OPCAB versus early mortality and morbidity: an issue between clinical relevance and statistical significance☆

Autor: Patrick Wouters, Chris Bogaerts, Christophe Bert, Jan Van Hemelrijck, Paul Sergeant, Koen Slabbaert, Bart Meyns, Gregory Sergeant
Rok vydání: 2004
Předmět:
Zdroj: European Journal of Cardio-Thoracic Surgery. 25:779-785
ISSN: 1010-7940
DOI: 10.1016/j.ejcts.2004.02.013
Popis: Objective: To evaluate the impact of OPCAB on major postoperative events in a large consecutive cohort of patients, covering the complete spectrum of risk. Methods: A consecutive series of 3333 CABG patients operated in a single institution (Jan/97 ‐ Jan/03) is analyzed after a complete (98%) midterm reengineering towards off-pump surgery (Oct/99). Patients in cardiogenic shock are excluded. The on- ðN ¼ 1593Þ or off-pump ðN ¼ 1740Þ datasets are comparable for most demographic and non-cardiac variability. The studied events are early mortality, early stroke, early infarct, early dialysis and hospital stay. Three methods adjust for possible patient selection: similar datasets, forced inclusion of a saturated OPCAB propensity score and finally multivariate correction. Results: Non-risk adjusted. The 3-month survival was 96.7 ^ 0.4% (OPCAB) and 95.9 ^ 0.5% (ECC) ðP ¼ 0:2Þ: The 8-day freedom from stroke was 99.4 ^ 0.2% (OPCAB) and 98.5 ^ 0.3% (ECC) ðP ¼ 0:004Þ: The prevalence of dialysis was 1.67% in OPCAB and 2.27% in ECC ðP ¼ 0:2Þ: The 8-day freedom from infarct was 98.4 ^ 0.2% (OPCAB) and 98.3 ^ 0.2% (ECC) ðP ¼ 0:7Þ: The freedom from hospital discharge day 15 was 17.6 ^ 0.9% (OPCAB) and 18.4 ^ 0.8% (ECC) ðP ¼ 0:001Þ: Propensity score corrected and adjusted for event-related variability. The survival effect remained non-significant ðP ¼ 0:3Þ; also for patients with a EuroSCORE . 8 ðP ¼ 0:9Þ: The stroke effect became nonsignificant ðP ¼ 0:2Þ; but stayed significant for patients with severe internal carotid artery stenosis ðP ¼ 0:02Þ: The dialysis-effect remained non-significant ðP ¼ 0:6Þ; also for patients with an elevated creatinine ðP ¼ 0:7Þ: The early infarct-effect remained non-significant ðP ¼ 0:8Þ; also for the female patients ðP ¼ 0:8Þ: The hospital discharge was significantly influenced by the OPCAB approach for the total group ðP ¼ 0:02Þ as well as for the patients with EuroSCORE . 8 ðP ¼ 0:01Þ: Conclusions: The observed 20% reduction of mortality, 60% reduction of stroke and 20% reduction of dialysis were partly neutralized by the adjusting methods and demand, at least, larger datasets to obtain statistical significance. Subdatasets with fewer patients but higher risk identified risk-reducing effects for stroke. Hospital stay was shortened by the OPCAB approach. The interactions between risk, number of patients and the risk-reducing effect are the cornerstones of evidence generation for the OPCAB approach. These results were obtained through a very strict reengineering and cannot be extended to all OPCAB programs. q 2004 Elsevier B.V. All rights reserved.
Databáze: OpenAIRE