PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial.

Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Coylewright M ，Dick S ，Zmolek B ，Askelin J ，Hawkins E ，Branda M ，Inselman JW ，Zeballos-Palacios C ，Shah ND ，Hess EP ，LeBlanc A ，Montori VM ，Ting HH ... -  《Circulation-Cardiovascular Quality and Outcomes》

Predicting the Benefits of Percutaneous Coronary Intervention on 1-Year Angina and Quality of Life in Stable Ischemic Heart Disease: Risk Models From the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation).

Percutaneous coronary intervention (PCI) is a therapy to reduce angina and improve quality of life in patients with stable ischemic heart disease. However, it is unclear whether the quality of life after PCI is more dependent on the PCI or other patient-related factors. To address this question, we created models to predict angina and quality of life 1 year after PCI and medical therapy. Using data from the 2287 stable ischemic heart disease patients randomized in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) to PCI plus optimal medical therapy (OMT) versus OMT alone, we built prediction models for 1-year Seattle Angina Questionnaire angina frequency, physical limitation, and quality of life scores, both as continuous outcomes and categorized by clinically desirable states, using multivariable techniques. Although most patients improved regardless of treatment, marked variability was observed in Seattle Angina Questionnaire scores 1 year after randomization. Adding PCI conferred a greater mean improvement (about 2 points) in Seattle Angina Questionnaire scores that were not affected by patient characteristics (P values for all interactions >0.05). The proportion of patients free of angina or having very good/excellent physical limitation (physical function) or quality of life at 1 year was 57%, 58%, 66% with PCI+OMT and 50%, 55%, 59% with OMT alone group, respectively. However, other characteristics, such as baseline symptoms, age, diabetes mellitus, and the magnitude of myocardium subtended by narrowed coronary arteries were as, or more, important than revascularization in predicting symptoms (partial R2=0.07 versus 0.29, 0.03 versus 0.22, and 0.05 versus 0.24 in the domain of angina frequency, physical limitation, and quality of life, respectively). There was modest/good discrimination of the models (C statistic=0.72-0.82) and excellent calibration (coefficients of determination for predicted versus observed deciles=0.83-0.97). The health status outcomes of stable ischemic heart disease patients treated by OMT+PCI versus OMT alone can be predicted with modest accuracy. Angina and quality of life at 1 year is improved by PCI but is more strongly associated with other patient characteristics. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00007657.

Zhang Z ，Jones P ，Weintraub WS ，Mancini GBJ ，Sedlis S ，Maron DJ ，Teo K ，Hartigan P ，Kostuk W ，Berman D ，Boden WE ，Spertus JA ... -  《Circulation-Cardiovascular Quality and Outcomes》

Shared decision making in patients with stable coronary artery disease: PCI choice.

Coylewright M ，Shepel K ，Leblanc A ，Pencille L ，Hess E ，Shah N ，Montori VM ，Ting HH ... -  《PLoS One》

PREPARED Study: A Study of Shared Decision-Making for Coronary Artery Disease.

Doll JA ，Jones WS ，Lokhnygina Y ，Culpepper S ，Parks RL ，Calhoun C ，Au DH ，Patel MR ... -  《Circulation-Cardiovascular Quality and Outcomes》

Percutaneous coronary intervention versus medical therapy in stable coronary artery disease: the unresolved conundrum.

One of the major dilemmas facing physicians is what diagnostic and therapeutic approaches should be recommended to those stable coronary artery disease patients whose symptoms are adequately controlled on medical therapy. This study sought to assess the evidence-based data relating to whether: 1) all patients with significant coronary lesions (i.e., ischemia-producing) should undergo percutaneous coronary intervention (PCI); 2) the best therapeutic approach is optimal medical therapy; or 3) PCI should be performed, but only in certain subsets of patients. We reviewed all recent meta-analyses of prospective randomized trials that compared the outcomes of medical therapy and PCI in stable, symptomatically controlled, coronary artery disease patients. To provide greater insights to the clinician, we then analyzed, in depth, 3 comprehensive and widely quoted randomized trials. Review of recently published (2012) meta-analyses, and the detailed analyses of 3 widely quoted individual studies, indicate no difference exists between PCI and medical therapy in nonfatal MI or in all-cause or cardiovascular mortality. Thus, clinical equipoise exists: in other words, there is no evidence-based justification for adopting 1 therapeutic strategy over the other. Therefore, it is not inappropriate, until additional evidence emerges, for the responsible, experienced physician to weigh several sources of information in formulating a recommendation to the patient, even though definitive evidence-based data are not as yet available. Such sources may include assessment of the individual patient's clinical presentation, assessment of the severity of ischemia, and the patient's precise coronary anatomy. Critical for more-reliable decision making will be future development of accurate measures of the individual patient's risk of MI and/or death, whether by biomarker, imaging, or ischemia assessments.

Epstein SE ，Waksman R ，Pichard AD ，Kent KM ，Panza JA ... -  《-》