Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST-EU registry.

BACKGROUND: Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. OBJECTIVE: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS. METHODS: We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. RESULTS: A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no-overlap BRS (no-overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre- and postdilatation. At 1-year, there were no differences in PoCE between the overlap versus no-overlap group (18.4% vs. 18.2%; HR 1.07, [0.80-1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48-2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one-month (1.3% vs. 1.5%, P = 0.769) or at 1-year (1.9% vs. 2.1%, P = 0.823). CONCLUSIONS: In "Real-world" clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no-overlapping BRS. These preliminary data should be confirmed. © 2016 Wiley Periodicals, Inc.

Everolimus-eluting bioresorbable vascular scaffolds versus second generation drug-eluting stents for percutaneous treatment of chronic total coronary occlusions: Technical and procedural outcomes from the GHOST-CTO registry.

OBJECTIVES: We aimed at comparing the acute performance of bioresorbable scaffolds (BRS) and second-generation drug-eluting stents (DES) for the treatment of chronic total occlusions (CTO). BACKGROUND: There is a lack of knowledge regarding the use of BRS in CTO. METHODS: Key outcomes of interest were technical and procedural success. Technical success was defined as successful stent delivery and implantation, postprocedural residual diameter stenosis <30% within the treated segment, and restoration of thrombolysis in myocardial infarction (TIMI) grade 3 flow. Procedural success was defined as technical success with no in-hospital major adverse cardiac events (MACE). RESULTS: Between May 2013 and May 2014, 32 patients underwent CTO percutaneous coronary intervention (PCI) with the Absorb BRS (Abbott Vascular, Santa Clara, CA) and were compared with a historical control group of 54 patients who had undergone CTO PCI with second-generation DES. Baseline characteristics were similar between the BRS and DES groups, with the exception of a larger mean reference vessel diameter in the BRS group (2.92 ± 0.34 vs 2.50 ± 0.68; P < 0.001). Technical success was less likely to be achieved in the BRS group compared with the DES group (78.1% vs 96.3%, P = 0.012). Procedural success rates were 78.1% and 94.4% in the BRS and DES group, respectively (P = 0.035). CONCLUSIONS: Compared with second-generation DES for PCI of CTO lesions, BRS were associated with lower rates of technical and procedural success. © 2016 Wiley Periodicals, Inc.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting. Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization. Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT). Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%).

Intra-Cardiac versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion with a Watchman FLX Device.

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry.

Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.

The "RotaTripsy Plus" Approach in a Heavily Calcified Coronary Stenosis.

Percutaneous treatment of heavily calcified coronary stenoses is one the most demanding setting, due to the high risk of acute and long-term complications. Various dedicated devices are currently available and their combined use can be an option in these high-risk procedures. We hereby report a successful case of several combined debulking technologies for the treatment of a long, highly calcified coronary lesion.

Endothelial Progenitor Cell Function in Patients With Coronary Chronic Total Occlusion and its Relationship With Collateral Circulation.

AIM: To evaluate the relationship between endothelial progenitor cell (EPC) count and function and collateral circulation in coronary chronic total occlusions (CTOs). METHODS: A total of 20 consecutive patients with successfully treated CTO lesions were included during a period of 12 months. EPC count and function were evaluated by flow cytometry and colony-forming unit (CFU) analysis at baseline (before percutaneous coronary intervention) and at 1-year follow-up. Patients were classified, according to Rentrop classification at the baseline angiography, as group 1 (Rentrop 3; n = 7) and group 2 (Rentrop <3; n = 13). Differences in EPC count and function were compared between groups. RESULTS: The EPC count did not differ between the 2 groups, either at baseline or at follow-up. CFU was significantly lower at follow-up compared with baseline in the overall population (16.6 10^6/mL (IQR, 10.2-29.4 10^6/mL) vs 7.1 10^6/mL (IQR, 5.3-25.0 10^6/mL); P=.046). Group 1 had both higher basal and follow-up CFU values compared with group 2 (35.4 10^6/mL (IQR, 21.5-41.8 10^6/mL) vs 13.3 10^6/mL (IQR, 6.9-17.5 10^6/mL) and 32.1 10^6/mL (IQR, 13.9-40.5 10^6/mL) vs 5.9 10^6/mL (IQR, 4.4-9.8 10^6/mL), respectively; P=.01 for both). By linear regression analysis, Rentrop grade 3 flow was an independent predictor of both basal and follow-up CFU levels (odds ratio, 3.66; 95% confidence interval, 6.41-29.69; P<.01; and odds ratio, 5.24; 95% confidence interval, 9.78-25.85; P<.01, respectively). CONCLUSION: Patients with Rentrop grade 3 collateral circulation exhibited higher EPC activity at baseline and at 1-year follow-up compared with those who had reduced collateral circulation. The role of this higher EPC activity in determining clinical endpoint should be investigated in a larger study.

Serial optical coherence tomography assessment of malapposed struts after everolimus-eluting stent implantation. A subanalysis from the HEAL-EES study.

BACKGROUND: Incomplete stent apposition (ISA) is related to stent thrombosis, which is a serious adverse event. We aim to assess the time-course of ISA after 2nd generation everolimus-eluting stent (EES) implantation. METHODS: In HEAL-EES study, we enrolled 36 patients who underwent percutaneous coronary intervention (PCI) with EES. OCT imaging was performed at baseline and follow-up. Patients were randomized 1:1:1 into 3 groups according to the time in which follow-up was performed: group A (6-month), group B (9-month), and group C (12-month). In this subanalysis, patients who had ISA segments at baseline and/or follow-up OCT were analyzed. RESULT: At baseline, among 41 lesions in 36 patients, 20 lesions in 18 patients had ISA segments and were analyzed. At baseline, there were 3.0% ISA struts in group A (n=8), 2.8% in group B (n=4), and 4.5% in group C (n=8). At follow-up, ISA struts were present in 0.09%, 0.16% and 0.64%; respectively in groups A, B, and C. At follow-up, there was a significant decrease in the frequency of ISA: group A 3.0% vs. 0.09% (p<0.001), group B 2.8% vs. 0.16% (p<0.001), and group C 4.5% vs. 0.64% (p<0.001). In group A, there was one late acquired ISA at follow-up. CONCLUSIONS: In patients undergoing 2nd generation EES implantation, area of acute ISA assessed by OCT, was almost resolved at 6-month follow-up.

Impact of stent overlapping on long-term clinical outcomes in patients with ST-segment elevation myocardial infarction: insights from the five-year follow-up of the EXAMINATION trial.

AIMS: The aim of this study was to compare the long-term outcomes of STEMI patients treated with overlap vs. no-overlap stents. METHODS AND RESULTS: We analysed the one- and five-year clinical outcomes of 1,498 STEMI patients according to overlapping stent implantation. The primary endpoint was a patient-oriented composite endpoint (PoCE) of all-cause death, myocardial infarction, and repeat revascularisation. Stent thrombosis data were also analysed. Four hundred and four (27.0%) patients were treated with overlapping stents, whereas the remaining 1,094 (73.0%) were not. At one and five years, there was no difference in PoCE between the overlap vs. no-overlap group, even after adjustment (14.9% vs. 12.4%; HR 1.20, 95% CI: 0.76-1.90; p=0.44, and 26.3% vs. 22.3%; HR 1.14, 95% CI: 0.80-1.62; p=0.47, respectively). At five years, within the overlap group, patients who received BMS had a trend towards a higher rate of PoCE and DoCE as compared to those who received EES. At one year, there was a trend towards a higher rate of definite/probable stent thrombosis in the overlap compared to the no-overlap group (2.2% vs. 1.6%; HR 2.35, 95% CI: 0.95-5.90; p=0.06). This difference was driven by a higher rate for BMS compared to EES (4.4% vs. 0%, p for interaction=0.03) in the overlap group. At five years, the absolute risk difference for overlap (3.5% vs. 2.2%, p=0.99) and interaction for BMS (p=0.03) were similar. CONCLUSIONS: In patients presenting with STEMI, the long-term PoCE was similar for the overlap and no-overlap groups. Overlap among patients receiving BMS appears to be associated with a higher risk for adverse cardiovascular outcomes and stent thrombosis.

Unfavorable bioresorbable vascular scaffold resorption, a cause of restenosis?

We report a case of bioresorbable vascular scaffold restenosis which could be caused by abnormal resorption 17months after implantation.

Bioresorbable vascular scaffolds technology: current use and future developments.

Coronary bioresorbable vascular scaffolds are a new appealing therapeutic option in interventional cardiology. The most used and studied is currently the Absorb BVS™. Its backbone is made of poly-L-lactide and coated by a thin layer of poly-D,L-lactide, it releases everolimus and is fully degraded to H2O and CO2 in 2-3 years. Absorb BVS™ seems to offer several theoretical advantages over metallic stent, as it gives temporary mechanical support to vessel wall without permanently caging it. Therefore, long-term endothelial function and structure are not affected. A possible future surgical revascularization is not compromised. Natural vasomotion in response to external stimuli is also recovered. Several observational and randomized trials have been published about BVS clinical outcomes. The main aim of this review is to carry out a systematic analysis about Absorb BVS™ studies, evaluating also the technical improvements of the Absorb GT1 BVS™.

Bioresorbable vascular scaffolds in clinical practice: state-of-the-art.

Coronary bioresorbable vascular scaffolds (BVS) are a new appealing therapeutic option in interventional cardiology. To date, the Absorb BVS™ (Abbott Vascular, Santa Clara, CA, USA) is the most used and studied device. Its backbone is made of poly-L-lactide and coated by a thin layer of poly-D,L-lactide; everolimus is released and the scaffold is fully degraded to H2O and CO2 in 2-3 years. The BVS technology seems to offer several theoretical advantages over metallic stent implantation. It gives temporary mechanical support to vessel wall, without permanently caging it. Hence, long-term endothelial function may be restored and natural vasomotion in response to external stimuli may be recovered. Finally, an eventual future surgical revascularization is not conditioned. Several observational and randomized trials assessing the performance and clinical outcomes of BVS have been recently published. The main aim of this review is to carry out a systematic analysis and to evaluate long-term efficacy and safety of the Absorb BVS™.

Minimally Invasive Transradial Percutaneous Closure of Aortic Paravalvular Leaks: Following the Steps of Percutaneous Coronary Intervention.

Two patients with severe aortic paravalvular leaks (PVLs) in a mechanical prosthesis were percutaneously treated. Procedures were performed with mild sedation, angiographic guidance, and a 6-French right radial artery approach with good final results. Percutaneous PVL treatment is routinely performed with general anaesthesia, transesophageal echocardiographic guidance, and femoral access. Although another case of radial aortic PVL closure has been previously reported, it was performed with an 8-French radial sheath, transesophageal echocardiographic guidance, and general anaesthesia. According to our initial experience, aortic PVLs could be treated in a minimally invasive way. Larger studies should be conducted to confirm these observations.

Late Right Coronary Ostium Occlusion After Percutaneous Aortic Paravalvular Leak Closure: Immediate Results Do Not Always Predict Long-Term Performance.

We present an 83-year-old woman with history of two aortic valve replacements; 2 years after the last replacement, she developed heart failure and severe paravalvular leak (PVL) was detected. Percutaneous PVL closure was completed with a single Amplatzer Vascular Plug III. Two months later, the patient presented with late coronary obstruction requiring emergent surgical revascularization. To the best of our knowledge, this is the first report of late coronary obstruction after percutaneous PVL closure.

Bioresorbable vascular scaffold implantation in acute coronary syndromes: clinical evidence, tips and tricks.

Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) is routine treatment for patients with acute coronary syndromes (ACS). However, permanent metallic caging of the vessel has several shortcomings, such as side branch jailing and impossibility of late lumen enlargement. Moreover, DES PCI is affected by vasomotion impairment. In ACS a high thrombus burden and vasospasm lead to a higher risk of acute and late acquired stent malapposition than in stable patients. This increases the risk of acute, late and very late stent thrombosis. In this challenging clinical setting, the implantation of bioresorbable vascular scaffolds (BVS) could represent an appealing therapeutic option. Temporary vessel scaffolding has proved to have several advantages over metallic stent delivery, such as framework reabsorption, late lumen enlargement, side branch patency, and recovery of physiological reactivity to vasoactive stimuli. In the thrombotic environment of ACS, BVS implantation has the benefit of capping the thrombus and the vulnerable plaque. Bioresorbable vascular scaffolds also seems to reduce the incidence of angina during follow-up. Acute coronary syndromes patients may therefore benefit more from temporary polymeric caging than from permanent stent platform implantation. The aim of this review is to update the available knowledge concerning the use of BVS in ACS patients, by analyzing the potential pitfalls in this challenging clinical setting and presenting tricks to overcome these limitations.

Current status and ongoing development of reversing agents for novel oral anticoagulants (NOACs).

Novel oral anticoagulants (NOACs) have been associated with multiple safety benefits compared with vitamin K antagonists in patients with diseases at high thromboembolic potential, including nonvalvular atrial fibrillation. Although these agents have several distinct advantages, they are limited by the lack of a proven antidote, which may represent a major concern in case of life-threatening bleeding. Several different drugs and compounds are currently under investigation as reversing agents of NOACs. This article provides an overview of potential NOACs antidotes, including recent patents of emerging compounds.

Novel oral anticoagulants versus warfarin in non-valvular atrial fibrillation: a meta-analysis of 50,578 patients.

BACKGROUND: Warfarin, despite its known limitations, is the reference standard treatment for patients with AF and risk factors for stroke. We performed a meta-analysis of phase III trials that compare novel oral anticoagulants (NOACs) with warfarin to determine whether they improve clinical outcomes of patients with non-valvular atrial fibrillation (AF). METHODS: Three randomized trials that compared NOACs with warfarin in AF were selected. The primary efficacy endpoint was the incidence of stroke or systemic embolism. The primary safety endpoint was the incidence of major bleeding. RESULTS: A total of 50578 patients were included. NOACs significantly decreased stroke or systemic embolism (2.8% vs 3.5%, odds ratio [OR] 0.82, 95% confidence interval [CI] 0.74-0.91, P<0.001), death (6.0% vs 6.3%, OR 0.88, 95% CI 0.82-0.95, P=0.001) and stroke (2.4% vs 3.0%, OR 0.79, 95% CI 0.71-0.88, P<0.001). The reduction in stroke was mainly driven by fewer hemorrhagic strokes (0.3% vs 0.8%, OR 0.79, 95% CI 0.71-0.88, P<0.001). Major bleeding occurred in 5.0% and 5.6% of patients in the NOACs and warfarin groups (OR 0.85, 95% CI 0.69-1.05, P=0.14 in the random-effects model). NOACs were associated with lower rates of intracranial bleeding (0.6% vs 1.3%, P<0.001) and higher rates of gastrointestinal bleeding (2.3% vs 1.3%, P=0.036). CONCLUSIONS: In patients with non-valvular AF, NOACs decrease stroke or systemic embolism, hemorrhagic stroke and mortality, with similar risk of major bleeding compared to warfarin.

Novel drugs for oral anticoagulation pharmacotherapy.

Long-term anticoagulation with warfarin is the mainstay of treatment in patients with diseases with high thromboembolic potential, such as atrial fibrillation. However, warfarin therapy carries a number of inherent limitations, including slow onset and offset of action, interindividual variability, food and drug interactions, lack of selectivity and a narrow therapeutic window. Recently developed oral anticoagulants that selectively block key factors in the coagulation cascade, with no need for monitoring or dose adjustment, have the potential to replace warfarin in clinical practice. The safety and efficacy of these agents in patients with atrial fibrillation, venous thromboembolisms and acute coronary syndromes have been the object of numerous recent large-scale clinical investigations. This article provides an overview of the evidence currently available on the use of novel, orally available, selective anticoagulants in patients at risk for thromboembolic events.

Global risk classification and clinical SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) score in patients undergoing percutaneous or surgical left main revascularization.

OBJECTIVES: The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). BACKGROUND: There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization. METHODS: The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated. RESULTS: The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029). CONCLUSIONS: In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease.