Board for Abbott Vascular. Krishnankutty Sudhir, Vivian W Mao, Weiying Zhao, Joanne Ferguson, Jin Wang, Lalitha Jonnavithula, Charles Simonton, David R Rutledge: Abbott Vascular stockholders/employees. This trial is registered with ClinicalTrials.gov, number NCT00676520.

  • on behalf of the XIENCE V USA Investigators


Correspondence to: Krishnankutty Sudhir, Abbott Vascular, 3200 Lakeside Drive, Santa Clara, CA 95054. E-mail: krishna.sudhir@av.abbott.com

Abstract

Objectives

The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI).

Background

The XIENCE V® Everolimus-eluting coronary stent was superior to the TAXUS® paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded.

Methods

XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year.

Results

At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients.

Conclusions

At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated. © 2012 Wiley Periodicals, Inc.

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