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Diabetes mellitus is often associated with increased risk of cardiovascular disease. For patients with diabetes who have undergone percutaneous coronary intervention (PCI), the best length of time to continue antiplatelet therapy to prevent both blood clots and bleeding is still uncertain. 

鈥淸Diabetes mellitus] remains an independent predictor of ischemic complications after percutaneous and surgical coronary revascularization鈥�Although DM has been associated with enhanced platelet reactivity and reduced sensitivity to some antiplatelet agents, the translational outlook of these observations remains unclear,鈥� Dr. Marco Roffi and coauthors remarked in a study recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions.¹

Study design and demographics

In this prespecified analysis from the MASTER DAPT trial [Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen], the primary goal was to determine if the treatment benefits of abbreviated (1 month) versus standard (鈮�3 months) antiplatelet therapy in patients with high bleeding risk would be modified by diabetes status. Patients with high bleeding risk who underwent a percutaneous coronary intervention with only an Ultimaster stent and remained stable and free of major adverse cardiac events for the first month after the procedure were eligible to participate in the study. 

Between February 28, 2017 through December 5, 2019, a total of 4579 patients were randomly assigned 1:1 to an abbreviated (n = 2,295 patients [diabetic: n = 754 and nondiabetic: n = 1,541]) or standard (n = 2,284 [diabetic: n =784 and nondiabetic, n = 1,500]) antiplatelet therapy regimen. 

Most of the patients were not diagnosed with diabetes (nondiabetic: n = 3,041 (66%) versus diabetic: n = 1,538 (34%). Patients with diabetes were younger, had higher body mass index, and had more cardiovascular risk factors than participants without diabetes. 

Those in the abbreviated group stopped taking dual antiplatelet therapy at the start of the study and continued a single antiplatelet therapy until the study ended. If a participant in the abbreviated therapy cohort and was taking oral blood thinners, they continued single therapy for up to 6 months. Patients in the standard group continued dual APT for a minimum of an additional 5 months, or 2 months if taking blood thinners, followed by single APT. 

Clinical findings

The primary study outcomes were 11-month net adverse clinical event(s) (NACEs), major adverse cardiac and cerebral event(s) (MACCEs), and major or clinically relevant nonmajor bleeding (MCB). Diabetes status did not impact treatment efficacy. Both abbreviated and standard APT regimens demonstrated similar rates of NACEs and MACCEs in patients with and without diabetes.

Patients receiving abbreviated therapy experienced a substantial reduction in major or clinically relevant non-major bleeding compared to those on standard therapy. A significant advantage of abbreviated APT was observed in terms of bleeding risk but was comparable in the rates of NACEs and MACCEs. This reduction MCB was evident in both diabetic and non-diabetic patients. Compared to standard therapy, MCB was lower with abbreviated APT in nondiabetic patients (95/1,541 [6.25%] vs 139/1,500 standard patients [9.37%]; HR: 0.65; 95% CI: 0.50-0.85; P = 0.001) and diabetic patients (53/754 [7.13%] vs 72/784 standard patients [9.33%]; HR: 0.75; 95% CI: 0.52-1.06; P = 0.11).

 鈥淭he observation of similar NACE and MACCE rates and a consistent bleeding reduction with abbreviated compared with standard APT in both diabetic and nondiabetic patients suggests that [diabetes mellitus] does not justify per se a more prolonged APT course in [high bleeding risk] patients without ischemic and/or active bleeding events in the first month after PCI鈥�[diabetes mellitus] is an ischemic risk equivalent, and DAPT duration should be informed by both ischemic and bleeding risks within and beyond the first year after PCI,鈥� the authors wrote.

Study limitations and future directions

The authors addressed several limitations of their analysis. 

• Since the MASTER DAPT trial was not powered to specifically assess the impact of abbreviated vs. standard APT in patients with diabetes at high risk for bleeding, the current study should be viewed as hypothesis-generating rather than definitive. 
• The study was conducted in a very specific patient population; therefore, the results may not be applicable to non-high-risk patients or those treated with different stent types. 
• Additionally, the study also excluded patients who experienced ischemic or bleeding events within the first month after PCI, which may limit the generalizability of the findings to patients who experience early adverse events.
• The authors also stated the participants received DAPT longer than currently recommended guidelines for patients taking oral anticoagulants.

Overall, the study suggests diabetes mellitus is an independent risk factor for adverse cardiovascular events. Participants with diabetes were found to have a higher incidence of MACCEs compared to non-diabetic patients, emphasizing the need for careful risk assessment and tailored treatment strategies according to diabetic status. Shorter duration of APT may not compromise clinical outcomes and may be a beneficial treatment option for patients with diabetes and high bleeding risk undergoing PCI. More definitive research is needed to validate these findings. 

Published: December 27, 2024