Only 1.2% of NSTEMI trials explicitly included T2MI patients, 26% permitted them, while 58.4% excluded T2MI, highlighting their underrepresentation.
Are individuals with type 2 myocardial infarction adequately represented in NSTEMI randomized clinical trials?
Type 2 myocardial infarction is significantly underrepresented in NSTEMI trials, highlighting a critical gap in evidence-based management for this population.
Tasa de eventos absoluta: 0% vs 0%
Abstract Introduction T2MI accounts for nearly half of all MI cases and has a crude risk of recurrent major adverse cardiovascular events comparable to type 1 MI. Observational studies show that T2MI management differs significantly from T1MI. Current American College of Cardiology (ACC)/American Heart Association (AHA) NSTEMI guidelines do not distinguish management of MI by subtype. Moreover, the European Society of Cardiology (ESC) 2023 acute coronary syndrome guidelines note that insufficient evidence exists to provide formal recommendations for T2MI management. Randomized clinical trials are a critical source of comparative effectiveness evidence for creating clinical guidelines. However, significant uncertainty exists regarding the inclusion of T2MI individuals in NSTEMI randomized clinical trials and, consequently, the generalizability of their results to this population. Purpose We performed a systematic literature review to evaluate the representativeness of individuals with T2MI in NSTEMI randomized clinical trials. Methods NSTEMI trials were retrieved from Embase and Medline using related MeSH terms. The search, conducted in March 2024, yielded 1851 trials. After removing duplicates, secondary analyses, non-English, non-randomized, ongoing, and STEMI trials, 165 eligible trials (8.9%) remained. Three physicians independently reviewed the methods sections of all the trials and by adopting a systematic approach, classified them into four categories based on the inclusion/exclusion of T2MI: 1) Included, 2) Permitted, 3) Excluded (Definite, Very Probable, Probable), and 4) Uncertain (Figure 1). Trial type and interventions were analyzed specifically for the trials that included or permitted T2MI. Results Of the 165 trials, only 2 (1.2%), MINT and REALITY, explicitly included T2MI ("Definite Inclusion"). Both were recent (2021, 2023) and investigated blood transfusion strategies. Individuals with T2MI were permitted in 43 trials (26%), though not necessarily indicating their actual inclusion. Among those, interventions studied included revascularization (20.9%), anticoagulation (11.6%), antiplatelet therapy (16.3%), lipid-lowering therapy (7%), and adjunct therapies (43.8%). Individuals with T2MI were explicitly or likely excluded from 97 trials (58.4%), classified as "Definite" (n = 4), "Very Probable" (n = 27), and "Probable" Exclusion (n = 66). T2MI eligibility could not be determined in 23 trials (13.8%) due to insufficient eligibility information (Figure 2). Of all the trials, 158 were on treatment and 7 on diagnostic strategies. Only 1 of the 7 diagnostic trials permitted T2MI. Conclusion These findings highlight that T2MI is significantly underrepresented in NSTEMI trials, limiting evidence-based management. Substantial caution is needed in applying clinical strategies validated in NSTEMI trials to T2MI. Future trials should clarify MI subtype eligibility and consider dedicated T2MI studies to guide clinical management.Figure 1.T2MI classification criteria Figure 2.T2MI distribution among trials
Atallah et al. (Sat,) reported a other. Only 1.2% of NSTEMI trials explicitly included T2MI patients, 26% permitted them, while 58.4% excluded T2MI, highlighting their underrepresentation.