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.

Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration.

BACKGROUND: The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS: We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS: Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

One-Year COMBO Stent Outcomes in Acute Coronary Syndrome: from the COMBO Collaboration.

PURPOSE: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). RESULTS: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. CONCLUSIONS: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Outcomes with retrograde versus antegrade chronic total occlusion revascularization.

OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.

Second-generation cryoballoon ablation for recurrent atrial fibrillation after an index procedure with radiofrequency versus cryo: Different pulmonary vein reconnection patterns but similar long-term outcome-Results of a multicenter analysis.

INTRODUCTION: Repeated procedures are often needed for long-term success of atrial fibrillation ablation. There are scarce data regarding cryoballoon use for such procedure. METHODS AND RESULTS: We analyzed acute effect and long-term follow-up of second-generation cryoballoon ablation, performed as a repeat procedure after an index radiofrequency vs cryoballoon ablation. Sixty-one patients from three centers were included. In 36 cases radiofrequency (RF-I) and in 25 cryoballoon ablation (CB-I) was the index procedure. During redo procedure, pulmonary vein reconnection was less frequent in CB-I vs RF-I (51.5% vs 66.9%; P = 0.017). After cryoballoon, left inferior (P = 0.027) and right superior (P = 0.06) pulmonary veins were less likely to exhibit reconnection. Moreover, patients after initial RF ablation frequently presented multiple-vein reconnection (P = 0.018), while patients after cryoablation more often had only one vein reconnected (P = 0.008). During reablation procedures, all 149 reconnected veins in both groups were isolated, with no differences in procedural parameters, except for procedure time, shorter in CB-I group (65.5 vs 71.1 minutes; P = 0.04). Transient phrenic nerve palsy was the only complication in both groups (5.6% and 8.0%; ns). After mean follow-up of 15 ± 9 months, 70.3% of patients were free from atrial fibrillation (AF), with no differences between the groups (P = 0.71). In multivariate Cox-regression analysis, the persistent form of arrhythmia (P = 0.009) and relapse in the blanking period (P = 0.0004) were the only independent predictors of AF recurrence. CONCLUSIONS: The use of second-generation cryoballoon is associated with less frequent pulmonary vein reconnection compared with RF ablation. Cryoballoon is safe and effective for repeated AF ablation, regardless of the technique used for the initial procedure.

Gait Analysis in Patients with Symptomatic Pes Planovalgus Following Subtalar Arthroereisis with the Talus Screw.

Background: Pes planovalgus is one of the most common pediatric skeletal deformities. There have been no studies to analyze in detail the spatiotemporal variables of gait following arthroereisis. Purpose of the study: The purpose of our study was to assess gait parameters in patients with symptomatic flexible flatfoot following treatment with the talus screw. Methods: This was a prospective study assessing the 22 patients treated surgically due to symptomatic flexible flatfoot with the talus screw. Patients underwent gait assessment with a G-Sensor. We analyzed the following gait parameters: gait cycle duration, step length, support phase duration, swing phase duration, double support duration, single support duration, cadence, velocity, step length. Results: The post-operative gait parameter assessment for the operated and non-operated foot showed a significant difference only in terms of step length. Cadence increased from the pre-operative mean of 82.29 steps/min to a post-operative mean of 102.94 steps/min. Gait velocity increased significantly from 0.81 m/s before to 0.96 m/s after surgery. Discussion: Arthroereisis with the talus screw helps improve gait parameters following surgery. Post-operatively, we observed increased gait velocity and cadence and decreased gait cycle duration in the operated limb. Conclusion: Short-term biomechanical outcomes of pes planovalgus treatment with the talus screw are good.

Impact of Bifurcation Involvement and Location in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the EuroCTO Registry.

Bifurcation involvement close to or within the occluded segment poses increasing difficulties for chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). However, this variable is not considered in the angiography-based CTO scoring systems nor has been extensively investigated in large multicenter series. Accordingly, we analyzed a CTO-PCI registry involving 92 European centers to explore the incidence, angiographic and procedural characteristics, and outcomes specific to CTO-PCIs with bifurcation involvement. A total of 3,948 procedures performed between January and November 2023 were examined (33% with bifurcation involvement). Among bifurcation lesions, 38% and 37% were located within 5 mm of the proximal and distal cap, respectively, 16% within the CTO body, and in 9% of cases proximal and distal bifurcations coexisted. When compared with lesions without bifurcation involvement, CTO bifurcation lesions had higher complexity (J-CTO 2.33 ± 1.21 vs 2.11 ± 1.27, p <0.001) and were associated with higher use of additional devices (dual-lumen microcatheter in 27.6% vs 8.4%, p <0.001, and intravascular ultrasound in 32.2% vs 21.7%, p <0.001). Radiation dose (1,544 [836 to 2,819] vs 1,298.5 [699.1 to 2,386.6] mGy, p <0.001) and contrast volume (230 [160 to 300] vs 190 [130 to 250] ml, p <0.001) were also higher. Technical success was similar (91.5% with bifurcation involvement vs 90.4% without bifurcation involvement, p = 0.271). However, the bifurcation lesions within the CTO segment (intralesion) were associated with lower technical success than the other bifurcation-location subgroups (83.7% vs 93.3% proximal, 93.4% distal, and 89.0% proximal and distal, p <0.001). On multivariable analysis, the presence of an intralesion bifurcation was independently associated with technical failure (odds ratio 2.04, 95% confidence interval 1.24 to 3.35, p = 0.005). In conclusion, bifurcations are present in approximately one-third of CTOs who underwent PCI. PCI of CTOs with bifurcation can be achieved with high success rates except for bifurcations within the occluded segment, which were associated with higher technical failure.

Duration of dual antiplatelet therapy and outcomes after coronary stenting with the Genous™ bio-engineered R stent™ in patients from the e-HEALING registry.

OBJECTIVE: We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous™ endothelial progenitor cell capturing R stent™ placement in patients from the e-HEALING registry. BACKGROUND: Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended. METHODS: Patients were analyzed according to continuation or discontinuation of DAPT at a 30-day and 6-month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression. RESULTS: No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65-1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55-1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable. CONCLUSIONS: In a post-hoc analysis of e-HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding.

Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Twelve-month outcomes after coronary stenting with the Genous™ bio-engineered R Stent™ in diabetic patients from the e-HEALING registry.

OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous™ EPC capturing R stent™ during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. RESULTS: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).

Chronic total occlusion percutaneous coronary intervention in everyday clinical practice - an expert opinion of the Association of Cardiovascular Interventions of the Polish Cardiac Society.

Coronary chronic total occlusions (CTO) are increasingly encountered during invasive and non-invasive coronary angiography and remain the most challenging lesions for percutaneous revascularization. During recent years success rates and safety outcomes of CTO percutaneous coronary intervention (PCI) have substantially improved, particularly due to the introduction of new techniques and dedicated equipment as well as specialized training programs of CTO operators. Significantly, the steady advances in CTO PCI techniques have coincided with the new data from randomized clinical trials supporting the role of percutaneous recanalization of CTO in relieving angina and improving the quality of life. The current expert consensus document outlines the rationale, clinical outcomes as well as technical, safety and reimbursement issues of CTO PCI. In addition, the requirements for achieving and maintaining competency in CTO PCI among interventional cardiologists are discussed. Finally, we present the modified hybrid algorithm (the so-called Polish hybrid algorithm) providing some unique refinements to the contemporary CTO PCI strategies. Continuous efforts (including active engagement with the payer) are urgently needed to increase guideline-recommended referrals to CTO PCI, and thus improve the quality of life of CTO patients in Poland.

Predictors and trends of contrast use and radiation exposure in a large cohort of patients treated with percutaneous coronary interventions: Chronic total occlusion analysis based on a national registry.

BACKGROUND: The aim herein, was to assess predictors and current trends of radiation exposure and total contrast amount use in patients treated with percutaneous coronary intervention within chronic total occlusion (CTO PCI) and non-CTO PCI. METHODS: Based on a nationwide registry (ORPKI), 535,857 patients treated with PCI between 2014 and 2018 were analysed. The study included 12,572 (2.34%) patients treated with CTO PCI. The CTO PCI and non-CTO PCI groups were compared before and after propensity score matching (PSM). Multifactorial mixed regression models were used to assess predictors of contrast amount use and radiation exposure. RESULTS: The mean total contrast dose and radiation exposure decrease reached statistical significance in following years for the CTO PCI (p = 0.002 and p < 0.001) and non-CTO PCI groups (p < 0.001 and p < 0.001). Multifactorial analysis revealed that non-CTO PCI was a strong independent predictor of lower total contrast dose (estimate: -17.41; 95% confidence interval [CI]: -18.45 to -16.49, p < 0.001) and radiation exposure (estimate: -264.28; 95% CI: -273.75 to -254.81, p < 0.001). After PSM, it was confirmed that CTO PCI was an independent predictor of greater radiation exposure (estimate: 328.6; 95% CI: 289.1-368.1; p < 0.001) and total contrast dose (estimate: 30.5; 95% CI: 27.28-33.74; p < 0.001). CONCLUSIONS: Contrast dose and radiation exposure have decreased in previous years with regard to the CTO PCI and non-CTO PCI groups. CTO PCI was found to be an independent predictor of greater total contrast dose and radiation exposure in the overall group of patients treated with PCI.

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).

Acute coronary syndrome - a frequent clinical manifestation of bare metal in-stent restenosis.

BACKGROUND: In-stent restenosis (ISR) complicates 20-30% of percutaneous coronary interventions (PCI) with bare metal stent (BMS) implantation. Although the widespread use of drug eluting stents (DES) across Europe caused a considerable reduction of BMS implantations, their number is still lower than the number of BMS implantations in several countries. AIM: The clinical presentation of ISR has not been well characterissed. Thus, we attempted to analyze this condition and assess the treatment of ISR in everyday clinical practice. METHODS: We searched our database for all cases of bare metal ISR between 1999 and 2007. Follow-up angiography after PCI was not a routine procedure but a clinically driven examination. Clinical presentations of ISR were divided into: stable angina, and acute coronary syndromes (ACS), i.e. unstable angina (UA) and myocardial infarction (MI) (further subdivided into NSTEMI and STEMI). Analysis included variables associated with different clinical manifestations, methods of ISR treatment and in-hospital complications of ISR. RESULTS: In-stent restenosis was identified in 432 (3%) of 15,910 patients who underwent PCI. The mean age was 61.6 + or - 15.6 (27-86) years, and 295 (68.3%) patients were men. Risk factor distribution was typical for a Caucasian population. Recurrent clinical episode occurred at a mean of 7 (1-108) months after PCI. Exertional angina was present in 245 (56.7%) patients, UA in 128 (29.6%) patients and MI in 59 (13.7%) patients, including STEMI in 28 (6.5%) and NSTEMI in 31 (7.2%) patients. Overall, ACS was diagnosed in 187 patients or 43.3% of all cases of ISR. Multivariate analysis showed a positive correlation between previous MI and younger age and ACS as the clinical manifestation of ISR, and a negative correlation between more severe restenosis and ACS manifestation. The incidence of clinical complications (MI or death) was higher in patients with ACS as the clinical manifestation of ISR (6.9% vs 1.6%). CONCLUSIONS: In-stent restenosis after BMS implantation is a serious clinical problem. More than 40% of patients with ISR present with ACS, including 13.7% patients with MI, more frequently among younger patients and patients with previous MI. Most patients with ISR are treated with repeated PCI with high success rate (97.7%), although the risk of clinical complications is considerably higher in patients presenting with ACS.

Five-year report from the Polish national registry on percutaneous coronary interventions with a focus on coronary artery perforations within chronic total occlusions.

INTRODUCTION: Patients treated within chronic total occlusions (CTO) using percutaneous coronary intervention (PCI) are at increased risk of periprocedural complications. AIM: To assess the frequency of periprocedural complications with particular emphasis on coronary artery perforations (CAPs) among patients treated with PCIs stratified according to CTOs and their predictors. MATERIAL AND METHODS: Based on a nationwide registry (ORPKI), we analysed 535,853 patients treated with PCI between 2014 and 2018. The study included 12,572 (2.34%) patients treated with CTO PCI. We compared CTO PCI to a non-CTO PCI group before and after propensity score matching (PSM). Multifactorial mixed regression models were used to assess predictors of periprocedural complications and CAPs which occurred within the catheterization laboratory. RESULTS: Frequencies of all periprocedural complications (2.75% vs. 1.93%, p < 0.001) and CAP (0.72% vs. 0.16%, p < 0.001) were significantly higher in the CTO PCI group. Multifactorial regression analysis performed in the all-comers group of patients treated with PCI showed that PCI within CTO was related to a higher CAP rate (odds ratio (OR) = 2.18; 95% confidence interval (CI): 1.68-2.82, p < 0.001). After PSM, we extracted 5,652 patients treated within CTO and 5,652 patients with non-CTO PCI. CTO PCI was also related to a higher frequency of CAPs (OR = 1.89; 95% CI: 1.11-3.31, p = 0.01). CONCLUSIONS: The frequency of periprocedural complications and CAPs remained stable during the assessed period of time. CTO PCI was confirmed to be among the predictors of increased CAP rate in the overall group of patients treated within CTO.

1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration.

BACKGROUND: The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. OBJECTIVE: We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. METHODS: The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). RESULTS: This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. CONCLUSIONS: In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. CLINICALTRIAL. GOV IDENTIFIER-NUMBERS: NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry.

BACKGROUND: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. OBJECTIVE: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. METHODS: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. RESULTS: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. CONCLUSIONS: Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration.

BACKGROUND: Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels. OBJECTIVE: We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. RESULTS: The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74-1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93-5.00, p = 0.07. CONCLUSIONS: One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.

Comparison of One-Year Outcomes in Patients >75 Versus ≤75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry).

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p <0.001) were significantly higher in elderly patients. In conclusion, elderly patients >75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Differences in patients and lesion and procedure characteristics depending on the age of the coronary chronic total occlusion.

INTRODUCTION: Whether duration of chronic total occlusion (CTO) affects lesion and procedural characteristics remains largely unknown. AIM: To investigate whether CTO duration influences lesion characteristics and revascularization success. MATERIAL AND METHODS: EuroCTO Registry data on patients who had CTO percutaneous coronary intervention between January 2015 and April 2017 were analyzed. Three groups were created based on occlusion age: 3 to 6 months (n = 1415), 7 to 12 months (n = 973), > 12 months (n = 1656). RESULTS: Patients with greater CTO duration were older (63.0 (56.0-70.0); 63.0 (56.0-71.0); 66.0 (59.0-73.0) years respectively; p < 0.001), had more 3-vessel disease (32.2%; 30.9%; 46.1% respectively; p < 0.001) and more frequent prior coronary artery bypass grafting (8.2%; 9.9%; 29.4% respectively; p < 0.001). In multivariate analysis, occlusion duration was associated with moderate/severe calcification (OR = 1.52; 95% CI: 1.28-1.80; p < 0.001), lesion length > 20 mm (OR 1.77; 95% CI 1.49-2.10; p < 0.001), and collateral circulation Werner type 2 (OR = 1.20; 95% CI: 1.01-1.43; p = 0.041). The CTO duration was associated with lower procedural success (OR for success 0.60; 95% CI: 0.46-0.79; p < 0.001). In multivariate analysis in-hospital adverse events did not differ according to duration of CTO. CONCLUSIONS: Coronary artery CTO duration is associated with greater extent of calcification, lesion length, development of collateral circulation and, most importantly, with lower procedural success.