A 67-year-old female patient presented with ongoing chest discomfort for the previous 5 hours. Her medical history was notable for hypertension, diabetes, and increased cholesterol. Current medications included aspirin 81 mg daily, lisinopril 5 mg daily, amlodipine 5 mg daily, insulin, and atorvastatin 40 mg daily. Her physical exam demonstrated a blood pressure of 138/78 mmHg, heart rate of 85 bpm, and respiratory rate of 16. The remainder of the physical exam was normal. Admission laboratory results were notable for a creatinine of 1.4 mg/dl with a creatinine clearance of 45 ml/min, hemoglobin of 11.0 g/L (normal range 12-16), white blood cell count of 11 10e9 (upper range of normal 9.7 10e9), high-density lipoprotein of 45 mg/dL, and low-density lipoprotein of 70 mg/dL. The initial electrocardiogram showed mild lateral ST depression. The patient was treated with sublingual nitroglycerin x2 with relief of her symptoms. Subsequently, treatment with intravenous nitroglycerin and heparin was initiated and, she was admitted to the coronary intensive care unit. Initial troponin I was 0.15 ng/ml (upper limit of normal 0.04 ng/ml), increasing to 1.2 ng/ml over the next 6 hours. Coronary angiography the next day demonstrated a 40% proximal left anterior descending artery stenosis, 70% mid left circumflex lesion, and a thrombotic 90% proximal right coronary artery lesion. Successful stenting of the right coronary artery and left circumflex was performed with 2 drug-eluting stents with a total length of 40 mm. Atorvastatin was increased to 80 mg. She was subsequently discharged with aspirin, ticagrelor, and metoprolol in addition to her insulin. She follows up with you at 1 and 3 months and has not had chest pain, but she does note some easy bruising and wants to know what she can do to mitigate further risk of bleeding.
Based on the TWILIGHT DM (Ticagrelor With Aspirin or Alone In High-Risk Patients With Diabetes Mellitus After Coronary Intervention) study, which of the following would be appropriate?
Show Answer
The correct answer is: D. Stop the aspirin but continue ticagrelor 90 mg twice daily
Using data from eight different trials, the PRECISE DAPT (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) bleeding score was developed and validated.1 An online calculator is currently available: http://www.precisedaptscore.com/predapt/webcalculator.html. This patient has a PRECISE DAPT bleeding score of 35, indicating a high risk for bleeding with an estimated 12-month risk of Thrombolysis in Myocardial Infarction major bleeding of 1.9% and Thrombolysis in Myocardial Infarction major or minor bleeding of 3.8%.
Bleeding is not uncommon among patients treated with dual antiplatelet therapy (DAPT), may not always be reported to the clinician, and may contribute to early DAPT discontinuation.2
The TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial examined the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among high-risk patients undergoing percutaneous coronary intervention.3 In this trial, after 3 months of ticagrelor plus aspirin, patients continued on ticagrelor and were randomized to aspirin or placebo for 1 year. In this pre-specified analysis4 of the diabetes mellitus (DM) cohort (n = 2,620; 37% of the total population), similar to the overall trial results, ticagrelor monotherapy in patients with DM reduced the risk of clinically relevant bleeding (4.5% vs. 6.7%; hazard ratio 0.65; 95% confidence interval 0.47-0.91; p = 0.012) without increased ischemic events (4.6% vs. 5.9%; hazard ratio 0.77; 95% confidence interval 0.55-1.09; p = 0.14).
These data suggest that risk of bleeding can be reduced by a strategy of ticagrelor monotherapy, following 3 months of DAPT, without incurring any increased risk of ischemic events even among patients with DM requiring insulin. Because this was a subgroup analysis, additional dedicated prospective studies in patients with DM should be performed to confirm the benefits of a ticagrelor monotherapy strategy after a brief period of DAPT and to further expand the generalizability of this strategy to patients with ST-segment elevation myocardial infarction because these patients were excluded from this study. Recent data from the TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) trial indicates that a treatment-similar strategy is effective.5
Choice A would be correct based on current guidelines but puts the patient at increased risk of bleeding. Choice B would be reasonable after 1 year based on the results of the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54) trial. Choice C would be reasonable if the patient developed bleeding; however, decreasing bleeding risk by changing to ticagrelor alone would be a better alternative.
References
Costa F, van Klaveren D, James S, et al. Derivation and Validation of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) Score: A Pooled Analysis of Individual-Patient Datasets From Clinical Trials. Lancet 2017;389:1025-34.
Wang TY, McCoy L, Henry TD, et al. Early Post-Discharge Bleeding and Antiplatelet Therapy Discontinuation Among Acute Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention. J Am Coll Cardiol 2014;63:1700-2.
Mehran R, Baber U, Sharma SK, et al. Ticagrelor With or Without Aspirin in High-Risk Patients After PCI. N Engl J Med 2019;381:2032-42.
Angiolillo DJ, Baber U, Sartori S, et al. Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol 2020;75:2403-13.
Kim BK, Hong SJ, Cho YH, et al. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA 2020;323:2407-16.
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