Aspirin-free antiplatelet strategies after percutaneous coronary interventions.

Dual antiplatelet therapy (DAPT) with aspirin and a platelet P2Y12 receptor inhibitor is the standard antithrombotic treatment after percutaneous coronary interventions (PCI). Several trials have challenged guideline-recommended DAPT after PCI by testing the relative clinical effect of an aspirin-free antiplatelet approach-consisting of P2Y12 inhibitor monotherapy after a short course (mostly 1-3 months) of DAPT-among patients undergoing PCI without a concomitant indication for oral anticoagulation (OAC). Overall, these studies have shown P2Y12 inhibitor monotherapy after short DAPT to be associated with a significant reduction in the risk of bleeding without an increase in thrombotic or ischaemic events compared with continued DAPT. Moreover, the effects of the P2Y12 inhibitor monotherapy without prior DAPT or following a very short course of DAPT after PCI are being investigated in emerging studies, of which one has recently reported unfavourable efficacy results associated with the aspirin-free approach compared with conventional DAPT. Finally, P2Y12 inhibitor alone has been compared with aspirin alone as chronic therapy after DAPT discontinuation, thus challenging the historical role of aspirin as a standard of care for secondary prevention following PCI. A thorough understanding of study designs, populations, treatments, results, and limitations of trials testing P2Y12 inhibitor monotherapy vs. DAPT or vs. aspirin is required to consider adopting this treatment in clinical practice. This review addresses the use of aspirin-free antiplatelet strategies among patients undergoing PCI without a concomitant indication for OAC, providing an overview of clinical evidence, guideline indications, practical implications, ongoing issues, and future perspectives.

Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium.

Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. The use of antiplatelet therapy comes at the expense of an increased risk of bleeding complications. Defining the optimal intensity of platelet inhibition according to the clinical presentation of atherosclerotic cardiovascular disease and individual patient factors is a clinical challenge. Modulation of antiplatelet therapy is a medical action that is frequently performed to balance the risk of thrombotic or ischemic events and the risk of bleeding. This aim may be achieved by reducing (ie, de-escalation) or increasing (ie, escalation) the intensity of platelet inhibition by changing the type, dose, or number of antiplatelet drugs. Because de-escalation or escalation can be achieved in different ways, with a number of emerging approaches, confusion arises with terminologies that are often used interchangeably. To address this issue, this Academic Research Consortium collaboration provides an overview and definitions of different strategies of antiplatelet therapy modulation for patients with coronary artery disease, including but not limited to those undergoing percutaneous coronary intervention, and consensus statements on standardized definitions.

Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR.

BACKGROUND: The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS: We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS: A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P = 0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P = 0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS: In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).

Immediate multivessel revascularization after myocardial infarction: change of strategy?

Multivessel coronary artery disease (MVD) is a frequently encountered condition in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) of the culprit vessel. Several studies have demonstrated the benefit of complete coronary revascularization compared with the treatment of the culprit lesion only in patients with STEMI. Based on this evidence, the current European guidelines recommend that in haemodynamically stable patients with STEMI and MVD, routine complete revascularization should be achieved either during the same procedure in concomitance with the treatment of the culprit lesion (immediate multivessel PCI) or with a subsequent intervention within 45 days from the index PCI of the culprit lesion (deferred multivessel PCI). However, the guidelines do not express a preference for immediate vs. delayed multivessel PCI. Therefore, the optimal timing of the treatment of non-culprit lesions in patients with STEMI and haemodynamic stability is still debated and has been evaluated in recent studies that showed the non-inferiority of immediate vs. delayed multivessel PCI. The article discusses the results and clinical implications of these studies on the timing of complete revascularization of non-culprit lesions in haemodynamically stable patients with STEMI.

Overcoming professional barriers encountered by women in interventional cardiology: an EAPCI statement.

Despite the increasing proportion of female medical and nursing students, there is still a significant under-representation of women working as healthcare providers in interventional cardiology, with very few of them reaching senior leadership, academic positions, or acting principal investigators, as well as actively involved in company advisory boards. In this position paper, we will describe the current status of women working in interventional cardiology across Europe. We will also provide an overview of the most relevant determinants of the under-representation of women at each stage of the interventional cardiology career path and offer practical suggestions for overcoming these challenges.

The stent in the high-bleeding risk patient: antiplatelet monotherapy?

Dual antiplatelet therapy (DAPT) is the recommended treatment after percutaneous coronary intervention (PCI). The introduction into clinical practice of new drug-eluting stents (DESs) with significantly improved safety profiles has made it possible to shorten the DAPT. Randomized studies have established the superiority of DES over bare metal stents in high-bleeding risk (HBR) patients treated with antiplatelet monotherapy after 1 month of DAPT from PCI. This regimen has been adopted in randomized trials comparing different DES in patients with HBR. Furthermore, antiplatelet monotherapy after 1 month of DAPT from PCI has been shown to reduce bleeding risk without increasing ischaemic events compared with a conventional DAPT regimen (3-12 months) in a recent randomized study that included HBR patients treated with DES. Parallel to the trend of shortening DAPT, there is growing debate about which antiplatelet monotherapy is optimal after discontinuation of DAPT, with some recent studies exploring the paradigm shift from aspirin monotherapy to P2Y12 inhibitor monotherapy. Finally, future studies are underway to evaluate the clinical effect of monotherapy with ticagrelor or prasugrel directly after implantation of DES thus eliminating DAPT.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

OBJECTIVE: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). BACKGROUND: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. RESULTS: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. CONCLUSIONS: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

OBJECTIVES: To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. BACKGROUND: Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated. METHODS: Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. RESULTS: Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death (adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke (adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level. CONCLUSION: Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Timing of cardioversion in atrial fibrillation: the sooner the better?

Management of recent-onset (<36 h) atrial fibrillation (AF) in the emergency room is highly variable, particularly concerning the type and timing of cardioversion, and the logistics of the treatment pathway. In clinical practice, it is fairly common for patients with recent-onset AF an attempt at re-establishing sinus rhythm, either with electric or pharmacologic cardioversion, as soon as feasible. Nonetheless, a 'wait-and-see' approach, and potentially delayed cardioversion, could represent a valid alternative to early cardioversion, considering that, often, in recent-onset AF, sinus rhythm is re-established spontaneously, thus repealing the need for active cardioversion, hence avoiding the possible risks of treatment. These concepts form the rationale for a recent multicentric randomized trial, Rate Control vs. Electrical Cardioversion Trial 7 - Acute Cardioversion vs. Wait and See (RACE 7 ACWAS), comparing the efficacy of delayed cardioversion, within 48 h from symptoms onset, in case of lack of spontaneous conversion, with early cardioversion in symptomatic patients with recent-onset AF. In patients presenting to the emergency department with recent-onset, symptomatic AF, a wait-and-see approach was non-inferior to early cardioversion in maintaining the sinus rhythm at 4 weeks. Nonetheless a system employing a delayed cardioversion strategy increases the costs of treatment, complicates the treatment pathway, and could represent a psychological burden for the patients. Accordingly, delayed cardioversion could not represent a practical choice for many hospitals with limited resources and without an adequate outpatient organization.

Impact of coronary artery disease and percutaneous coronary intervention in women undergoing transcatheter aortic valve replacement: From the WIN-TAVI registry.

OBJECTIVES: To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. METHODS: The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. RESULTS: A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adj HR 1.56, 95%CI 1.03-2.39, P = 0.038 and adj HR 1.96, 95% CI 1.1-3.5, P = .021, respectively). Patients with recent PCI had increased risk of all-cause death (adj HR 1.89, 95% CI 1.0-3.5, P = 0.04) and stroke (adj HR 3.7, 95% CI 1.0-13.5, P = 0.046) compared with patients without CAD. CONCLUSION: The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

Clinical outcomes of patients with diabetes mellitus treated with Absorb bioresorbable vascular scaffolds: a subanalysis of the European Multicentre GHOST-EU Registry.

BACKGROUND: Data on the clinical performance of bioresorbable scaffolds in patients with diabetes mellitus (DM) are still limited. The present study reported 1-year clinical outcomes associated with the use of everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS; Abbott Vascular, Santa Clara, CA) in DM patients. METHODS AND RESULTS: This was a subanalysis from the GHOST-EU (Gauging coronary Healing with biOresorbable Scaffolding plaTforms in Europe) multicenter retrospective registry including patients treated with Absorb BVS between November 2011 and September 2014. In this study, a comparative analysis stratified according to DM was performed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target-vessel myocardial infarction (MI) and clinically-driven target-lesion revascularization (TLR). A total of 1,477 patients were treated with 2,224 Absorb BVS; 381 (25.8%) and 1,096 (74.2%) patients were with and without DM, respectively. The 1-year rate of TLF was higher among patients with DM (7.8%) than those without DM (4.3%); the increase in TLF was driven by TLR (6.5% vs. 3.3%, P = 0.009); no significant differences in cardiac death (1.1% vs. 0.9%, P = 0.68) and target-vessel MI (3.1% vs. 2.2%, P = 0.38) were observed, respectively. Definite/probable scaffold thrombosis rate tended to be higher among patients with DM than those without DM (3.0% vs. 1.7%, P = 0.14, respectively). CONCLUSIONS: Absorb BVS use in patients with DM was associated with increased 1-year TLF and scaffold thrombosis compared with non-diabetes patients.

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry.

OBJECTIVES: The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. BACKGROUND: BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. METHODS: Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. RESULTS: True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191-419) days. The Kaplan-Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78-12.3; P = 0.002 and HR 3.37; 95% CI: 1.38-8.26; P = 0.008, respectively). CONCLUSIONS: BVS use for coronary bifurcation lesions in an "all-comer" population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

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.

Strategies and Outcomes of Repeat Mitral Valve Interventions after Failed MitraClip Therapy.

Percutaneous mitral valve repair (PMVR) with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) is a valid therapeutic option for patients with severe mitral regurgitation (MR) deemed to be at high or prohibitive surgical risk. Despite the reassuring data on efficacy and long-term durability of the procedure, the proportion of patients with residual or relapsing severe MR after MitraClip therapy is not negligible. In light of the detrimental prognostic impact of severe MR, repeat interventions are increasingly performed in clinical practice using different techniques. In high-risk settings, percutaneous procedures have proven to be effective and safe at reducing MR. Building on this, we sought to summarize the current landscape and clinical experience of reinterventions after failed MitraClip therapy, so as to assist physicians facing the clinical hurdle of proper treatment management after failed PMVR.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis.

BACKGROUND: The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are unclear. PURPOSE: To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either TAVI or SAVR. DATA SOURCES: MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations. STUDY SELECTION: Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR. DATA EXTRACTION: Two investigators independently extracted study data and rated risk of bias. DATA SYNTHESIS: 16 638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]). LIMITATION: The number of trials was limited, and study designs and patient characteristics were heterogeneous. CONCLUSION: Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk. PRIMARY FUNDING SOURCE: None.

Switching of platelet P2Y12 receptor inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Review of the literature and practical considerations.

The combination of aspirin and a P2Y12 receptor inhibitor is the cornerstone of treatment in patients with acute coronary syndromes (ACSs) and in those undergoing percutaneous coronary intervention (PCI). At the present time, 3 different oral P2Y12 receptor inhibitors are available on the market; 2 have obtained the indication for ACS (clopidogrel and ticagrelor) and 1 for ACS with planned PCI (prasugrel). An intravenous direct acting P2Y12 inhibitor, cangrelor, has also been recently approved by US and European regulatory agencies for patients undergoing PCI. Although the correct timing and modality of transition from intravenous cangrelor to oral P2Y12 inhibitors is still controversial and needs further evidence, switching between oral P2Y12 receptor inhibitors frequently occurs in clinical practice for several reasons. This practice raises the question of the relative safety of this strategy and of which switching approaches are preferable. In this article, we review the data on switching antiplatelet treatment strategies with P2Y12 receptor inhibitors and discuss practical considerations for switching therapies in patients with ACS undergoing PCI.

Update on clinical evidence (Part II): A summary of the main post market studies.

Bioresorbable vascular scaffolds (BVS, Absorb, Abbott Vascular, Santa Clara, CA) received the CE mark in October 2011, and were approved by the Food and Drug Administration in July 2016. After their introduction in clinical practice a broad amount of post-marketing clinical experience with BVS has been generated so far in Europe and outside the United States. The available BVS registries differ in many aspects, including their being single-center or multicenter, single-arm or controlled, sponsored or investigator-initiated, published or presented at a large-scale international meeting. This article provides an overview of clinical results of the main post-marketing studies of BVS available. © 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.