Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) has shown a higher procedural risk. The goal of this study was to compare complications and mortality of patients undergoing CTO-PCI with patients without CTO (non-CTO-PCI) by using propensity score matching. The national Inpatient Sample database (NIS), years 2016-2020, was studied using International Classification of Diseases, Tenth Revision Codes. Among 501,680 PCI hospitalizations, 250,840 had CTO-PCI and none-CTO-PCI. After matching, CTO-PCI had higher mortality (3.12% vs 2.62%, OR: 1.20, CI: 1.1 to 1.29, p <0.001) and higher odds of procedure-related myocardial infarction (0.65% vs 0.28%, (OR: 2.39, CI: 1.95–2.92, p <0.001), perforation (0.62% vs 0.19%, OR: 3.33, CI: 2.63 to 4.22, p <0.001), tamponade (0.40% vs 0.18%, OR: 2.18, CI: 1.7 to 2.8, p <0.001), procedural bleeding (1.13% vs 0.63%, OR: 1.8, CI: 1.57 to 2.07, p <0.001), post procedural cerebral infarction (0.03 vs 0.01, OR: 2.43, CI: 0.99 to 5.94, p = 0.05), acute post procedural respiratory failure (0.45% vs. 0.23%, OR: 1.96, CI: 1.56–2.47, p <0.001) and contrast induced nephropathy (0.07% vs 0.04%, OR: 1.95, CI: 1.10 to 3.44, p = 0.02). Overall risk for all complications was more than double (2.56% vs 1.21%, OR: 2.14; 1.93–2.37, p <0.001). When perforation, tamponade, or bleeding occurred, mortality was significantly higher in CTO-PCI compared to non-CTO-PCI (perforations: 2.43% vs. 0.69 %, p <0.001, tamponade: 2.88% vs 1.68%, p = 0.03 and bleeding 2.30% vs 1.14%, p = 0.02). In conclusion, propensity-matched national cohort confirmed that CTO-PCI was associated with higher in-hospital complications and mortality compared to non-CTO-PCI, mostly driven by perforation, bleeding, and tamponade. These findings support the previous report that CTO-PCI is associated with worse in-hospital outcomes.
A chronic total occlusion (CTO) of the coronary artery is defined as a complete coronary occlusion for ≥3 months. ,, It is also apparent that the number of patients with CTO who undergo PCI has continued to increase over the years, likely as a result of improvements in catheter technology and revascularization approaches. ,, For example, a study completed in 2013 demonstrated that 30% of patients with CTO had a PCI. The benefits of successful PCI for those patients with CTO are very limited, if any, including angina relief or improved quality of life. ,,, However, the methodology of studies showing such benefits tends to compare outcomes of successful vs unsuccessful PCI for CTO instead of comparing PCI for CTO with optimal medical therapy (OMT) or no therapy. Those studies that do explore PCI for CTO against OMT or no therapy have found no significant difference in hard outcomes like mortality. , Moreover, PCI in the setting of CTO has the potential for many serious negative ramifications that can result from the procedure, such as pseudoaneurysm, retroperitoneal bleed, periprocedural MI, coronary dissection, arrhythmias, stent thrombosis, stroke, and many more. ,, A retrospective observational cohort study of CTO-PCI interventions revealed higher mortality and complications in comparison to non-CTO PCI despite multivariable adjustment. However, despite being the largest study ever reported, it was not a propensity score match. , In accordance with conflicting studies that make different recommendations regarding the use of PCI in the setting of CTO, there is no professional consensus, and current recommendations remain vague. The goal of this study was to perform the largest retrospective data analysis comparing CTO PCI to non-CTO PCI for the occurrence of in-hospital mortality and complications using propensity score matching, adjusting for numerous baseline characteristics and high-risk features.
Methods
Data Source
The study cohort was derived from the National Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), and Agency for Healthcare Research and Quality database (AHRQ). The NIS is the largest U.S. database of hospital stays, containing a de-identified sample of discharge records from hospitals nationwide; it’s one of several files in HCUP, a family of de-identified hospital databases and tools curated from state and hospital data systems; and AHRQ is the federal agency that sponsors HCUP and makes these datasets and methods available. HCUP NIS data are publicly available and deidentified, and thus, the study was exempt from institutional review board approval. The NIS database contains weighted, discharge‐level data approximating ∼35 million hospitalizations annually, derived from a 20% stratified sample of discharges from U.S. community hospitals, and is designed to yield national estimates representative of ∼98% of the U.S. population.
Study Population
We queried the NIS for the 2016–2020 releases and constructed the cohort using both ICD-10-CM diagnoses and ICD-10-PCS procedure codes. Hospitalizations with PCI were identified by ICD-10-PCS codes 02703(4–7)Z, 02703(D–G)Z, 02703TZ, 02713(4–7)Z, 02713(D–G)Z, 02713TZ, 02723(4–7)Z, 02723(D–G)Z, 02723TZ, 02733(4–7)Z, 02733(D–G)Z, 02733TZ, 02H(0–3)3DZ, 02H(0–3)3YZ, 027(0–3)3ZZ, 02C(0–3)3Z7, 02C(0–3)3ZZ, and 02F(0–3)3ZZ. Cases of CTO were flagged using ICD-10-CM I25.82. Analyses were restricted to patients older than 30 years, and demographic variables extracted for description included age, sex, and race.
We evaluated in-hospital all-cause mortality and procedure-related complications identified by ICD-10-CM codes: postprocedural myocardial infarction (I97.89), contrast-induced nephropathy (N99.0), cardiac perforation (I97.51), procedural bleeding (I97.410, I97.411, I97.610, I97.611, I97.630, I97.631), cardiac tamponade (I31.4), acute postprocedural respiratory failure (J95.821), and postprocedural ischemic stroke (I97.821).
Statistical Analysis
All analyses were conducted using SAS software (version 9.4; SAS Institute, Cary, NC), and STATA 19.5 (Stata Corporation, College Station, TX). Data were obtained from the National Inpatient Sample (NIS) for years 2016–2020 and analyzed in accordance with Healthcare Cost and Utilization Project (HCUP) recommendations to account for the complex survey design.
Descriptive Analysis
Baseline patient demographics, clinical characteristics, and hospital-level variables were summarized for patients undergoing CTO intervention and those without CTO intervention. Continuous variables were reported as means with standard deviations or medians with interquartile ranges, as appropriate, and compared using survey-weighted linear regression. Categorical variables were reported as weighted percentages and compared using survey-weighted Rao–Scott chi-square tests.
Propensity Score Estimation and Matching
To reduce confounding due to baseline differences between CTO and non-CTO patients, propensity score matching was performed. Propensity scores representing the probability of undergoing CTO intervention were estimated using survey-weighted logistic regression, incorporating hospital clustering (HOSP_NIS), stratification (NIS_STRATUM), and discharge-level sampling weights (DISCWT). Covariates included age, gender race, chronic kidney disease, chronic obstructive pulmonary disease, three-vessel coronary artery disease, prior percutaneous coronary intervention, history of coronary artery bypass grafting, anemia, cardiomyopathy, smoking status (current and former), valvular heart disease, endocarditis, prior stroke, diabetes mellitus, hypertension, hyperlipidemia, alcohol use, and peripheral vascular disease (PVD).
Patients were matched 1:1 using greedy nearest-neighbor matching on the logit of the propensity score with a caliper width of 0.2 standard deviations of the logit of the propensity score. Only matched pairs were retained for downstream analyses. Covariate balance before and after matching was assessed using standardized mean differences, with values <0.1 indicating adequate balance.
Outcome Analysis
Primary and secondary outcomes, including in-hospital mortality and postprocedural complications, were compared between matched CTO and non-CTO cohorts. Survey-weighted logistic regression models were used to estimate odds ratios (ORs) with 95% confidence intervals (CIs), incorporating propensity score matching weights to account for the matched design. A survey-weighted generalized linear model (GLM) with a negative binomial distribution and a log link to model Length of stay (LOS). We used incidence rate ratios (IRRs) to quantify the association between the predictor variables and LOS. All statistical tests were 2-sided, and a p-value <0.05 was considered statistically significant. All analyses were conducted following the implementation of population discharge weights.
Results
Propensity score matching yielded 250,840 well-matched pairs (N = 501,680). Covariate balance was excellent, with all standardized differences <0.1, most <0.01. While 3-vessel disease, cardiomyopathy history, and stroke history remained statistically significant by conventional testing (all p <0.001), their standardized differences were minimal (0.028, 0.022, and 0.019, respectively), well below the recommended threshold of 0.1 for adequate balance.
After matching, CTO-PCI had higher mortality (3.12% vs 2.62%, OR: 1.20, CI: 1.1 to 1.29, p <0.001) and higher odds of procedure-related myocardial infarction (0.65% vs 0.28%, (OR: 2.39, CI: 1.95 to 2.92, p <0.001), perforation (0.62% vs 0.19%, OR: 3.33, CI: 2.63 to 4.22, p <0.001), tamponade (0.40% vs 0.18%, OR: 2.18, CI: 1.7 to 2.8, p <0.001), procedural bleeding (1.13% vs 0.63%, OR: 1.8, CI: 1.57 to 2.07, p <0.001), post procedural cerebral infarction (0.03 vs 0.01, OR: 2.43, CI: 0.99 to 5.94, p = 0.05), acute post procedural respiratory failure (0.45% vs. 0.23%, OR: 1.96, CI: 1.56–2.47, p< 0.001) and contrast induced nephropathy (0.07% vs 0.04%, OR: 1.95, CI: 1.10 to 3.44, p = 0.02). Overall risk for all complications was more than double in CTO-PCI cohort (2.56% vs 1.21%, OR 2.14; 1.93 to 2.37, p <0.001). When perforation, tamponade, or bleeding occurred, mortality was significantly higher in CTO-PCI compared to non-CTO-PCI (perforations: 2.43% vs. 0.69 %, p <0.001, tamponade: 2.88% vs 1.68%, p = 0.03, and bleeding 2.30% vs 1.14%, p = 0.02) ( Tables 1 and 2 ) .
Table 1
Study cohort baseline characteristics and propensity score-matched risk factors
| Propensity score matching | CTO | ||||
|---|---|---|---|---|---|
| 2016–2020 | Total (N = 501,680) | No (N = 250,840) | Yes (N = 250,840) | p-value | Odds ratio (C.I.) |
| Propensity score matched risk factors | Standardized Difference | ||||
| Age | 0.77 | 0.002 | |||
| Mean±SD | 66.98±11.79 | 66.97±11.81 | 66.99±11.77 | ||
| Median (IQR) | 67(59-76) | 67(59-76) | 67(59-76) | ||
| Gender | 0.17 | -0.008 | |||
| Male | 73.36% | 73.55% | 73.17% | ||
| Female | 26.64% | 26.45% | 26.83% | ||
| Race | 0.55 | ||||
| White | 75.53% | 75.74% | 75.33% | ||
| Black | 9.85% | 9.82% | 9.87% | ||
| Hispanic | 7.83% | 7.75% | 7.90% | ||
| Asian/Pac Isl | 2.87% | 2.85% | 2.88% | ||
| Native American | 0.58% | 0.53% | 0.63% | ||
| Others | 3.35% | 3.31% | 3.38% | ||
| PCI three vessel | 2.22% | 2.05% | 2.39% | <0.001 | 0.028 |
| Diabetes | 47.35% | 47.42% | 47.27% | 0.64 | -0.003 |
| Chronic kidney disease | 27.41% | 27.38% | 27.43% | 0.87 | 0.001 |
| Hypertension | 87.49% | 87.64% | 87.33% | 0.16 | -0.009 |
| COPD | 20.44% | 20.39% | 20.49% | 0.73 | 0.002 |
| Prior percutaneous coronary intervention | 50.25% | 50.25% | 50.24% | 0.99 | 0.000 |
| History of coronary artery bypass graft | 22.89% | 22.87% | 22.91% | 0.87 | 0.001 |
| History of anemia | 0.01% | 0.01% | 0.02% | 0.44 | 0.004 |
| History of cardiomyopathy | 0.77% | 0.67% | 0.88% | <0.001 | 0.022 |
| Previous smokers | 30.38% | 30.34% | 30.43% | 0.79 | 0.002 |
| Current smokers | 17.15% | 17.03% | 17.26% | 0.37 | 0.006 |
| Valvular heart disease | 12.08% | 11.98% | 12.18% | 0.34 | 0.007 |
| History of stroke | 1.57% | 1.44% | 1.71% | <0.001 | 0.019 |
| Hyperlipidemia | 77.41% | 77.62% | 77.20% | 0.15 | -0.010 |
| Alcohol | 2.73% | 2.64% | 2.83% | 0.05 | 0.011 |
| Peripheral vascular diseases | 8.65% | 8.48% | 8.81% | 0.07 | 0.012 |
| Age group | 0.64 | ||||
| 30-45 | 3.83% | 3.83% | |||
| 46-60 | 25.57% | 25.57% | |||
| 61+ | 70.61% | 70.61% | |||
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