真实世界下PCI术后Ⅰ期心脏康复干预现状及其效果的注册登记研究

中文摘要

背景：

经皮冠状动脉介入治疗（Percutaneous Coronary Intervention, PCI）是冠心病患者的重要治疗手段，但其术后患者普遍存在运动耐量下降及心理问题，影响生活质量。心脏康复（Cardiac Rehabilitation, CR）作为综合性管理模式，可有效改善患者预后，国内外已有大量文献报告其具备可靠的临床获益及成本效益，并且已有严格制定的指南及专家共识推荐其在心血管疾病患者中的应用及推广，但目前临床实践中心脏康复存在显著的护理质量差异。真实世界研究（Real-World Study, RWS）通过注册登记平台对多维度临床数据进行系统性收集、整合与分析，为评估真实世界下PCI术后心脏康复护理的干预现状与效果提供了重要方法学支持。当前国内护理领域在注册登记研究平台建设方面仍处于起步阶段，尚未形成成熟且可直接应用的注册登记平台。同时，基于真实世界研究（RWS）范式的临床护理实践探索相对滞后，相关领域的高质量学术成果产出也较为有限。

目的：

（1）构建PCI护理注册登记平台，验证该平台数据收集与管理的可行性及有效性。（2）通过该注册登记平台全面收集真实世界下PCI患者人口学资料、病情、治疗、心脏康复护理及预后的连续性资料，建立PCI患者I期心脏康复护理数据库。

（3）了解PCI术后患者Ⅰ期心脏康复阶段的临床特征，评估目前真实世界下PCI术后Ⅰ期心脏康复干预现状及其效果，并分析其潜在影响因素，提出PCI术后Ⅰ期心脏康复护理临床实践策略的改进措施。

方法：

（1）通过文献回顾、临床调研及专家小组讨论，参考目前国内外较为成熟的注册登记平台设计及治理模式，并结合我国临床诊疗及护理实际情况，构建信息化PCI护理注册登记平台，并进行30例病例登记预实验，评估其登记流程的可行性，验证其数据完整性与质量控制方案的有效性。

（2）采用回顾性观察性队列研究设计，通过注册登记平台收集2024年8月1日至2024年10月31日北京某三级甲等心血管专科医院住院行PCI术患者住院期间的连续性数据资料，构建回顾性观察队列。进行数据清洗与预处理，采用描述性统计方法，了解PCI术后患者特征及Ⅰ期心脏康复护理干预现状；采用多重校正方法与效应量评估量化PCI术后康复干预的临床实际效应，并通过重症亚组模型解析个性化康复策略的有效性及潜在影响因素。

结果：

1、PCI护理注册登记平台构建

（1）本研究构建的PCI护理注册登记平台包含包含6个一级维度、48个二级条目及176项具体参数，涵盖人口学特征资料、疾病史与危险因素、PCI治疗特征及心脏康复护理干预情况。

（2）PCI护理注册登记平台功能包括：①HIS系统结构化数据提取；②非结构化信息人工录入；③实时逻辑校验；④双重溯源核查。预实验阶段（n=30）验证显示，系统数据缺失率优化至<8%，单例登记耗时中位数为23.5分钟，溯源核查达标率超过95%。

2、PCI术后患者人口学特征和临床特征

共纳入分析5684例入院行PCI术的患者。

（1）人口学特征显示，男性占比显著（78.3%），年龄60.06±14.31岁，以60-75岁组占比最高（47.3%），其中93.1%为已婚状态，职业分布以退休（31.7%）、商业服务业（22.3%）及专业技术从业者（17.1%）为主，外阜城镇基本医疗保险覆盖率达77.3%。

（2）临床特征显示，在既往史方面，心血管相关危险因素以高脂血症（77.4%）、高血压（63.4%）为主，其次为吸烟史（49.4%）及糖尿病（38.2%）。在PCI治疗方面，单支病变占比最高（78.9%），其次为双支（18.8%）及三支病变（2.3%），有38.0%存在既往PCI史；有99.3%的患者接受球囊辅助治疗，其中52.9%的患者使用≥3个球囊，而有22.1%未联合支架置入；进行支架置入的患者中，有52.3%的患者本次置入支架数量≥2个；有3.8%的患者术后穿刺部位延迟拔管，7.7%的患者术后转入CCU进行重症监护。

3、PCI术后患者Ⅰ期心脏康复护理干预现状

全部5684例患者住院期间均进行了常规心脏康复护理，其中仅2.85%（162/5684）的患者接受了个性化心脏康复护理，具体内容包含分级运动康复、肺功能康复、戒烟指导、健康教育等，平均接受个性化康复干预2.06次，涵盖分级徒手训练（床上训练实施率74.07%，平均1.64次/例；床边训练实施率14.2%，平均2.17次/例）与肺功能康复（实施率85.19%，平均1.90次/例），其中12.96%（21/162）患者能够实现由床上到床旁活动的康复进阶。

4、PCI术后患者Ⅰ期心脏康复护理干预效果

（1）心功能恢复情况

①左室射血分数（LVEF）在入院、术后及出院时存在显著动态变化（χ²=61.23，p<0.001），术后值较入院基线下降（均p<0.05），出院时虽部分恢复但仍低于基线水平。入院时6.4%患者（366/5684）LVEF<50%，89.9%处于目标区间（50-70%）；至出院时，LVEF<50%比例降至5.9%（335/5684），但基线低下患者仅14.2%（52/366）恢复至正常范围，全队列中有25.8%（1467/5684）患者LVEF改善；②肌酸激酶同工酶（CK-MB）在入院、术后及出院时的分布存在显著差异（χ²=2868.05，p<0.001），术后CK-MB较入院基线显著升高，出院时部分回落但仍高于基线水平，效应量r值（0.30–0.60）提示术后变化具有中等至大效应；③N末端B型利钠肽前体（NT-proBNP）在入院、术后及出院时的分布存在显著差异（χ²=917.95，p<0.001），术后NT-proBNP较入院基线显著升高，出院时部分回落但仍高于基线水平，效应量r值（0.05–0.30）提示变化幅度为小至中等效应。

（2）日常生活能力改善情况

入院时85.84%（4879例）患者功能状态为L4（完全自理），出院时94.19%（5354例）维持或提升至L4，其中原L4组85.45%（4857例）未发生功能退化；入院时L1（完全辅助）患者中70.0%（159/227）出院时提升至L3/L4（大部分/完全自理），L2（部分辅助）组90.2%（101/112）实现功能改善。卡方检验显示入院与出院功能状态分布存在极显著关联（p<0.001），日常生活能力呈逐步提升趋势（χ²=1188.446，p<0.001）。

（3）危险因素控制情况

PCI术后患者院内戒烟率达100%（5684/5684）。血糖控制方面，空腹血糖达标率从入院时43.7%（2484/5684）提升至出院时59.4%（3378/5684），糖尿病患者中77.2%（1674/2169）实现空腹血糖<7.0 mmol/L。血脂管理方面，LDL-C（<1.8 mmol/L）及非HDL-C（<2.6 mmol/L）出院时的联合达标率为39.1%（2225/5684），仅19.1%（1085例）四项指标全面达标；33.7%患者（1918例）存在甘油三酯（TG）升高，其中1.2%（66例）为严重高TG血症（≥5.7 mmol/L）。值得注意的是，93.9%患者（5339/5684）出院时LDL-C未较基线改善，入院未达标者中仅5.4%（185/3455）实现LDL-C降低（0.96%达降幅≥50%），提示血脂管理仍存在显著提升空间。

5、PCI术后重症患者Ⅰ期心脏康复护理干预现状与效果分析

（1）PCI术后重症患者组共纳入416例患者，分为个性化康复组（n=162）与非个性化康复组（n=254）。两组患者的基线特征在血管病变分布、急诊PCI实施率、医保覆盖率、职业类型、年龄及基线日常生活能力（ADL）评分等方面存在显著异质性（均p<0.05）。

（2）在矫正基线异质性后，多元线性回归模型显示，个性化康复干预与PCI术后重症患者ADL改善呈独立正相关（β=3.058，95% CI:0.461-5.656，p=0.021），模型解释力达76.3%（调整R²=0.763，p<0.001）。

（3）男性（β=3.752，p=0.036）、较低年龄（β=-0.171/年，p=0.002）及较高基线左室射血分数（β=0.207/%EF，p=0.008）与ADL改善显著相关，而手术操作及生化指标无统计学意义（p>0.05）。

（4）康复启动时间延迟（B=0.771/天，p<0.001）及运动训练总次数增加（B=1.121/次，p=0.003）与住院天数延长显著相关，而基线左室射血分数（LVEF）升高可缩短住院时间（B=-0.077/%EF，p=0.031）。急诊PCI患者较择期PCI患者ADL改善程度高33.042分（B=33.042，p<0.001），既往PCI史则显著降低ADL改善（B=-7.922，p=0.021）。

结论：

1、本研究构建的PCI护理注册登记平台紧密契合我国临床实践需求，该平台在单中心应用中能够保障数据采集效率与系统稳定性，其结构化数据管理架构为后续多中心研究奠定了基础。

2、基于标准化流程构建的临床数据治理模式能够有效整合碎片化护理数据，可作为未来多中心数据互操作的参考范本。

3、Ⅰ期心脏康复护理可以有效改善PCI术后患者日常生活能力，但需重点加强高危亚群（高龄/既往PCI史/基础心功能受损）的个性化心脏康复，增强术后心功能动态变化监测，需兼顾心肌损伤防控与容量负荷管理，关注血脂管理。

4、尽早启动心脏康复护理干预，并积极提升患者术前左室功能，可显著缩短重症患者的住院周期，加速康复进程。

A registry study on the Status quo and effects of phase I cardiac rehabilitation intervention after PCI in the real world

Abstract

Background:  

Percutaneous Coronary Intervention (PCI) is an important treatment method for patients with coronary heart disease. However, post-PCI patients generally experience decreased exercise tolerance and psychological problems, which affect their quality of life. Cardiac Rehabilitation (CR), as a comprehensive management model, can effectively improve patient prognosis. There are numerous domestic and international literature reports demonstrating its reliable clinical benefits and cost-effectiveness. Moreover, there are strict guidelines and expert consensus recommending its application and promotion in cardiovascular disease patients. However, there are significant differences in the quality of cardiac rehabilitation in clinical practice. Real-World Studies (RWS) systematically collect, integrate, and analyze multi-dimensional clinical data through registration and registration platforms, providing important methodological support for evaluating the current status and effects of cardiac rehabilitation nursing intervention in the real world after PCI. Currently, the construction of registration and registration research platforms in the domestic nursing field is still in its infancy, and no mature and directly applicable registration and registration platforms have been formed. At the same time, the exploration of clinical nursing practice based on the RWS paradigm is relatively lagging behind, and the output of high-quality academic achievements in this field is also limited.

Objective:  

(1) To construct a PCI nursing registration and registration platform and verify the feasibility and effectiveness of data collection and management on this platform.

(2) To comprehensively collect continuous data on the demographics, conditions, treatments, cardiac rehabilitation nursing, and prognosis of PCI patients in the real world through this registration and registration platform, and establish a database for phase I cardiac rehabilitation nursing of PCI patients.

(3) To understand the clinical characteristics of PCI patients in the phase I cardiac rehabilitation stage, evaluate the current status and effects of phase I cardiac rehabilitation intervention after PCI in the real world, analyze the potential influencing factors, and propose improvement measures for clinical practice strategies of phase I cardiac rehabilitation nursing after PCI.

Methods:  

(1) Through literature review, clinical investigation, and expert group discussion, referring to the design and governance models of relatively mature registration and registration platforms at home and abroad, and combining the actual situation of clinical diagnosis, treatment, and nursing in China, an information-based PCI nursing registration and registration platform was constructed. A pre-experiment was conducted with 30 cases to assess the feasibility of the registration process and verify the effectiveness of the data integrity and quality control plan.

(2) A retrospective observational cohort study design was adopted. Through the registration and registration platform, continuous data of inpatients who underwent PCI in a tertiary cardiovascular specialized hospital in Beijing from August 1, 2024 to October 31, 2024 were collected to construct a retrospective observational cohort. After data cleaning and preprocessing, descriptive statistical methods were used to understand the characteristics of PCI patients and the current status of phase I cardiac rehabilitation nursing intervention. Multiple correction methods and effect size assessment were used to quantify the actual clinical effects of post-PCI rehabilitation intervention, and the effectiveness and potential influencing factors of personalized rehabilitation strategies were analyzed through a critical care subgroup model.

Results:  

1. Construction of the PCI Nursing Registration and Registration Platform

(1) The PCI nursing registration and registration platform constructed in this study includes 6 primary dimensions, 48 secondary items, and 176 parameters, covering demographic characteristics, disease history and risk factors, PCI treatment characteristics, and cardiac rehabilitation nursing intervention.

(2) The functions of the PCI nursing registration and registration platform include: ① Structured data extraction from the HIS system; ② Manual entry of unstructured information; ③ Real-time logical verification; ④ Dual traceability verification. The pre-experiment stage (n=30) verification showed that the system data loss rate was optimized to less than 8%, the median time for single case registration was 23.5 minutes, and the compliance rate of traceability verification exceeded 95%.

2. Demographic and clinical characteristics of patients after PCI

A total of 5,684 patients admitted for PCI were included in the analysis.

(1) Demographic characteristics showed that the proportion of males was significant (78.3%), with an average age of 60.06 ± 14.31 years. The 60-75 age group had the highest proportion (47.3%). Among them, 93.1% were married, and the main occupations were retired (31.7%), commercial and service industry (22.3%), and professional and technical workers (17.1%). The coverage rate of basic medical insurance for non-local urban residents was 77.3%.

(2) Clinical characteristics showed that in terms of past medical history, cardiovascular-related risk factors were mainly hyperlipidemia (77.4%) and hypertension (63.4%), followed by smoking history (49.4%) and diabetes (38.2%). In terms of PCI treatment, single-vessel disease had the highest proportion (78.9%), followed by double-vessel (18.8%) and triple-vessel disease (2.3%). 38.0% of the patients had a history of previous PCI. 99.3% of the patients received balloon-assisted treatment, among which 52.9% of the patients used ≥ 3 balloons, and 22.1% did not combine stent implantation. Among the patients who received stent implantation, 52.3% of the patients had ≥ 2 stents implanted this time. 3.8% of the patients had delayed catheter removal at the puncture site after surgery, and 7.7% of the patients were transferred to the CCU for intensive care after surgery.

3. Current status of stage I cardiac rehabilitation nursing intervention for patients after PCI

All 5,684 patients received routine cardiac rehabilitation nursing during hospitalization. Only 2.85% (162/5,684) of the patients received personalized cardiac rehabilitation nursing, which included graded exercise rehabilitation, pulmonary function rehabilitation, smoking cessation guidance, and health education. The average number of personalized rehabilitation interventions received was 2.06 times, covering graded manual training (bed training implementation rate 74.07%, average 1.64 times per case; bedside training implementation rate 14.2%, average 2.17 times per case) and pulmonary function rehabilitation (implementation rate 85.19%, average 1.90 times per case). Among them, 12.96% (21/162) of the patients were able to advance from bed to bedside activities in rehabilitation.

4. Effect of stage I cardiac rehabilitation nursing intervention for patients after PCI

(1) Recovery of cardiac function

① Left ventricular ejection fraction (LVEF) showed significant dynamic changes at admission, post-surgery, and discharge (χ² = 61.23, p < 0.001). The post-surgery value was lower than the baseline at admission (all p < 0.05), and although it partially recovered at discharge, it was still lower than the baseline level. At admission, 6.4% of the patients (366/5,684) had LVEF < 50%, and 89.9% were within the target range (50-70%). By discharge, the proportion of LVEF < 50% decreased to 5.9% (335/5,684), but only 14.2% (52/366) of the patients with a low baseline recovered to the normal range. In the entire cohort, 25.8% (1,467/5,684) of the patients had improved LVEF; ② Creatine kinase isoenzyme (CK-MB) distribution at admission, post-surgery, and discharge showed significant differences (χ² = 2,868.05, p < 0.001). CK-MB was significantly higher post-surgery than the baseline at admission, and although it partially decreased at discharge, it was still higher than the baseline level. The effect size r value (0.30 - 0.60) indicated that the post-surgery change had a moderate to large effect. ③There were significant differences in the distribution of N-terminal pro-B-type natriuretic peptide (NT-proBNP) at admission, post-operation and discharge (χ² = 917.95, p < 0.001). NT-proBNP was significantly higher post-operation than at admission, and although it partially decreased at discharge, it remained higher than the baseline level. The effect size r value (0.05 - 0.30) indicated that the change was of small to moderate effect.

(1) Improvement in daily living ability

At admission, 85.84% (4879 cases) of patients had a functional status of L4 (fully independent), and at discharge, 94.19% (5354 cases) maintained or improved to L4. Among the original L4 group, 85.45% (4857 cases) did not experience functional decline. Among patients with L1 (fully assisted) at admission, 70.0% (159/227) improved to L3/L4 (mostly/fully independent) at discharge, and in the L2 (partially assisted) group, 90.2% (101/112) achieved functional improvement. Chi-square test showed a highly significant association between functional status at admission and discharge (p < 0.001), and daily living ability showed a gradual improvement trend (χ² = 1188.446, p < 0.001).

(2) Control of risk factors

The in-hospital smoking cessation rate of PCI patients was 100% (5684/5684). Regarding blood glucose control, the rate of achieving the fasting blood glucose target increased from 43.7% (2484/5684) at admission to 59.4% (3378/5684) at discharge. Among diabetic patients, 77.2% (1674/2169) achieved a fasting blood glucose level of < 7.0 mmol/L. In terms of lipid management, the combined target achievement rate of LDL-C (< 1.8 mmol/L) and non-HDL-C (< 2.6 mmol/L) was 39.1% (2225/5684), and only 19.1% (1085 cases) achieved all four lipid targets. 33.7% of patients (1918 cases) had elevated triglycerides (TG), among which 1.2% (66 cases) had severe hypertriglyceridemia (≥ 5.7 mmol/L). Notably, 93.9% of patients (5339/5684) did not show improvement in LDL-C at discharge compared to the baseline, and only 5.4% (185/3455) of those who did not meet the target at admission achieved a reduction in LDL-C (0.96% with a reduction of ≥ 50%), indicating that there is still significant room for improvement in lipid management.

5. Analysis of the current status and effect of stage I cardiac rehabilitation nursing intervention for critically ill patients after PCI

(1) A total of 416 critically ill patients after PCI were included and divided into the conventional rehabilitation group (n = 254) and the individualized rehabilitation group (n = 162). There were significant differences in baseline characteristics between the two groups in terms of vascular lesion distribution, emergency PCI implementation rate, medical insurance coverage, occupation type, age, and baseline activities of daily living (ADL) score (all p < 0.05).

(2) After adjusting for baseline heterogeneity, the multiple linear regression model showed that individualized rehabilitation intervention was independently and positively correlated with ADL improvement in critically ill patients after PCI (β = 3.058, 95% CI: 0.461 - 5.656, p = 0.021), and the model's explanatory power reached 76.3% (adjusted R² = 0.763, p < 0.001).

(3) Male gender (β = 3.752, p = 0.036), younger age (β = -0.171/year, p = 0.002), and higher baseline left ventricular ejection fraction (β = 0.207/%EF, p = 0.008) were significantly associated with ADL improvement, while surgical procedures and biochemical indicators had no statistical significance (p > 0.05).

(4) Delayed initiation of rehabilitation (B = 0.771/day, p < 0.001) and increased total number of exercise training sessions (B = 1.121/session, p = 0.003) were significantly associated with prolonged hospital stay, while higher baseline left ventricular ejection fraction (LVEF) was associated with shorter hospital stay (B = -0.077/%EF, p = 0.031). Patients undergoing emergency PCI had a 33.042-point higher improvement in ADL compared to those undergoing elective PCI (B = 33.042, p < 0.001), while a history of PCI significantly reduced ADL improvement (B = -7.922, p = 0.021).

Conclusion:

1. The PCI nursing registration platform developed in this study is closely aligned with the clinical practice requirements in China. In single-center applications, the platform ensures both the efficiency of data collection and system stability. Its structured data management framework provides a solid foundation for subsequent multi-center studies.  

2. A clinical data governance model based on standardized processes can effectively integrate fragmented nursing data and serves as a valuable reference for achieving future multi-center data interoperability.  

3. Phase I cardiac rehabilitation nursing significantly enhances the daily living abilities of patients following PCI surgery. However, it is crucial to emphasize personalized cardiac rehabilitation for high-risk subgroups (elderly patients, those with prior PCI history, or impaired baseline cardiac function). Additionally, continuous monitoring of postoperative cardiac function changes is necessary, while balancing myocardial injury prevention, volume load management, and lipid control.  

4. Initiating cardiac rehabilitation nursing interventions at an early stage, combined with proactive optimization of preoperative left ventricular function, can substantially reduce hospital stays for critically ill patients and expedite the recovery process.