Controlled antegrade and retrograde subintimal tracking (CART) for recanalisation of chronic total occlusions.

BACKGROUND: Controlled antegrade and retrograde subintimal tracking (CART) is rarely performed in contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: We aimed to analyse the indications, procedural characteristics, and outcomes of CART at a high-volume CTO programme. METHODS: We included all patients undergoing a retrograde CTO PCI in which CART was performed at our institution between January 2019 and November 2023. The primary endpoint was technical success. RESULTS: Of 1,582 CTO PCI, the retrograde approach was performed in 603 procedures (38.1%), and CART was used in 45 cases (7.5%). The mean age was 69.1±10.3 years, 93.3% were male, and prior coronary artery bypass graft surgery was present in 68.9%. The most common target CTO vessel was the right coronary artery (48.9%). Anatomical complexity was high (Multicentre CTO Registry of Japan [J-CTO] score of 3.6±0.9). The most common collateral used for CART was a saphenous vein graft (62.2%). Advanced calcium modification was required in 15.6% of cases. CART was successful in 73.3%. Technical and procedural success was 82.2%. Coronary perforation was diagnosed in 4 subjects (8.9%), but only 1 patient (2.2%) suffered tamponade and required pericardiocentesis. No other in-hospital major adverse cardiac events were diagnosed. CONCLUSIONS: CART is a useful technique in selected, very complex CTOs tackled with the retrograde approach. Success rates were high, while complication rates were low, considering the high anatomical complexity and baseline patient risk.

Extreme coronary radiation doses from intravascular brachytherapy.

PURPOSE: To evaluate coronary artery integrity after very high radiation doses from intravascular brachytherapy (IVBT) in the setting of source asymmetry. METHODS: Ten patients treated for right coronary artery (RCA) in-stent restenosis (ISR) between 2017 and 2021 and for whom follow-up angiograms were available were identified from departmental records. Procedural angiograms, taken to document source position, were used to estimate vascular wall doses. The 2.5 mm proximal source marker was used to estimate the distance from source center to the media and adventitia. Distances were converted to dose (Gy) using the manufacturers' dose fall-off table, measured in water. Follow-up films were scrutinized for any sign of late vascular damage. RESULTS: The average minimal distance from catheter center to the adjacent media and the adventitia was 0.9 mm (±0.2) mm and 1.4 mm (±0.2), respectively. The average maximum media and adventitial doses adjacent to the source were 75 Gy (±26) and 39 Gy (±14), respectively. Follow-up angiograms were available from 0.6 years to 3.9 years following IVBT (median: 1.6 years). No IVBT-treated vascular segment showed signs of degeneration, dissection or aneurysm. CONCLUSION: IVBT vascular wall doses are frequently far higher than prescribed. The lack of complications in this unselected group of patients gives a modicum of reassurance that raising the prescription dose is unlikely to lead to a sudden appearance of complications.

Increased prescription dose for large vessel intravascular brachytherapy.

BACKGROUND: Most randomized studies testing the effectiveness of IVBT were limited to vessels less than 4 mm diameter. In fact, it is now common to treat vessels larger than 4 mm. Accordingly, the authors instituted a prescription dose increase to 34 Gy at 2 mm from source center for vessels greater than 4.0 mm. The increase in prescription dose to 34 Gy at 2 mm from center is substantial, being 50% higher than the conventional maximum of 23 Gy. AIM: To take a close look at group of patients treated to 34 Gy, and for whom follow-up angiograms are available. METHODS: Ten patients treated for ISR with a prescription dose of 34 Gy and for whom follow-up angiograms were available were studied. Beta-radiation brachytherapy was performed with a Novoste Beta-Cath System using a strontium-90 (beta) source (Best Vascular, Springfield, VA). Source lengths of 40 or 60 mm were used. A dose of 34 Gy was prescribed at 2 mm from the source center. RESULTS: Patients were re-catheterized from 2 to 21 months (median: 16 months) following IVBT, all for symptoms suggested of restenosis. All patients had some degree of ISR of the target vessel, but no IVBT-treated vascular segment showed angiographic signs of degeneration, dissection or aneurysm. CONCLUSION: The authors' clinical impression, along with detailed review of the 10 cases, suggest that using a 34 Gy prescription dose at 2 mm from source center does not result in increased toxicity.

PCI for Flush Occluded Right Coronary Artery: Challenges and Techniques for Success.

A 74-year-old man with prior coronary artery bypass surgery had a failing vein graft to the right coronary artery (RCA). He underwent retrograde chronic total occlusion recanalization of an ostial flush-occluded RCA facilitated by retrograde angioplasty at the aorto-ostial junction after failed retrograde electrocautery. The graft was then sacrificed. (Level of Difficulty: Advanced.).

Image-guided intravascular brachytherapy dose escalation.

PURPOSE: Coronary stents reduce IVBT radiation dose with a single layer by 10-30%. However, the impact of multiple stent layers and stent expansion remains unexplored. Individualized dose adjustments considering variations in stent layers and expansion could improve radiation delivery effectiveness. METHODS: EGSnrc was used to compute the delivered vessel wall dose in various IVBT scenarios. Stent effects were modeled for the stent density of 25%, 50%, and 75% with 1, 2, and 3 layers respectively. Doses were calculated at 1.75 to 5.00 mm away from the source center, normalized to 100% at 2 mm. RESULTS: Dose fall-off increased with increasing stent density. With a single layer, the dose at 2 mm from source fell from 100% of prescription to 92%, 83% and 73% at 25%, 50% and 75% density, respectively. The computed dose to points with increasing radial distance from the source decreased progressively with increasing stent layers. With three layers, at 75% stent density, the dose at 2 mm from source center fell to 38%. CONCLUSIONS: A schema for image-guided IVBT dose adjustment is described. While it would be an improvement over current standard of care, myriad factors remain to be addressed in a comprehensive effort to optimize IVBT.

Complex Retrograde Chronic Occlusion Percutaneous Coronary Intervention via a Gastroepiploic Artery Graft.

Surgical bypass grafts are commonly used retrograde conduits to facilitate chronic total occlusion (CTO) percutaneous coronary intervention (PCI). While extensive experience exists using saphenous vein grafts as retrograde conduits in CTO PCI, information on the utilization of arterial grafts is more limited. In particular, the gastroepiploic artery (GEA) is a very uncommonly used arterial graft in contemporary bypass surgery and its role for retrograde CTO recanalization has received little study. We describe a case of right coronary artery CTO that was recanalized using the retrograde approach via a GEA graft to the posterior descending artery and highlight the specific challenges of this approach.

Outcomes of Medical Therapy Plus PCI for Multivessel or Left Main CAD Ineligible for Surgery.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used to revascularize patients ineligible for CABG, but few studies describe these patients and their outcomes. OBJECTIVES: This study sought to describe characteristics, utility of risk prediction, and outcomes of patients with left main or multivessel coronary artery disease ineligible for coronary bypass grafting (CABG). METHODS: Patients with complex coronary artery disease ineligible for CABG were enrolled in a prospective registry of medical therapy + PCI. Angiograms were evaluated by an independent core laboratory. Observed-to-expected 30-day mortality ratios were calculated using The Society for Thoracic Surgeons (STS) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) II scores, surgeon-estimated 30-day mortality, and the National Cardiovascular Data Registry (NCDR) CathPCI model. Health status was assessed at baseline, 1 month, and 6 months. RESULTS: A total of 726 patients were enrolled from 22 programs. The mean SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score was 32.4 ± 12.2 before and 15.0 ± 11.7 after PCI. All-cause mortality was 5.6% at 30 days and 12.3% at 6 months. Observed-to-expected mortality ratios were 1.06 (95% CI: 0.71-1.36) with The Society for Thoracic Surgeons score, 0.99 (95% CI: 0.71-1.27) with the EuroSCORE II, 0.59 (95% CI: 0.42-0.77) using cardiac surgeons' estimates, and 4.46 (95% CI: 2.35-7.99) using the NCDR CathPCI score. Health status improved significantly from baseline to 6 months: SAQ summary score (65.9 ± 22.5 vs 86.5 ± 15.1; P < 0.0001), Kansas City Cardiomyopathy Questionnaire summary score (54.1 ± 27.2 vs 82.6 ± 19.7; P < 0.0001). CONCLUSIONS: Patients ineligible for CABG who undergo PCI have complex clinical profiles and high disease burden. Following PCI, short-term mortality is considerably lower than surgeons' estimates, similar to surgical risk model predictions but is over 4-fold higher than estimated by the NCDR CathPCI model. Patients' health status improved significantly through 6 months.

External validation of the PROGRESS-CTO complication risk scores: Individual patient data pooled analysis of 3 registries.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with a considerable risk of complications, and risk stratification is of utmost importance. AIMS: To assess the clinical usefulness of the recently developed PROGRESS-CTO (NCT02061436) complication risk scores in an independent cohort. METHODS: Individual patient data pooled analysis of 3 registries was performed. RESULTS: Of the 4569 patients who underwent CTO PCI, 102 (2.2%) had major adverse cardiovascular events (MACE). Patients with MACE were older (69 ± 11 vs. 65 ± 10, p < 0.001), more likely to have a history of prior coronary artery bypass graft surgery, and unfavorable angiographic characteristics J-CTO score (2.4 ± 1.2 vs. 2.1 ± 1.3, p = 0.007), including blunt stump (59% vs. 49%, p = 0.047). Technical success was lower in patients with MACE (59% vs. 86%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO complication risk models were as follows: MACE 0.72 (95% confidence interval [CI], 0.67-0.76), mortality 0.73 (95% CI, 0.61-0.85), and pericardiocentesis 0.69 (95% CI, 0.62-0.77) in the validation dataset. The observed complication rates increased with higher PROGRESS-CTO complication scores. The PROGRESS-CTO MACE score showed good calibration in this external cohort, with MACE rates similar to the original study: 0.7% (score 0-1), 1.5% (score 2), 2.2% (score 3), 3.8% (score 4), 4.9% (score 5), 5.8% (score 6-7). CONCLUSION: Given the good discriminative performance, calibration, and ease of calculation, the PROGRESS-CTO complication scores could help assess the risk of complications in patients undergoing CTO PCI.

Failure patterns after intravascular brachytherapy for in-stent coronary restenosis.

INTRODUCTION: One strategy to improve the effectiveness of intravascular brachytherapy (IVBT) is to study its failures. Previous investigations described mostly discrete, focal recurrences, typically at the proximal or distal edges of the irradiated segment after plain angioplasty or bare metal stents. We reviewed failure patterns of 30 unselected drug-eluting stent (DES) patients who had follow-up angiograms for recurrence within their IVBT-treated vessel. METHODS: Records of 53 unselected IVBT patients treated between 2016 and 2021 were reviewed. Thirty of the 53 patients had at least one subsequent percutaneous intervention (PCI) for in-stent restenosis (ISR) after IVBT. Angiographic findings of those 30 patients with ISR within their previously irradiated vessel are reported here. RESULTS: Of the 30 patients, 21 (70%) developed recurrent ISR within the irradiated segment. Six of the 21 patients who failed within the irradiated segment also experienced ISR proximal or distal to the irradiated segment. Only 15 patients (50%) failed exclusively within the irradiated segment. In nine patients (30%), restenosis occurred proximally and/or distally to the irradiated segment, but not inside of the irradiated segment itself. CONCLUSIONS: We have shown here that 50% of failures after coronary IVBT for DES ISR occur exclusively within the irradiated segment. An additional 20% of patients had failure within and outside of the irradiated segment. These percentages suggest that a higher radiation dose might improve the long-term patency rates, a conclusion that should be tempered by the lack of universal follow-up.

The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease (OPTIMUM) Registry: Rationale and Design.

BACKGROUND: Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD. METHODS: We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated. RESULTS: Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality. CONCLUSIONS: OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population.

Conundrums of coronary brachytherapy.

PURPOSE: In the 1998-2005 heyday of intravascular coronary brachytherapy, a variety of delivery devices were developed and marketed. As the industry shrank, only one device, the Novoste Beta-Cath 3.5F System (Best Vascular, Norcross, GA) remained in commercial production. The 2008 instruction manual, the only official source of technical guidance, lacks recommendations for various common scenarios. METHODS AND MATERIALS: The clinical conundrums described here were encountered during regular use of the Novoste system in 81 patients treated from January to December of 2020 in the course of using the Novoste device in accordance with the 2008 manufacturer's instruction manual. Our experience and strategies are reported and critiqued. RESULTS: Ambiguous patient selection factors include vein grafts, multiple affected vessels, large vessels, retreatment, multiple overlapping stents and prior radiation. Procedural ambiguities include vessel size determination, proper prescription dose, very long lesions and eccentric source positioning. Potential procedural mishaps include stuck sources and the risk of contamination. CONCLUSIONS: The Novoste intravascular coronary brachytherapy system is the only commercially available brachytherapy delivery catheter, and may remain so for some time. The issues detailed here provide insight and guidance for current users and may prompt research into areas lacking adequate information.

Intravascular coronary brachytherapy combined with a drug-coated balloon.

BACKGROUND: Coronary artery disease leads to stenosis of the major cardiac vessels, resulting in ischemia and infarction. Percutaneous intervention (PCI) with balloon angioplasty can re-open stenosed vessels. Drug eluting stents (DES) and intravascular brachytherapy (IVBT) and drug-coated balloons (DCBs) are proven to decrease the likelihood of another restenosis after PCI, but neither is completely effective. Due to the limited long-term effectiveness of IVBT or DCB used separately for salvage PCI, we combined the two in some poor prognosis patients. METHODS: Combined IVBT+DCB was intended for a total of 36 patients from 2015-2020. PCI with some combination of ballooning, laser and directional/rotational atherectomy was used to maximally open the stenotic region prior to IVBT+DCB. Beta-radiation brachytherapy for all patients was done with a Novoste Beta-Cath. Lutonix 4.0 x 40 mm paclitaxel-coated balloons (Bard, Murray Hill, NJ) were employed. RESULTS: Overall survival at two years was 88%. Nine patients had follow-up angiograms, all for cardiac symptoms. Time from IVBT+DCB to follow-up angiography ranged from 4 to 33 months. The average months PCI-free interval before brachy therapy was 11.1 mos (95% CI 1.03-23.25) versus 23.3 mos after VBT (23.3 95% CI 12.3-32.3). The mean difference was 11.2 mos (95% CI 1.06-21.4, p < 0.031). None of the follow-up angiographic procedures displayed evidence of what could be interpreted as radiation damage. CONCLUSIONS: In this uncontrolled series, IVBT plus DCB appeared to lengthen the ISR-free interval relative to what had been achieved prior to the combined intervention. We view these results as mildly encouraging, worthy of further study.

Outcomes of retrograde chronic total occlusion percutaneous coronary intervention: A report from the OPEN-CTO registry.

OBJECTIVES: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58). CONCLUSIONS: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.

Impact of body mass index on outcome and health status after chronic total occlusion percutaneous coronary intervention: Insights from the OPEN-CTO study.

BACKGROUND: The effect of body mass index (BMI) on the procedural outcomes and health status (HS) change after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is largely unknown. METHODS: Thousand consecutive patients enrolled in a 12-center prospective CTO PCI study (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO]) were categorized into three groups by baseline BMI (obese ≥30, overweight 25-30, and normal 18.5-25), after excluding seven patients with BMI <18.5. Baseline and follow-up HS at 1 year were quantified using the Seattle Angina Questionnaire, Rose Dyspnea Score, and Personal Health Questionnaire-8 (PHQ-8). Hierarchical, multivariable logistic, and repeated measures linear regression models were used to assess procedural success, major adverse cardiovascular and cerebrovascular events (MACCE), and HS outcomes, as appropriate. RESULTS: The obese and overweight were 47.6% and 37.4%, respectively. While procedure time and contrast dose were similar among the groups, total radiation dose (mGy) was higher with increased BMI (3,019 ± 2,027, 2,267 ± 1,714, 1,642 ± 1,223, p < .01). Procedural success rates, as well as MACCE rates, were similar among the three groups (obese 83.1%, overweight 79.8%, normal 81.9%, p = .47 and 5.1, 8.4, and 8.7%, p = .11). These rates remained similar after adjustment for baseline characteristics. The HS improvement from baseline to 12 months after adjustment was similar in obese and overweight patients compared to normal weight patients. CONCLUSIONS: CTO PCI in obese and overweight patients can be performed with similar success and complication rates. Obese and overweight patients derive similar HS benefit from CTO PCI compared to normal weight patients.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Renal Dysfunction.

Although contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is performed with high success rates, 10% to 13% of patients presenting with CTOs have chronic kidney disease (CKD), and the comparative safety, efficacy, and health status benefit of CTO PCI in these patients, has not been well defined. We examined the association of baseline renal function with periprocedural major adverse cardiovascular and cerebral events and health status outcomes in 957 consecutive patients (mean age 65.3 ± 10.3 years, 19.4% women, 90.3% white, 23.6 CKD [estimated glomerular filtration rate {eGFR} < 60]) in the OPEN-CTO (Outcomes, Patients Health Status, and Efficiency in Chronic Total Occlusions Registry) study. Hierarchical multivariable regression models were used to examine the independent association of baseline eGFR with technical success, periprocedural complications and change in health status, using Seattle Angina Questionnaire (SAQ) over 1 year. Crude rates of acute kidney injury were higher (13.5% vs 4.4%, p <0.001) and technical success lower (81.8% vs 88.4%, p = 0.01) in patients with CKD. There were no significant differences in other periprocedural complications. After adjustment for confounding factors, there was no significant association of baseline eGFR with technical success or periprocedural major adverse cardiovascular and cerebral events (death, myocardial infarction, emergent bypass surgery, stroke, perforation), whereas patients with lower eGFR had higher rates of acute kidney injury. The difference in SAQ summary score, between patients on the 10th and 90th percentile for baseline eGFR distribution was not clinically significant (1 month: -0.91; 1 year: -3.06 points). In conclusion, CTO PCI success, complication rates, and the health status improvement after CTO PCI are similar in patients across a range of baseline eGFRs.

Initial report of safety and procedure duration of robotic-assisted chronic total occlusion coronary intervention.

BACKGROUND: No previous reports have examined the impact of robotic-assisted (RA) chronic total occlusion (CTO) PCI on procedural duration or safety compared to totally manual CTO PCI. METHODS: Among 95 patients who underwent successful PCI of a single CTO lesion at two centers, 49 (52%) were performed RA and were performed 46 (48%) totally manually. Cockpit time was the time the primary operator entered to robotic cockpit until the procedure was complete. "Theoretical" cockpit time in the control group was time the primary operator would have entered the cockpit after lesion crossing until the procedure was complete. Major adverse events (MAEs) were the composite of death, myocardial infarction, clinical perforation, significant vessel dissection, arrhythmia, acute thrombosis, and stroke. RESULTS: The lesion characteristics, procedural time, and contrast dose were similar. All procedures except for one (2%) selected for robotic completion after lesion crossing were completed successfully. The frequency of MAE was similar between groups and there were no in-hospital deaths. The cockpit time was 8 min longer in RA CTO PCI than the theoretical cockpit time in totally manual CTO PCI (40.6 ± 12.7 vs. 32.1 ± 17.8, p < .01). CONCLUSION: RA CTO PCI was not associated with excess adverse events compared with totally manual CTO PCI and resulted in an average 41 min cockpit time equaling to 48% of procedure time without radiation exposure or requirement for the primary operator to wear a lead apron. Understanding the relationship between cockpit time and reductions in radiation exposure and lead apron-related orthopedic complications for operators requires future study.

Late-term safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: Final 4-year results from the evaluation of the XIENCE coronary stent, Performance, and Technique in Chronic Total Occlusions (EXPERT CTO) multicenter trial.

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention.

Background Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P=0.36) or de-escalation (median rate ratio, 1.10; P=0.20) compared to no change of AAMs across sites. Conclusions Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.

De-escalation of antianginal medications after successful chronic total occlusion percutaneous coronary intervention: Frequency and relationship with health status.

BACKGROUND: Successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can markedly reduce angina symptom burden, but many patients often remain on multiple antianginal medications (AAMs) after the procedure. It is unclear when, or if, AAMs can be de-escalated to prevent adverse effects or limit polypharmacy. We examined the association of de-escalation of AAMs after CTO PCI with long-term health status. METHODS: In a 12-center registry of consecutive CTO PCI patients, health status was assessed at 6 months after successful CTO PCI with the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Among patients with technical CTO PCI success, we examined the association of AAM de-escalation with 6-month health status using multivariable models adjusting for revascularization completeness and predicted risk of post-PCI angina (using a validated risk model). We also examined predictors and variability of AAMs de-escalation. RESULTS: Of 669 patients with technical success of CTO PCI, AAMs were de-escalated in 276 (35.9%) patients at 1 month. Patients with AAM de-escalation reported similar angina and dyspnea rates at 6 months compared with those whose AAMs were reduced (any angina: 22.5% vs 20%, P = .43; any dyspnea: 51.8% vs 50.1%, P = .40). In a multivariable model adjusting for complete revascularization and predicted risk of post-PCI angina, de-escalation of AAMs at 1 month was not associated with an increased risk of angina, dyspnea, or worse health status at 6 months. CONCLUSIONS: Among patients with successful CTO PCI, de-escalation of AAMs occurred in about one-third of patients at 1 month and was not associated with worse long-term health status.

Physical Activity After Percutaneous Coronary Intervention for Chronic Total Occlusion and Its Association With Health Status.

Background Patients with chronic total occlusion ( CTO ) may not participate in regular exercise because of refractory angina. Exercise participation after percutaneous coronary intervention (PCI) for CTO ( CTO PCI ) and the association of exercise with health status after CTO PCI is unknown. Methods and Results Overall, 1000 patients enrolled in the Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion OPEN CTO is a registry were asked about participation in regular exercise at baseline and 12 months after CTO PCI , and the frequency of exercise (<1, 1-2, ≥3 times/week) was collected among exercisers. Health status was assessed using the Seattle Angina Questionnaire ( SAQ ). Multivariable regression assessed 12-month health status change across 4 groups defined by exercise frequency at baseline and 12 months after CTO PCI (no regular exercise at baseline and 12 months, reduced, increased, and consistent exercise at 12 months). Among 869 patients with complete exercise data, the proportion that exercised regularly increased from 33.5% at baseline to 56.6% 12 months after CTO PCI ( P<0.01). Predictors of regular exercise at 12 months included baseline exercise, smoking, baseline and increase in SAQ scores for angina frequency, physical limitation, quality of life, and summary. After multivariable adjustment, consistent or increased exercise frequency was associated with significantly greater improvement in SAQ scores for angina frequency, physical limitation, quality of life, and summary ( P<0.01). Conclusions Participation in regular exercise increased significantly 12 months after CTO PCI , and patients who had greater health status benefit after PCI were more likely to exercise regularly at 12 months. CTO PCI may enable coronary artery disease patients with limiting symptoms to engage in regular exercise and to support better long-term outcomes.