Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome

Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. \<1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.

Time frame: Day 0 (study enrollment)

Population: All enrolled participants

The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.

Time frame: Day 0 (study enrollment)

Population: All enrolled participants who had Duke CAD Index completed.

Time frame: Day 0 (study enrollment)

Population: All enrolled participants who had pre-procedure hemoglobin evaluation.

MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) \* 100.

Time frame: Baseline through 12 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) \* 100.

Time frame: Baseline, 1, 6, 12 and 15 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.

Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.

Time frame: Baseline through 15 months

Population: Participants who were treated with prasugrel or clopidogrel.

MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) \* 100.

Time frame: Baseline through 12 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.

Time frame: Baseline through 1, 6 and 15 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

Time frame: 15 months

Population: Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.