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Clinical trial--derived risk model may not generalize to real-world patients with acute coronary syndrome.
Am Heart J. 2004 Dec; 148(6):1020-7.AH

Abstract

BACKGROUND

Accurate risk stratification can guide clinical decision-making in the management of acute coronary syndromes (ACS). However, the applicability of risk models to the general ACS population remains unclear. The purpose of this study was to validate and compare a modified international clinical trial and a registry-based risk model in a contemporary, less selected ACS population.

METHODS

In the prospective, observational Canadian ACS Registry, 4627 patients with ACS were enrolled from 51 centers. Baseline patient data were recorded on standardized case report forms. We evaluated risk models derived from the Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) and the Global Registry of Acute Cardiac Events (GRACE) predicting in-hospital death among patients with non-ST-elevation ACS. Model discrimination was measured by the c-statistic, and calibration was assessed graphically and by the Hosmer-Lemeshow goodness-of-fit test.

RESULTS

In-hospital mortality rates were 2.4% overall and 1.5% among the patients with non-ST-elevation ACS (n = 2925; 63.2%) in our validation cohort. Both the in-hospital PURSUIT and GRACE risk models showed similar and good prognostic discrimination (c-statistics = 0.84 and 0.83, respectively; P = .69 for difference). The GRACE model also demonstrated good calibration (Hosmer-Lemeshow P = .40). In contrast, calibration in the PURSUIT model was poor (Hosmer-Lemeshow P < .001), with consistent overestimation of risks.

CONCLUSIONS

Both the PURSUIT and GRACE models demonstrated good discrimination for in-hospital mortality rates in the Canadian ACS Registry. However, the GRACE risk model, derived from a less selected population, provided superior calibration in risk assessment across the spectrum of ACS. Our findings underscore the potential importance of risk model validation in the general ACS population rather than a clinical trial population to establish its generalizability before integration into clinical practice.

Authors+Show Affiliations

Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15632888

Citation

Yan, Andrew T., et al. "Clinical Trial--derived Risk Model May Not Generalize to Real-world Patients With Acute Coronary Syndrome." American Heart Journal, vol. 148, no. 6, 2004, pp. 1020-7.
Yan AT, Jong P, Yan RT, et al. Clinical trial--derived risk model may not generalize to real-world patients with acute coronary syndrome. Am Heart J. 2004;148(6):1020-7.
Yan, A. T., Jong, P., Yan, R. T., Tan, M., Fitchett, D., Chow, C. M., Roe, M. T., Pieper, K. S., Langer, A., & Goodman, S. G. (2004). Clinical trial--derived risk model may not generalize to real-world patients with acute coronary syndrome. American Heart Journal, 148(6), 1020-7.
Yan AT, et al. Clinical Trial--derived Risk Model May Not Generalize to Real-world Patients With Acute Coronary Syndrome. Am Heart J. 2004;148(6):1020-7. PubMed PMID: 15632888.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical trial--derived risk model may not generalize to real-world patients with acute coronary syndrome. AU - Yan,Andrew T, AU - Jong,Philip, AU - Yan,Raymond T, AU - Tan,Mary, AU - Fitchett,David, AU - Chow,Chi-Ming, AU - Roe,Matthew T, AU - Pieper,Karen S, AU - Langer,Anatoly, AU - Goodman,Shaun G, AU - ,, PY - 2005/1/6/pubmed PY - 2005/4/22/medline PY - 2005/1/6/entrez SP - 1020 EP - 7 JF - American heart journal JO - Am Heart J VL - 148 IS - 6 N2 - BACKGROUND: Accurate risk stratification can guide clinical decision-making in the management of acute coronary syndromes (ACS). However, the applicability of risk models to the general ACS population remains unclear. The purpose of this study was to validate and compare a modified international clinical trial and a registry-based risk model in a contemporary, less selected ACS population. METHODS: In the prospective, observational Canadian ACS Registry, 4627 patients with ACS were enrolled from 51 centers. Baseline patient data were recorded on standardized case report forms. We evaluated risk models derived from the Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) and the Global Registry of Acute Cardiac Events (GRACE) predicting in-hospital death among patients with non-ST-elevation ACS. Model discrimination was measured by the c-statistic, and calibration was assessed graphically and by the Hosmer-Lemeshow goodness-of-fit test. RESULTS: In-hospital mortality rates were 2.4% overall and 1.5% among the patients with non-ST-elevation ACS (n = 2925; 63.2%) in our validation cohort. Both the in-hospital PURSUIT and GRACE risk models showed similar and good prognostic discrimination (c-statistics = 0.84 and 0.83, respectively; P = .69 for difference). The GRACE model also demonstrated good calibration (Hosmer-Lemeshow P = .40). In contrast, calibration in the PURSUIT model was poor (Hosmer-Lemeshow P < .001), with consistent overestimation of risks. CONCLUSIONS: Both the PURSUIT and GRACE models demonstrated good discrimination for in-hospital mortality rates in the Canadian ACS Registry. However, the GRACE risk model, derived from a less selected population, provided superior calibration in risk assessment across the spectrum of ACS. Our findings underscore the potential importance of risk model validation in the general ACS population rather than a clinical trial population to establish its generalizability before integration into clinical practice. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/15632888/Clinical_trial__derived_risk_model_may_not_generalize_to_real_world_patients_with_acute_coronary_syndrome_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002870304001917 DB - PRIME DP - Unbound Medicine ER -