Background: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). Methods: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. Results: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49–70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P <0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4–6.4] hours versus standard arm: 5.6 (interquartile range, 4.0–7.1) hours, P <0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P <0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 18/1646 [1.1%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53–2.11], noninferiority P value=0.001, superiority P value=0.744), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0–99.9%) for 30-day death or myocardial infarction. Conclusions: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. Clinical Trial Registration: URL: https://www.anzctr.org.au . Unique identifier: ACTRN12615001379505.

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Chew , The appropriateness of coronary investigation in myocardial injury and Type 2 myocardial infarction (ACT-2): A randomized trial design. Ymhj (2018),

Aims Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE‐MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. Methods and results From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge‐to‐edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI‐ineligible patients referred to bailout‐TEER, high‐risk surgery or medical therapy (MT). The primary composite endpoint was all‐cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0–83.0, EuroSCORE II 4.7% [IQR 2.7–9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI‐ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout‐TEER, high‐risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout‐TEER, in 42.9% of patients undergoing high‐risk surgery and in 47.9% of patients remaining on MT. Conclusion This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI‐ineligible patients, bailout‐TEER and high‐risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.