| Literature DB >> 26880670 |
Chenfei Rao1, Tasce Bongiovanni2, Xi Li1, Huawei Gao3, Heng Zhang3, Jing Li1, Yan Zhao1, Xin Yuan3, Kun Hua1, Shengshou Hu3, Harlan M Krumholz2, Lixin Jiang1, Zhe Zheng3.
Abstract
INTRODUCTION: Complex coronary artery disease (left main and three-vessel disease) carries high risks of adverse events and cost burden. However, in China, little is known about which patients are directed toward which treatment strategies and what outcomes are being achieved. METHODS AND ANALYSIS: Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, this prospective study of three-Vessel Disease, the China PEACE-3VD study, has a plan to consecutively register over 4000 patients with a diagnosis of 3VD and/or left-main disease by elective coronary angiography at 24 large cardiovascular centres in China. We centrally conducted medical record abstraction and SYNTAX Score calculation for all registered patients. The sites invited patients to the prospective cohort, and conducted 1-year follow-up on major events, including cardiac events, symptoms, secondary prevention and quality of life. The estimated entire sample size of eligible patients of 4000 was determined based on both feasibility and consideration of adequate statistical precision for describing the treatment decisions, guidelines adherence and appropriateness of treatment for patients with complex coronary artery diseases. The study is designed to investigate patient, clinician and hospital factors associated with each treatment strategy (percutaneous coronary intervention, coronary artery bypass grafting or medical therapy) as well as appropriateness of treatment choice, current guideline compliance and patient-reported outcomes for patients with complex coronary artery disease in large cardiovascular centres in China, as a foundation for enhanced knowledge in the field and to assist quality improvement initiatives. ETHICS AND DISSEMINATION: The study protocol was approved by the ethics committee at the China National Center for Cardiovascular Diseases. Findings will be shared with participating hospitals, policymakers and the academic community, to promote quality monitoring, quality improvement and the efficient allocation, and use of coronary revascularisation procedures in China. TRIAL REGISTRATION NUMBER: NCT01625312; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/Entities:
Mesh:
Year: 2016 PMID: 26880670 PMCID: PMC4762131 DOI: 10.1136/bmjopen-2015-009743
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1Design and study overview of China PEACE-3VD. CABG, coronary artery bypass grafting; Meds indicates medical therapy; CCAD, complex coronary artery disease; EQ-5D, EuroQol Questionnaire; PCI, percutaneous coronary intervention; PEACE-3VD, Patient-centered Evaluative Assessment of Cardiac Events three-vessel disease study; SAQ, Seattle Angina Questionnaire.
Figure 2Geographic distribution of China PEACE-3VD participating Centres. PEACE-3VD, Patient-centered Evaluative Assessment of Cardiac Events three-vessel disease study.
China PEACE-3VD data elements
| Variables | Medical record | SYNTAX Score | Baseline | Follow-up interviews | ||
|---|---|---|---|---|---|---|
| 1-month | 6-month | 12-month | ||||
| Clinical characteristics | ||||||
| Medical history | √ | |||||
| CAD family history | √ | √ | ||||
| Lab testing | √ | |||||
| Physical testing | √ | |||||
| Image examination | √ | |||||
| SYNTAX Score | √ | |||||
| Treatment | ||||||
| Progress note | √ | |||||
| Drug treatment | √ | |||||
| Procedures | √ | |||||
| Secondary prevention | √ | |||||
| Secondary prevention compliance | √ | √ | √ | |||
| Patient characteristics | ||||||
| Basic information | √ | |||||
| Contact | √ | √ | √ | √ | ||
| BMI/weight/waistline | √ | √ | √ | √ | ||
| Socioeconomic status | √ | √ | ||||
| Outcomes | ||||||
| Death | √ | √ | √ | |||
| MACCE | √ | √ | √ | |||
| Rehospitalisation | √ | √ | √ | |||
| Depression | √ | √ | √ | √ | ||
| EQ-5D | √ | √ | √ | √ | ||
| SAQ | √ | √ | √ | √ | ||
| Blood pressure | √ | √ | √ | √ | ||
| Blood glucose | √ | √ | √ | |||
| Blood lipid | √ | √ | √ | |||
| Hepatic function | √ | √ | √ | |||
| Renal function | √ | √ | √ | |||
BMI, body mass index; CAD, coronary artery disease; EQ-5D, EuroQol Questionnaire; MACCE, major adverse cardiac and cerebrovascular event; SAQ, Seattle Angina Questionnaire.
Baseline characteristics and cumulative outcomes of patients enrolled and not enrolled in China PEACE-3VD*
| Characteristics | Enrolled (n=2089) | Not enrolled (n=1383) | p Value |
|---|---|---|---|
| Age, years | 62.4±9.8 | 63.4±10.3 | 0.007 |
| Male, % | 70.7 | 67.5 | 0.051 |
| No insurance, % | 25.5 | 22.7 | 0.059 |
| Diabetes mellitus, % | 27.8 | 25.7 | 0.163 |
| Hypertension, % | 67.0 | 65.3 | 0.306 |
| Prior MI, % | 33.5 | 34.9 | 0.414 |
| Prior heart failure, % | 2.7 | 3.3 | 0.370 |
| Prior stroke, % | 11.4 | 12.8 | 0.228 |
| LVEF <40%, % | 5.6 | 4.6 | 0.207 |
| SYNTAX Scores | 22.0±11.0 | 22.1±11.3 | 0.791 |
| One year outcomes, % | |||
| MACCE | 8.3 | ||
| All-cause death | 2.9 | ||
| MI | 1.4 | ||
| Stroke | 0.9 | ||
| Additional revascularisation | 4.3 | ||
*This table included all available data as of July 2015, and the database was not locked.
CABG, coronary artery bypass grafting; LVEF, left ventricular ejection fraction; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infraction.