Achieving the Full "PROMISE" of Imaging Outcomes Research.
Achieving the Full "PROMISE" of Imaging Outcomes Research.
复制标题
实现影像结果研究的全面“承诺”。
DOI：
10.1161/circulationaha.116.022876
复制
发表时间：
2016
期刊：
影响因子：
37.8
通讯作者：
Douglas,PamelaS
中科院分区：
文献类型：
--
作者：
Douglas,PamelaS
Like many areas in cardiology, ongoing imaging technology development cre-ates a need for high-quality data on how best to incorporate potential game changers such as coronary computed tomographic angiography (CTA) into clinical care. In 2015, several large, outcomes-based, randomized trials compared the use of CTA with stress testing for the diagnosis of stable chest pain, including the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain; NCT01174550), SCOT-HEART (Scottish Computed Tomography of the Heart; NCT01149590), and PLATFORM (Prospective Longitudinal Trial of FFRCT Outcome and Resource Impacts; clinical outcomes of FFRCT-guided diagnostic strategies versus usual care trial; NCT01943903) trials. 1–3 Although each of these studies provides evidence that CTA improves diagnostic thinking and catheterization laboratory referral decisions, clinical event rates with CTA and usual care strategies were similar. As a result, although many observers view these trials as establishing new evidence-based testing options, others find them to be insufficiently compelling to change clinical care. This debate aside, digging more deeply into these trials uncovers a great deal of important and novel information about patients with stable chest pain and suspected coronary artery disease, applicable to both clinical care and future research. These data are particularly important given the large size of this population and the dearth of contemporary studies of patients undergoing elective testing for suspected coronary artery disease (CAD). Although all 3 trial cohorts were symptomatic and had a high risk factor burden, they had low cardiovascular event rates, just 1% to 2% per year. This low event rate has prompted some observers to suggest that a strategy of watchful waiting or deferred testing, instead of either CTA or stress testing, should be considered. However, the event rates in the absence of some form of testing are unknown, and current Class I American College of Cardiology/American Heart Association guideline recommendations suggest that referral for testing was appropriate in these real-world populations. A watchful waiting strategy is a potential topic for future prospective trials. PROMISE, SCOT HEART, and PLATFORM all compared evaluation strategies rather than direct test and test comparisons; in addition, all 3 trials opted for a pragmatic design with lower complexity and cost, using site interpretation of imaging and determination of subsequent care to provide important real-world results. The success of this approach highlights the feasibility of prospective imaging comparativeeffectiveness research and supports the recommendation that new technologies should prove themselves in this way.Another point relates to the evolving definition of what constitutes significant CAD and how this should be included in developing/refining diagnostic technologies and strategies. It is becoming increasingly clear that we need to consider both stenosis and hemodynamics in our risk assessments and treatments. Indeed, the PLATFORM results demonstrate the utility of such complementary data in improving processes of care. In this study, patient care guided by CTA accompanied by selective
