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Published on: November 8, 2024
On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From
Bahira Shahim1,2,3, Björn Redfors1,4,5, Thomas D Stuckey6
1Clinical Trials Center Cardiovascular Research Foundation New York NY.
Insights
High platelet reactivity (HPR) increases ischemic event risk after stenting, particularly in non-insulin-treated diabetes mellitus patients. This study found HPR is more common in diabetics but its risk impact varies by diabetes treatment type.
Area of Science:
- Cardiovascular Medicine
- Clinical Research
- Pharmacology
Background:
- Diabetes mellitus and high platelet reactivity (HPR) are independent risk factors for ischemic events post-percutaneous coronary intervention (PCI).
- The interplay between HPR and diabetes mellitus status in predicting adverse outcomes after PCI remains incompletely understood.
Purpose of the Study:
- To investigate whether the risk associated with HPR on clopidogrel therapy after drug-eluting stent (DES) implantation differs based on diabetes mellitus status.
- To analyze the interaction between HPR and different diabetes mellitus classifications (insulin-treated vs. non-insulin-treated) on major adverse cardiac events (MACE).
Main Methods:
- Prospective, multicenter ADAPT-DES registry included 8582 patients undergoing DES implantation.
- HPR was defined as P2Y12 reaction units >208 using the VerifyNow assay.
- Cox multivariable analysis assessed MACE (cardiac death, MI, stent thrombosis) risk, with interaction analysis for HPR and diabetes status (no diabetes, non-ITDM, ITDM).
Main Results:
- HPR was more frequent in patients with diabetes mellitus (28.3% of cohort, 41.1% of diabetics had ITDM).
- HPR was associated with increased 2-year MACE rates in both diabetic and non-diabetic patients (P_interaction=0.36).
- A significant interaction (P_interaction=0.01) showed HPR elevated MACE risk more in non-insulin-treated diabetes mellitus (aHR 2.28) than in insulin-treated diabetes mellitus (aHR 1.02).
Conclusions:
- HPR is more prevalent in diabetes mellitus patients and elevates MACE risk irrespective of diabetes status.
- The impact of HPR on MACE is more pronounced in lower-risk non-insulin-treated diabetes mellitus patients compared to higher-risk insulin-treated diabetes mellitus patients.
Abstract:
Background Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR-associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. Methods and Results ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point-of-care assay. Cox multivariable analysis was used to assess whether HPR-associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin-treated diabetes mellitus (ITDM), non-ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2-year rates of MACE in patients with and without diabetes mellitus (Pinteraction=0.36). A significant interaction was present between HPR and non-insulin-treated diabetes mellitus versus ITDM for 2-year MACE (adjusted hazard ratio [HR] for non-ITDM, 2.28 [95% CI, 1.39-3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70-1.50]; Pinteraction=0.01). Conclusions HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower-risk non-ITDM patients than in higher-risk patients with ITDM. Registration URL: https://clinicaltrials.gov/ct2/show/NCT00638794; Unique identifier: NCT00638794. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents).
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