Procedural embolic protection strategies for carotid artery stenting: current status and future prospects.

INTRODUCTION: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others. AREAS COVERED: This review provides a general overview of current embolic protection strategies for CAS. The phases of the procedure which can affect the early risk of stroke and how to reduce it with novel techniques and devices have been discussed. EXPERT OPINION: Innovations in device technologies have dramatically improved the safety and efficacy of CAS. To minimize the gap with surgery, a thorough, patient-oriented approach should be pursued. Endovascular technologies and techniques should be selected on an individual basis to address unique lesion characteristics and vascular anatomies. Meticulous pre-procedural planning, both clinical and anatomical, is needed to assess the embolic risk of each procedure. Only by having an in-depth understanding of the wide range of available endovascular devices and techniques, the operator will choose the most appropriate strategy to optimize CAS results.

Recanalization of Chronic Total Occlusions in Patients With vs Without Chronic Kidney Disease: The Impact of Contrast-Induced Acute Kidney Injury.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with high contrast volumes, which can be particularly deleterious in patients with chronic kidney disease (CKD). We aimed to study the outcomes of CTO PCI in subjects with vs without CKD, and the impact of contrast-induced acute kidney injury (CI-AKI). METHODS: This multicentre registry included patients who underwent CTO PCI at 5 centres. CI-AKI was defined as an increase in serum creatinine ≥0.3 mg/dL or ≥50% from baseline within 72 hours. Study endpoints were CI-AKI, and all-cause death and target-lesion failure (TLF: cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) on follow-up. RESULTS: Study population included 1092 patients (CKD n = 214, no CKD n = 878). Patients with CKD had more comorbidities and adverse angiographic features, compared with subjects without CKD. Patients with CKD experienced lower technical (79% vs 87%, P = 0.001) and procedural (79% vs 86%, P = 0.008) success rates. CI-AKI developed in 9.1% (CKD 15.0% vs no CKD 7.8%, P = 0.001). Rates of in-hospital need for dialysis were 0.5% vs 0%, respectively (P = 0.03). Patients with CKD had higher 24-month rates of all-cause death (11.2% vs 2.7%, P < 0.001) and new need for dialysis (1.1% vs 0.1%, P = 0.03), but similar TLF rates (12.4% vs 10.5%, P = 0.47). CI-AKI was not an independent predictor of all-cause death or TLF. CONCLUSIONS: CTO PCI in patients with CKD is associated with lower success rates and higher incidence of CI-AKI. The need for dialysis both in-hospital and on follow-up is infrequent. Although patients with CKD suffer higher rates of all-cause death, TLF rates are similar regardless of CKD status.

Impact of Incomplete Revascularization on Long-Term Outcomes Following Chronic Total Occlusion Percutaneous Coronary Intervention.

We aimed to evaluate the impact of incomplete revascularization (ICR) on long-term outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Consecutive patients undergoing CTO PCI at 4 centers were included. Baseline SYNTAX score (bSS: low [≤ 22], intermediate [>22 and <33], high [≥33]), residual SYNTAX score (rSS: 0, >0 and ≤8, >8), and SYNTAX revascularization index (SRI: 100 × (bSS-rSS)/bSS: 100%, 50% to 99%, <50%) were calculated. The primary end point was major adverse cardiac events (MACEs; cardiac death, any myocardial infarction, any revascularization) on follow-up. Multivariable Cox regression analysis was conducted to identify predictors of MACEs. Overall, 686 patients were included (low bSS: n = 437; intermediate bSS: n = 187; high bSS: n = 62). Occlusion complexity, crossing strategies, and procedural success rates were similar across groups. The degree of ICR increased with higher bSS categories (rSS was 2.5 ± 4.7 in low vs 6.2 ± 9.3 in intermediate vs 9.1 ± 12.2 in high bSS, p <0.001). The SRI followed a similar pattern. Median follow-up was 781 (369 to 1,217) days. Three-year MACE rates increased with higher bSS and rSS, and decreasing SRI categories (bSS: low 19.4% vs intermediate 25.9% vs high 33.3%, p = 0.02), which was driven by a higher incidence of repeat revascularization. Compared with an rSS = 0, both an rSS >0 and ≤8 (hazard ratio 2.06, p = 0.004) and an rSS >8 (hazard ratio 3.19, p <0.001) were independent predictors of MACEs. Similar findings were observed when the SRI was entered in a separate model. In conclusion, even a mild degree of ICR is associated with a higher incidence of MACEs on long-term follow-up after CTO PCI.

Long-Term Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusion in Patients Who Have Undergone Coronary Artery Bypass Grafting vs Those Who Have Not.

BACKGROUND: We aimed to investigate the procedural and long-term outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients who had undergone previous coronary artery bypass grafting (CABG) vs those who had not, and to evaluate the role of the Registry of CrossBoss and Hybrid procedures in France, the Netherlands, Belgium, and United Kingdom (RECHARGE) score in predicting acute and long-term outcomes. METHODS: We compiled a multicentre registry of consecutive patients undergoing CTO PCI at 7 centres between January 2009 and April 2017. The primary end point was target-vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization on follow-up. RESULTS: Overall, 2058 patients were included (patients who underwent CABG, n = 401; CABG-naïve patients, n = 1657). Patients who had undergone CABG were older and had a higher prevalence of comorbidities and higher occlusion complexity (RECHARGE score, 3.6 ± 1.3 vs 1.8 ± 1.2; P < 0.001). Antegrade dissection/re-entry techniques and the retrograde approach were used more frequently in patients who had undergone CABG. Procedural metrics were worse, and technical (82% vs 88%; P = 0.001) and procedural (81% vs 87%; P = 0.001) success was lower in patients who had undergone CABG. They also experienced a higher rate of major complications (3.7% vs 1.5%; P = 0.004). The RECHARGE score was inversely associated with technical success (P < 0.001). Median follow-up was 377 days (interquartile range, 277-766 days). The 24-month TVF rate was higher in patients who had undergone CABG than in CABG-naïve patients (16.1% vs 9.0%; P < 0.001). On multivariable analysis, the RECHARGE score (hazard ratio, 1.61; P < 0.001) remained an independent predictor of TVF, together with longer total stent length and not using a drug-eluting stent. CONCLUSIONS: Compared with CABG-naïve patients, CTO PCI in patients who had undergone CABG shows higher procedural complexity, worse success rates, and higher adjusted risk of TVF on follow-up.

Vascular response and healing profile of everolimus-eluting bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: A one-year optical coherence tomography analysis from the GHOST-CTO registry.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) have been heralded with potential benefits that are especially desired in long lesions, including chronic total occlusions (CTOs). Procedural feasibility and mid-term outcomes of BVS in CTOs have been reported. However, there is still a paucity of data regarding the vascular and healing response to BVS in CTOs evaluated by optical coherence tomography (OCT). METHODS: This study included prospectively 21 patients who had a CTO lesion treated with a BVS. Angiography and OCT scan were recorded at either post-implantation and 1-year follow-up. Quantitative coronary angiography and OCT analyses were performed by an independent core laboratory. RESULTS: The angiographic analysis showed a significant increase in the percentage of in-segment diameter stenosis at 1year (11.89±9.5% vs. 21.84±11.7%; p=0.002). The OCT analysis showed a trend (p=0.07) towards increased mean scaffold area and significant reductions in mean lumen diameter (3.1±0.36mm vs. 2.85±0.47mm; p=0.0046), mean lumen area (7.8±1.73mm2 vs. 6.76±2mm2; p=0.0082) and minimal lumen area (5.26±1.86mm2 vs. 3.56±1.52mm2; p<0.0001). Malapposition area and volume decreased from 0.26±0.17mm2 to 0.08±0.1mm2 (p=0.0003) and from 14.17±12.92mm3 to 3.99±4.46mm3 (p=0.0014), respectively. The rate of uncovered or malapposed struts, measured at the frame level, was 5.29±6.48% at 1year. CONCLUSIONS: In a small series of CTO patients treated with BVS implantation, OCT outcomes at 1year displayed an overall favorable vascular response and healing profile.

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions: The BONITO Registry (Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions).

BACKGROUND: There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. METHODS AND RESULTS: We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. CONCLUSIONS: Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.

Personalizing oral anticoagulant treatment in patients with atrial fibrillation.

For decades, warfarin has remained the standard oral anticoagulation for stroke prevention in atrial fibrillation (AF). Three novel oral anticoagulants (NOACs) have been recently approved for stroke prevention in non-valvular AF: dabigatran, rivaroxaban and apixaban. Better pharmacological and clinical profiles make these newcomers a preferable alternative over warfarin. Current AF guidelines do not endorse NOACs over warfarin, or one NOAC over another. Indeed, choice of the anticoagulation regimen should be personalized based on the relative efficacy and safety of different agents across subgroups stratified by thrombotic and bleeding risk, as well as on other clinical factors, including anticoagulation control on warfarin, drug interactions, compliance and need for coagulation monitoring. This review appraises i) the randomized evidence on approved NOACs versus warfarin in AF across subgroups stratified by risk factors of stroke and bleeding and by the anticoagulation level reached on warfarin; and ii) clinical factors impacting on the anticoagulation regimen selection.

Usefulness of the logistic clinical SYNTAX score for predicting 1-year mortality in patients undergoing percutaneous coronary intervention of the left main coronary artery.

OBJECTIVES: To externally validate the logistic clinical SYNTAX in patients undergoing percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA). BACKGROUND: A novel version of the clinical SYNTAX score (CSS) has been recently introduced to overcome the limitations of categorical risk scores for PCI by the incorporation of clinical variables and the SYNTAX score (SXscore) into a logistic formula for predicting 1-year mortality. METHODS: Core and extended models of the logistic CSS (logCSS(core) and logCSS(ext)) were applied to 400 patients undergoing LMCA PCI, and their performance was compared with those of the standard CSS, SXscore, and age, creatinine, and ejection fraction (ACEF) score by different measures of discrimination and calibration. RESULTS: A significant gradient in the distribution of 1-year mortality was noted with all the models (P < 0.001), with the SYNTAX and ACEF scores showing the lowest (0.64) and the highest (0.75) c-statistic, respectively. Based on Somers' D(xy) rank correlation, discrimination of both the logCSS(core) and the logCSS(ext) was numerically lower than that of the ACEF score. The logCSS(core) was miscalibrated toward underpredicting all-cause mortality in low-predicted probabilities, while the logCSS(ext) tended to underpredict in low-predicted probabilities and overpredict in high-predicted probabilities. Slope and intercept values reflected a better calibration ability of the logCSS(core) compared with the logCSS(ext). The global accuracy of the logCSS(core) was superior to that of the logCSS(ext) (Brier score 0.087 vs. 0.095). CONCLUSIONS: A personalized approach to risk stratification of LMCA PCI with the logistic CSS is feasible and of potential clinical utility. However, in this study, the logistic CSS did not achieve superior discrimination compared with other categorical models, and suffered from mild to moderate miscalibration.

Platelet function profiles in the elderly: results of a pharmacodynamic study in patients on clopidogrel therapy and effects of switching to prasugrel 5 mg in patients with high platelet reactivity.

Studies specifically designed to assess clopidogrel response in the elderly as well as treatment alternatives to improve platelet inhibition in this high-risk population are lacking. This study aimed to define pharmacodynamic (PD) profiles, including high platelet reactivity (HPR) rates, among elderly patients on maintenance clopidogrel therapy and to assess the PD effects of prasugrel 5 mg/day in elderly with HPR. This was a prospective observational PD study enrolling consecutive ≥ 75-year-old patients on maintenance clopidogrel therapy (75 mg/day) who were tested for clopidogrel response by the VerifyNow P2Y12 assay and light transmittance aggregometry (LTA). HPR rates were estimated using multiple definitions. HPR patients identified by the VerifyNow P2Y12 assay [P2Y12 reaction unit (PRU) ≥ 230] were switched to prasugrel 5 mg/day, and platelet function testing was performed after 15 days of treatment. PD testing was completed in 100 patients. The HPR prevalence varied between 25% and 32%, depending on the definition used. A PRU ≥ 230 was observed in 25 patients; of these, 20 switched to prasugrel 5 mg/day. This resulted in significant reduction in PRU mean values (279.8 ± 45.1 vs. 171.7 ± 65.2, p=0.0002) with an absolute between-treatment difference of 108.1 (95% confidence intervals 75.2-140.9). Accordingly, switching to prasugrel 5 mg/day overcame HPR in most (80%) patients. Consistently, all LTA measures were significantly lower after prasugrel compared with clopidogrel. In conclusion, a considerable proportion of elderly patients exhibit HPR while on standard clopidogrel therapy. Switching to 5 mg/day prasugrel in elderly patients with HPR is associated with enhanced platelet inhibition and overcomes HPR in the majority of these patients.