Determinants of One-Year Outcome After Successful Percutaneous Coronary Intervention for Chronic Total Occlusion; Insight from Japanese CTO-PCI Expert Registry.

Although outcomes have improved with new-generation drug-eluting stents, few reports have analyzed the risk factors associated with chronic outcomes of chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). This study aimed to investigate the independent risk factors for target lesion revascularization (TLR) and major adverse cardiac and cerebrovascular events (MACCEs) after CTO-PCI using Japanese multicenter data. A total of 3,666 patients, who underwent CTO-PCI and completed a 1-year follow-up, registered at the Japanese CTO-PCI Expert Registry from 2014 to 2019, were examined. The primary outcome was defined as TLR, and the secondary outcome was MACCEs at the 1-year follow-up. TLRs and MACCEs occurred in 175 (4.8%) and 524 (14.3%) patients, respectively. Multivariate logistic regression analysis demonstrated that in-stent occlusion (ISO) (odds ratio [OR] 2.604, 95% confidence interval [CI] 1.695 to 4.001), hemodialysis (OR 1.784, 95% CI 1.062 to 2.997), diabetes mellitus with insulin use (OR 1.741, 95% CI 1.060 to 2.861), moderate-to-severe calcification (OR 1.726, 95% CI 1.197 to 2.487), and the right coronary artery as the target vessel (OR 1.468, 95% CI 1.018 to 2.117) were significantly associated with TLR. Hemodialysis (OR 2.214, 95% CI 1.574 to 3.113), ISO (OR 1.499, 95% CI 1.127 to 1.993), arteriosclerosis obliterans (OR 1.414, 95% CI 1.074 to 1.863), and multivessel disease (OR 1.356, 95% CI 1.117 to 1.647) were significantly associated with MACCEs. One-year outcomes of new-generation drug-eluting stents for CTO-PCI were favorable, and ISO as a lesion factor and hemodialysis as a patient factor were strongly associated with TLR and MACCEs, respectively.

Retrograde Coronary Chronic Total Occlusion Intervention (JR-CTO) Score: From the Japanese CTO-PCI Expert Registry.

BACKGROUND: Despite the effectiveness of the retrograde approach for chronic total occlusion (CTO) lesions, there are no standardized tools to predict the success of retrograde percutaneous coronary intervention (PCI). OBJECTIVES: The aim of this study was to develop a prediction tool to identify CTO lesions that will achieve successful retrograde PCI. METHODS: This study evaluated data from 2,374 patients who underwent primary retrograde CTO-PCI and were enrolled in the Japanese CTO-PCI Expert Registry between January 2016 and December 2022 (NCT01889459). All observations were randomly assigned to the derivation and validation cohorts at a 2:1 ratio. The prediction score for guidewire failure in retrograde CTO-PCI was determined by assigning 1 point for each factor and summing all accrued points. RESULTS: The JR-CTO score (moderate-severe calcification, tortuosity, Werner collateral connection grade ≤1, and nonseptal collateral channel) demonstrated a C-statistic for guidewire failure of 0.72 (95% CI: 0.67-0.76) and 0.71 (95% CI: 0.64-0.77) in the derivation and validation cohorts, respectively. Patients with lower scores had higher guidewire and technical success rates and decreased guidewire crossing time and procedural time (P < 0.01). CONCLUSIONS: The JR-CTO (Japanese Retrograde Chronic Total Occlusion) score, a simple 4-item score that predicts successful guidewire crossing in patients undergoing retrograde CTO-PCI, has the potential to support clinical decision-making for the retrograde approach.

Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

BACKGROUND: There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years. AIMS: We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. METHODS: The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES. RESULTS: From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. CONCLUSIONS: The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.

Impact of minimum contrast media volumes during percutaneous coronary intervention for chronic total occlusion lesion.

Contrast media exposure is associated with contrast-induced nephropathy (CIN) following percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Aim of this study is to assess the utility of minimum contrast media volume (CMV ≤ 50 mL) during CTO-PCI for CIN prevention in patients with chronic kidney disease (CKD). We extracted data from the Japanese CTO-PCI expert registry; 2863 patients with CKD who underwent CTO-PCI performed from 2014 to 2020 were divided into two groups: minimum CMV (n = 191) and non-minimum CMV groups (n = 2672). CIN was defined as an increased serum creatinine level of ≥ 25% and/or ≥ 0.5 mg/dL compared with baseline levels within 72 h of the procedure. In the minimum CMV group, the CIN incidence was lower than that in the non-minimum CMV group (1.0% vs. 4.1%; p = 0.03). Patient success rate was higher and complication rate was lower in the minimum CMV group than in the non-minimum CMV group (96.8% vs. 90.3%; p = 0.02 and 3.1% vs. 7.1%; p = 0.03). In the minimum CMV group, the primary retrograde approach was more frequent in the case of J-CTO = 1,2 and 3-5 groups compared to that in non-minimum CMV-PCI group (J-CTO = 0; 11% vs. 17.7%, p = 0.06; J-CTO = 1; 22% vs. 35.8%, p = 0.01; J-CTO = 2; 32.4% vs. 46.5%, p = 0.01; and J-CTO = 3-5; 44.7% vs. 80.0%, p = 0.02). Minimum CMV-PCI for CTO in CKD patients could reduce the incidence of CIN. The primary retrograde approach was observed to a greater extent in the minimum CMV group, especially in cases of difficult CTO.

Machine Learning for Prediction of Technical Results of Percutaneous Coronary Intervention for Chronic Total Occlusion.

(1) Background: The probability of technical success in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents essential information for specifying the priority of PCI for treatment selection in patients with CTO. However, the predictabilities of existing scores based on conventional regression analysis remain modest, leaving room for improvements in model discrimination. Recently, machine learning (ML) techniques have emerged as highly effective methods for prediction and decision-making in various disciplines. We therefore investigated the predictability of ML models for technical results of CTO-PCI and compared their performances to the results from existing scores, including J-CTO, CL, and CASTLE scores. (2) Methods: This analysis used data from the Japanese CTO-PCI expert registry, which enrolled 8760 consecutive patients undergoing CTO-PCI. The performance of prediction models was assessed using the area under the receiver operating curve (ROC-AUC). (3) Results: Technical success was achieved in 7990 procedures, accounting for an overall success rate of 91.2%. The best ML model, extreme gradient boosting (XGBoost), outperformed the conventional prediction scores with ROC-AUC (XGBoost 0.760 [95% confidence interval {CI}: 0.740-0.780] vs. J-CTO 0.697 [95%CI: 0.675-0.719], CL 0.662 [95%CI: 0.639-0.684], CASTLE 0.659 [95%CI: 0.636-0.681]; p < 0.005 for all). The XGBoost model demonstrated acceptable concordance between the observed and predicted probabilities of CTO-PCI failure. Calcification was the leading predictor. (4) Conclusions: ML techniques provide accurate, specific information regarding the likelihood of success in CTO-PCI, which would help select the best treatment for individual patients with CTO.

Procedural results and in-hospital outcomes of percutaneous coronary intervention for chronic total occlusion in patients with reduced left ventricular ejection fraction: Sub-analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: To evaluate the procedural results and in-hospital outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients with reduced left ventricular ejection fraction (LVEF). BACKGROUND: While the technical success of general CTO-PCI has improved, CTO-PCI patients with reduced LVEF remain at high-risk for adverse events. METHODS: The data of 820 patients with LVEF ≤ 35% (Group 1), 1816 patients with LVEF = 35%-50% (Group 2), and 5503 patients with LVEF ≥ 50% (Group 3), registered in the Japanese CTO-PCI Expert Registry from January 2014 to December 2019, were retrospectively analyzed. The primary endpoint was in-hospital major adverse cardiac or cerebrovascular events (MACCEs), including death, myocardial infarction, stent thrombosis, stroke, and emergent revascularization. Secondary endpoints included procedural details, guidewire success, and technical success. RESULTS: There were no differences in guidewire and technical success rates between the groups. In-hospital MACCEs was significantly higher in Group 1 (Group 1 vs. Group 2 vs. Group 3: 3.4% vs. 1.7% vs. 1.5%, p = 0.001) and was especially driven by death (1.3% vs. 0.3% vs. 0.1%, p < 0.001) and stroke (0.7% vs. 0.2% vs. 0.2%, p = 0.007). Multivariate analysis showed that LVEF ≤ 35% (odds ratio [OR]; 1.58, 95% confidence interval [CI]; 1.04-2.41, p = 0.03) and New York Heart Association (NYHA) class ≥ 3 (OR; 2.01, 95% CI; 1.03-3.93, p = 0.04) were predictors of in-hospital MACCEs. CONCLUSIONS: In-hospital MACCEs were significantly higher in patients with LVEF ≤ 35%. LVEF ≤;35% and NYHA class ≥ 3 were predictors of in-hospital MACCEs after CTO-PCI.

Impact of Timing and Treatment Strategy on Coronary Perforation During Percutaneous Coronary Intervention for Chronic Total Occlusion.

Coronary perforations during chronic total occlusion percutaneous coronary intervention (CTO-PCI) are potential complications and reportedly associated with adverse events. This study aimed to describe the clinical characteristics and timing of perforations during CTO-PCI. Data from the Japanese CTO-PCI expert registry included 8,760 patients who underwent CTO-PCI between January 2014 and January 2019. The major adverse cardiac and cerebrovascular events were defined as death, tamponade, myocardial infarction, stent thrombosis, stroke, and revascularization. The guidewire manipulation time was defined as the time required to cross the CTO without perforation. Among these patients, 333 (3.8%) developed perforation during the CTO crossing attempt. Of the 333 patients, 29 developed cardiac tamponades (8.7%). Perforations more frequently occurred in a retrograde wiring than in an anterograde wiring (6.6% vs 1.7%, p <0.0001). A longer guidewire manipulation time was associated with the occurrence of perforation (median 101 minutes [interquartile range 59 to 150 minutes] in the perforation group vs 54.9 minutes [interquartile range 21.1 to 112.7 minutes] in the nonperforation group, p <0.0001). Risk factors for perforation were age, history of coronary bypass graft, right coronary artery lesion, de novo lesion, use of a stiff guidewire, and guidewire manipulation time of >60 minutes during anterograde wiring and age, non-left anterior descending artery lesion, use of a polymer-jacketed guidewire, and use of epicardial channel during retrograde wiring. In conclusion, risk factors for perforation were different between anterograde and retrograde wirings. A prolonged guidewire manipulation time was associated with the occurrence of perforation, especially during anterograde wiring.

Operator experience and clinical outcomes of percutaneous coronary intervention for chronic total occlusion: insights from a pooled analysis of the Japanese CTO PCI Expert Registry and the Retrograde Summit General Registry.

There have not been enough studies to examine the association between difference in operator experience and technical success rate in contemporary percutaneous coronary intervention for chronic total occlusion (CTO-PCI). The present study sought to provide insights into the impact of operator experience on clinical outcomes of CTO-PCI through a comparison of two largest Japanese CTO-PCI registries consisting of operators with different CTO-PCI experience. After combining clinical data from the Japanese CTO-PCI Expert Registry (ER) 2014-2016 (N = 4316) including CTO-PCI performed by highly experienced operators and the Retrograde Summit General Registry (RSGR) 2014-2016 (N = 2230) including CTO-PCI performed by less experienced operators, a pooled analysis was performed to compare clinical outcomes of CTO-PCI in 2 registries. The overall technical success rate and the incidence of in-hospital major adverse events were comparable between ER and RSGR (90.1% vs 88.9%, p = 0.133, 1.7% vs 1.5%, p = 0.606, respectively). Technical success rate in ER was significantly higher among the patients treated with primary antegrade approach (91.8% vs 89.5%, p = 0.009), whereas there was no significant difference among the patients treated with the primary retrograde approach (85.7% vs 85.3%, p = 0.857). Multivariate analysis suggested ER operator could not be an independent predictor for technical success. CTO-PCI performed by less experienced but appropriately trained operators could achieve similarly high technical success rate with comparable safety compared with those performed by highly experienced specialists in contemporary Japanese context.

Predictors of prolonged guidewire manipulation time for native coronary chronic total occlusion percutaneous coronary intervention via primary antegrade approach.

OBJECTIVES: This study aimed to identify the predictive factors for the guidewire manipulation time (GWMT) of ≥20 and 30 min for chronic total occlusion-percutaneous coronary intervention (CTO-PCI) via the primary antegrade approach (PAA). BACKGROUND: Selection of primary retrograde approach (PRA) and the optimal timing to switch from antegrade to retrograde approach for coronary CTO-PCI is still debatable. METHODS: Using the Japanese CTO-PCI expert registry data, we selected and analyzed 4461 patients who underwent CTO-PCI via PAA alone. The considerable lesion/anatomical factors for GWMT ≥20 and 30 min were analyzed. The risks of prolonged GWMT ≥20 and 30 min were stratified as easy, intermediate, difficult, and very difficult according to the multivariate analysis. RESULTS: Nine lesion/anatomical characteristics (blunt stump, side branch at proximal cap, bifurcation at the exit point, calcification, tortuosity, occlusion length ≥ 20 mm, reattempt, nonleft anterior descending artery (nonleft anterior descending artery [LAD]), and tandem CTO) were independent predictors of GWMT ≥20 min (all p < 0.05). Excluding the nonLAD and tandem CTO, the same factors of GWMT ≥20 min correlated with GWMT ≥30 min (all p < 0.05). The distributions were increased in easy, intermediate, difficult, and very difficult subsets of GWMT ≥20 min (58.3%, 77.2%, 89.1%, and 100%) and GWMT ≥30 min (47.5%, 69.2%, 83.9%, and 100%). CONCLUSIONS: These predictive factors of prolonged GWMT should be assessed before CTO-PCI via PAA and when considering an adequate timing to switch the retrograde or PRA if clinically available.

Occlusion patterns, strategies and procedural outcomes of percutaneous coronary intervention for in-stent chronic total occlusion.

BACKGROUND: In-stent chronic total occlusion (CTO) presents various occlusion patterns, which complicate percutaneous coronary intervention (PCI). AIMS: The aim of the study was to investigate the initial outcome and strategy of PCI for in-stent CTO according to the angiographic occlusion patterns. METHODS: This study assessed 791 in-stent CTOs from the Japanese CTO-PCI Expert Registry from 2015 to 2018. They were divided into four patterns: pattern A (n=419), CTO within the stent segment; pattern B (n=196), CTO beyond the distal edge; pattern C (n=85), CTO beyond the proximal edge; and pattern D (n=69) CTO beyond both the proximal and distal edges. RESULTS: There were significant differences in the technical success rates (96.2%, 86.2%, 92.9%, and 75.4% for patterns A-D, respectively; p<0.001), guidewire crossing times (22 [interquartile range: 10-46], 52 [24-102], 40 [20-78], and 86 [45-127] min, respectively; p<0.001), and the rates of antegrade approach alone (90.9%, 61.2%, 67.1%, and 31.9%, respectively; p<0.001). CONCLUSIONS: PCI for CTO within the stent segment was associated with excellent initial outcomes with the antegrade approach. However, PCI for CTO beyond both the proximal and distal edges was associated with the poorest outcomes, even with the bidirectional approach.

Safety of Percutaneous Coronary Intervention for Chronic Total Occlusion in Patients With Multi-Vesel Disease: Sub-Analysis of the Japanese Retrograde Summit Registry.

BACKGROUND: The success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has gradually increased thanks to the continuous development of devices and techniques. However, the impact of multi-vessel disease (MVD) on its success rate and safety is not well known. METHODS: The clinical records of 5009 patients enrolled in the Japanese Retrograde Summit Registry and who had undergone PCI for CTO at 65 centers between 2012 and 2015 were reviewed. We compared the outcome for patients with and without MVD. RESULTS: Two thousand nine hundred and seventy-eight patients (59%) had MVD. Although there was no significant difference in the J-CTO score between the two groups [MVD group 1.51 ± 1.07 vs. SVD group 1.48 ± 1.07, p = 0.48], the procedural success rate of CTO-PCI in the MVD group was significantly lower than that in the SVD group (87.2% vs. 90.2%, p = 0.001). However, occurrence of procedure-related adverse events (4% vs. 5%, p = 0.11), total fluoroscopy (70 ± 45 min vs. 69 ± 50 min, p = 0.75) and procedural time (154 ± 86 min vs. 151 ± 89 min, p = 0.36), and total amount of contrast media (219 ± 102 mL vs. 222 ± 105 mL, p = 0.33) did not differ between the two groups. CONCLUSIONS: Although MVD had an impact on the success rate of CTO-PCI, it did not affect procedure-related adverse events.

Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions.

We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72). The AUC of the derivation model was 0.650. The model's performance was similar in the validation cohort (AUC, 0.610). When assigned a point for each associated factor (HD = 3, LVEF <35%, ISO = 2, and DM = 1 point), the average predicted versus the observed MACCE probability using the Japan-CTO extension score for the low, moderate, high, and very high risk groups was 8.1% vs. 7.3%, 16.9% vs. 15.9%, 22.0% vs. 26.1%, and 56.2% vs. 44.4%, respectively. This novel risk model may allow for the estimation of long-term risk and be useful in disseminating appropriate revascularization procedures.

Scoring System for Identification of "Survival Advantage" after Successful Percutaneous Coronary Intervention in Patients with Chronic Total Occlusion.

BACKGROUND: Percutaneous coronary intervention (PCI) is widely used in patients with chronic total occlusion (CTO), but its benefit in improving long-term outcomes is controversial. We aimed to develop a prediction score for grading "survival advantage" conferred by successful results of CTO-PCI and a scoring system for prediction of the influence of CTO-PCI results on major adverse cardiac and cerebrovascular events (MACCEs). METHODS: Follow-up data of 2625 patients who underwent CTO-PCI at 65 Japanese centers were analyzed. An integer scoring system was developed by including statistical effect modifiers on the association between successful CTO-PCI and one-year mortality. RESULTS: Follow-up at 12 months was completed in 2034 patients. During follow-up, 76 deaths (3.7%) occurred. Patients with successful CTO-PCI had a better one-year survival than patients with failed CTO-PCI (log rank P = 0.016). Effect modifiers for the association between successful procedure and one-year mortality included diabetes (P interaction = 0.043), multivessel disease (P interaction = 0.175), Canadian Cardiovascular Society class ≥2 (P interaction = 0.088), and prior myocardial infarction (MI) (P interaction = 0.117). Each component was assigned a single point and summed to develop the scoring system. The patients were then categorized to specify the prediction of survival advantage by successful PCI: ≤2 (normal) and ≥3 (distinct). The differences in one-year mortality between patients with successful and failed treatment were -0.7% and 11.3% for normal and distinct score categories, respectively. In the scoring system for MACCE, score components were prior MI (P interaction = 0.19), left anterior descending artery (LAD)-CTO (P interaction = 0.079), and reattempt of CTO-PCI (P interaction = 0.18). The differences in one-year MACCEs between successful and failed patients for each score category (0, 1, and ≥2) were -1.7%, 7.5%, and 15.1%, respectively. CONCLUSIONS: The novel scoring system assessing the advantage of successful PCI can be easily applied in patients with CTO. It is a valid instrument for clinical decision-making while assessing the survival advantage of CTO-PCI and the influence of procedural results on MACCEs.

The impact of percutaneous coronary intervention using the novel dynamic coronary roadmap system.

The dynamic coronary roadmap (DCR) is a novel technology that creates a dynamic, motion-compensated, real-time overlay of the coronary arteries on a fluoroscopic image. Whether the DCR reduces contrast volume and enables safe and effective treatment was examined. A total of 146 patients undergoing percutaneous coronary intervention (PCI) from June 2017 to September 2017 in our hospital were retrospectively evaluated. Chronic total occlusion lesions, acute coronary syndrome, and hemodialysis patients were excluded. Patients were divided into the control group (PCI without DCR, 92 patients, 103 lesions) and the DCR group (38 patients, 43 lesions). The primary endpoint was contrast medium volume, and secondary endpoints were radiation dose, fluoroscopy time, and clinical success rate. There was no significant difference in the success rate (100% vs. 100%, P = 1.000) between the groups. Fluoroscopy time (16.3 ± 11.2 min. vs. 11.4 ± 5.5 min, P = 0.007) and contrast medium volume (152.1 ± 73.0 ml vs. 118.8 ± 49.7 ml, P = 0.006) were significantly lower in the DCR group than in the control group. DCR use during PCI was associated with a significant reduction in contrast volume and fluoroscopy time compared to a control group despite similar clinical, lesion, and procedural characteristics.

Ischemic and Bleeding Risk After Percutaneous Coronary Intervention in Patients With Prior Ischemic and Hemorrhagic Stroke.

Background Prior stroke is regarded as risk factor for bleeding after percutaneous coronary intervention (PCI). However, there is a paucity of data on detailed bleeding risk of patients with prior hemorrhagic and ischemic strokes after PCI. Methods and Results In a pooled cohort of 19 475 patients from 3 Japanese PCI studies, we assessed the influence of prior hemorrhagic (n=285) or ischemic stroke (n=1773) relative to no-prior stroke (n=17 417) on ischemic and bleeding outcomes after PCI. Cumulative 3-year incidences of the co-primary bleeding end points of intracranial hemorrhage, non-intracranial global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO) moderate/severe bleeding, and the primary ischemic end point of ischemic stroke/myocardial infarction were higher in the prior hemorrhagic and ischemic stroke groups than in the no-prior stroke group (6.8%, 2.5%, and 1.3%, P<0.0001, 8.8%, 8.0%, and 6.0%, P=0.001, and 12.7%, 13.4%, and 7.5%, P<0.0001). After adjusting confounders, the excess risks of both prior hemorrhagic and ischemic strokes relative to no-prior stroke remained significant for intracranial hemorrhage (hazard ratio (HR) 4.44, 95% CI 2.64-7.01, P<0.0001, and HR 1.52, 95% CI 1.06-2.12, P=0.02), but not for non-intracranial bleeding (HR 1.18, 95% CI 0.76-1.73, P=0.44, and HR 0.94, 95% CI 0.78-1.13, P=0.53). The excess risks of both prior hemorrhagic and ischemic strokes relative to no-prior stroke remained significant for ischemic events mainly driven by the higher risk for ischemic stroke (HR 1.46, 95% CI 1.02-2.01, P=0.04, and HR 1.49, 95% CI 1.29-1.72, P<0.0001). Conclusions Patients with prior hemorrhagic or ischemic stroke as compared with those with no-prior stroke had higher risk for intracranial hemorrhage and ischemic events, but not for non-intracranial bleeding after PCI.

A Novel Algorithm for Treating Chronic Total Coronary Artery Occlusion.

BACKGROUND: Guidewire manipulation time is rarely used in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) strategies. OBJECTIVES: This study sought to develop an algorithm based on angiographic characteristics and guidewire manipulation time. METHODS: This study assessed 5,843 patients undergoing CTO PCI between January 2014 and December 2017 and enrolled in the Japanese CTO-PCI expert registry and analyzed their CTO-PCI strategies, procedural outcomes, and guidewire manipulation time. RESULTS: Primary retrograde approach was performed on 1,562 patients. The average Japanese CTO score of primary antegrade approach and primary retrograde approach were 1.7 ± 1.1 and 2.3 ± 1.1, respectively (p < 0.001). The overall guidewire and technical success rates were 92.8% and 90.6%, respectively. Median guidewire manipulation time of guidewire success and failure were 56 min (interquartile range [IQR]: 22 to 111 min) and 176 min (IQR: 130 to 229 min), respectively. Median successful guidewire crossing time of single wiring and parallel wiring in the antegrade alone were 23 min (IQR: 11 to 44 min) and 60 min (IQR: 36 to 97 min), and rescue retrograde approach and primary retrograde approach were 126 min (IQR: 87 to 174 min) and 107 min (IQR: 70 to 161 min), respectively (p < 0.001). Significant predictors for antegrade guidewire failure in primary antegrade approach, which were reattempt, CTO length of ≥20 mm, and no stump, did not predict guidewire failure after collateral channel crossing in primary retrograde approach. CONCLUSIONS: Results from a large registry with information on guidewire manipulation time as well as CTO characteristics suggest a redefinition of the current strategy algorithms.

Assessment of reattempted percutaneous coronary intervention strategy for chronic total occlusion after prior failed procedures: Analysis of the Japanese CTO-PCI Expert Registry.

OBJECTIVES: We aimed to investigate strategies for reattempted percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs) by highly skilled operators after a failed attempt. BACKGROUND: Development of complex techniques and algorithms has been standardized for CTO-PCI. However, there is no appropriate strategy for CTO-PCI after a failed procedure. METHOD: From 2014 to 2016, the Japanese CTO-PCI Expert Registry included 4,053 consecutive CTO-PCIs (mean age: 66.8 ± 10.9 years; male: 85.6%; Japanese CTO [J-CTO] score: 1.92 ± 1.15). Initial outcomes and strategies for reattempted CTO-PCIs were evaluated and compared with first-attempt CTO-PCIs. RESULTS: Reattempt CTO-PCIs were performed in 820 (20.2%) lesions. The mean J-CTO score of reattempt CTO-PCIs was higher than that of first-attempt CTO-PCIs (2.86 ± 1.03 vs. 1.68 ± 1.05, p < .001). The technical success rate of reattempt CTO-PCIs was lower than that of first-attempt CTO-PCIs (86.7% vs. 90.8%, p < .001). Regarding successful CTO-PCIs, the strategies comprised antegrade alone (reattempt: 36.1%, first attempt: 63.8%), bidirectional approach (reattempt: 54.4%, first attempt: 30.3%), and antegrade approach following a failed bidirectional approach (reattempt: 9.4%, first attempt: 5.4%). Parallel wire technique, intravascular ultrasound guide crossing, and bidirectional approach technique were frequently performed in reattempt CTO-PCIs. Reattempt CTO-PCIs showed higher rates of myocardial infarction (2.1% vs. 0.9%, p < .001) and coronary perforation (6.9% vs. 4.2%, p = .002) than first-attempt CTO-PCIs. CONCLUSIONS: The technical success rate of reattempt CTO-PCIs is lower than that of first-attempt CTO-PCIs. However, using more complex strategies, the success rate of reattempt CTO-PCI can be improved by highly skilled operators.

Retrograde balloon crossing to overcome antegrade delivery failure for a heavily calcified chronic total occlusion.

We herein report a case of percutaneous coronary intervention to a heavily calcified chronic total occlusion in the left anterior descending artery. Although we successfully performed retrograde wire crossing and wire externalization, we were unable to deliver small-sized balloon catheters in the lesion antegradely, even with strong back-up of wire externalization because of the heavy calcium mass. However, a balloon catheter was easily crossed retrogradely, and the lesion was successfully treated. Thus, retrograde balloon crossing might be a way to overcome device delivery failure in calcified lesions. .

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.