Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost

In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial)

Saphenous vein grafts (SVGs) have high rates of in-stent restenosis (ISR). We compared the baseline clinical and angiographic characteristics of patients and lesions that did develop ISR with those who did not develop ISR during a median follow-up of 2.7 years in the DIVA study (NCT01121224). We also examined the ISR types using the Mehran classification. ISR developed in 119 out of the 575 DIVA patients (21%), with similar incidence among patients with drug-eluting stents and bare-metal stents (BMS) (21% vs 21%, p = 0.957). Patients in the ISR group were younger (67 ± 7 vs 69 ± 8 years, p = 0.04) and less likely to have heart failure (27% vs 38%, p = 0.03) and SVG lesions with Thrombolysis In Myocardial Infarction 3 flow before the intervention (77% vs 83%, p <0.01), but had a higher number of target SVG lesions (1.33 ± 0.64 vs 1.16 ± 0.42, p <0.01), more stents implanted in the target SVG lesions (1.52 ± 0.80 vs 1.31 ± 0.66, p <0.01), and longer total stent length (31.37 ± 22.11 vs 25.64 ± 17.42 mm, p = 0.01). The incidence of diffuse ISR was similar in patients who received drug-eluting-stents and BMS (57% vs 54%, p = 0.94), but BMS patients were more likely to develop occlusive restenosis (17% vs 33%, p = 0.05). © 202

TCT-128 Saphenous Vein Graft Occlusion Following Native Vessel Chronic Total Occlusion Percutaneous Coronary Intervention

Background: The practice of occluding patent saphenous vein grafts (SVGs) after successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of the native vessel has received limited study. Methods: We analyzed baseline clinical and angiographic characteristics and procedural outcomes of 51 patients who following successful CTO PCI of the native vessel underwent attempted SVG occlusion between 2015 and 2022 at 14 centers. Results: Mean patient age was 71 ± 8 years and 80% were men. The most common CTO target vessel was the right coronary artery (41%), followed by the left circumflex artery (35%). Retrograde crossing was the successful crossing strategy in 78% (n = 40) and the SVG was the collateral used for all the retrograde cases. Recurrent SVG failure (51%) was the most common reason for treating the native vessel instead of the SVG supplying the same vessel. Coils were used in 71% (n = 36) to occlude the SVG with a mean number of 1.9 ± 1.1 coils, and Amplatzer vascular plugs were used in 29% (n = 15) of the cases. All procedures were technically successful and the SVG was occluded completely (TIMI 0 flow) in 75% (n = 38) of the cases. Follow up was available for 38 patients (75%): during a mean follow up of 312 days, the incidence of target lesion failure was 5.4% (n = 2). There were no other associated periprocedural or in-hospital complications. Conclusion: SVG occlusion after successful native vessel CTO PCI, is associated with favorable periprocedural and mid-term outcomes. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-170 Development and Validation of a Scoring System for Predicting Clinical Coronary Artery Perforation During Percutaneous Coronary Interventions of Chronic Total Occlusions: The PROGRESS-CTO Perforation Score

Background: Coronary artery perforation is a feared complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and often leads to serious adverse clinical events. Methods: We analyzed clinical and angiographic parameters from 9,618 CTO PCIs in the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention). Logistic regression prediction modeling was used to identify independently associated variables, and models were internally validated with bootstrapping. Clinical coronary artery perforation was defined as any perforation requiring treatment. Results: The incidence of clinical coronary perforation was 3.8% (n = 367). Five factors were independently associated with perforation and were included in the score: patient age ≥ 65 years, +1 point (OR: 1.79; 95% CI: 1.37-2.33); moderate or severe calcification, +1 point (OR: 1.85; 95% CI: 1.41-2.42); blunt or no stump, +1 point (OR: 1.45; 95% CI: 1.10-1.92); use of antegrade dissection and re-entry strategy, +1 point (OR: 2.43; 95% CI: 1.61-3.69); and use of the retrograde approach, +2 points (OR: 4.02; 95% CI: 2.95-5.46). The resulting score showed acceptable performance on receiver-operating characteristic curve (area under the curve: 0.741; 95% CI: 0.712-0.773). The Hosmer-Lemeshow test indicated good fitness (P = 0.991), and internal validation with bootstrapping demonstrated a good agreement with the model (observed area under the curve: 0.736; 95% bias-corrected CI: 0.706-0.767). Conclusions: The PROGRESS-CTO perforation score is a useful tool for prediction of clinical coronary perforation in CTO PCI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-171 Predicting the Risk of Perforation Requiring Pericardiocentesis in Chronic Total Occlusion Percutaneous Coronary Intervention: The PROGRESS-CTO Pericardiocentesis Score

Background: Estimating the risk for complications facilitates risk-benefit assessment and procedural planning in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods: We analyzed the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; NCT02061436) and created a risk score for pericardiocentesis. Patients with histories of coronary artery bypass graft surgery were excluded. Logistic regression prediction modeling was used to identify independently associated variables, and the model was internally validated with bootstrapping. Results: Of the 7,672 CTO PCI cases performed between 2012 and 2022 at 40 centers, 83 (1.1%) required pericardiocentesis. The final prediction model identified predictors of pericardiocentesis: age ≥ 65 years (OR: 2.10; 95% CI: 1.27-3.46), 1 point; female sex (OR: 2.25; 95% CI: 1.39-3.63), 1 point; moderate to severe calcification (OR: 3.28; 95% CI: 1.96-5.49), 1 point; antegrade dissection re-entry (OR: 2.83, 95% CI: 1.45-5.51), 1 point; and retrograde strategy (OR: 3.50; 95% CI: 2.08-5.87), 2 points; with a bootstrap corrected C statistic of 0.78 (95% CI: 0.72-0.83). The calculated risk percentages for pericardiocentesis on the basis of the PROGRESS-CTO mortality score ranged from 0.18% to 8.74% for pericardiocentesis, and 55% of patients had PROGRESS-CTO pericardiocentesis scores of 1 or 2, corresponding to a pericardiocentesis risk of 0.4% to 1.6%. Conclusions: The PROGRESS-CTO pericardiocentesis risk score can facilitate risk-benefit assessment and procedural planning in patients undergoing CTO PCI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-117 Impact of Proximal Cap Ambiguity on the Outcomes of Chronic Total Occlusion Intervention: Insights From the PROGRESS-CTO Registry

Background: The impact of proximal cap ambiguity on procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. Methods: We examined the clinical and angiographic characteristics and procedural outcomes of 11,169 CTO PCIs performed in 10,932 patients at 42 US and non-US centers between 2012 and 2022. Results: Proximal cap ambiguity was present in 35% of CTO lesions. Patients whose lesions had proximal cap ambiguity were more likely to have had prior PCI (65% vs 59%; P \u3c 0.01) and prior coronary artery bypass graft surgery (37% vs 24%; P \u3c 0.01). Lesions with proximal cap ambiguity were more complex with higher J-CTO score (3.1 ± 1.0 vs 2.0 ± 1.2; P \u3c 0.01) and lower technical (79% vs 90%; P \u3c 0.01) and procedural success (77% vs 89%; P \u3c 0.01) rates compared with non-ambiguous CTO lesions. The incidence of major adverse cardiovascular events (MACE) was higher in cases with proximal cap ambiguity (2.5% vs 1.7%; P \u3c 0.01). The retrograde approach was more commonly used among cases with ambiguous proximal cap (51% vs 21%; P \u3c 0.01) and was more likely to be the final successful crossing strategy (29% vs 13%; P \u3c 0.01). PCIs of CTOs with ambiguous proximal cap required longer procedure time (140 [95-195] vs 105 [70-150] min; P \u3c 0.01) and more contrast volume (225 [160-305] vs 200 [150-280] mL; P \u3c 0.01). Conclusion: Proximal cap ambiguity in CTO lesions is associated with higher utilization of the retrograde approach, lower technical and procedural success rates, and higher incidence of in-hospital MACE. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-109 Use of Subintimal Tracking and Reentry Technique in Chronic Total Occlusion Percutaneous Coronary Intervention

Background: There are limited data on the use of the subintimal tracking and reentry (STAR) technique for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods: We analyzed 2,353 CTO PCIs performed using antegrade dissection re-entry (ADR) in the PROGRESS-CTO Registry, between 2012 and June 2022 at 41 centers. Results: STAR was used in 450 cases (19.1%), primary STAR in 325 (13.8%) and secondary STAR (STAR after other ADR approaches) in 125 (5.3%). The Stingray system was used in 1,048 (44.5%), limited antegrade subintimal tracking (LAST) in 177 (7.5%), and contrast-guided STAR in 31 (1.3%) of re-entry cases. The mean patient age was 65.3 ± 10 years and 86.0% were men. STAR cases were more complex with higher Japan-CTO (3.05 ± 1.08 vs 2.87 ± 1.14, P = 0.002) and PROGRESS (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) CTO (1.58 ± 1.14 vs 1.20 ± 1.04, P \u3c 0.001) scores compared to non-STAR cases. The cases where STAR was used had lower technical (69.3% vs 79.1%, P \u3c 0.001) and procedural (67.7% vs 76.3%, P \u3c 0.001) success compared with cases where STAR was not used. The incidence of major cardiac adverse events was similar (3.70% vs 3.52%, P = 0.858) between STAR and non-STAR cases. Primary STAR was associated with higher technical and procedural success and similar MACE compared with secondary STAR (Figure). Conclusion: STAR is used in 19.1% of antegrade re-entry CTO PCI cases and is associated with higher angiographic complexity, lower technical and procedural success rates and similar major complication rates compared to antegrade re-entry cases that did not use STAR. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

TCT-113 Predicting the Risk of In-Hospital Major Adverse Cardiovascular Events in Chronic Total Occlusion Percutaneous Coronary Intervention: The PROGRESS-CTO MACE Score

Background: Estimating the risk of complications in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) facilitates risk-benefit assessment and procedural planning. Methods: We analyzed the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO; NCT02061436) and created a risk score for in-hospital major adverse cardiovascular events (MACE). Logistic regression prediction modeling was used to identify independently associated variables and the model was internally validated with bootstrapping. Results: Of the 10,480 CTO PCI cases performed between 2012-2022 at 40 US and non-US centers, in-hospital MACE occurred in 215 (2.05%). The final prediction model identified 5 independent predictors of MACE: age ≥65 years, odds ratio (OR) 1.57, 95% confidence interval (CI) 1.10-2.26, 1 point; female sex, OR 2.46, 95% CI 1.72-3.53, 2 points; moderate to severe calcification, OR 1.71, 95% CI 1.20-2.44, 1 point; Blunt stump, OR 1.63, 95% CI 1.14-2.33, 1 point; and Antegrade dissection re-entry, OR 2.21, 95% CI 1.32-3.72, 1 point; and retrograde strategy, OR 2.86, 95% CI 1.94-4.22, 2 points; with a bootstrap corrected c-statistic of 0.72, 95% CI 0.68-0.76. The calculated risk percentages for MACE based on the PROGRESS-CTO MACE score ranged from 0.4% to 9.4% for MACE; 42% of patients had PROGRESS-CTO MACE score of 2-3, corresponding to a MACE risk of 1.1%-2.0%. Conclusion: The PROGRESS-CTO in-hospital MACE risk score can facilitate risk-benefit assessment and procedural planning in patients undergoing CTO PCI. Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP

In-Stent CTO Percutaneous Coronary Intervention: Individual Patient Data Pooled Analysis of 4 Multicenter Registries

OBJECTIVES: The authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs). BACKGROUND: The outcomes of PCI for ISR CTOs have received limited study. METHODS: The authors examined the clinical and angiographic characteristics and procedural outcomes of 11,961 CTO PCIs performed in 11,728 patients at 107 centers in Europe, North America, Latin America, and Asia between 2012 and 2020, pooling patient-level data from 4 multicenter registries. In-hospital major adverse cardiovascular events (MACE) included death, myocardial infarction, stroke, and tamponade. Long-term MACE were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: ISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p \u3c 0.0001) and prior coronary artery bypass graft surgery (27% vs. 24%; p = 0.03). Mean J-CTO (Multicenter CTO Registry in Japan) score was 2.32 ± 1.27 in the ISR group and 2.22 ± 1.27 in the de novo group (p = 0.01). Technical (85% vs. 85%; p = 0.75) and procedural (84% vs. 84%; p = 0.82) success was similar for ISR and de novo CTOs, as was the incidence of in-hospital MACE (1.7% vs. 2.2%; p = 0.25). Antegrade wiring was the most common successful strategy, in 70% of ISR and 60% of de novo CTOs, followed by retrograde crossing (16% vs. 23%) and antegrade dissection and re-entry (15% vs. 16%; p \u3c 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence intervals: 1.01 to 1.70; p = 0.04). CONCLUSIONS: ISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs