Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial.

BACKGROUND: Previous studies have investigated a 1 to 6-month short dual antiplatelet therapy (S-DAPT) after percutaneous coronary intervention (PCI) with modern drug eluting-stents to reduce bleeding events. OBJECTIVES: To investigate cardiovascular outcomes in patients at high bleeding risk (HBR) according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria after PCI with the Synergy bioresorbable-polymer everolimus-eluting stents (EES). METHODS: We applied ARC-HBR criteria in the population of the prospective, single-arm, multicenter POEM (Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy Stent in Patients at HBR Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy) trial. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 12 months. RESULTS: The original POEM cohort included 356 patients (80.4 %) fulfilling ARC-HBR criteria. Oral anticoagulant (OAC) usage and age ≥75 years were the most frequent major and minor ARC-HBR criteria, respectively. The ARC-HBR group was mainly represented by men (71.1 %), with 74.4 ± 9.3 years and a high burden of cardiovascular risk factors. DAPT was prescribed in 79.3 %, and single antiplatelet (SAPT) with OAC in 18.7 %. 12-month follow-up was completed in 96.2 %. The primary endpoint occurred in 5.2 % (95 % CI 3.29-8.10) of patients, whereas bleeding Academic Research Consortium type 3-5 occurred in 2.7 % (95 % CI, 1.39 %-5.05 %). CONCLUSION: Previous results of the POEM trial showed positive outcomes regarding ischemic and bleeding events with an S-DAPT regimen after Synergy EES. These results are also confirmed in sub-group analysis when ARC-HBR criteria are applied.

One-Month Dual Antiplatelet Therapy in Patients With Chronic and Acute Coronary Syndromes Treated With Bioresorbable Polymer Everolimus-Eluting Stents.

There is a paucity of data regarding the safety of a 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). We aimed to compare the clinical outcomes of patients at HBR with chronic coronary syndrome (CCS) or ACS treated with PCI using bioresorbable polymer everolimus-eluting stent (BP-EES) followed by 1-month DAPT. Patients at HBR who underwent PCI with BP-EES were prospectively enrolled in 10 Italian centers. All patients were treated with 1-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by oral anticoagulation only after that. The primary end point was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Overall, 263 patients (59.4%) with CCS and 180 patients (40.6%) with ACS were enrolled. No significant difference was evident between patients with CCS and ACS for the primary end point (4.3% vs 5.6%, respectively, p = 0.497) and for each isolated component. The risk for Bleeding Academic Research Consortium (BARC) type 1 to 5 or type 3 to 5 bleedings was also similar between patients with CCS and ACS (4.3% vs 5.2%, p = 0.677, and 1.6% vs 2.9%, p = 0.351, respectively). In conclusion, among HBR patients with ACS who underwent PCI with BP-EES, a 1-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared with those with CCS.

SUOH 03 Guidewire for the Management of Coronary Artery Dissection: Insights from a Multicenter Registry.

Background: In the setting of coronary artery dissection, both spontaneous and iatrogenic, fixing the intimal tear, usually with stent implantation, can be extremely challenging if the distal wire position has been lost. Common complications are mainly related to the inadvertent subintimal tracking of the guidewire while attempting to gain the distal true lumen. Aims: To report the registry results of using the SUOH 0.3 guidewire for managing coronary artery dissection in a real-world multicenter setting. Methods: The study population in this retrospective, multicenter, international registry included 75 consecutive patients who underwent PCI and required an antegrade wiring of a dissected coronary artery. Results: Successful use of SUOH 0.3 was achieved in 69 (92%) patients. The use of a microcatheter was associated with a significantly higher rate of TIMI 3 flow at the end of the procedure (no microcatheter: n = 17, 81%; microcatheter: n = 52, 96.3%; p = 0.017). The first recanalization attempt was made with the SUOH 03 guidewire in 48 (64%) cases, and it was successful in 42 (87%). The overall PCI success rate was reported in 72 (96%) patients, with no significant differences among patients with different origins, mechanisms, and locations of dissection. Conclusions: In this setting, the SUOH 0.3 guidewire provides high procedural success without additional complex techniques.

Radial artery occlusion after transradial procedures: impact on 1-year adverse events.

BACKGROUND: Radial artery occlusion after transradial procedures is a frequent iatrogenic thrombotic process. The impact on prognosis has not been investigated. This study sought to investigate whether radial artery occlusion is related to increased risk of major adverse cardiac and cerebrovascular events, defined as death, myocardial infarction, stroke and coronary revascularization. METHODS: Eight hundred thirty-seven consecutive patients who underwent a transradial coronary procedure had patency of radial artery checked at 24 hours. Radial artery occlusion occurred in 41 over 837 patients (4.8%); 764 (91.2%) were available for planned follow-up at 1 year and were included in the analysis. Event-free survival rate between patients with and without radial artery occlusion was calculated using Kaplan-Meier estimates, and Cox proportional-hazards models were used to identify independent risk factors. RESULTS: At a median 370-day follow-up (IQR: 366-375 days), adverse events occurred in 37 patients (4.8%), 2 in patients with radial artery occlusion and 35 in patients without. One-year survival rate was 94.9% vs. 95% (unadjusted HR=1.026, 95% CI: 0.24 to 4.6, P=0.9). After multivariable modeling, age and coronary artery disease extension was associated with increased risk of adverse events. CONCLUSIONS: Age and coronary artery disease extension were independent predictors of adverse events at follow-up. RAO had no prognostic impact.

One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients.

Background It is unknown whether contemporary drug-eluting stents have a similar safety profile in high bleeding risk patients treated with 1-month dual antiplatelet therapy following percutaneous coronary interventions. Methods and Results We performed an interventional, prospective, multicenter, single-arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable-polymer everolimus-eluting stent followed by 1-month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1-year primary outcome occurred in 4.82% (95% CI, 3.17%-7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% (Pnoninferiority<0.001) notwithstanding the lower-than-expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%-2.50%), 3.42% (95% CI, 2.08%-5.62%), and 0.94% (95% CI, 0.35%-2.49%), respectively. Conclusions Among high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable-polymer everolimus-eluting stent, a 1-month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03112707.

Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients.

OBJECTIVES: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). BACKGROUND: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. METHODS: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. RESULTS: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). CONCLUSIONS: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis.

Predictors of patent and occlusive hemostasis after transradial coronary procedures.

OBJECTIVES: To assess the independent predictors of patent and occlusive hemostasis (PH and OH, respectively) during radial hemostasis after coronary procedures. BACKGROUND: Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, inadequate, and excessive anticoagulation are all predictors of RAO. METHODS: As a part of a previously published study investigating the relationship between residual anticoagulation and risk of RAO, 837 patients undergoing transradial diagnostic coronary angiography or percutaneous coronary interventions were enrolled. Cumulative heparin dose used during the procedure and ACT measured before sheath removal were recorded. PH with reverse Barbeau test was attempted in all patients (NCT02762344). RESULTS: PH was less frequently obtained for increasing cumulative heparin dose and ACT values (p < .0001 and p = .0034, respectively). At logistic regression analysis both cumulative heparin dose and ACT values were independent predictors of OH (OR 1.017, 95% IC 1.011-1.023 p < .0001 and OR 1.004, 95% IC 1.001-1.006, p = .0004) while adjusted probability for RAO showed exponential relationship with both parameters. CONCLUSIONS: The level of anticoagulation is strongly related to the incidence of RAO, and should be taken into account when choosing hemostasis protocol.

Transradial artery access for percutaneous cardiovascular procedures: state of the art and future directions.

The transradial access (TRA) for cardiac catheterization and percutaneous coronary intervention (PCI) has been widely adopted in the last decades since its first description in the late 40s. The transradial approach has been associated with favorable outcomes as compared with transfemoral access (TFA) in several registries and randomized clinical trials, mainly due to the lower incidence of access-site bleedings, vascular complications and improved patient comfort. This review aimed to summarize the body of evidence supporting the use of TRA, to discuss clinical implications, possible technical limitations and future directions, such as the implementation of TRA as the primary access for complex procedures and structural interventions.

Long-Term Outcomes of Coronary and Carotid Artery Disease Revascularization in the FRIENDS Study.

OBJECTIVES: The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies. BACKGROUND: Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. METHODS: This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team. RESULTS: The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively). CONCLUSIONS: An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized.

The Activated Clotting Time Paradox: Relationship Between Activated Clotting Time and Occlusion of the Radial Artery When Used as Vascular Access for Percutaneous Coronary Procedures.

BACKGROUND: Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, and insufficient anticoagulation are all predictors of RAO. However, excessive anticoagulation can lead to longer time to achieve complete hemostasis and less patent hemostasis rate. This study was designed to assess the relationship among residual anticoagulation at the end of a percutaneous coronary procedure and the risk of RAO. METHODS: Eight hundred thirty-seven patients undergoing transradial catheterization were enrolled. Activated clotting time (ACT) was measured before sheath removal. Patients were divided into 3 groups according to ACT values (ACT <150 s, ACT between 150 and 249 s, ACT >250 s), patent hemostasis with reverse Barbeau test was attempted in all patients, and compression device removed as soon as possible. Within 24 hours, patency of radial artery was checked by Doppler using reverse Barbeau technique. RESULTS: Incidence of RAO was higher for the extreme ACT values. Patent hemostasis were less frequently obtained and time to hemostasis significantly longer for increasing ACT values (P=0.004 for trend and <0.0001 for trend, respectively). At logistic regression analysis, ACT values <150 s were an independent predictor of RAO (odds ratio, 3.53; 95% IC, 1.677-7.43; P=0.001) while adjusted probability for RAO confirmed U-shaped relationship with ACT values. CONCLUSIONS: The level of anticoagulation is strongly related to incidence of RAO and should be measured objectively by ACT. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02762344.

[Endovascular treatment of symptomatic carotid artery dissection]. / Trattamento endovascolare della dissezione carotidea sintomatica.

Internal carotid artery dissection is one of the possible causes of stroke in young adults. The effectiveness of medical therapy alone is often limited and endovascular strategy should be considered, particularly in the presence of persisting neurological symptoms. Currently, there is no general consensus on the most appropriate therapeutic strategy to follow in symptomatic carotid artery dissection. We here report a case of symptomatic carotid artery dissection treated with an endovascular approach, and we review the recent literature regarding this therapeutic strategy. Materials and methods for performing endovascular treatment are also described, along with the possible steps to follow. Data in the literature and our clinical experience suggest that stenting is promising in patients with internal carotid artery dissection and should be considered as a valid therapeutic strategy in case of failure of medical therapy in highly experienced centers.

Optical coherence tomography assessment of newgeneration mesh-covered stents after carotid stenting.

AIMS: The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation mesh-covered stent. METHODS AND RESULTS: Sixteen consecutive patients undergoing CAS with mesh-covered stents and highdefinition OCT image acquisition were enrolled in the study. Cross-sectional OCT images for the presence of strut malapposition (SM) and plaque prolapse (PP) were evaluated using a proximal or distal embolic protection device (EPD). CGuard stents were used in 11 patients (68.8%) and RoadSaver stents in five (31.2%). With OCT analysis, the incidence of SM was 20.5% for CGuard vs. 26.8% for RoadSaver, p=0.26, and the incidence of PP was 10.8% for CGuard vs. 20.7% for RoadSaver, p=0.05. No neurological complications (stroke/TIA) occurred during the procedural and post-procedural periods. CONCLUSIONS: The OCT findings of two different types of mesh-covered stent after CAS were obtained safely. Our work indicates that current mesh-covered carotid stents may show differences in SM and PP. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to longterm clinical outcomes, require further evaluation.

Drug-coated balloon: Long-term outcome from a real world three-center experience.

OBJECTIVES: In-stent restenosis (ISR) and diffuse small vessel disease still represent challenging subsets for percutaneous coronary interventions, also in the new-generation DES era. We aim at reporting on the long-term clinical outcome of drug-coated balloons (DCB) in all-comers population. METHODS: Consecutive patients treated with DCB between January 2011 and December 2014 were retrospectively studied in three centers of northern Italy. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TLR. RESULTS: We included 143 patients. Of the 167 lesions treated, 41 (24.5%) were de novo lesions in small coronary vessels (<2.5 mm) and 126 (75.4%) were ISR. Among ISR lesions, 78.5% were DES-ISR, 32.5% were focal, 15.8% multifocal, 30.1% diffuse, 18.2% proliferative, and 3.1% were total occlusions. Procedural success was achieved in 94.6% of cases. Overall survival free from MACEs was 91.6% at 12 months, and 75.3% at 48 months, with a total of 3 cardiac deaths, 8 MI, and 27 TLR. No thrombotic event occurred in the treated segments. There were no differences in MACESs between the ISR and de novo lesions groups. At multivariate analysis, acute coronary syndromes, previous MI, previous surgical revascularization, peripheral arterial disease and diabetes were independent predictors of MACEs at long-term follow-up. CONCLUSIONS: DCB proved a valid revascularization strategy in an all-comers population of patients with ISR and de novo lesions in small vessels, with an acceptable rate of cardiac events up to 48 months follow-up.

Independent Modular Filter for Embolic Protection in Carotid Stenting.

BACKGROUND: Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. METHODS AND RESULTS: A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. CONCLUSIONS: The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01783639.

A New Strategy for Transcatheter Left Atrial Appendage Closure With Cerebral Embolic Protection in Patient With Left Auricular Thrombosis and Total Contraindication to Long-Term Anticoagulation.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, occurring in 1%-2% of the general population. An important aspect is the treatment of AF in terms of stroke prevention. In patients with absolute contraindication to long-term anticoagulation due to high bleeding risk, a valuable alternative exists in left atrial appendage (LAA) closure. Unfortunately, thrombus in the LAA is a contraindication to the procedure because of high risk of embolization. We describe a clinical case with permanent AF, absolute contraindication to long-term anticoagulation therapy, and persistent thrombus formation in the LAA that was treated with transcatheter LAA closure and supraaortic trunk protection system in order to avoid risk of periprocedural stroke.