Role of Drug-coated Balloons in Small-vessel Coronary Artery Disease

Percutaneous coronary intervention of small-vessel coronary artery disease (SVD) remains challenging due to difficulties with device delivery and high restenosis rate, even with the use of newer-generation drug-eluting stents. Drug-coated balloons represent an attractive emerging percutaneous coronary intervention option in patients with SVD. Potential advantages of drug-coated balloons in SVD include enhanced deliverability because of their small profile, avoidance of foreign-body implantation, and shorter duration of dual antiplatelet therapy

TCT-121 Extraplaque Versus Intraplaque Tracking in Chronic Total Occlusion Percutaneous Coronary Intervention

Background: The impact of modern extraplaque (EP) tracking techniques on long-term outcomes remains controversial. Methods: We performed a systematic review and meta-analysis of studies that compared EP vs intraplaque (IP) tracking in CTO PCI. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the Der-Simonian and Laird random-effects method. Results: Our meta-analysis included seven observational studies with 2,982 patients. Patients who underwent EP tracking had significantly more complex CTOs with higher J-CTO scores (2.9 ± 1.2 vs 1.6 ± 1.1, P \u3c 0.001), longer lesion length, more severe calcification, and significantly longer stented segments. During a median follow-up of 12 months (range 9-12 months), EP tracking was associated with a higher risk of major adverse cardiovascular events (MACE) (OR 1.50, 95% CI 1.10-2.06, P = 0.01) and target vessel revascularization (TVR) (OR 1.69, 95% CI 1.15-2.48, P = 0.01) compared with IP tracking. There was no difference in the incidence of all-cause death (OR 1.37, 95% CI 0.67-2.78, P = 0.39), myocardial infarction (MI) (OR 1.48, 95% CI 0.82-2.69, P = 0.20), or stent thrombosis (OR 2.09, 95% CI 0.69-6.33, P = 0.19) between EP and IP tracking. Conclusion: Compared with IP tracking, EP tracking was utilized in more complex and longer CTOs, required more stents, and was associated with a higher risk of MACE at 12 months, driven by a higher risk of TVR, but without an increased risk of death or MI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-118 Comparative Analysis of Patients’ Characteristics in Chronic Total Occlusion Revascularization Studies: Trials Versus Real-World Registries

Background: The few randomized controlled trials (RCTs) on chronic total occlusion (CTO) percutaneous coronary interventions (PCI) are subject to selection bias. Methods: We performed a meta-analysis of national and dedicated CTO PCI registries and compared patient characteristics and outcomes with those of RCTs that randomized patients to CTO PCI vs medical therapy. Given the large sample size differences between RCTs and registries, we focused on the absolute numbers and their clinical significance. We considered a 5% relative difference between groups to be potentially clinically relevant. Results: From 2012 to 2022, 6 RCTs compared CTO PCI vs medical therapy (n = 1,047) and were compared with 15 registries (5 national and 10 dedicated CTO PCI registries). Compared with registry patients, RCT patients had fewer comorbidities, including diabetes, hypertension, previous myocardial infarction, and prior coronary artery bypass graft surgery. RCT patients had shorter CTO length (29.6 ± 19.7 vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower J-CTO scores (2.0 ± 1.1 vs 2.3 ± 1.2, a relative difference of 13%) compared with those enrolled in dedicated CTO registries. Procedural success was similar between RCTs (84.5%) and dedicated CTO registries (81.4%) but was lower in national registries (63.9%). Conclusion: There is a paucity of randomized data on CTO PCI outcomes (6 RCTs, 1,047 patients). These patients have lower-risk profiles and less complex CTOs than those in real-world registries. Current evidence from RCTs may not be representative of real-world patients and should be interpreted within its limitation. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-126 Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention of the Left Anterior Descending Artery

Background: Improvement of left ventricular ejection fraction (LVEF) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been modest in prior studies. Methods: Our cohort included patients who underwent LAD CTO PCI at a single center (Henry Ford Hospital) from 2014 to 2021. We evaluate the change in LVEF after LAD CTO PCI using the paired t test in all patients, those with ischemic cardiomyopathy (CM), and those who underwent a viability test. Results: From December 2014 to February 2022, a total of 237 LAD CTO PCI procedures were performed at Henry Ford Hospital (proximal LAD: 56.6%). In-hospital MACE occurred in 13 patients (5.5%; death: 1.3%). Landmark analysis after discharge showed an overall survival of the cohort was 92.7% and MACE-free survival of 85.0% over a median follow-up of 2 years. The median baseline EF was 50% (IQR 35%-55%). Only 51 patients had reduced baseline LVEF (40% or less). After a median follow-up of 9.2 months (IQR 3-28.6 months), there was a significant improvement in LVEF after LAD CTO PCI (mean 10.9%, 95% CI 7.1%-14.8%, P \u3c 0.001). When limiting the analysis to patients who had ischemic cardiomyopathy, proximal LAD CTO PCI, and were on optimal medical therapy (n = 29), LVEF was significantly improved (mean increase of 14%, 95% CI 9.5-18.5%, P \u3c 0.001) after a median follow-up period of 6.2 months (3-29.5 months). Conclusion: LAD CTO PCI was associated with a significant 10% improvement in LVEF in ICM patients and was more pronounced (14% improvement) in those who had proximal LAD treated and were on optimal medical therapy. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

Outcomes with Orbital and Rotational Atherectomy for Inpatient Percutaneous Coronary Intervention

INTRODUCTION: Our objective was to describe the contemporary outcomes of orbital atherectomy (OA) vs. rotational atherectomy (RA) use for inpatient percutaneous coronary intervention (PCI) in the United States. Data on the use of OA vs. RA in contemporary inpatient PCI are limited. METHODS: We queried the Nationwide Readmission Database (NRD) from January to November for the years 2016-2017 to identify hospitalizations of patients who underwent PCI with atherectomy. We conducted a multivariate regression analysis to identify variables associated with in-hospital mortality. RESULTS: We included 77,040 records of patients who underwent inpatient PCI with atherectomy. Of those, 71,610 (93%) had RA, and 5430 (7%) had OA. There was no significant change in the trend of using OA or RA over 2016 and 2017. OA was less utilized in patients presenting with ST-segment elevation myocardial infarction (STEMI) (4.3% vs. 46.8%, p \u3c 0.001). In our cohort, OA was associated with lower in-hospital mortality (3.1% vs. 5%, p \u3c 0.001) and 30-day urgent readmission (\u3c 0.01% vs. 0.2%, p = 0.009), but a higher risk of coronary perforation (1.7% vs. 0.6%, p \u3c 0.001) and cardiac tamponade (1% vs. 0.3%, p \u3c 0.001) and a higher cost of index hospitalization ($28,199 vs.$23,188, p \u3c 0.001) compared with RA. CONCLUSION: RA remains the predominant atherectomy modality for inpatient PCI in the United States (93%). There was no change in the trend of use for either modality over the years 2016 and 2017. OA was noted to have a lower incidence of in-hospital death, but a higher risk of coronary perforation and a higher cost of index hospitalization for the overall unmatched cohorts

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database

BACKGROUND: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). METHODS: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). RESULTS: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. CONCLUSIONS: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications

Comparative Analysis of Patient Characteristics in Cardiogenic Shock Studies: Differences Between Trials and Registries

OBJECTIVES: This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients. BACKGROUND: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients. METHODS: We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries. RESULTS: We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P \u3c 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P \u3c 0.001), dyslipidemia (36.4% vs 53.6%, P \u3c 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P \u3c 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P \u3c 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P \u3c 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P \u3c 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P \u3c 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P \u3c 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P \u3c 0.001) and 30-day mortality (39.9% vs 45.9%, P \u3c 0.001) were lower in RCT patients. CONCLUSIONS: RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality

Sex Differences in Trends and In-Hospital Outcomes among Patients with Critical Limb Ischemia: A Nationwide Analysis

Background Critical limb ischemia (CLI) represents the most severe form of peripheral artery disease and is associated with significant mortality and morbidity. Contemporary data comparing the sex differences in trends, revascularization strategies, and in-hospital outcomes among patients with CLI are scarce. Methods and Results Using the National Inpatient Sample database years 2002 to 2015, we identified hospitalizations for CLI. Temporal trends for hospitalizations for CLI were evaluated. The differences in demographics, revascularization, and in‐hospital outcomes between both sexes were compared. Among 2 400 778 CLI hospitalizations, 43.6% were women. Women were older and had a higher prevalence of obesity, hypertension, heart failure, and prior stroke. Women were also less likely to receive any revascularization (34.7% versus 35.4%, P\u3c 0.001), but the trends of revascularization have been increasing among both sexes. Revascularization was associated with lower in‐hospital mortality among women (adjusted odds ratio [OR], 0.76; 95% CI, 0.71–0.81) and men (adjusted OR, 0.69; 95% CI, 0.65–0.73). On multivariable analysis adjusting for patient‐ and hospital‐related characteristics as well as revascularization, women had a higher incidence of in‐hospital mortality, postoperative hemorrhage, need for blood transfusion, postoperative infection, ischemic stroke, and discharge to facilities compared with men. Conclusions In this nationwide contemporary analysis of CLI hospitalizations, women were older and less likely to undergo revascularization. Women had a higher incidence of in‐hospital mortality and bleeding complications compared with men. Sex‐specific studies and interventions are needed to minimize these gaps among this high‐risk population

Meta-analysis of the impact of successful chronic total occlusion percutaneous coronary intervention on left ventricular systolic function and reverse remodeling

We sought to examine the impact of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on left ventricular (LV) function.We performed a systematic review and meta-analysis of studies published between January 1980 and November 2017 on the impact of successful CTO PCI on LV function.A total of 34 observational studies including 2735 patients were included in the meta-analysis. Over a weighted mean follow-up of 7.9 months, successful CTO PCI was associated with an increase in LV ejection fraction by 3.8% (95%CI 3.0-4.7, P < 0.0001, I2 = 45%). In secondary analysis of 15 studies (1248 patients) that defined CTOs as occlusions of at least 3-month duration and reported follow-up of at least 3-months after the procedure, successful CTO PCI was associated with improvement in LV ejection fraction by 4.3% (95%CI [3.1, 5.6], P < 0.0001). In the 10 studies (502 patients) that reported LV end-systolic volume, successful CTO PCI was associated with a decrease in LV end-systolic volume by 4 mL, (95%CI -6.0 to -2.1, P < 0.0001, I2 = 0%). LV end-diastolic volume was reported in 9 studies with 403 patients and did not significantly change after successful CTO PCI (-2.3 mL, 95%CI -5.7 to 1.2 mL, P = 0.19, I2 = 0%).Successful CTO PCI is associated with a statistically significant improvement in LV ejection fraction and decrease in LV end-systolic volume, that may reflect a beneficial effect of CTO recanalization on LV remodeling. The clinical implications of these findings warrant further investigation