This study aimed to identify causes of in-hospital death in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PPCI) in the Beijing metropolitan area. A total of 56,763 PPCIs were performed at 56 eligible hospitals between January 1, 2010, and December 31, 2018, among which 1,278 patients died. Causes of death were analyzed and finally adjudicated by a review board. The overall in-hospital mortality rate was 2.25%, ranging annually from 1.96% to 2.48% over the study period. Of these, 1,069 (83.6%) deaths were attributed to disease severity-related causes, mainly cardiogenic shock of 44.4%, mechanical complications of 15.2%, malignant arrhythmia of 8.1% and heart failure of 6.2%. Another 209 (16.4%) patients died from PPCI-related complications, including coronary no-reflow of 8.5%, stent thrombosis of 3.5%, and PPCI-related bleeding of 2.4%. The incidence of PPCI-related death has decreased from 1.02% in 2010 to 0.15% in 2018 (p <0.001). Hospitals in the highest quartile PPCI volume (>130 PPCI annually) had lower incidence of in-hospital death (1.97% vs 2.62%, 2.99%, and 2.56%, p <0.001), disease severity-related death (1.66% vs 2.13%, 2.4%, and 2.17%, p <0.001) and PPCI-related death (0.31% vs 0.48%, 0.59%, and 0.39%, p = 0.003), as compared to those with the first, second and third quartiles of annual PPCI volume. In conclusion, among patients with STEMI and treated with PPCI, in-hospital mortality keeps at a relatively low level in Beijing area. Most deaths are due to pathophysiological deteriorations following STEMI. Hospital PPCI volume remains serve as an important indicator for quality of care.
The ST-segment elevation myocardial infarction (STEMI) is a severe type of coronary artery disease which causes millions of death and enormous medical costs worldwide. In recent decades, widespread utilization of reperfusion therapy has significantly reduced mortality associated with STEMI. Findings from the French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction (FAST-MI Program) indicate a decline in 6-month mortality from 17.2% in 1995 to 5.3% in 2015, paralleling increased use of reperfusion therapy. The Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines Registry (ACTION-GWTG Registry) shows a 25% reduction of in-hospital mortality from 2008 to 2012. Current guidelines , recommend rapid reperfusion, with primary percutaneous coronary intervention (PPCI) as the first choice. In China, STEMI remains one of leading causes of mortality. A report shows that death rates of acute myocardial infarction (AMI) continued to increase from 2002 to 2016, reaching 58.69 per 100,000 in cities and 74.72 per 100,000 in rural areas. The China PEACE-Retrospective Acute Myocardial Infarction Study (China PEACE study) demonstrated little improvement in in-hospital mortality from STEMI despite increased the use of reperfusion therapy. Moreover, China Acute Myocardial Infarction registry (CAMI registry) showed that only 57.5% of STEMI patients received reperfusion therapy and 46.0% of PPCI, with in-hospital mortality rate being nearly 3 times higher in county-level than provincial hospitals. Despite advances, key issues remain unclear: how low in-hospital mortality can be reduced after optimal PPCI, what the main causes of in-hospital deaths are, and whether PPCI quality control affects operators’ performance and clinical outcomes. Few studies in recent decades have addressed these questions. In the present study utilizes data from the Beijing Percutaneous Coronary Intervention Registry (BJ-PCI Registry, NCT01417325) between 2010 and 2018. This analysis aims to identify the achievable in-hospital mortality rate, explore the causes of death, and evaluate the impact of quality control on outcomes in patients in STEMI patients undergone PPCI—critical knowledge for future reducing mortality in contemporary reperfusion era.
Methods
Study population and procedures
Numbers of patients who underwent PCI, including elective PCI, PPCI and rescue PCI at 56 qualified hospitals (21 tertiary hospitals and 35 nontertiary hospitals) in Beijing, were reported monthly to the Beijing Quality Control and Improvement Center for Cardiovascular Intervention located at Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS), and National Center for Cardiovascular Diseases (NCCD). Data of patients with STEMI who underwent PPCI and died during hospitalization were collected to constitute the BJ-PCI Registry, and were analyzed in the current study.
STEMI was diagnosed in accordance with international guidelines, based mainly on ST segment elevation of electrocardiogram (ECG) following ischemic symptoms lasting >20 minutes. After informed consent and loading doses of dual antiplatelet agents, PPCI were performed by experienced interventional cardiologists via transfemoral or transradial approach. Infarct related artery (IRA) was identified on emergent coronary angiogram, and PPCI was performed. Use of thrombus aspiration, 2b/3a inhibitors and stent implantation were at the operators’ discretion. Only IRAs were treated in almost all cases.
This study was approved by the institutional review board central committee at Fuwai Hospital, Chinese Academy of Medical Sciences, and National Center for Cardiovascular Diseases.
Data collection process
The BJ-PCI Registry is 1 part of a quality control and promotion project started in 2008. The number and type of PCI were recorded and reported monthly to the Beijing Quality Control and Improvement Center for Cardiovascular Intervention. For death cases, demographic, clinical and procedural information were meticulously collected by a dedicated registry coordinator at each hospital, alongside mandatory submission of procedure CDs to the Center. To ensure rigorous oversight, the director of the center convened a quarterly review board meeting comprising interventional and general cardiologists from each hospital’s quality control committee. The board meticulously scrutinized each procedure and adjudicated the cause of death thorough discussion ( Figure 1 ).
Study flow chart. PPCI = primary percutaneous coronary intervention.
Each coordinator underwent initial training that provided definitions and instructions for completing the standardized report form. All information was collected using a standardized process with rigorous quality control. Furthermore, semiannually inspection with random on-site audits and quarterly data checking at the Beijing Municipal Health Big Data and Policy Research Center were conducted to ensure data accuracy and avoid under-reporting and misinformation.
Definitions
STEMI was defined as the presence of typical ischemic chest pain or discomfort (lasting ≥10 to 20 minutes and not completely relieved by nitroglycerine), persistent ST-segment elevation in 2 contiguous leads or new or presumed new left bundle branch block (LBBB), with or without elevated cardiac biomarkers (e.g., CK-MB or troponin). Reperfusion treatment was initiated based on clinical and electrocardiogram (ECG) criteria without awaiting biomarker confirmation, consistent with guideline recommendations. PPCI was defined as PCI performed for STEMI without prior fibrinolysis. Cardiogenic shock was defined as systolic blood pressure persistently <90 mmHg or requiring vasopressors, inotropic support, or intra-aortic balloon pumping to maintain systolic blood pressure >90 mmHg.
Causes of death
The causes of death, adjudicated by the review board, were categorized as disease severity-related or PPCI-related. Disease severity-related death referred to mortality resulting from complications or deterioration of STEMI itself, such as cardiogenic shock, mechanical complications, malignant arrhythmia, heart failure and multiorgan failure, without procedural complications identified. Mechanical complications included free wall rupture, ventricular septal rupture and papillary muscle rupture. Malignant arrhythmia referred to incessant ventricular tachycardia or ventricular fibrillation.
The PPCI-related death referred to fatal complication of the procedure, including coronary no reflow, definite or probable stent thrombosis, coronary perforation and PPCI-related bleeding, acting as a determinant or precipitating factor for the patient’s demise. Coronary no reflow was defined as persistent thrombolysis in myocardial infarction (TIMI) flow grade ≤1 in the culprit vessel after balloon dilation or stent placement. Stent thrombosis was defined as “definite” after angiographic confirmation or “probable” in case of any unexplained death that was related to acute ischemia in the stented territory. Any bleeding was considered PPCI-related if it occurred within 72 hours postprocedure, and death from such bleeding was labeled as a procedural complication. Bleeding occurred after 72 hours was defined as the late bleeding, and considered non-PPCI related.
Statistical analysis
Continuous variables were summarized as mean ± standard deviation or median and interquartile range (IQR). Student t tests or rank tests were used to compare continuous variables. Categorical variables were summarized as frequency (group percentage) and compared between groups by Pearson X 2 or Fisher exact test. p <0.05 (2-sided test) was statistically significant. All analysis was performed with SAS 9.4 software (SAS Institute, USA).
Results
In-hospital death rate during 2010 to 2018
From January 2010 to December 2018, a total of 67,691 STEMI patients underwent emergent angiography in Beijing municipal area. Among them, 56,763 received PPCIs, were 33,824 (59.6%) treated at province-level hospitals. Another 10,928 patients did not receive PPCI (emergent angiography only) due to various reasons. A total of 1,278 patients died after PPCI and were included in this analysis. The overall in-hospital death rate was 2.25%, ranging from 1.96% to 2.48% annually ( Figures 2 and 3 ).
Number of PPCI and death during 2010 to 2018. PPCI = primary percutaneous coronary intervention.
In-hospital death rate in patients under PPCI from 2010 to 2018. PPCI = primary percutaneous coronary intervention.
Additionally, 253 patients died among the 10,928 who underwent angiography without PCI, yielding a mortality rate of 2.32%. The overall in-hospital mortality rate for the entire cohort was 2.26%.
Clinical and procedural characteristics
As shown in Tables 1 and 2 and Supplementary Table 1–3 , mean age was 69.7 ± 11.8 years, 766 (59.9%) were men. History of hypertension, diabetes, coronary heart disease and prior coronary revascularization were present in 721 (56.4%), 476 (37.2%), 270 (21.1%) and 155 (12.1%), respectively. Median symptom-to-door time was 300 (150 to 540) min, 26.2% arrived within 180 min, and 18.1% after 720 min. Infarctions were anterior in 779 (61.0%) of patients, and the culprit vessel was left main (LM) in 7.4%, left anterior descending (LAD) in 52.0%, and right coronary artery (RCA) in 27.2%. Cardiogenic shock occurred in 41%, and 90.1% had multivessel diseases. TIMI flow grade 3 post-PPCI was achieved in 66.5%. The majority (78.2%) of patients died within the first week after PPCI, and 40.2% within 24h.
Table 1
Patient characteristics between disease severity-related and primary percutaneous coronary intervention–related death
|
Total
( n = 1,278) |
Disease severity-related ( n = 1,069, 83.6%) |
PPCI-related
( n = 209, 16.4%) |
p-value | |
|---|---|---|---|---|
| Age | ||||
| Mean ± SD | 69.7 ± 11.8 | 69.6 ± 12.0 | 70.1 ± 11.1 | 0.57 |
| <65 years, n (%) | 372 (29.1) | 318 (29.7) | 54 (25.8) | 0.26 |
| ≥65 years, n (%) | 906 (70.9) | 751 (70.3) | 155 (74.2) | |
| Sex | 0.26 | |||
| male , n (%) | 766 (59.9) | 648 (60.6) | 118 (56.5) | |
| female, n (%) | 512 (40.1) | 421 (39.4) | 91 (43.5) | |
| Hypertension, n (%) | 721 (56.4) | 601 (56.2) | 120 (57.4) | 0.75 |
| Diabetes, n (%) | 476 (37.2) | 395 (37.0) | 81 (38.8) | 0.62 |
| History of CHD, n (%) | 270 (21.1) | 227 (21.2) | 43 (20.6) | 0.83 |
| Prior revascularization, n (%) | 155 (12.1) | 131 (12.3) | 24 (11.5) | 0.76 |
| OTD, min | ||||
| median (IQR) | 300 (150-540) | 300 (150-540) | 240 (120-540) | 0.63 |
| <180, n (%) | 335 (26.2) | 273 (25.5) | 62 (29.7) | 0.22 |
| 180-, n (%) | 419 (32.8) | 352 (32.9) | 67 (32.1) | 0.81 |
| 360-, n (%) | 293 (22.9) | 252 (23.6) | 41 (19.6) | 0.21 |
| >720, n (%) | 231 (18.1) | 192 (18.0) | 39 (18.7) | 0.81 |
| SBP (mmHg) | ||||
| Mean ± SD | 105.6 ± 29.0 | 104.0 ± 29.2 | 113.8 ± 26.0 | <0.001 |
| <90 mmHg, n (%) | 412 (32.2) | 375 (35.1) | 37 (17.7) | <0.001 |
| ≥90 mmHg, n (%) | 866 (67.8) | 694 (64.9) | 172 (82.3) | |
| HR (bpm) | ||||
| Mean ± SD | 83.0 ± 24.9 | 83.0 ± 25.1 | 83.2 ± 23.8 | 0.89 |
| <60, n (%) | 229 (17.9) | 195 (18.2) | 34 (16.3) | 0.50 |
| 60-99, n (%) | 765 (59.9) | 631 (59.0) | 134 (64.1) | 0.17 |
| ≥100, n (%) | 284 (22.2) | 243 (22.7) | 41 (19.6) | 0.32 |
| Killip classification | <0.001 | |||
| 1 | 320 (25.0) | 215 (20.1) | 105 (50.2) | <0.001 |
| 2 | 392 (30.7) | 320 (29.9) | 72 (34.4) | 0.20 |
| 3 | 42 (3.3) | 38 (3.6) | 4 (1.9) | 0.22 |
| 4 | 524 (41.0) | 496 (46.4) | 28 (13.4) | <0.001 |
| Infarction sites | 0.03 | |||
| anterior , n (%) | 779 (61.0) | 668 (62.5) | 111 (53.1) | 0.01 |
| inferior and lateral , n (%) | 462 (36.1) | 373 (34.9) | 89 (42.6) | 0.03 |
| others , n (%) | 37 (2.9) | 28 (2.6) | 9 (4.3) | 0.18 |
Table 2
Procedural information between disease severity-related and primary percutaneous coronary intervention–related death
|
Total
( n = 1,278) |
Disease severity-related ( n = 1,069, 83.6%) |
PPCI-related
( n = 209, 16.4%) |
p-value * | ||
|---|---|---|---|---|---|
| NO. of diseased vessels | 0.51 | ||||
| 1, n (%) | 126 (9.9) | 108 (10.1) | 18 (8.6) | ||
| ≥2, n (%) | 1,152 (90.1) | 961 (89.9) | 191 (91.4) | ||
| Culprit vessel | 0.30 | ||||
| LM, n (%) | 95 (7.4) | 82 (7.7) | 13 (6.2) | 0.47 | |
| LAD, n (%) | 664 (52.0) | 560 (52.4) | 104 (49.8) | 0.49 | |
| LCX, n (%) | 122 (9.5) | 107 (10.0) | 15 (7.2) | 0.20 | |
| RCA, n (%) | 348 (27.2) | 280 (26.2) | 68 (32.5) | 0.06 | |
| IRA >1, n (%) | 49 (3.8) | 40 (3.7) | 9 (4.3) | 0.70 | |
| Stent placed, n (%) | 1,016 (79.5) | 848 (79.3) | 168 (80.4) | 0.73 | |
| No. of Stents | 0.03 | ||||
| 0, n (%) | 262 (20.5) | 221 (20.7) | 41 (19.6) | 0.73 | |
| 1, n (%) | 663 (51.9) | 568 (53.1) | 95 (45.5) | 0.04 | |
| ≥2, n (%) | 353 (27.6) | 280 (26.2) | 73 (34.9) | 0.01 | |
| Use of IABP, n (%) | 555 (43.4) | 460 (43.0) | 95 (45.5) | 0.52 | |
| TIMI flow grade after PPCI | <0.001 | ||||
| 0, n (%) | 161 (12.6) | 82 (7.7) | 79 (37.8) | <0.001 | |
| 1, n (%) | 58 (4.5) | 29 (2.7) | 28 (13.4) | <0.001 | |
| 2, n (%) | 209 (16.4) | 183 (17.1) | 26 (12.4) | 0.09 | |
| 3, n (%) | 850 (66.5) | 775 (72.5) | 75 (35.9) | <0.001 | |
| Time to death | 0.15 | ||||
| <24h, n (%) | 514 (40.2) | 429 (40.1) | 85 (40.7) | 0.88 | |
| 1 to 3 days, n (%) | 265 (20.7) | 228 (21.3) | 37 (17.7) | 0.24 | |
| 4 to 7 days, n (%) | 221 (17.3) | 182 (17.0) | 39 (18.7) | 0.57 | |
| 8 to 14 days, n (%) | 151 (11.8) | 124 (11.6) | 27 (12.9) | 0.59 | |
| >14 days, n (%) | 127 (9.9) | 106 (9.9) | 21 (10.0) | 0.95 | |
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