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Racial Disparities in Chronic Total Occlusion Percutaneous Coronary Interventions: Insights From the PROGRESS-CTO Registry
Abstract
Objectives. There is limited data on race and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The authors sought to evaluate CTO PCI techniques and outcomes in different racial groups.
Methods. We examined the baseline characteristics and procedural outcomes of 11 806 CTO PCIs performed at 44 US and non-US centers between 2012 and March 2023. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, repeat target-vessel revascularization, pericardiocentesis, cardiac surgery, and stroke prior to discharge.
Results. The most common racial group was White (84.5%), followed by Black (5.7%), “Other” (3.9%), Hispanic (2.9%), Asian (2.4%), and Native American (0.7%). There were significant differences in the baseline characteristics between different racial groups. When compared with non-White patients, the retrograde approach and antegrade dissection re-entry were more likely to be the successful crossing strategies in White patients without any significant differences in technical success (86.4% vs 86.4%; P = .93), procedural success (84.8% vs 85.0%; P = .79), and in-hospital MACE (2.0% vs 1.5%; P = .15) between the 2 groups. The technical success rate was significantly higher in the “Other” racial group (91.0% vs 86.4% in White, 86.9% in Asian, 84.5% in Black, 84.5% in Hispanic, and 83.3% in Native American; P = .03) without any significant differences in procedural success or in-hospital MACE rates between the groups.
Conclusions. Despite differences in baseline characteristics and procedural techniques, the procedural success and in-hospital MACE of CTO PCI were not significantly different between most racial groups.
Introduction
There has been a rapid growth in racial and ethnic minorities in the United States; it is estimated that by 2060, the proportion of non-Hispanic White population in the US will decrease to 44% from approximately 60% currently.1 Racial disparities have been reported in the treatment of coronary artery disease (CAD), structural heart disease, and peripheral arterial disease.2,3
In the past few years, there has also been considerable development in coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI), with success rates of CTO PCI approaching 90% in the hands of experienced operators around the world.4-9 These outcomes are due to advancement in techniques, technology, and algorithmic approaches to CTO PCI.10,11 Most patients included in CTO PCI studies were White. Despite increasing data on racial disparities in post-PCI outcomes in general,12-15 there is limited data on racial disparities in CTO PCI. We compared contemporary techniques and outcomes of retrograde CTO PCI between racial groups in a large multicenter registry.
Methods
We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 11 806 CTO PCIs, performed at 44 US and non-US centers (Canada, Egypt, Greece, Russia, and Turkey) between 2012 and March 2023. Data collection was recorded in a dedicated online database (PROGRESS-CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; ClinicalTrials.gov identifier: NCT02061436). Study data were collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at the Minneapolis Heart Institute Foundation.16,17 The study was approved by the institutional review board of each site. In this analysis, we compared the baseline characteristics, procedural aspects, and in-hospital outcomes of CTO PCI between different racial groups. The race was categorized by the physician or research personnel entering the data. As Hispanic ethnicity can overlap with other races, this was made a separate category altogether. All Hispanic patients regardless of being White or Black Hispanics were categorized in the Hispanic category.
Coronary CTOs were defined as coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3 months duration. Estimation of the duration of occlusion was clinical, based on the first onset of angina, prior history of myocardial infarction (MI) in the target-vessel territory, or comparison with a prior angiogram. Poor quality distal vessel was defined as the distal target distal vessel with a less than 2-mm diameter or with significant diffuse atherosclerotic disease based on visual angiographic assessment/estimation by the operators. Calcification was assessed by angiography as mild (spots), moderate (involving ≤ 50% of the reference lesion diameter), or severe (involving > 50% of the reference lesion diameter). Moderate proximal vessel tortuosity was defined as the presence of at least 2 bends greater than 70° or 1 bend greater than 90°, and severe tortuosity as 2 bends greater than 90° or 1 bend greater than 120° in the CTO vessel. Good quality distal vessel was defined as the distal target distal vessel with a greater than 2-mm diameter or without significant diffuse atherosclerotic disease based on visual angiographic assessment/estimation by the operators.
Technical success was defined as successful CTO revascularization with achievement of less than 30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow. Procedural success was defined as the achievement of technical success without any in-hospital major adverse cardiac event (MACE). In-hospital MACE included any of the following adverse events prior to hospital discharge: death, MI, recurrent symptoms requiring urgent repeat target-vessel revascularization with PCI or coronary artery bypass graft (CABG) surgery, tamponade requiring either pericardiocentesis or surgery, and stroke. MI was defined using the Third Universal Definition of Myocardial Infarction (type 4a MI).18 Vascular access complications were defined as vascular access bleeding, acute vessel closure, or development of pseudoaneurysm or arteriovenous fistula. The Japanese CTO (J-CTO) score was calculated as described by Morino et al19 and the PROGRESS-CTO score as described by Christopoulos et al.20
Statistical analysis. Categorical variables were expressed as percentages and were compared using Pearson’s chi-squared test or Fisher’s exact test, as appropriate. Continuous variables were presented as mean ± standard deviation or median (interquartile range [IQR]), unless otherwise specified, and were compared using the student’s t-test and one-way analysis of variance (ANOVA) for normally distributed variables and the Wilcoxon rank-sum test for non-parametric variables. Variables associated with technical success and MACE were examined using univariable logistic regression. All statistical analyses were performed using JMP, version 16.0 (SAS Institute). A P-value of less than .05 was considered to indicate statistical significance.
Results
A total of 11 806 CTO PCI cases were analyzed. The most common racial group was White (n = 9978 patients, 84.5% of the total patient population), followed by Black (n = 670, 5.7%), Hispanic (n = 337, 2.9%), Asian (n = 278, 2.4%), and Native American (n = 84, 0.7%). The group “other” did not belong to any of the above racial groups and comprised 3.9% (n = 458) of the population. The baseline clinical characteristics of the study patients are summarized in Table 1. Mean age was 64.7 ± 21.2 years. When compared with non-White patients, White patients were more likely to be older, men, and smokers; more likely to have cerebrovascular disease and family history of heart disease; and less likely to have diabetes mellitus and heart failure. The mean left ventricular ejection fraction was slightly lower and baseline creatinine level slightly higher in non-White patients.
Non-White patients were less likely to present with stable angina and more likely to present with acute coronary syndromes (unstable angina, non-ST elevation, and ST elevation myocardial infarction [STEMI]) and more likely to be on maximally tolerated antianginal therapy when compared with White patients.
The baseline angiographic characteristics of the study lesions are demonstrated in Table 2. The most common CTO target vessel was the right coronary artery (RCA) (52.5%). Among White patients, the target vessel in CTO lesions was more often the RCA and less often the left anterior descending or left circumflex artery. There were no significant differences between the J-CTO and PROGRESS-CTO scores between the 2 groups. CTO lesions in the White patients were more likely to have had a previous unsuccessful CTO PCI attempt, moderate to severe calcification, good quality distal landing zone, and interventional collaterals. There were no significant differences in moderate to severe tortuosity, proximal cap ambiguity, blunt/no stump, lesion length, and in-stent occlusions in CTO lesions between the 2 groups.
Procedural strategies are summarized in Table 2 and Figure 1. Antegrade wiring was the most successful crossing strategy in lesions in both White (56.1%) and non-White (59.1%) patients. CTO lesions in White patients less often used antegrade wiring, and more often used antegrade dissection re-entry (ADR) and the retrograde approach as final successful crossing strategies.
CTO lesions in White patients were more likely to be balloon-uncrossable and balloon-undilatable and required higher use of rotational atherectomy and intravascular lithotripsy when compared with CTO lesions in non-White patients. CTO PCI in White patients also required higher air kerma radiation dose and more stents. The fluoroscopy times and contrast volumes were not significantly different between the 2 groups.
Intravascular ultrasound (IVUS) was used in 48.2% of all cases. Use of IVUS was significantly higher in non-White than in White patients (54.1% vs 47.2%; P < .001). IVUS was used to facilitate wire crossing (9.8%), guide the reverse-controlled antegrade and retrograde tracking (2.1%), resolve proximal cap ambiguity/IVUS-guided puncture (9.1%), and for stent sizing (68.4%) and optimization (63.1%).
There were no significant differences between White and non-White patients in overall technical success (86.4% vs 86.4%; P = .93), procedural success (84.8% vs 85.0%; P = .79), and in-hospital MACE (2.0% vs 1.5%; P = .15) (Table 3; Figure 2). The incidence of coronary perforation was significantly higher in White patients, however there were no significant differences in the incidence of tamponade and pericardiocentesis between the 2 groups, suggesting that most perforations were nonactionable. There were no significant differences in the incidence of death, MI, stroke, and repeat PCI between the 2 groups.
There were significant differences in the baseline clinical and angiographic characteristics between different races (Table 4). The proportion of males in Black patients was lower when compared with other racial groups. Native American patients had the highest prevalence of prior CABG, were more likely to have longer lesion length, and less likely to have interventional collaterals. Hispanic patients were more likely to have moderate to severe target vessel calcification, followed by White patients. The patients in the “other” group were more likely to have proximal cap ambiguity and less likely to have good quality distal landing zone. The overall J-CTO score was the highest in Blacks (2.5 ± 1.2), followed by Whites (2.4 ± 1.3) and Native Americans (2.4 ± 1.2). Blacks also had the highest PROGRESS-CTO score among all racial groups.
Antegrade wiring was the most successful crossing strategy in all racial groups (Table 5). Antegrade wiring was more often and the retrograde approach less often the final successful crossing strategy in the Hispanic population. The retrograde approach was least likely to be the successful crossing strategy in Hispanic patients, while antegrade dissection re-entry was the least likely successful crossing strategy in the “other” group. The frequency of unsuccessful CTO lesion crossing ranged from 10.0% to 15.3% and was lowest in the “other” group and highest in Native American patients. The procedural metrics also varied significantly between groups.
Technical success was significantly higher in the “other” racial group (91.0% vs 86.4% in White, 86.9% in Asian, 84.5% in Black, 84.5% in Hispanic, and 83.3% in Native Americans; P = .03) but there were no significant differences in procedural success and in-hospital MACE between the groups (Figure 3).
Sub analyses were also performed separately in US patients, showing significant differences in the successful crossing strategies utilized in different racial groups, as summarized in Table 6. Similar to what was observed in the overall database, the retrograde approach was least likely to be the successful crossing strategy in Hispanic patients and antegrade dissection re-entry was least likely to be the successful crossing strategy in the Asian and “other” groups. There were no significant differences in technical success, procedural success, and in-hospital MACE between groups (Figure 4).
Discussion
The main findings of our study are that: (1) most patients who underwent CTO PCI were White; (2) CTO lesions in White patients less often required antegrade wiring and more often used ADR compared with non-Whites; (3) the overall incidence of coronary perforation was significantly higher in White patients without any significant differences in technical and procedural success and in-hospital MACE rates; (4) there were significant differences in the CTO PCI procedural strategies used in different racial subgroups; (5) despite significant differences in baseline and angiographic characteristics, there were no significant differences in success and in-hospital MACE between most of the racial subgroups; and (6) in sub analysis of the US population, technical and procedural success and in-hospital MACE of CTO PCI were similar across all racial subgroups.
Utilization of CTO PCI and baseline clinical characteristics. White patients comprised the largest proportion (84.5%) of the patients in the registry. Considering that, as of 2021, non-Hispanic Whites represent the majority (59.3%) of the US population,21 their representation in the registry is disproportionately higher. Moreover, the Black, Hispanic, and Asian races were underrepresented in the registry.
According to the American Heart Association,22,23 White males have the highest prevalence of CAD (8.7%), followed by Hispanic males (6.8%), Black males (6.7%), and Asian males (5.0%). Although there are differences in the prevalence of CAD in different racial groups, the magnitude of the difference is likely not high enough to explain the over-representation of White patients in the registry. A study from the Nationwide Inpatient Sample Database that included 29 915 patients undergoing CTO PCI from 2016 to 2018 revealed significantly lower rates of CTO PCI in Black vs White men (14% vs 14.9%; P = .01) and Black vs all men (14% vs 15.1%; P < .001).24
Why is the rate of CTO PCI disproportionately lower in minorities? Social, economic, and cultural factors may play a role. Black patients receive less education and lower income than White patients, which could hinder appropriate care.25 In a study of 5689 patients eligible for statin use, Black patients were less likely than Whites to trust their clinician (82.3% vs 93.8%; P < .001).26 These factors could play an important role in underdiagnosis and undertreatment in the Black community. Similar dynamics may be at play in other minority groups.
Patients from underrepresented racial and ethnic groups are less likely to be insured,27 which could make the cost of devices and drugs prohibitive and exacerbate the lack of access to clinically indicated procedures. Moreover, the geographic regions in which many of these minority groups reside often have poor access to services. Racial disparities will likely continue in CTO PCI and other cardiac interventions, as minorities have been underrepresented in clinical trials. A review of cardiovascular trials at www.clinicaltrials.gov found that Blacks and Hispanics comprised only 4% and 11% of the studied patients, respectively.28
There were significant differences in baseline characteristics between different racial groups. The prevalence of major cardiovascular risk factors was high in all racial groups, as was the prevalence of prior CABG (28.6%). The proportion of women among Black patients undergoing CTO PCI was higher when compared with women in other racial groups. This is not surprising, as Black women have higher rates of CAD compared with women of other races.23 A pooled analysis of 10 randomized trials evaluating outcomes of PCI also showed a higher proportion of women among Black patients undergoing PCI when compared with the proportion of women among other races.12
Angiographic characteristics and procedural techniques. Compared with non-White patients, complex CTO PCI techniques (retrograde and ADR) were more likely to be the successful crossing strategies, along with higher use of rotational atherectomy and intravascular lithotripsy, in White patients. This could potentially be explained by significantly higher prevalence of moderate to severe target vessel calcification, prior CTO PCI failure, and a trend towards higher J-CTO score in White patients. Moreover, White patients had a higher prevalence of interventional collaterals and good quality target distal vessel, which make retrograde and ADR techniques more feasible.5,29 Use of advanced CTO and calcium modification techniques potentially explains the significantly higher incidence of overall coronary perforation in White patients. In 105 949 patients included in the British Cardiovascular Intervention Society (BCIS) registry undergoing complex high-risk indicated procedures (CHIP, including CTO PCI) between 2006 to 2017, White patients comprised 84% of the population, and when compared with Black, Asian, and other ethnic minorities, had more extensive calcified lesions with higher rates of rotational atherectomy and cutting balloons use.30
When analyzing different racial groups separately, combined use of retrograde and ADR was highest in Whites (30.6%), followed by Blacks (29.9%), likely because these groups had the highest J-CTO scores and high prevalence of target vessel calcifications (after Hispanics). In the “other” groups, antegrade wiring and retrograde were more likely and ADR less likely to be the successful crossing strategies.
CTO PCI outcomes. Despite the baseline clinical and angiographic differences and the procedural strategies used in our study, the CTO PCI success rates (technical success 83.3%-91.0%; procedural success 82.9%-89.5%) remain up to the current standards for high volume centers and the in-hospital MACE rates remain low across all racial groups (0%-2.9%). Although the technical success was significantly different between the groups, this was driven by higher rate of technical success in the “other” group, which included a large non-US population and likely reflects geographical variations in practice patterns and patient selection. Indeed, when only the US population was analyzed, there was no significant differences between the technical and procedural success and in-hospital MACE between racial groups.
Although numerous studies have evaluated the effect of race on overall post-PCI outcomes,12,13,15,31 data on racial disparities in CTO PCI remains scarce. Using data from the National Cardiovascular Data Registry, Brilakis et al32 evaluated the outcomes of 22 365 CTO PCIs. In this study, Black race was associated with lower success in CTO PCI (hazard ratio [HR] 0.6, [0.50-0.92]; P=.013), however, CTO PCI success rate in this study was very low (59%) and very few operators performed 50 or more CTO PCIs per year. Shamkhani et al30 studied 105 949 patients undergoing CHIP between 2006 to 2017 in the BCIS registry (approximately 32% were CTO PCIs), and showed that minority patients (Black, Asian, and ethnic minorities) had similar mortality (OR 1.1; 95% CI, 0.8-1.5; P=.659) and major adverse cardiac and cerebrovascular events when compared with White patients (OR 1.0; 95% CI, 0.8-1.1; P = .564) following adjustment. CTO PCI specific outcomes were not reported in that study. A recent prespecified analysis from the PROTECT II trial (A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 [Abiomed] vs intra-aortic balloon pump in patients undergoing high-risk PCI), including 425 patients undergoing high-risk PCI using hemodynamic support, revealed similar 90-day rates of major adverse events (40.9% and 44.5%; P = .53) in non-White patients compared with White patients.33 While the study populations in these studies are not directly comparable with ours, the results with respect to outcomes are generally concordant.
Overall, in the hands of experienced operators, the success rates of CTO PCI remain high, and the in-patient MACE rate remains low and similar between different racial groups. This emphasizes that the limiting factor to minorities receiving CTO PCI is not the success rates and outcomes, but rather access to the procedure. For minority patients to benefit from the procedure, further efforts need to focus on providing access to care at regional, institutional, and national levels.
Study limitations. The PROGRESS-CTO is an observational registry with no independent adjudication of clinical events and there was no core laboratory assessment of the study angiograms. We reported in-hospital outcomes without long-term follow-up. Races other than Whites were underrepresented and selection bias cannot be excluded. The procedures reported in the registry were performed at centers experienced in CTO PCI, potentially limiting the generalizability of the results to centers with limited CTO PCI experience.
Conclusions
There were significant variations in the baseline clinical and angiographic characteristics and the CTO PCI procedural strategies used in different racial groups. Despite these differences, procedural success and in-hospital MACE were not significantly different between most racial groups in this multicenter, high-volume CTO PCI registry.
Affiliations and Disclosures
From the 1Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; 2UT Southwestern Medical Center, Dallas, Texas, USA; 3Henry Ford Cardiovascular Division, Detroit, Michigan, USA; 4Division of Cardiology, Department of Medicine, University of Washington, Seattle, Washington, USA; 5Meshalkin Novosibirsk Research Institute, Novosibirsk, Russia; 6Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation; 7Acibadem Kocaeli Hospital, Izmit, Turkey; 8Oklahoma Heart Institute, Tulsa, Oklahoma, USA; 9Massachusetts General Hospital, Boston, Massachusetts, USA; 10Cleveland Clinic, Cleveland, Ohio, USA; 11Wellspan York Hospital, York, Pennsylvania, USA; 12Texas Health Presbyterian Hospital, Dallas, Texas, USA; 13Gagnon Cardiovascular Institute, Morristown Medical Center, New Jersey, USA; 14University Hospitals, Case Western Reserve University, Cleveland, Ohio, USA; 15Emory University Hospital Midtown, Atlanta, Georgia, USA; 16Christ Hospital, Cincinnati, Ohio, USA; 17HonorHealth Heart Group Shea, Scottsdale, Arizona, USA; 18Selcuk University, Konya, Turkey; 19Memorial Bahcelievler Hospital, Istanbul, Turkey; 20Aswan Heart Center, Magdi Yacoub Foundation, Cairo, Egypt; 21North Oaks Health System, Hammond, Louisiana, USA.
Disclosures: Dr. Allana is a consultant for Boston Scientific Corporation and Abiomed. Dr Azzalini has received consulting fees from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Inc., Philips, Abbott Vascular, Reflow Medical, and Cardiovascular Systems, Inc. Dr. Alaswad is a consultant and speaker for Boston Scientific, Abbott Cardiovascular, Teleflex, and Cardiovascular Systems, Inc. Dr. Jaffer has received research sponsorship from Canon, Siemens, Shockwave, Teleflex, Mercator, Boston Scientific, HeartFlow, and Amarin; is a consultant for Boston Scientific, Siemens, Magenta Medical, International Medical Device Solutions, Asahi Intecc, Biotronik, Philips, Intravascular Imaging, and DurVena; holds equity interest in Intravascular Imaging, Inc., DurVena, and Massachusetts General Hospital; and has licensing arrangements with Terumo, Canon, and Spectrawave, for which he has the right to receive royalties. Dr. Khatri receives personal honoraria for proctoring and speaking for Abbott Vascular, Medtronic, Terumo, and Shockwave Medical. Dr. Davies receives speaking honoraria from Abiomed, Asahi Intecc, Inc., Boston Scientific, Medtronic, Siemens Healthineers, Shockwave, and Teleflex; and serves on advisory boards for Abiomed, Boston Scientific, Medtronic, and Rampart. Dr. Choi receives speaking honoraria from Shockwave. Dr. Karmpaliotis receives honoraria from Boston Scientific, Abbott Vascular, and Abiomed; and holds equity in Saranas, Soundbite, and Traverse Vascular. Dr. Poommipanit is a consultant for Medtronic, Asahi Intecc, Inc., and Abbott Vascular. Dr. Nicholson is a proctor and is on the speakers’ bureau and advisory board for Abbott Vascular, Boston Scientific, and Asahi Intecc, Inc.; and reports intellectual property with Vascular Solutions. Dr. Jaber receives consulting fees from Inari Medical and Medtronic. Dr. Rinfret is a consultant for Boston Scientific, Teleflex, Medtronic, Abbott, and Abiomed. Dr. ElGuindy receives consulting honoraria from Medtronic, Boston Scientific, Asahi Intecc, Inc., and Terumo; and proctorship fees from Medtronic, Boston Scientific, Asahi Intecc, and Terumo. Dr. Abi‐Rafeh receives proctor and speaker honoraria from Boston Scientific and Shockwave Medical. Dr. Brilakis receives consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor, Circulation), Amgen, Asahi Intecc, Inc., Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Elsevier, GE Healthcare, IMDS, InfraRedx, Medicure, Medtronic, Opsens, Siemens, and Teleflex; research support from Boston Scientific, GE Healthcare; is the owner of Hippocrates LLC; and is a shareholder in MHI Ventures, Cleerly Health, and Stallion Medical. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.
Funding and Acknowledgments: The authors are grateful for the philanthropic support of our generous anonymous donors, and the philanthropic support of Drs. Mary Ann and Donald A. Sens, Mrs. Diane and Dr. Cline Hickok, Mrs. Wilma and Mr. Dale Johnson, Mrs. Charlotte and Mr. Jerry Golinvaux Family Fund, the Roehl Family Foundation and the Joseph Durda Foundation. The generous gifts of these donors to the Minneapolis Heart Institute Foundation's (MHIF) Science Center for Coronary Artery Disease (CCAD) helped support this research project. Study data were collected and managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at the MHIF, Minneapolis, Minnesota.
Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute, 920 E 28th Street #300, Minneapolis, MN 55407, USA. Email: esbrilakis@gmail.com; X: @esbrilakis, @AllanaSalman
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