Management of patients treated with oral anticoagulant therapy undergoing percutaneous coronary intervention with stent implantation: the PERSEO Registry.

In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention with stent (PCI), international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). Aim of this study was to evaluate contemporary real-world data on antithrombotic regimens and outcome in patients on OAC undergoing PCI with stent. Consecutive patients on OAC undergoing PCI were enrolled in the multicentre, prospective, observational PERSEO registry (NCT03392948). Primary end-point was net adverse clinical events (NACE) with VKA vs DOAC, whereas a secondary pre-specified end-point was NACE with DAT vs TAT both at 1-year follow-up. From February 2018 to February 2022, 1234 consecutive patients were included. The main indication for OAC was atrial fibrillation (86%) and the mean CHA2DS2VASc and HAS-BLED scores were 4±2 and 3.6±1, respectively. Of the 1228 patients discharged alive, 222 (18%) were on VKA and 1006 (82%) on DOAC (p<0.01). DAT was employed in 197 patients whereas TAT in 1028. At follow-up, NACE rate was significantly higher with VKA compared to DOAC (23% vs 16%, p=0.013) and confirmed after propensity score adjustment. TAT and DAT did not differ as regards NACE rate (17% vs 19%, p=0.864) even though, compared to TAT, DAT was associated with less major bleedings (2% vs 5%, p= 0.014), confirmed after propensity score adjustment. In conclusion, in patients on OAC undergoing PCI, DOAC, compared to VKA, was associated with a significantly lower occurrence of NACE and DAT reduced bleedings compared to TAT.

[Drug-eluting stents in contemporary interventional practice: the STENT PANORAMA project (Part I)]. / Gli stent coronarici a rilascio di farmaco nella pratica interventistica contemporanea: progetto STENT PANORAMA (Parte I).

STENT PANORAMA is a project carried out by the Young Interventional Cardiologists of Triveneto coordinated by the Italian Society of Interventional Cardiology (GISE) Veneto delegation. The project includes two parts: the first, here reported, is aimed at describing in a standardized and easily usable way the main technological characteristics of the latest generation of the drug eluting stents (DES) that are most widely used in the Italian cath-labs. The second, to follow, will aim to summarize the main scientific evidence regarding the performance of individual devices with particular reference to subgroups of clinical interest. The ambitious goal of the STENT PANORAMA working group is to provide the interventional cardiologist with a thorough, practical, and functional knowledge of the DES currently available in the modern therapeutic armamentarium to promote a therapeutic strategy tailored to the patient.

Current Management of In-Stent Restenosis.

In-stent restenosis (ISR) remains the primary cause of target lesion failure following percutaneous coronary intervention (PCI), resulting in 10-year incidences of target lesion revascularization at a rate of approximately 20%. The treatment of ISR is challenging due to its inherent propensity for recurrence and varying susceptibility to available strategies, influenced by a complex interplay between clinical and lesion-specific conditions. Given the multiple mechanisms contributing to the development of ISR, proper identification of the underlying substrate, especially by using intravascular imaging, becomes pivotal as it can indicate distinct therapeutic requirements. Among standalone treatments, drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation have been the most effective. The main advantage of a DCB-based approach is the avoidance of an additional metallic layer, which may otherwise enhance neointimal hyperplasia, provide the substratum for developing neoatherosclerosis, and expose the patient to a persistently higher risk of coronary ischemic events. On the other hand, target vessel scaffolding by DES implantation confers relevant mechanical advantages over DCB angioplasty, generally resulting in larger luminal gain, while drug elution from the stent surface ensures the inhibition of neointimal hyperplasia. Nevertheless, repeat stenting with DES also implies an additional permanent metallic layer that may reiterate and promote the mechanisms leading to ISR. Against this background, the selection of either DCB or DES on a patient- and lesion-specific basis as well as the implementation of adjuvant treatments, including cutting/scoring balloons, intravascular lithotripsy, and rotational atherectomy, hold the potential to improve the effectiveness of ISR treatment over time. In this review, we comprehensively assessed the available evidence from randomized trials to define contemporary interventional treatment of ISR and provide insights for future directions.

Trends in transcatheter aortic valve implantation practice and clinical outcomes at an Irish tertiary referral centre.

OBJECTIVE: A paucity of data exists on how transcatheter aortic valve implantation (TAVI) practice has evolved in Ireland. This study sought to analyse temporal trends in patient demographics, procedural characteristics, and clinical outcomes at an Irish tertiary referral centre. METHODS: The prospective Mater TAVI database was divided into time tertiles based on when TAVI was performed: Group A, November 2008-April 2013; Group B, April 2013-September 2017; and Group C, September 2017-February 2022. Patient and procedural characteristics and clinical outcomes were compared across groups. RESULTS: A total of 1063 (Group A, 59; Group B, 268; and Group C:, 736) patients were treated with TAVI during the study period (mean age 81.1±7.4, mean Society of Thoracic Surgeons score 5.9±5.1).Conscious sedation (Group A, 0%; Group B, 59.9%; and Group C, 90.2%, p<0.001) and femoral artery access (Group A, 76.3%; Group B, 90.7%; and Group C, 96.6%, p<0.001) were used more frequently over time. The median length of hospital stay reduced from 9 days (IQR 7, 18) in Group A to 2 days (IQR 2, 3) in Group C. In-hospital death was numerically higher in Group A compared with Group C (6.8% vs 1.9%, p=0.078). At 1-year follow-up, the rate of death and/or stroke was similar in Group A and Group C (20.3% vs 12.0%, adjusted HR 1.49, 95% CI (0.59 to 3.74)). CONCLUSION: There was exponential growth in TAVI procedural volume during the study period. A minimalist approach to TAVI emerged, and this was associated with significantly shorter procedure duration and hospital stay. Clinical outcomes at 1-year follow-up did not change significantly over time.

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. METHODS: Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. RESULTS: The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. CONCLUSIONS: IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Pharmacological and clinical appraisal of factor XI inhibitor drugs.

The evolution of anticoagulation therapy, from vitamin K antagonists to the advent of direct oral anticoagulants (DOACs) almost two decades ago, marks significant progress. Despite improved safety demonstrated in pivotal trials and post-marketing observations, persistent concerns exist, particularly regarding bleeding risk and the absence of therapeutic indications in specific subgroups or clinical contexts. Factor XI (FXI) has recently emerged as a pivotal contributor to intraluminal thrombus formation and growth, playing a limited role in sealing vessel wall injuries. Inhibiting FXI presents an opportunity to decouple thrombosis from haemostasis, addressing concerns related to bleeding events while safeguarding against thromboembolic events. Notably, FXI inhibition holds promise for patients with end-stage renal disease or cancer, where clear indications for DOACs are currently lacking. Various compounds have undergone design, testing, and progression to phase 2 clinical trials, demonstrating a generally favourable safety and tolerability profile. However, validation through large-scale phase 3 trials with sufficient power to assess both safety and efficacy outcomes is needed. This review comprehensively examines FXI inhibitors, delving into individual classes, exploring their pharmacological properties, evaluating the latest evidence from randomized trials, and offering insights into future perspectives.

PCSK9 inhibitors: current status and emerging frontiers in lipid control.

INTRODUCTION: Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of global mortality, imposing substantial healthcare economic burdens. Among the modifiable risk factors, hypercholesterolemia, especially elevated low-density lipoprotein cholesterol (LDL-C), plays a pivotal role in ASCVD development. Novel therapies such as PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) inhibitors are emerging to address this concern. These inhibitors offer the potential to reduce ASCVD risk by directly targeting LDL-C levels. AREAS COVERED: The article reviews the structural and functional aspects of PCSK9, highlighting its role in LDL receptor regulation. The pharmacological strategies for PCSK9 inhibition, including monoclonal antibodies, binding peptides, gene silencing, and active immunization, are explored. Clinical evidence from various trials underscores the safety and efficacy of PCSK9 inhibitors in reducing LDL-C levels and potentially improving cardiovascular outcomes. Despite these promising results, challenges such as cost-effectiveness and long-term safety considerations are addressed. EXPERT OPINION: Among PCSK9 inhibitors, monoclonal antibodies represent a cornerstone. Many trials have showed their efficacy in reducing LDL-C and the risk for major adverse clinical events, revealing long-lasting effects, with special benefits particularly for statin-intolerant and familial hypercholesterolemia patients. However, long-term impacts, high costs, and patient selection necessitate further research.

Antithrombotic Therapy for Primary and Secondary Prevention of Ischemic Stroke: JACC State-of-the-Art Review.

Stroke is a devastating condition with significant morbidity and mortality worldwide. Antithrombotic therapy plays a crucial role in both primary and secondary prevention of stroke events. Single or dual antiplatelet therapy is generally preferred in cases of large-artery atherosclerosis and small-vessel disease, whereas anticoagulation is recommended in conditions of blood stasis or hypercoagulable states that mostly result in red thrombi. However, the benefit of antithrombotic therapies must be weighed against the increased risk of bleeding, which can pose significant challenges in the pharmacological management of this condition. This review provides a comprehensive summary of the currently available evidence on antithrombotic therapy for ischemic stroke and outlines an updated therapeutic algorithm to support physicians in tailoring the strategy to the individual patient and the underlying mechanism of stroke.

Applied coronary physiology for planning and guidance of percutaneous coronary interventions. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology.

The clinical value of fractional flow reserve and non-hyperaemic pressure ratios are well established in determining an indication for percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD). In addition, over the last 5 years we have witnessed a shift towards the use of physiology to enhance procedural planning, assess post-PCI functional results, and guide PCI optimisation. In this regard, clinical studies have reported compelling data supporting the use of longitudinal vessel analysis, obtained with pressure guidewire pullbacks, to better understand how obstructive CAD contributes to myocardial ischaemia, to establish the likelihood of functionally successful PCI, to identify the presence and location of residual flow-limiting stenoses and to predict long-term outcomes. The introduction of new functional coronary angiography tools, which merge angiographic information with fluid dynamic equations to deliver information equivalent to intracoronary pressure measurements, are now available and potentially also applicable to these endeavours. Furthermore, the ability of longitudinal vessel analysis to predict the functional results of stenting has played an integral role in the evolving field of simulated PCI. Nevertheless, it is important to have an awareness of the value and challenges of physiology-guided PCI in specific clinical and anatomical contexts. The main aim of this European Association of Percutaneous Cardiovascular Interventions clinical consensus statement is to offer up-to-date evidence and expert opinion on the use of applied coronary physiology for procedural PCI planning, disease pattern recognition and post-PCI optimisation.

Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial.

AIMS: The best interventional strategy for the treatment of drug-eluting stent (DES) in-stent restenosis (ISR) is still unclear and no data from randomized trials beyond 3-year follow-up are available. We aimed to define 10-year comparative efficacy and safety of plain balloon (PB), paclitaxel-coated balloon (PCB), and paclitaxel-eluting stent (PES) for percutaneous coronary intervention (PCI) of DES-ISR. METHODS AND RESULTS: Clinical follow-up of patients randomly assigned to PB, PCB, and PES in the ISAR-DESIRE 3 trial was extended to 10 years and events were independently adjudicated. The primary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion thrombosis, or target lesion revascularization. The major secondary safety endpoint was a composite of cardiac death, target vessel myocardial infarction, or target lesion thrombosis. The major secondary efficacy endpoint was target lesion revascularization. Incidences by the Kaplan-Meier method were compared by the log-rank test. Risk estimation was primarily performed by Cox proportional hazards regression and supplemented by weighted Cox regression accounting for non-proportional hazards and Royston-Parmar flexible parametric regression with a time-varying coefficient. Primary results were further assessed by landmark, lesion-level, per-protocol, and competing risk analyses. A total of 402 patients (500 lesions) with DES-ISR were randomly assigned to PB angioplasty (134 patients, 160 lesions), PCB angioplasty (137 patients, 172 lesions), and PES implantation (131 patients, 168 lesions). Clinical follow-up did not significantly differ among treatments [PB, 9.62 (4.50-10.02) years; PCB, 10.01 (5.72-10.02) years; PES, 9.08 (3.14-10.02) years; P = 0.300]. At 10 years, the primary composite endpoint occurred in 90 patients (72.0%) assigned to PB, 70 patients (55.9%) assigned to PCB, and 72 patients (62.4%) assigned to PES (P < 0.001). The pairwise comparison between PCB and PES resulted in a non-significant difference [multiplicity-adjusted P = 0.610; Grambsch-Therneau P = 0.004; weighted Cox: hazard ratio (HR) 1.10, 95% confidence interval (CI) 0.80-1.51; Cox: HR 1.10, 95% CI 0.79-1.52; Royston-Parmar: HR 1.08, 95% CI 0.72-1.60]. The major secondary safety endpoint occurred in 39 patients (34.1%) assigned to PB, 39 patients (34.0%) assigned to PCB, and 42 patients (40.0%) assigned to PES (P = 0.564). Target lesion revascularization occurred in 71 patients (58.0%) assigned to PB, 55 patients (43.9%) assigned to PCB, and 42 patients (38.6%) assigned to PES (P < 0.0001). The pairwise comparison between PES and PCB resulted in a non-significant difference (multiplicity-adjusted P = 0.282; Grambsch-Therneau P = 0.002; weighted Cox: HR 0.83, 95% CI 0.56-1.22; Cox: HR 0.81, 95% CI 0.54-1.21; Royston-Parmar: HR 0.75, 95% CI 0.47-1.20). Lesion-level and per-protocol analyses were consistent. At landmark analyses, an excess of death and cardiac death associated with PES compared with PCB was observed within 5 years after PCI, though 10-year differences did not formally reach the threshold of statistical significance after adjustment for multiplicity. Competing risk regression confirmed a non-significant difference in target lesion revascularization between PCB and PES and showed an increased risk of death associated with PES compared with PCB. CONCLUSION: Ten years after PCI for DES-ISR, the primary and major secondary endpoints between PCB and PES were not significantly different. However, an excess of death and cardiac death within 5 years associated with PES and the results of the competing risk analysis are challenging to interpret and warrant further analysis. PES and PCB significantly reduced target lesion revascularization compared with PB.

Effects on Mortality and Major Bleeding of Radial Versus Femoral Artery Access for Coronary Angiography or Percutaneous Coronary Intervention: Meta-Analysis of Individual Patient Data From 7 Multicenter Randomized Clinical Trials.

BACKGROUND: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. METHODS: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. RESULTS: A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63-0.95]; P=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45-0.67]; P<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin level (Pinteraction=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association. CONCLUSIONS: TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42018109664.

Management of in-stent restenosis.

In-stent restenosis (ISR) remains the most common cause of stent failure after percutaneous coronary intervention (PCI). Recent data suggest that ISR-PCI accounts for 5-10% of all PCI procedures performed in current clinical practice. This State-of-the-Art review will primarily focus on the management of ISR but will begin by briefly discussing diagnosis and classification. We then move on to detail the evidence base underpinning the various therapeutic strategies for ISR before finishing with a proposed ISR management algorithm based on current scientific data.

Meta-Analysis of Short vs. Prolonged Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation and Role of Continuation with either Aspirin or a P2Y12 Inhibitor Thereafter.

AIM: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an ongoing debate and novel data has emerged. The aim of this meta-analysis was to assess outcomes of short vs. control DAPT duration. In addition, the role of single antiplatelet therapy (SAPT) after DAPT with either aspirin or P2Y12 inhibitor monotherapy was analyzed. METHODS: The authors searched MEDLINE and Cochrane databases and proceedings of international meetings for randomized controlled trials (RCT) comparing ≤ 3 months with ≥ 6 months DAPT after DES implantation. The primary and co-primary outcomes of interest were definite or probable stent thrombosis (ST) and bleeding. In addition, we performed an analysis on studies who continued with either aspirin or P2Y12 monotherapy after DAPT. RESULTS: 9 RCTs comprising 41,864 patients were included and we analyzed a short DAPT duration of median 1.5 months vs. 12.1 months in the control group. The risk for ST was similar with short vs. control DAPT duration (0.5 vs. 0.5%; hazard ratio 1.17[95% CI 0.89-1.54]; p=0.26). Bleeding was significantly reduced with short vs. control DAPT duration (1.9 vs. 3.0%; 0.65[0.54-0.77]; p＜0.0001).ST was not different between short vs. control DAPT duration in the analysis of the 4 RCTs who continued with aspirin after DAPT and the 5 P2Y12 RCTs, respectively, and no heterogeneity was detected (p=0.861). Bleeding was also reduced with short vs. control DAPT in both the aspirin (1.2 vs. 1.7%; 0.71[0.51-0.99]; p=0.04) and P2Y12 inhibitor studies (2.1 vs. 3.4%; 0.62[0.47-0.80]; p=0.0003) and no heterogeneity was detected (p=0.515). CONCLUSIONS: Our meta-analysis shows that short DAPT ≤ 3 months followed by SAPT reduces bleeding and is not associated with an increase in ST. The results were consistent within the aspirin and P2Y12 SAPT studies.

Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves.

BACKGROUND: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI). AIMS: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis. METHODS: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated. RESULTS: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm3, TAV 848mm3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different. CONCLUSIONS: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation.

Association between surgical risk and 30-day stroke after transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). OBJECTIVES: With this meta-analysis we aimed to evaluate the incidence of 30-day stroke with TAVR and SAVR focusing on its possible correlation with surgical risk. METHODS: Major electronic databases were searched for studies published between January 2002 and October 2019 reporting the rates of 30-day stroke after TAVR and SAVR. Data were pooled using fixed- and random-effects models. The primary outcome of the study was stroke rate within 30-day from TAVR or SAVR. Results were stratified according to surgical risk score (high, intermediate and low). RESULTS: A total of 23 studies were identified (TAVR: 14,589 patients; SAVR: 11,681 patients). Regardless of the model used, in the overall population TAVR was associated with a significant reduction in the risk of stroke compared with SAVR (fixed effect: OR 0.78, 95% CI 0.66-0.92, p = .003; random-effects: OR 0.80, 95% CI 0.64-1.00, p = .045). Rates of 30-day stroke after TAVR and SAVR were not significantly different in the high- (OR 1.01, 95% CI 0.44-1.98, p = .105) and intermediate-risk groups (OR 0.92, 95% CI 0.63-1.36, p = .319), while low-risk patients had a lower rate of 30-day stroke after TAVR than SAVR (OR 0.65, 95% CI 0.50-0.83, p < .001). Meta-regression showed a significant association between surgical risk score and 30-day stroke rate (p = .007). CONCLUSIONS: TAVR is associated with a lower risk of 30-day stroke compared with SAVR, mainly as a result of the significant advantage observed in patients at low surgical risk.

Short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy vs. prolonged dual antiplatelet therapy after percutaneous coronary intervention with second-generation drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials.

AIMS: After percutaneous coronary intervention (PCI) with second-generation drug-eluting stent (DES), whether short dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with a P2Y12 receptor inhibitor confers benefits compared with prolonged DAPT is unclear. METHODS AND RESULTS: Multiple electronic databases, including PubMed, Scopus, Web of Sciences, Ovid, and ScienceDirect, were searched to identify randomized clinical trials comparing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT after PCI with second-generation DES implantation. The primary and co-primary outcomes of interest were major bleeding and stent thrombosis 1 year after randomization. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by fixed-effect and random-effects models. Multiple sensitivity analyses including random-effects models 95% CI adjustment were applied. A sensitivity analysis comparing trials using P2Y12 inhibitor SAPT with those using aspirin SAPT was performed. A total of five randomized clinical trials (32 145 patients) were available. Major bleeding was significantly lower in the patients assigned to short DAPT followed by P2Y12 inhibitor SAPT compared with those assigned to 12-month DAPT (random-effects model: HR 0.63, 95% 0.45-0.86). No significant differences between groups were observed in terms of stent thrombosis (random-effects model: HR 1.19, 95% CI 0.86-1.65) and the secondary endpoints of all-cause death (random-effects model: HR 0.85, 95% CI 0.70-1.03), myocardial infarction (random-effects model: HR 1.05, 95% CI 0.89-1.23), and stroke (random-effects model: HR 1.08, 95% CI 0.68-1.74). Sensitivity analyses showed overall consistent results. By comparing trials testing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT with trials testing ≤3 months of DAPT followed by aspirin SAPT vs. 12-month of DAPT, there was no treatment-by-subgroup interaction for each endpoint. By combining all these trials, regardless of the type of SAPT, short DAPT was associated with lower major bleeding (random-effects model: HR 0.63, 95% CI 0.48-0.83) and no differences in stent thrombosis, all-cause death, myocardial infarction, and stroke were observed between regimens. CONCLUSION: After second-generation DES implantation, 1-3 months of DAPT followed by P2Y12 inhibitor SAPT is associated with lower major bleeding and similar stent thrombosis, all-cause death, myocardial infarction, and stroke compared with prolonged DAPT. Whether P2Y12 inhibitor SAPT is preferable to aspirin SAPT needs further investigation.