XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

MI= ARC (Academic Research Constortium) defined

Time frame: 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1

Time frame: up to 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: acute: post index procedure until hospital discharge

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

MI= Academic Research Consortium (ARC) defined

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

Time frame: at 14 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.

Time frame: 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

by TIMI flow

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

by TIMI flow

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

by TIMI flow

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

by TIMI flow

Time frame: at 14 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: at baseline

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: at 180 days

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: at 1 year

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: acute: post index procedure until hospital discharge

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.

Time frame: at 180 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: at 30 days

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Time frame: at 1 year

Population: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: 1 year

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: 180 days

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.

Time frame: at baseline

Population: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.