Cardiovascular Research, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA; Department of Biomedical and Health Informatics, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Cardiovascular Research, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA; Department of Biomedical and Health Informatics, University of Missouri-Kansas City, Kansas City, Missouri, USA.
J Am Coll Cardiol. 2022 Aug 23;80(8):755-765. doi: 10.1016/j.jacc.2022.05.045.
The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial randomized participants with chronic coronary disease (CCD) to guideline-directed medical therapy with or without angiography and revascularization. The study examined the association of nonadherence with health status outcomes.
The study sought to compare 12-month health status outcomes of adherent and nonadherent participants with CCD with an a priori hypothesis that nonadherent patients would have better health status if randomized to invasive management.
Self-reported medication-taking behavior was assessed at randomization with a modified 4-item Morisky-Green-Levine Adherence Scale, and participants were classified as adherent or nonadherent. Twelve-month health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ-7) summary score (SS), which ranges from 0 to 100 (higher score = better). The association of adherence with outcomes was evaluated using Bayesian proportional odds models, including an interaction by study arm (conservative vs invasive).
Among 4,480 randomized participants, 1,245 (27.8%) were nonadherent at baseline. Nonadherent participants had worse baseline SAQ-7 SS in both conservative (72.9 ± 19.3 vs 75.6 ± 18.4) and invasive (71.0 ± 19.8 vs 74.2 ± 18.7) arms. In adjusted analyses, adherence was associated with higher 12-month SAQ-7 SS in both treatment groups (mean difference in SAQ-7 SS with conservative treatment = 1.6 [95% credible interval: 0.3-2.9] vs with invasive management = 1.9 [95% credible interval: 0.8-3.1]), with no interaction by treatment.
More than 1 in 4 participants reported medication nonadherence, which was associated with worse health status in both conservative and invasive treatment strategies at baseline and 12 months. Strategies to improve medication adherence are needed to improve health status outcomes in CCD, regardless of treatment strategy. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
ISCHEMIA（国际比较医学与介入治疗效果研究）试验将患有慢性冠状动脉疾病（CCD）的参与者随机分为接受指南指导的药物治疗加或不加血管造影和血运重建的两组。该研究检测了不依从与健康状况结果之间的关系。
本研究旨在比较 CCD 患者依从组和不依从组的 12 个月健康状况结果，并提出了一个预先假设，即如果随机接受介入治疗，不依从的患者健康状况会更好。
使用改良的 Morisky-Green-Levine 依从性量表在随机分组时评估患者的药物服用行为，并将患者分为依从组或不依从组。采用西雅图心绞痛问卷（SAQ-7）总分（SS）评估 12 个月的健康状况，SAQ-7 总分范围为 0 到 100（得分越高表示健康状况越好）。采用贝叶斯比例优势模型评估依从性与结局之间的关系，包括按研究臂（保守治疗与介入治疗）进行交互作用。
在 4480 名随机分组的参与者中，有 1245 名（27.8%）在基线时不依从。在保守治疗（72.9 ± 19.3 比 75.6 ± 18.4）和介入治疗（71.0 ± 19.8 比 74.2 ± 18.7）两组中，不依从的参与者基线时的 SAQ-7 SS 均较差。在调整后的分析中，在两组治疗中，依从性与较高的 12 个月 SAQ-7 SS 相关（与保守治疗相比，SAQ-7 SS 的平均差异为 1.6 [95%可信区间：0.3-2.9]；与介入治疗相比，SAQ-7 SS 的平均差异为 1.9 [95%可信区间：0.8-3.1]），且无治疗的交互作用。
超过 1/4 的参与者报告药物不依从，这与基线和 12 个月时保守和介入治疗策略下的健康状况较差有关。无论治疗策略如何，都需要采取策略来提高药物依从性，以改善 CCD 的健康状况结果。（国际比较医学与介入治疗效果研究 [ISCHEMIA]；NCT01471522）。
