Search

Aims: We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR)., Background: Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated., Methods: Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y 12 inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study., Results: We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints., Conclusions: This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest Dr. Testa has received consulting fees, personal and institutional honoraria, and has served on the advisory board participation from Abbott, Medtronic, Biotronik, Boston Scientific Corporation, Terumo Lifesciences, Meril, Cardionovum, Concept Medical. Dr. Piccolo has received speaker fees from Abbott Vascular and Biotronik and has served on the advisory board for Daiichi-Sankyo. Dr. De Luca has received speaker fees from AstraZeneca, Daiichi-Sankyo and Sanofi. Dr. Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer (New York, NY, United States)/BMS. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

After percutaneous coronary interventions (PCIs), patients remain at high risk of developing recurrent cardiovascular events. Despite advances in interventional cardiology, the correct management of residual low-density lipoprotein cholesterol (LDL-C) risk continues to be crucial for improving long-term outcomes after PCI. However, several observational studies have demonstrated suboptimal LDL-C control, poor adherence to statin therapy, and underutilization of high-intensity statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitors in real-world clinical practice despite a strong endorsement from international guidelines. Recent studies have shown that early intensive lipid-lowering therapy stabilizes atheromatous plaque and increases fibrous cap thickness in patients with acute coronary syndrome. This finding emphasizes the importance of achieving therapeutic targets by establishing an effective treatment as early as possible. The aim of this expert opinion paper of the Interventional Cardiology Working Group of the Italian Society of Cardiology is to discuss the management of lipid-lowering therapy in patients undergoing PCIs according to Italian reimbursement policies and regulations, with a particular focus on the discharge phase., (Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Since their introduction in clinical practice in 1986, different types of coronary stents have been developed and become available for the treatment of coronary artery disease. Stent thrombosis (ST) is an uncommon but harmful complication after percutaneous coronary implantation, with a high occurrence of acute myocardial infarction and risk of mortality. Among several procedural and clinical predictors, the type of coronary stent is a strong determinant of ST. This article reviews the available evidence on the most used coronary stent types in the modern era and the related risk of ST., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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 P2Y 12 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% ( P noninferiority <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.

Patients at High Bleeding Risk (HBR) are a sizable part of the population undergoing Percutaneous Coronary Intervention (PCI) and stent implantation. This population historically lacks standardized definition, thus limiting trial design, data generalizability, and clinical decision-- making. To overcome this limitation, the Academic Research Consortium (ARC) has recently released comprehensive guidelines defining HBR criteria for study design purposes and daily clinical practices. Furthermore, several risk scores have been developed aiming to discriminate against HBR patients and support physicians for clinical decision-making when faced with this complex subset of patients. Accordingly, the first part of this review article will explore guideline-recommended risk scoring as well as ARC-HBR criteria and their relative application for daily clinical practice. The second part of this review article will explore the complex interplay between the risk of bleeding and coronary thrombotic events in patients deemed at HBR. Indeed, several features that identify these patients are also independent predictors of recurrent ischemic events, thus challenging revascularization strategies and optimal antithrombotic therapy. Accordingly, several clinical trials have been conducted to evaluate the safety and efficacy of the new generation of coronary platforms and different antithrombotic strategies for HBR patients to minimize both ischemic and bleeding events. Accordingly, in this part, we discuss current guidelines, trials, and observational data evaluating antithrombotic strategies and stent technologies for patients at HBR., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.

Patients with severely calcified coronary lesions undergoing percutaneous revascularization have a substantial risk of adverse outcomes, both during the procedure and in the long term. Over the last decade, a renewed interest has been observed about devices for plaque modification and lesion preparation, new technologies have been introduced in clinical practice and well-known devices have undergone technical and procedural improvements. The available tools for intravascular imaging allow a detailed evaluation of the calcific plaques within all the layers of the vessel wall. The complementary use of all these tools is ultimately aimed at optimizing the mechanics of balloon angioplasty and the delivery and expansion of drug-eluting stents. It has been fully demonstrated that rotational atherectomy improves procedural success when treating heavily calcified lesions. Intravascular lithotripsy, techniques and materials used during complex procedures such as chronic total occlusions, increasing operators' experience, as well as new drug-eluting stents with excellent mechanical characteristics, have further contributed to the feasibility and the safety of treating most fibrotic and heavily calcified vessels. We finally propose an algorithm for evaluation and treatment of severely calcific coronary lesions to demonstrate how such percutaneous revascularization procedures are planned and performed.

Objectives: We aimed to evaluate the use of bare metal stent (BMS) implantation in current percutaneous coronary intervention (PCI) era, focusing on indications for use and clinical outcomes., Background: Limited data on BMS usage in current clinical practice are available., Methods: All patients who underwent PCI with at least one BMS implantation in 18 Italian centers from January 1, 2013 to December 31, 2017, were included in our registry. Rates of BMS use and reasons for BMS implantations were reported for the overall study period and for each year. Primary outcomes were mortality, bleeding (Bleeding Academic Research Consortium-BARC and Thrombolysis in Myocardial Infarction-TIMI non-CABG definitions), and major adverse cardiac events (MACE) defined as the composite of all-cause and cardiac death, any myocardial infarction, target vessel revascularization, or any stent thrombosis., Results: Among 58,879 patients undergoing PCI in the study period, 2,117 (3.6%) patients (mean age 73 years, 69.7% males, 73.3% acute coronary syndrome) were treated with BMS implantation (2,353 treated lesions). The rate of BMS implantation progressively decreased from 10.1% (2013) to 0.3% (2017). Main reasons for BMS implantation were: ST-elevation myocardial infarction (STEMI) (23.1%), advanced age (24.4%), and physician's perception of high-bleeding risk (34.0%). At a mean follow-up of 2.2 ± 1.5 years, all-cause and cardiac mortality were 25.6 and 12.7%, respectively; MACE rate was 35.3%, any bleeding rate was 13.0% (BARC 3-5 bleeding 6.3%, TIMI non-CABG major bleeding 6.1%)., Conclusion: In a large, contemporary, real-world, multicenter registry, BMS use progressively reduced over the last 5 years. Main reasons for BMS implantation were STEMI, advanced age, and physician's perception of high-bleeding risk. High rates of mortality and MACE were observed in this real-world high-risk population., (© 2020 Wiley Periodicals, Inc.)

Background: There is recent new evidence regarding the combined use of direct oral antiocoagulants and antiplatelet agents in patients with Atrial Fibrillation undergoing PCI., Purpose: To compare the efficacy of dual antithrombotic treatment (DAT) including a direct oral anticoagulant (DOAC) and an antiplatelet agent versus triple antithrombotic treatment (TAT) with a vitamin K antagonist (VKA)., Data Sources: PubMed, SCOPUS and Google Scholar from through 09/09/2019; references of eligible studies; relevant scientific sessions abstracts and cardiology websites., Study Selection: Randomized controlled trials that compared DAT including a DOAC with TAT including a VKA and that reported at least the rates of stroke, Stent thrombosis and bleeding., Data Extraction: Two investigators independently extracted study data and assessed study quality., Data Synthesis: Four randomized trials that compared DAT including a DOAC with TAT including a VKA were available. Among these, one trial included two independent treatment arms with different DOAC dose, both compared against TAT. For this reason, the two arms were treated independently, resulting in 5 randomized comparisons available for meta-analysis, with a total of 8654 patients involved. The primary safety endpoint was significantly lower in the DAT arm (14.4%) compared to the TAT arm (23%) (RD = -0.08; p<0.001). In addition, we found no significant difference in the incidence of stroke between the treatment arms (p = 0.23). Similarly, no significant difference in the incidence of Stent Thrombosis between the treatment arms (p = 0.08)., Limitations: All trials included were open-label, even though data were blindly analyzed. Qualifying criteria are heterogeneous., Conclusions: Compared TAT including a VKA, a therapeutic DAT regimen including a DOAC was associated with a significant reduction of the primary safety endpoint in AF patients undergoing PCI with stent implantation for an ACS or chronic coronary syndrome, while no significant difference was found in the rate of ischemic adverse events, including stroke, acute myocardial infarction or stent thrombosis., Competing Interests: The authors have declared that no competing interests exist.

Importance: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated., Objective: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial., Design, Setting, and Participants: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015., Interventions: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred., Main Outcomes and Measures: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups., Results: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25)., Conclusions and Relevance: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes., Trial Registration: ClinicalTrials.gov identifier: NCT02053038.

Stent thrombosis (ST) is a rare but severe complication of coronary procedures with high mortality, high relapse rate and a very complex pathophysiology. An individual's susceptibility to ST is multifactorial and results from interactions between clinical factors, endothelial biology, hypersensitivity and/or inflammatory reactions, blood rheology, platelet reactivity, clotting factors, physical and mechanical properties of the stent and from the effects of these different factors on the fluid dynamics of blood flow. Since the introduction of stents 32 years ago, continuous improvements in our understanding of the pathophysiology of ST have triggered important advances, including new therapies, new technologies and an increased awareness of the implications of implantation techniques. Furthermore, advances in medical imaging and in the mathematical processing of this information have allowed a more detailed assessment of the mechanisms of ST at the time of its onset. Evidence shows that addressing the risk factors for ST leads to a substantial reduction in its incidence, both early and late after stent implantation. A better knowledge of the mechanisms of this complication is, however, necessary to direct the choice of the most appropriate strategy for its prevention and treatment.

Background: BRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited., Methods: We systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322)., Results: Thirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I 2  = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I 2  = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I 2  = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I 2  = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I 2  = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I 2  = 0%, P = 0.04)., Conclusions: Implantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.

Vascular smooth muscle cells (VSMCs) and endothelial cells (ECs) are crucial in vascular remodeling. They exert pivotal roles in the development and progression of atherosclerosis, vascular response to injury, and restenosis after transcatheter angioplasty. As a witness of their importance in the cardiovascular system, a large body of evidence has accumulated about the role played by micro RNAs (miRNA) in modulating both VSMCs and ECs. More recently, a growing number of long noncoding RNA (lncRNAs) came beneath the spotlights in this research field. Several mechanisms have been revealed by which lncRNAs are able to exert a relevant biological impact on vascular remodeling. The aim of this review is to provide an integrated summary of ncRNAs that exert a relevant biological function in VSMCs and ECs of the vascular wall, with emphasis on the available clinical evidence of the potential usefulness of these molecules as circulating biomarkers of in-stent restenosis., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to describe the incidence and clinical characteristics, including intracoronary imaging features, of clinical restenosis in bioresorbable coronary scaffolds (BRS). Further, the authors searched for clinical and procedural predictors of scaffold restenosis (ScR) and report on the clinical outcomes after treatment of ScR in a cohort of consecutive all-comer patients., Background: Data from randomized controlled trials demonstrate a higher rate of target lesion failure in patients treated with BRS as compared with those treated with metal drug-eluting stents. Although in-scaffold thrombosis has been thoroughly investigated, there are little data available on the incidence and characteristics of ScR., Methods: A total of 657 consecutive patients (age 63 ± 12 years, 79% men, 21% diabetics, 67% acute coronary syndrome) who received a total of 883 BRS for the treatment of coronary artery stenoses between May 2012 and January 2015 were enrolled in a retrospective registry., Results: During the median follow-up of 1,076 days (interquartile range: 762 to 1,206 days), a total of 49 cases of ScR were found in 41 patients (Kaplan-Meier incidence: 2.4%, 6.0%, and 9.0% at 12-, 24-, and 36-month follow-up, respectively). ScR presented as stable angina or as incidental finding in 73% of the cases. The angiographic pattern was complex (type II to IV) in 55% of the ScR lesions. The neointima was homogeneous with high signal intensity in all but 3 cases at optical coherence tomography. Prior revascularization (hazard ratio [HR]: 2.7; 95% confidence interval [CI]: 1.5 to 5.1; p = 0.002), diabetes (HR: 2.9; 95%CI: 1.5 to 5.4; p = 0.001), lesion types B2 or C (HR: 2.8; 95% CI: 1.5 to 5.4; p = 0.002), and implantation technique (HR: 0.3; 95% CI: 0.1 to 0.6; p = 0.001) emerged as independent predictors of ScR. Oversizing (HR: 6.29; 95% CI: 2.4 to 16.4), undersizing (HR: 5.15; 95% CI: 1.99 to 13.30), and a residual stenosis >27% (HR: 8.9; 95% CI: 3.6 to 21.8) were associated with an increased ScR risk., Conclusions: The 3-year incidence of ScR was similar to that observed in similar settings with newer-generation drug-eluting stents. It is often associated with a benign presentation and a complex angiographic pattern. Predictors of ScR match those of metallic stent restenosis, and the implantation technique used at index appears to play an important role., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery bypass graft (CABG) surgery has traditionally represented the standard of care for left main coronary artery (LMCA) disease. However, percutaneous coronary intervention with stent implantation (PCI) has more recently emerged as a valuable alternative. The long-time awaited results of the largest randomized trials on the long-term impact of PCI versus CABG in LMCA disease, the newly published NOBLE and EXCEL studies, revealed contrasting results. Thus, aim of the present meta-analysis was to review the most robust evidence from randomized comparisons of CABG versus PCI for revascularization of LMCA., Methods: Randomized studies comparing long-term clinical outcomes of CABG or Stent-PCI for the treatment of LMCA disease were searched for in PubMed, the Chochrane Library and Scopus electronic databases. A total of 5 randomized studies were selected, including 4499 patients., Results: No significant difference between CABG and PCI was found in the primary analysis on the composite endpoint of death, stroke and myocardial infarction (OR = 1·06 95% CI 0·80-1·40; p = 0·70). Similarly, no differences were observed between CABG and PCI for all-cause death (OR = 1·03 95% CI 0·81-1·32; p = 0·81). Although not statistically significant, a lower rate of stroke was registered in the PCI arm (OR = 0·86; p = 0·67), while a lower rate of myocardial infarction was found in the CABG arm (OR = 1·43; p = 0·17). On the contrary, a significantly higher rate of repeat revascularization was registered in the PCI arm (OR = 1·76 95% CI 1·45-2·13; p < 0·001)., Conclusions: The present meta-analysis, the most comprehensive and updated to date, including 5 randomized studies and 4499 patients, demonstrates no difference between Stent-PCI and CABG for the treatment of LMCA disease in the composite endpoint of death, stroke and myocardial infarction. Hence, a large part of patients with unprotected left main coronary artery disease can be managed equally well by means of both these revascularization strategies.

Background: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES)., Objectives: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up., Methods: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively., Results: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I 2  = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I 2  = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (p interaction  = 0.49)., Conclusions: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary bioresorbable scaffolds (BRS) were developed to overcome the limitations of standard metallic stents, especially to address late events after percutaneous coronary interventions. The aim of this meta-analysis was to evaluate the efficacy and safety of BRS, compared with Everolimus-eluting stents (EES), using the data available from randomized trials, with a focus on long-term outcomes., Methods: Published randomized trials comparing BRS to EES for the treatment of coronary artery disease were searched for within PubMed, Cochrane Library and Scopus electronic databases up to April 4th 2017. The summary measure used was odds ratio (OR) with 95% confidence intervals., Results: A total of 5 studies were eligible, including 5219 patients. At 2 years, BRS was associated with higher rates of target lesion failure (9.4% vs 7.2%; OR = 1.33; 95% CI 1.07 to 1.63; p = 0.008) and device thrombosis (2.3% vs 0.7%; OR = 3.22; 95% CI 1.86 to 5.57; p < 0.0001) compared with EES. The incidence of both early (within 30 days after implantation, 1.1% vs 0.5%, OR 1.97, 95% CI 1.02 to 3.81; p = 0.05) and very-late device thrombosis (>1 year, 0.6% vs 0.1%, OR 4.03, 95% CI 1.37 to 11.82; p = 0.01) was higher with BRS compared with EES., Conclusions: BRS may be associated with worse two-years clinical outcomes compared with EES in patients with coronary artery disease.

Background: Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR., Methods: We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk., Results: At 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, -0.2 percentage points; 95% confidence interval [CI], -2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P=0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P=0.001)., Conclusions: Coronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. (Funded by Philips Volcano; DEFINE-FLAIR ClinicalTrials.gov number, NCT02053038 .).

The purpose of the study to assess the comparability of immediate changes in plaque/media volume (PV) on three modalities of intravascular ultrasound (IVUS) after implantation of either bioresorbable vascular scaffold (BVS) or everolimus-eluting metallic stent (EES) in Absorb II Study. The two devices have different device volume and ultrasound backscattering that may interfere with the "plaque/media" assessed by three modalities on IVUS: grayscale, backscattering of radiofrequency and brightness function. In a multicenter randomized controlled trial, 501 patients with stable or unstable angina underwent documentary IVUS pre- and post- implantation. The change in plaque/media volume (PV) was categorized into three groups according to the relative PV change in device segment: PV "increased" >+5% (PVI), PV unchanged ±5% (PVU), and PV decreased <-5% (PVD). The change in PV was re-evaluated three times: after subtraction of theoretical device volume, after analysis of echogenicity based on brightness function. In 449 patients, 483 lesions were analyzed pre- and post-implantation. "PVI" was more frequently observed in BVS (53.8%) than EES group (39.4%), p = 0.006. After subtraction of the theoretical device volume, the frequency of "PVI" decreased in both BVS (36.2%) and EES (32.1%) groups and became comparable (p = 0.581). In addition, the percentage of "PVI" was further reduced in both device groups after correction for either radiofrequency backscattering (BVS 34.4% vs. EES 22.6%) or echogenicity (BVS 25.2% vs. EES 9.7%). PV change in device segment was differently affected by BVS and EES devices implantation due to their differences in device volume and ultrasound backscattering. It implies that the lumen volume was also artifactually affected by the type of device implanted. Comparative IVUS assessment of lumen and plaque/media volume changes following implantation of BVS and EES requires specific methodological adjustment.

Definition of the optimal duration of dual anti-platelet therapy (DAPT) is an important clinical issue, given the large number of patients having percutaneous coronary intervention (PCI), the costs and risks of pharmacologic therapy, the consequences of stent thrombosis, and the potential benefits of DAPT in preventing ischaemic outcomes beyond stent thrombosis. Nowadays, the rationale for a prolonged duration of DAPT should be not only the prevention of stent thrombosis, but also the prevention of ischaemic events unrelated to the coronary stenosis treated with index PCI. A higher predisposition to athero-thrombosis may persist for years after an acute myocardial infarction, and even stable patients with a history of prior myocardial infarction are at high risk for major adverse cardiovascular events. Recently, results of pre-specified post-hoc analyses of randomized clinical trials, including the PEGASUS-TIMI 54 trial, have shed light on strategies of DAPT in various clinical situations, and should impact the next rounds of international guidelines, and also routine practice. Accordingly, the 2015 to 2016 the Board of the Italian Society of Cardiology addressed newer recommendations on duration of DAPT based on most recent scientific information. The document states that physicians should decide duration of DAPT on an individual basis, taking into account ischaemic and bleeding risks of any given patient. Indeed, current controversy surrounding optimal duration of DAPT clearly reflects the fact that, nowadays, a one size fits all strategy cannot be reliably applied to patients treated with PCI. Indeed, patients usually have factors for both increased ischaemic and bleeding risks that must be carefully evaluated to assess the benefit/risk ratio of prolonged DAPT. Personalized management of DAPT must be seen as a dynamic prescription with regular re-evaluations of the risk/benefit to the patient according to changes in his/her clinical profile. Also, in order to derive more benefit than harm from new treatments, a multi-parametric approach using several risk scores of the ischaemic and bleeding risks might improve the process of risk factor characterization. In patients with high ischaemic risk, particularly those with a history of myocardial infarction, the benefits of extended DAPT (particularly with ticagrelor up to 3 years) are likely to outweigh the risks.

Background: The effect of optical coherence tomography (OCT) guidance on the implantation strategy during all phases of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVSs) in a real-world scenario has been poorly investigated., Methods: Consecutive patients undergoing BVS implantation at our institution were included in this registry. Frequency-domain OCT pullbacks were performed at the operator's discretion during all phases of BVS implantation procedures to optimize preparation of lesions, confirm BVS size, and optimize expansion and apposition of scaffolds., Results: Between September 2012 and July 2015, 203 BVSs were implanted in 101 consecutive patients at our institution (2.01 BVSs/patient). In 66 patients, the procedure was performed under OCT guidance. In the OCT subgroup, 66 (77.6%) of the 85 treated lesions were complex (B2/C AHA/ACC type). Overall, 147 OCT pullbacks were performed and 72/147 (49.0%) pullbacks indicated the need for changing strategy. After angiography-only-guided optimisation of BVS in 27 (31.8%) lesions, an OCT examination prompted performance of a second post-expansion. This resulted in an increase in the minimal scaffold area (5.5 to 6.3mm(2), p=0.004) and a decrease in the incomplete scaffold apposition area (1.1 to 0.6mm(2), p=0.082), with no new stent fractures. When the population was divided according to the time of BVS implantation, an initial learning adaptation became evident, with the number of OCT-guided changes in strategy significantly decreasing between the initial and final time periods (p=0.017)., Conclusions: OCT guidance for BVS implantation significantly affects the procedural strategy, with favourable effects on acute results and the learning curve., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Background: Aim of the present study was to evaluate all randomized trials, comparing intracoronary adenosine versus placebo in STEMI patients undergoing primary PCI., Methods and Results: PubMed, the Cochrane Library and ISI Web of Knowledge electronic databases were scanned for eligible studies up to February 23rd 2015. The summary measure used was risk ratio (RR) with 95% confidence intervals. A total of 13 studies were eligible, including 1487 patients. Incidence of ST resolution was significantly higher in the IC adenosine group than in the placebo group (RR = 1.20 [1.05–1.38]; p = 0.008). At metaregression, a significant correlation was found between the magnitude of the adenosine-related effect on ST resolution and the mean ischemic time (p = 0.011) or the percentage of patients with the LAD as the infarct-related artery (p = 0.03). Furthermore, we found a larger increase in LVEF (p = 0.02) with a parallel reduction in the incidence of heart failure (HF) (RR = 0.50 [0.28–0.89]; p = 0.02) in the IC adenosine group. Finally, IC adenosine administration was associated with a significantly lower incidence of major adverse cardiac events (MACE) both at short- (RR = 0.62 [0.39–0.98] p = 0.04) and long-term (RR = 0.61 [0.39–0.95] p = 0.03)., Conclusions: This is the first meta-analysis demonstrating a clinical benefit for IC adenosine in hard endpoints, such as adverse cardiovascular events, in patients undergoing primary PCI.

Background: Radial artery is currently the preferred access route for percutaneous coronary procedures. The major reason for its widespread use is the higher safety as compared to femoral artery access. Initially most centers have preferred the right radial artery. However, an advantage has been hypothesized for the left radial access especially for the more favorable vascular anatomy. For this reason, the aim of the present meta-analysis was to compare procedural performance of left and right radial artery access for percutaneous coronary interventions., Methods: We performed a meta-analysis of all available studies comparing right radial access and left radial access for coronary procedures. Corrected standardized mean difference (Hedges' g) and odds ratios (OR) were used to estimate the mean effect respectively for continuous variables and frequencies., Results: The present analysis includes 14 studies with 7603 procedures. A statistically significant difference in the amount of contrast medium utilized for the procedure (0.12 [0.03-0.21], p=0.007), in fluoroscopy time (0.16 [0.06-0.25], p=0.001) and in total procedural time (0.22 [0.11; 0.33], p<0.001) was observed in favor of the left radial access. At the same time, no significant difference in the rate of procedural failure was observed between the right and the left radial access routes (OR=1.01 [0.70-1.47], p=0.942)., Conclusions: Left radial access is associated to a modest yet significant reduction in fluoroscopy time, procedural time and in the amount of contrast medium administered, while failure rate was similar between right and left radial approaches., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Objectives: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD)., Background: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery., Methods: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months., Results: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30)., Conclusions: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims Dual antiplatelet therapy (DAPT) can be shortened up to 1 month in high-bleeding risk (HBR) patients receiving a contemporary biodegradable-polymer sirolimus-eluting stent. We aimed to summarize the evidence on a similar DAPT regimen after biodegradable-polymer everolimus-eluting stent (EES) implantation in patients at HBR. Methods and results We pooled the individual participant data from the available trials evaluating this strategy, namely, the SENIOR and the POEM trials. Inclusion criteria were ≥1 biodegradable-polymer EES implantation and ≤1-month duration of DAPT. The primary endpoint was the 1-year composite of cardiovascular death, myocardial infarction, or stroke. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3–5 bleeding. Landmark analyses were performed at 1 month, the time point for intended DAPT interruption. We included 766 participants (age 77.5 ± 8.2 years, women 31.9%), 323 from the SENIOR and 443 from the POEM trial. The primary endpoint occurred in 45 participants (6.0%; 95% confidence interval [CI], 4.3–7.7%) through 1 year of follow-up, with 21 (2.8%; 95% CI, 1.6–3.9%) events during the first month and 24 (3.4%; 95% CI, 2.0–4.7%) thereafter. The incidences of cardiovascular death, myocardial infarction, and stroke were 2.2% (95% CI, 0.36–2.50%), 3.1% (95% CI, 1.8–4.3%), and 1.2% (95% CI, 0.4–2.0%), respectively. BARC type 3–5 bleeding ocuurred in 1.1% (95% CI, 0.3–1.8%) at 1 month and 2.9% (95% CI, 1.6–4.1%) at 1 year. Conclusion HBR patients receiving biodegradable-polymer EES had few ischemic and bleeding events when given 1 month of DAPT. One-month DAPT after biodegradable-polymer EES implantation seems safe in patients at HBR. [ABSTRACT FROM AUTHOR]

Primary percutaneous coronary intervention (PCI) is the current class I therapeutic approach to treat acute ST-elevation myocardial infarction (STEMI). While primary PCI can restore adequate flow in the infarcted artery in the majority of cases, some patients experience the 'no-reflow' phenomenon, i.e., an abnormal myocardial reperfusion occurring even after the occluded coronary artery has been opened. No-reflow occurs when microvascular obstruction arises from embolization of thrombus or components of the atheromatous plaques. These embolic materials travel downstream within the infarct-related artery at time of primary PCI, leading to compromised blood flow. Currently, no expert consensus documents exist to outline an optimal strategy to prevent or treat no-reflow. Interventional cardiologists frequently employ intracoronary adenosine, calcium channel blockers, nicorandil, nitroprusside or glycoprotein IIb/IIIa inhibitors. However, evidence suggests that these interventions consistently enhance myocardial blood flow in only a specific subset of patients experiencing no-reflow. A recent and innovative therapeutic approach gaining attention is low-dose fibrinolysis during primary PCI, which offers the potential to augment coronary flow post-myocardial revascularization. [ABSTRACT FROM AUTHOR]

Background Robotic-assisted percutaneous coronary intervention (R-PCI) is increasingly gaining acceptance owing to several advantages. Case summary Here, we report the first-in-human R-PCI performed with RObotic System for Endovascular Surgery (ROSES), an innovative robotic system designed to perform transcatheter angioplasty. We have reported a case of severe proximal posterolateral (PL) branch disease of the right coronary artery managed with R-PCI. Discussion In this early clinical experience, the use of the ROSES robotic system seems to be safe and effective. However, this report still represents an early feasibility study, and the use of this technology in more challenging anatomies including the presence of severe tortuosity, severe calcification, or interventions requiring multiple wires and balloons needs to be further studied. A larger, prospective, multicentre pivotal clinical trial designed to test the ROSES robotic angioplasty system in a larger number of patients is currently ongoing. [ABSTRACT FROM AUTHOR]

Iterations in stent technologies, advances in pharmacotherapy, and awareness of the implications of implantation techniques have markedly reduced the risk of stent failure, both in the form of stent thrombosis (ST) and in-stent restenosis (ISR). However, given the number of percutaneous coronary interventions (PCI) performed worldwide every year, ST and ISR, albeit occurring at a fairly low rate, represent a public health problem even with contemporary DES platforms. The understanding of mechanisms and risk factors for these two PCI complications has been of fundamental importance for the parallel evolution of stent technologies. Risk factors associated with ST and ISR are usually divided into patient-, lesion-, device- and procedure-related. A number of studies have shown how certain risk factors are related to early (1 month) versus late/very late ST (between 1 month and 1 year and >1 year, respectively). However, more research is required to conclusively show the role of time-dependence of risk factors also in the incidence of ISR (early [1 year] or late [>1 year]). A thorough risk assessment is required due to the complex etiology of ST and ISR. The most effective strategy to treat ST and ISR is still to prevent them; hence, it is crucial to identify patient-, lesion-, device- and procedure-related predictors. [ABSTRACT FROM AUTHOR]

Background: Simultaneous ulnar and radial artery compression (SURC) has emerged as a strategy to increase radial artery flow and mitigate radial artery occlusion (RAO) while achieving adequate hemostasis after transradial access (TRA), though its technical adoption has been limited worldwide. Methods: A systematic search of studies comparing SURC versus isolated radial artery compression after TRA for coronary angiography and/or intervention was performed. Data were pooled by meta-analysis using random-effects models. Odds ratios (OR) with relative 95% confidence intervals (CI) and standardized mean difference were used as measures of effect estimates. The primary endpoint was the occurrence of overall RAO. Results: A total of 6 studies and 6793 patients were included. SURC method as compared to isolated radial artery compression was associated with a lower risk of RAO both overall (OR 0.29; 95% CI, 0.13–0.61, p < 0.001; number needed to treat to benefit [NNTB] =38) and in-hospital (OR 0.28; 95% CI: 0.10 to 0.75; p = 0.01, NNTB = 36), with a reduced risk of unsuccessful patent hemostasis (OR: 0.13; 95% CI: 0.02 to 0.85; p = 0.03, NNT = 5) and upper extremity pain (OR: 0.48; 95% CI: 0.24 to 0.95; p = 0.04, NNTB = 124). No significant difference was observed in hemostasis time and in the risk of hematoma. Conclusion: Compared to isolated radial artery compression, SURC is associated with lower risk of RAO, unsuccessful patent hemostasis, and reported upper limb pain, without any trade-off in safety outcomes. With further development of dedicated dual compression devices, the proposed technique should be freed from usage constraints. [ABSTRACT FROM AUTHOR]

A 2010 Italian Society of Interventional Cardiology registry showed that efficient ST-segment-elevation myocardial infarction networks cover [almost equal to]50% of Italy. Italy is assigned a total of [Euro sign]20.23 billion dedicated to health care for the strengthening of territorial assistance through the creation of new structures (such as community hospitals and homes). It is hoped that the Recovery Fund (Next Generation Eu) will enable Italy to reorganize a universal health system that previously guaranteed all citizens equal health treatment regardless of income. [Extracted from the article]

The respective ischemic and bleeding risks of early aspirin discontinuation following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) remain uncertain. We performed a prospero-registered review of randomized controlled trials (RCTs) comparing a P2Y12 inhibitor-based single antiplatelet strategy following early aspirin discontinuation to a strategy of sustained dual antiplatelet therapy (DAPT) in ACS or PCI patients requiring, or not, anticoagulation for another indication (CRD42019139576). We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included nine RCTs comprising 40,621 patients. Compared to prolonged DAPT, major bleeding (2.2% vs. 2.8%; RR 0.68; 95% CI: 0.54 to 0.87; p = 0.002; I2: 63%), non-major bleeding (5.0 % vs. 6.1 %; RR: 0.66; 95% CI: 0.47 to 0.94; p = 0.02; I2: 87%) and all bleeding (7.4% vs. 9.9%; RR: 0.65; 95% CI: 0.53 to 0.79; p < 0.0001; I2: 88%) were significantly reduced with early aspirin discontinuation without significant difference for all-cause death (p = 0.60), major adverse cardiac and cerebrovascular events (MACE) (p = 0.60), myocardial infarction (MI) (p = 0.77), definite stent thrombosis (ST) (p = 0.63), and any stroke (p = 0.59). In patients on DAPT after an ACS or a PCI, early aspirin discontinuation prevents bleeding events with no significant adverse effect on the ischemic risk or mortality. [ABSTRACT FROM AUTHOR]

Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS. [ABSTRACT FROM AUTHOR]

Bioresorbable scaffolds have the potential to introduce a paradigm shift in interventional cardiology, a true anatomical and functional “vascular restoration” instead of an artificial stiff tube encased by persistent metallic foreign body. Early clinical studies using the first commercially available drug-eluting bioresorbable vascular scaffold (BVS) reported very promising safety and efficacy outcomes, comparable to best-in-class second-generation drug-eluting metal stent. To date, more than 60,000 Absorb BVSs have been implanted with only the interim analysis of one randomized trial (ABSORB II RCT) available. Recent registries have challenged the initial claim that BVS is immune from Scaffold Thrombosis (ST). However, suboptimal device expansion and insufficient intracoronary imaging guidance can explain higher than expected ST, especially in complex lesions. The aim of this review article is to critically evaluate the results of the available Absorb BVS studies and discuss the lessons learned to optimize lesion selection and implantation technique of such devices. [ABSTRACT FROM AUTHOR]