| Autor: |
Udelson, James E., Kelsey, Michelle D., Nanna, Michael G., Fordyce, Christopher B., Yow, Eric, Clare, Robert M., Mark, Daniel B., Patel, Manesh R., Rogers, Campbell, Curzen, Nicholas, Pontone, Gianluca, Maurovich-Horvat, Pal, De Bruyne, Bernard, Greenwood, John P., Marinescu, Victor, Leipsic, Jonathon, Stone, Gregg W., Ben-Yehuda, Ori, Berry, Colin, Hogan, Shea E., Redfors, Bjorn, Ali, Ziad A., Byrne, Robert A., Kramer, Christopher M., Yeh, Robert W., Martinez, Beth, Mullen, Sarah, Huey, Whitney, Anstrom, Kevin J., Al-Khalidi, Hussein R., Chiswell, Karen, Vemulapalli, Sreekanth, Douglas, Pamela S. |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Popis: |
Importance: guidelines recommend deferral of testing for symptomatic people with suspected coronary disease (CAD) and low pretest probability. No randomized trial has prospectively evaluated such a strategy.Objective: to assess process of care and health outcomes in people identified as minimal risk for CAD when testing is deferred.Design: randomized, pragmatic effectiveness trial.Setting: prespecified subgroup analysis of the PRECISE trial, at 65 North American and European sites. Participants: identified as minimal risk by the validated PROMISE Minimal Risk Score (PMRS).Intervention: randomization to a precision strategy using the PMRS to assign those with minimal risk to deferred testing and others to coronary CTA with selective CT-derived fractional flow reserve, or to usual testing (stress testing or catheterization, with PMRS blinded). Randomization was stratified by PMRS risk.Main outcome: composite of all-cause death, nonfatal myocardial infarction (MI), or catheterization without obstructive CAD through 12 months.Results: among 2103 participants, 422 (20%) were identified as minimal risk and randomized to deferred testing (n=214) or usual testing (n=208). Mean age (SD) was 46 (8.6) years; 72% were women. During follow-up, 138 (64%) of those randomized to deferred testing never had testing,whereas 76 (36%) had a downstream test (at median [IQR] 48 [15, 78] days) for worsening (30%), uncontrolled (10%), or new (6%) symptoms or changing provider (19%) or participant (10%) preference. Results were normal for 96% of these tests. The primary endpoint occurred in 2 (0.9%) deferred testing and 13 (6.3%) usual testing participants, HR (95% CI) 0.15 (0.03, 60.66), p=0.012. No death or MI was observed in the deferred testing participants, while 1noncardiovascular death and 1 MI occurred in the usual testing group. Two participants hadcatheterizations without obstructive CAD in the deferred testing group and 12 with usual testing (p=0.016). At baseline, 70% of participants had frequent angina, and there was similar reduction of frequent angina to Conclusion and relevance: in symptomatic participants with suspected CAD, identification of minimal risk by the PMRS guided a strategy of initially deferred testing. The strategy was safe with no observed adverse outcome events, fewer catheterizations without obstructive CAD, and similar symptom relief compared with usual testing.Trial registration: ClinicalTrials.Gov NCT03702244. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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