XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

• Type 2: Any overt, actionable sign of hemorrhage
• Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
• Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
• Type 3c: ICH; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
• Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood or packed RBC within 48h;Chest tube output ≥ 2L within 24h
• Type 5: Fatal bleeding

The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome \& the baseline demographic, clinical and procedural covariates as the predictors.

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

• Any unexplained death within the first 30 days
• Irrespective of the time after the index procedure, any MI that 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

All Death:

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

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.

All Myocardial Infarction (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

• Clinical symptoms of ischemia;
• ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
• Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

• Periprocedural MI:
• Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
• Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
• Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

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.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

• Clinical symptoms of ischemia;
• ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
• Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

• Periprocedural MI:
• Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
• Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
• Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

• Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
• Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
• Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
• Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

Target Lesion Revascularization (TLR) 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. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

Clinically Indicated [CI] Revascularization:

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

• A positive history of recurrent angina pectoris, presumably related to the target vessel;
• Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
• Abnormal results of any invasive functional diagnostic test
• A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

• A positive history of recurrent angina pectoris, presumably related to the target vessel;
• Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
• Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
• A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

• Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
• Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
• Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
• Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
• Type 5: Fatal bleeding
• Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious
• Type 5b: Definite fatal bleeding;overt bleeding or autopsy or imaging confirmation