Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial.

BACKGROUND: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear. AIMS: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation. METHODS: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions. RESULTS: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32). CONCLUSIONS: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access. CLINICALTRIALS: gov identifier: NCT04837404.

Performance of the minimalistic hybrid approach algorithm versus other conventional algorithms in the percutaneous treatment of chronic total occlusions.

BACKGROUND: The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. METHODS: We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. RESULTS: Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). CONCLUSION: The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.

The safety and feasibility of live-stream proctoring for CTO procedures.

OBJECTIVE: To assess the technical feasibility of a new method of educational training, based on audio-video (AV) communication between an interventional cardiologist and the cath lab staff members in one location and a remote expert proctor. METHODS: Overall, 9 patients underwent a percutaneous coronary intervention (PCI) targeting a chronic total occlusion (CTO) between June 2021 and January 2022 at a single Belgian center using the virtual proctoring approach. For this assessment, the strategic planning of the CTO PCI and all the decisions throughout the intervention were the responsibility of the proctor. The operator was guided via an AV link, by the proctor throughout the procedure. RESULTS: The operator performed each procedural step, guided by the remote proctor, who had continuous access to all relevant interventional details. No major adverse cardiac events (MACE) occurred during the index hospitalization or within 6 months follow-up. CONCLUSIONS: A new method of virtual proctoring based on live AV communication is feasible, even in the case of highly complex CTO PCI procedures. This strategy also appears safe and may provide the patient the benefit of incremental expertise. This approach is facilitated by advances in AV communication and allows physicians to share expertise irrespective of location. It could increase global interaction between colleagues and facilitate sharing of knowledge, which are both key aspects in the development of CTO PCI. This preliminary experience could serve as a basis for future large studies to study the potential role and benefits of virtual proctoring for complex CTO PCI procedures.

The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials.

BACKGROUND: We aimed to study the incidence of acute kidney injury (AKI) in out-of-hospital cardiac arrest (OHCA) patients treated according to low-normal or high-normal mean arterial pressure (MAP) targets. METHODS: A post hoc analysis of the COMACARE (NCT02698917) and Neuroprotect (NCT02541591) trials that randomized patients to lower or higher targets for the first 36 h of intensive care. Kidney function was defined using the Kidney Disease Improving Global Outcome (KDIGO) classification. We used Cox regression analysis to identify factors associated with AKI after OHCA. RESULTS: A total of 227 patients were included: 115 in the high-normal MAP group and 112 in the low-normal MAP group. Eighty-six (38%) patients developed AKI during the first five days; 40 in the high-normal MAP group and 46 in the low-normal MAP group (p = 0.51). The median creatinine and daily urine output were 85 µmol/l and 1730 mL/day in the high-normal MAP group and 87 µmol/l and 1560 mL/day in the low-normal MAP group. In a Cox regression model, independent AKI predictors were no bystander cardiopulmonary resuscitation (p < 0.01), non-shockable rhythm (p < 0.01), chronic hypertension (p = 0.03), and time to the return of spontaneous circulation (p < 0.01), whereas MAP target was not an independent predictor (p = 0.29). CONCLUSION: Any AKI occurred in four out of ten OHCA patients. We found no difference in the incidence of AKI between the patients treated with lower and those treated with higher MAP after CA. Higher age, non-shockable initial rhythm, and longer time to ROSC were associated with shorter time to AKI. CLINICAL TRIAL REGISTRATION: COMACARE (NCT02698917), NEUROPROTECT (NCT02541591).

Clinical outcomes of coronary intravascular lithotripsy in patients with stent failure (COIL registry).

BACKGROUND: Intravascular lithotripsy (IVL) has been demonstrated to be an effective treatment of calcified de novo coronary lesions. Safety data on the use of IVL within stented segments are lacking. We sought to evaluate the safety, feasibility, and long-term outcomes of IVL in patients with stent failure. METHODS: This was a retrospective multi-centre registry that included consecutive patients with stent failure who had undergone IVL treatment. The primary efficacy endpoint was procedural success defined as residual stenosis <30% (determined by quantitative coronary angiography analysis) in patients who survived hospital admission without in-hospital adverse events. Major adverse cardiovascular events (MACE) were defined as the composite endpoints of cardiovascular death, spontaneous myocardial infarction, and target vessel revascularisation at one-year follow up. RESULTS: 102 patients were included in this study. Mean age was 73 ± 9 years and 81% were male. The duration from previous stent implantation and IVL treatment was 24 (interquartile range 7-76) months, of which 10.8% received IVL for acute under-expanded stent. IVL treatment allowed significant improvement in both minimal lumen diameter (1.14 ± 0.60 to 2.53 ± 0.59, P < 0.001) and degree of stenosis (66.8 ± 19.9 to 20.3 ± 11.3%, P < 0.001). The rate of procedural success was 78.4% (80/102 of patients). The one-year MACE was 15.7%. Ostial disease (HR 5.16; 95% CI 1.19 to 22.33; P = 0.028) and lesion length (HR 1.05; 95% CI 1.01 to 1.10; P = 0.010) were independently associated with one-year MACE. CONCLUSIONS: In patients with stent failure, IVL is a safe and feasible treatment for this high-risk group.

Vascular Access in Percutaneous Coronary Intervention of Chronic Total Occlusions: A State-of-the-Art Review.

The outcomes of chronic total occlusion percutaneous coronary intervention have considerably improved during the last decade with continued emphasis on improving procedural safety. Vascular access site bleeding remains one of the most frequent complications. Several procedural strategies have been implemented to reduce the rate of vascular access site complications. This state-of-the-art review summarizes and describes the current evidence on optimal vascular access strategies for chronic total occlusion percutaneous coronary intervention.

Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries.

BACKGROUND: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. RESULTS: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p < 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p < 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p < 0.001), proximal cap ambiguity (52% vs. 34%, p < 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). CONCLUSION: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.

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.

Validation of the OPEN-CLEAN Chronic Total Occlusion Percutaneous Coronary Intervention Perforation Score in a Multicenter Registry.

Coronary artery perforation is one of the most common and feared complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We evaluated the utility of the recently presented OPEN-CLEAN (Coronary artery bypass graft, Length of occlusion, Ejection fraction, Age, calcificatioN) perforation score in an independent multicenter CTO PCI dataset. Of the 2,270 patients who underwent CTO PCI at 7 centers, 150 (6.6%) suffered coronary artery perforation. Patients with perforations were older (69 ± 10 vs 65 ± 10, p <0.001), more likely to be women (89% vs 82%, p = 0.010), more likely to have history of previous coronary artery bypass graft (38% vs 20%, p <0.001), and unfavorable angiographic characteristics such as blunt stump (64% vs 42%, p <0.001), proximal cap ambiguity (51% vs 33%, p <0.001), and moderate-severe calcification (57% vs 43%, p = 0.001). Technical success was lower in patients with perforations (69% vs 85%, p <0.001). The area under the receiver operating characteristic curve of the OPEN-CLEAN perforation risk model was 0.74 (95% confidence interval 0.68 to 0.79), with good calibration (Hosmer-Lemeshow p = 0.72). We found that the CTO PCI perforation risk increased with higher OPEN-CLEAN scores: 3.5% (score 0 to 1), 3.1% (score 2), 5.3% (score 3), 7.1% (score 4), 11.5% (score 5), 19.8% (score 6 to 7). In conclusion, given its good performance and ease of preprocedural calculation, the OPEN-CLEAN perforation score appears to be useful for quantifying the perforation risk for patients who underwent CTO PCI.

ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial.

INTRODUCTION: Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date. METHODS AND ANALYSIS: A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee ('Medisch Ethische Toetsing Commissie Isala Zwolle') for all Dutch sites, 'Comité Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comité d'éthique CHU-Charleroi-ISPPC' for Centre Hospilatier Universitaire de Charleroi and 'Ethik Kommission de Ärztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. REGISTRATION DETAILS: ClinicalTrials.gov identifier: NCT03846752.

Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access.

Background The use of large-bore (LB) arterial access and guiding catheters has been advocated for complex percutaneous coronary intervention. However, the impact of LB transradial access (TRA) and transfemoral access (TFA) on extremity dysfunction is currently unknown. Methods and Results The predefined substudy of the COLOR (Complex Large-Bore Radial PCI) trial aimed to assess upper and lower-extremity dysfunction after LB radial and femoral access. Upper-extremity function was assessed in LB TRA-treated patients by the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire and lower-extremity function in LB TFA-treated patients by the Lower Extremity Functional Scale questionnaire. Extremity pain and effect of access site complications and risk factors on extremity dysfunction was also analyzed. There were 343 patients who completed analyzable questionnaires. Overall, upper and lower-extremity function did not decrease over time when LB TRA and TFA were used for complex percutaneous coronary intervention, as represented by the median Quick Disabilities of the Arm, Shoulder, and Hand score (6.8 at baseline and 2.1 at follow-up, higher is worse) and Lower Extremity Functional Scale score (56 at baseline and 58 at follow-up, lower is worse). Clinically relevant extremity dysfunction occurred in 6% after TRA and 9% after TFA. A trend for more pronounced upper-limb dysfunction was present in female patients after LB TRA (P=0.05). Lower-extremity pain at discharge was significantly higher in patients with femoral access site complications (P=0.02). Conclusions Following LB TRA and TFA, self-reported upper and lower-limb function did not decrease over time in the majority of patients. Clinically relevant limb dysfunction occurs in a small minority of patients regardless of radial or femoral access. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03846752.

Postdischarge prognostic significance of periprocedural myocardial injury after percutaneous intervention of chronic total occlusion.

BACKGROUND: The postdischarge prognostic implication of periprocedural myocardial injury in patients undergoing percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) remains scarcely studied. AIMS: The aim of this study is to assess the prognostic value of periprocedural myocardial injury, defined by increased high-sensitive troponin T (hs-TnT) levels according to updated guidelines, after CTO PCI. METHODS: Between September 2011 and April 2020, 726 patients undergoing CTO PCI at 2 Belgian referral centres were prospectively included and divided into 4 groups based on postprocedural hs-TnT levels (unelevated; ≥5 times the upper limit of normal (ULN); ≥35 times the ULN; ≥70 times the ULN). Postprocedural hs-TnT levels were subsequently related to patient and procedural characteristics, 1-year major adverse cardiac and cerebrovascular events (MACCE; excluding in-hospital MACCE) as well as 1-year mortality. RESULTS: At 1 year follow-up (FU), elevated hs-TnT≥5 times and ≥35 times the ULN were associated with higher MACCE rates (p=0.001; p=0.007, respectively). In addition, they also resulted in a higher 1-year mortality rate (p=0.009;p=0.021, respectively). Patients with increased hs-TnT≥5 times the ULN (35% of patients) more frequently had signs of more advanced atherosclerotic disease (previous CABG p<0.001; stroke p≤0.001 and peripheral vascular disease p<0.001) and had higher procedural complexity (Japanese CTO Score p=<0.001, stent length>48 mm p<0.001, procedure time p<0.001). Antegrade wire escalation did not result in lower event rate of postdischarge MACCE compared with the other CTO crossing techniques combined (p=0.158). CONCLUSION: Periprocedural myocardial injury was associated with a significantly higher rate of MACCE and all-cause mortality after 12 months of FU.

Contemporary Strategies and Outcomes of Dedicated Chronic Total Occlusion Percutaneous Coronary Intervention Programs: A Prospective Multicentre Registry.

BACKGROUND: The field of CTO PCI is expanding, but successful and safe percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTO) requires a substantial resource and experience investment. We aimed to assess temporal trends in strategies and outcomes of 2 dedicated programs for CTO PCI. METHODS: Between 2011 and 2020, 920 CTO PCI procedures were prospectively included at 2 referral centres in Belgium. Temporal trends were assessed, and logistic regression models were built to identify predictors of outcome. RESULTS: Despite an increase in lesion complexity (the J-CTO score increased from 1.3 in year 1 to 1.7-2.0 in years 8-9, p < 0.001), technical success improved from 70.0% to 85.6% in year 9 (p value for trend <0.001). We observed the most significant improvement starting at years 3-4 (OR 2.3 in year 4 versus year 1, p=0.018). Together with an increase in success rates and lesions complexity, there was an increase in the use of dual injections, retrograde approaches, the number of balloons and stents, and the use of microcatheters. Conversely, there was a decrease in large bore access, an increase in radial approach, and a shift towards contemporary dissection/reentry techniques. This strategy resulted in a stable major complication rate of 4.7% (p value for trend 0.33). The rate of coronary procedure-related myocardial injury was high (71.0%) and was associated with the use of more intracoronary devices. CONCLUSIONS: Three to four years after initiation of a dedicated CTO PCI program with 50 CTO PCIs per year, consistent high technical success and low complication rates are achieved using contemporary strategies.

Procedural characteristics and outcomes following chronic total occlusion coronary intervention: pooled analysis from 5 registries.

BACKGROUND: Recent improvements in clinical skills, technology, and hardware have resulted in improved success rates with chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We performed a study level pooled analysis from the five largest registries of percutaneous coronary intervention (PCI) of CTO. RESEARCH DESIGN AND METHODS: We conducted pooled analysis of 9500 patients in registries and data on procedural characteristics, technical success, and MACCE was collected. RESULTS: A total of 9500 patients were included in the analysis. Mean age was 65.4 years with previous CABG in 24.8%, reattempt procedure in 24.8% and mean JCTO score was 2.2. Final wiring strategy in hybrid algorithm-based registries was AWE in 40.8-58%, Retrograde in 24-35%, ADR in 16-25% and in Expert JCTO and EURO CTO was AWE in 72-75% and retrograde in 25-28%. Technical success was achieved in 87.8%. In hospital MACCE was 2.5% (95% CI: 1.8- 3.4%), mortality 0.44% (95% CI: 0.23-0.84%), stroke 0.2% (95% CI: 0.1-0.3%); myocardial infraction 1.6% (95% CI: 1.1-2.2%); and cardiac tamponade 0.8% (95% CI: 0.5 to 1.3%). CONCLUSION: CTO PCI is currently performed with high technical success rates and low complication rates in experienced hands utilizing various techniques.

Global Chronic Total Occlusion Crossing Algorithm: JACC State-of-the-Art Review.

The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration.

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 < 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 < 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence interval: 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.

Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention.

OBJECTIVES: The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site-related bleeding or vascular complications. BACKGROUND: The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach. METHODS: An international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site-related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success. RESULTS: The primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose. CONCLUSIONS: In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752).

Impact of prior coronary artery bypass grafting in patients undergoing chronic total occlusion-percutaneous coronary intervention: Procedural and clinical outcomes from the REgistry of Crossboss and Hybrid procedures in FrAnce, the NetheRlands, BelGium, and UnitEd Kingdom (RECHARGE).

AIM: Chronic total occlusions (CTO) in patients with history of coronary artery bypass graft (CABG) show more advanced and complex atherosclerotic pathology. Aim of our study is to compare outcomes in patients undergoing CTO percutaneous coronary intervention (PCI) with previous CABG versus those without in the REgistry of Crossboss and Hybrid procedures in FrAnce the NetheRlands, BelGium and UnitEd Kingdom (RECHARGE). METHODS & RESULTS: The RECHARGE cohort (1,252 patients) was divided in two groups according to the presence of previous CABG (217) or not. We also focused, in the post-CABG group, on a comparison between CTO in previously grafted vessels versus non-grafted vessels. The CTO complexity scores were higher and the success rate (71.9% vs. 88.7%, p < .001) was lower in the CABG group, this difference was driven by higher failure rates in high-complexity-score CTO. The rate of in-hospital complications was similar. In the post-CABG group, the procedural success of CTO located in previously grafted vessels versus those in vessels not previously grafted, was comparably suboptimal (73.1% vs. 68%, p = .47). CONCLUSION: Patients undergoing CTO PCI with prior CABG have a higher prevalence of comorbidities and more complex lesion characteristics. In the post-CABG population the success rate was significantly lower, particularly in high CTO complexity scores, though complication rates were comparable. In the post-CABG population, the CTO success rate was independent of the presence of a previous graft on the CTO vessel.