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Informed consent is an imperative step in primary percutaneous coronary intervention (PCI), which may directly affect the patient’s final decision. In addition, time of informed consent is an important part of door-to-balloon time for primary PCI. However, up to now, little is known about the quality of decision making before primary PCI. Therefore,we investigated the status and factors that affects informed consent of primary PCI.
301 consecutive cases with STEMI who arrived at Peking University People's Hospital within 12 hours from the onset of symptom between August 2014 to February 2017 were included. Data were collected through consulting medical records and performing questionnaire investigations. Patients were divided into consent group and refusal group according to the final decision. Those who received primary PCI were further categorized into two groups based on the 26.5min cut-off time. We examined the differences in clinical information and informed consent information between those groups. Multivariate logistic regression was used to determine the factors associated with decline or delay consent for Primary PCI.
1. Among the 301 patients with STEMI reviewed, primary PCI was accepted by 236 patient (78.4%). And 115 patients participated in the investigation, among these cases, only 13 conversations (11.3%) included all 7 elements of informed decision making.
2. Multivariate logistic analysis showed that old age (OR 5.03, 95% CI 1.65∼15.30, p=0.004),outside Beijing (OR 4.41, 95% CI 1.10∼17.65, p=0.036),symptom relief (OR 6.41, 95% CI 2.39∼17.22, p<0.001),history of chronic kidney disease (OR 8.97, 95% CI 3.15∼25.53, p<0.001),and history of myocardial infarction (OR 3.15, 95% CI 1.09∼9.05, p=0.034) were associated with refusal of primary PCI. While self-rated severe symptoms (OR 0.13, 95% CI 0.05∼0.33,p<0.001) and understanding the importance of timely reperfusion (OR 0.12, 95% CI 0.02∼0.91, p<0.041) were predictors of consent to primary PCI.
3. 194 patients completely recorded times of informed consent in the consent group. Among these cases, the median of informed consent time was 26.5 (15.8, 42.0) minutes. Symptom to door ≥4 h (OR 2.34,95% CI 1.25∼4.39, p=0.008),admission during regular hours (OR 2.85, 95% CI 1.43∼5.68, p=0.003),and understanding the differences between coronary angiography and stent (OR 9.92, 95% CI 1.88∼52.3,p=0.007) were independent predictors of informed consent delay. However, self-rated severe symptoms (OR 0.033,95% CI 0.13∼0.85,p=0.021),ST segment elevation in first ECG (OR 0.33,95% CI 0.13∼0.83, p=0.019) and discussion of strategies of risks (OR 0.19,95% CI 0.05∼0.67,p=0.010)were associated with timely informed consent.
The decision making process of primary PCI was not standardized. Informed consent of primary PCI was affected by multiple clinical features and decision making process. Informed decision making should be conducted according to the characteristics of different types of patients.