XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

Completed

Conditions: Coronary Occlusion
Coronary Artery Disease
Angina
Coronary Artery Stenosis
Myocardial Ischemia

Interventions: Device: XIENCE PRIME - Long Length (LL)
Device: XIENCE PRIME - Core Size

Registration Number: NCT01721096

Lead Sponsor: Abbott Medical Devices

Brief Summary: The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Detailed Description: The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 536

Inclusion Criteria

Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
Patient provides Informed Consent Form

Exclusion Criteria

If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Long Length (LL)	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.
XIENCE PRIME - Core Size	XIENCE PRIME - Core Size	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Subacute Stent Thrombosis (ST)	Subacute (>24 hours to 30 days)	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Number of Participants With Acute Stent Thrombosis (ST)	Time Frame: Acute (0-24 hours)	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Number of Participants With Late Stent Thrombosis (ST)	Late (>30 days to 1 year)	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Total Number of Participants With Overall Stent Thrombosis	1 year post index procedure	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

Secondary Outcome Measures

Name	Time	Method
Success Rate: Percentage of Participants With Implant Success Rate by Device	Participants will be followed for the duration of hospital stay, an average of 5 days	Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).
Success Rate: Percentage of Participants With Procedural Success by Lesion	Participants will be followed for the duration of hospital stay, an average of 5 days	Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).
Number of Participants With Target Vessel Failure (TVF)	3 year post index procedure	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).
Number of Participants With Target Lesion Revascularization (TLR)	3 year post index procedure	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)	Participants will be followed for the duration of hospital stay, an average of 5 days
Number of Participants With All Death/All MI/All Revascularization (DMR)	4 year post index procedure	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure(TVF)	4 year post index procedure	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Target Lesion Failure (TLF)	4 year post index procedure	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	4 year post index procedure	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants With Death or Myocardial Infarction (MI)	4 year post index procedure	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	4 year post index procedure	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	4 year post index procedure	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	4 year post index procedure	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Number of Participants With Myocardial Infarction (MI)	4 year post index procedure	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Target Lesion Revascularization(TLR)	4 year post index procedure	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	4 year post index procedure	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Number of Participants With All Revascularization	4 year post index procedure	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Percent Diameter Stenosis (%DS)	8 months post index procedure	The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	1 year post index procedure	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))	1 year post index procedure	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Acute Gain: In-stent, In-segment	8 months post index procedure	The difference between post- and pre-procedural MLD.
Net Gain: In-stent, In-segment	8 months post index procedure	Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).
Late Loss(LL): In-stent, In-segment, Proximal, and Distal	8 months post index procedure	Late loss is calculated as MLD post procedure - MLD at follow-up.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	4 year post index procedure	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	4 year post index procedure	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Number of Participants Experienced Bleeding	4 year post index procedure	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding