Postprocedural Anticoagulation Research Articles

Post-PCI anticoagulation with unfractionated heparin in acute coronary syndrome: insight from the STOPDAPT-3 trial

Abstract Background The guidelines recommend the post-procedural anticoagulation should be discontinued after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) except for the specific indications.(1) However, these guideline recommendations were not well supported by data, and therefore, post-PCI parental anticoagulation has been commonly implemented in patients with ACS in the previous studies.(2-5) Purpose To clarify the preference and clinical situations of post-PCI unfractionated heparin (UFH) in ACS patients and to explore the influence of post-PCI UFH on cardiovascular and bleeding outcomes. Methods STOPDAPT-3 trial is a randomized controlled trial to demonstrate the efficacy and safety of the aspirin-free prasugrel monotherapy strategy compared to the conventional dual antiplatelet therapy after PCI in patients with high-bleeding risk or ACS.(6) Data on periprocedural heparin use and its doses were vigorously collected. The current study population was the ACS patients enrolled in the STOPDAPT-3 without use of mechanical circulatory support devices. The two co-primary endpoints were the bleeding outcome defined as the BARC 3 or 5 criteria and the cardiovascular outcome defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Outcomes were assessed at 30 days from index PCI. Results Among 4088 ACS study patients, 2339 (57.2%) patients received post-PCI UFH. Median dose of UFH was 7.1 (IQR 6.0-8.8) units/kg/hour and the median duration was 25 (IQR 24-48) hours. As many as 57.7% of patients received 10000 units/day of heparin after PCI irrespective of body weight. STEMI patients more frequently received post-PCI UFH compared to NSTE-ACS (72.3% and 38.8%, P<0.001) and the patients with intraprocedural adverse angiographic findings such as thrombus, slow-flow, no-reflow, or final TIMI flow <=2 also more frequently received post-PCI UFH than those without (67.6% and 47.5%, P<0.001). Post-PCI UFH was associated with a significantly increased risk of bleeding endpoint (4.75% and 2.52%, adjusted HR 1.69 [95%CI 1.15-2.46], P=0.007) and a numerically increased risk of cardiovascular endpoint (3.16% and 1.72%, adjusted HR 1.56 [95%CI 0.98-2.46], P=0.06). Even in the patients with intraprocedural adverse angiographic findings, post-PCI UFH did not show a clear benefit for cardiovascular endpoint (3.15% and 1.72%, adjusted HR 1.73 [95%CI 0.88-3.41]. P=0.11). Conclusion(s) Post-PCI anticoagulation with UFH was frequently implemented in ACS patients enrolled in the latest large Japanese clinical trial. Post-PCI UFH use was associated with harm in terms of bleeding without a benefit in reducing cardiovascular events.

TCT-5 Safety and Efficacy of Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial Infarction: A Meta-Analysis of RCTs

TCT-5 Safety and Efficacy of Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial Infarction: A Meta-Analysis of RCTs

Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial

The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p <0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p <0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111.

Impact of different energy sources on coagulation biomarkers and silent cerebral events in balloon-based ablation for atrial fibrillation

BackgroundDifferent energy sources of balloon-based ablation for pulmonary vein isolation (PVI) cause different kinds of endothelial damage and coagulation responses associated with thromboembolic risk. ObjectivesTo compare the impact of different balloon-based ablation, cryo-balloon ablation (CBA) and laser balloon ablation (LBA), on coagulation/fibrinolysis biomarkers and silent cerebral events (SCEs) in paroxysmal atrial fibrillation (PAF). MethodsPAF patients who underwent PVI using either CBA (n=52) or LBA (n=53) without radiofrequency touch-up ablation were eligible. Time-course (day-0 [before ablation], day-1, day-2, and day-28) of myocardial enzymes and inflammatory and coagulation/fibrinolysis biomarkers was evaluated during the perioperative period. Brain MRI was performed within 2 days after the procedure to evaluate SCEs. ResultsThere was no difference in patient characteristics between CBA and LBA.CBA had greater myocardial injury (troponin-I and creatine kinase MB) and lower inflammatory reaction (WBC and neutrophil/lymphocyte ratio) than LBA. The coagulation biomarkers maximally increased by day-2 and then decreased in both groups. In day-28, the serum prothrombin fragment 1+2 and D-dimer levels in LBA were significantly higher than the values in CBA. The fibrinolysis biomarker (plasmin-α2 plasmin inhibitor complex) did not increase after the procedure in either group. The incidence of SCEs was comparable between CBA and LBA (11% vs. 15%, p=0.591). No thromboembolic event was observed. ConclusionCBA and LBA had different effects on myocardial injury, inflammatory reaction, and coagulation activity but did not affect the incidence of thromboembolic events. LBA had significantly higher coagulation activity in day-28 and may require more careful post-procedural anticoagulation than CBA.

Comparison of peri-device sealing and procedural outcome after LAA closure in patients with and without isolated left atrial appendage

Abstract Background Catheter-based electrical isolation of the left atrial appendage (LAA) is increasingly performed in patients with symptomatic atrial fibrillation (AF) not responding to pulmonary vein isolation (PVI). Since the electrically isolated LAA is known to be susceptible to thromboembolism, endovascular LAA occlusion (LAAO) is increasingly being used. Objective We performed a procedural and clinical outcome analysis over 12 months in patients receiving two different LAAO device systems and compared those with versus those without LAA isolation (LAAI). Methods Between 08/2021 and 10/2022 we enrolled 83 consecutive patients (median age 73.2 years; median CHA2DS2-VASc Score 3.0; 51 men [61%]) of whom 59 (71%) had LAAI and 24 (29%) no LAAI. All patients had a least one previous catheter ablation procedure of AF. LAAO was done 6 weeks after the last ablation procedure. The main indication for LAAO was the implementation of electrical LAAI. In the no-LAAI group, all patients had lost persistent LAAI. Implanted devices were Watchman FLXTM (n=30) and LAmbreTM (n=53). Pertinent procedural data, periprocedural complications, as well as peri-device leaks (PDL) at 45 days were assessed according to device type. The composite endpoints (death, TIA/stroke, device thrombus, bleeding) and the clinical impact after switch of anticoagulation therapy were assessed at 12 months follow-up. Results The distribution of LAAI/No LAAI were found in 21[70%]/9 patients treated with the Watchman device and in 38[72%]/15 patients treated with the LAmbre device (p=0.87). PDL on follow-up (f/u) TEE was observed in 13/54 LAAI patients (24%) and 10/23 No-LAAI patients (43%, p=0.089). Leak distribution (&amp;lt;3mm/3-5mm/&amp;gt;5mm/no leak) at f/u was different between LAAI groups (LAAI: 12/1/0/41; No LAAI: 5/4/1/13; p=0.027) but not between device types. The mechanisms of leaks according to device type are listed in Table 1. Procedural complications were observed in 6/59 LAAI patients and 0/24 No-LAAI patients (p=0.11). The composite endpoint of death, stroke, severe bleeding, device-related thrombus and thromboembolism was reached by a total of 2 patients (both LAAI with LAmbre device). In 9/13 LAAI-group patients (69%) with PDL (all &amp;lt;6 mm) the sealing effect was assumed to be incomplete with perfusion of the LAA. Post procedural anticoagulation therapy was switched after the control TEE from NOAC/VKA (8/1) to aspirin alone. None of these patients reached the composite endpoint after 12 months. Conclusions LAAO can be performed safely and efficaciously in patients with LAAI. Compared with patients without LAAI after LAAO, the occurrence of minor leaks, periprocedural complications, and composite endpoint events was not different between the two patient groups. Despite the presence of incomplete sealing with perfusion of LAA in the LAAI group, the switch in post-procedural anticoagulation seems to be safe regarding the composite endpoint after 12 months.Mechanism of PDL of the LAmbre DeviceMechanism of PDL between the LAAO types

Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial.

Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction, although no conclusive data support this practice. The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days. Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]). Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180.

Abstract 14077: Anticoagulation Following Percutaneous Coronary Intervention in Acute Coronary Syndrome: A Systematic Review and Meta-Analysis

Introduction: To maximize reperfusion and thrombus breakdown, anticoagulation therapy may be continued after percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome (ACS). However, limited evidence exists to support this practice. Methods: An electronic search was conducted using MEDLINE and EMBASE databases from inception to March 19th, 2023. Eligible studies comparing 30-day outcomes of post-procedural anticoagulation (PPAC) with no PPAC after PCI in patients with ACS were screened for inclusion. The primary outcome was 30-day mortality. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were estimated using a random-effect model. Results: Total 6 studies (3 observational, 3 post-hoc analyses of randomized controlled trials) with 61,901 patients (PPAC=38,900, no PPAC=23,001) were selected. There were no significant differences in all-cause mortality (RR 0.79 [0.52-1.19], P=0.26), cardiac mortality (RR 0.69 [0.43-1.11], P=0.13), myocardial infarction (RR 0.86 [0.61-1.21] P=0.39), stroke (RR 1.18 [0.87-1.59], P=0.29), and major bleeding (RR 0.91 [0.65-1.27], P=0.58) between PPAC and no PPAC groups. However, PPAC was associated with a higher rate of stent thrombosis at 30 days (RR 1.34 [1.04-1.73], P=0.02). Conclusions: Overall, PPAC following PCI for ACS did not improve survival or cardiovascular morbidity. However, there was a slightly higher incidence of stent thrombosis in the PPAC cohort. Further randomized studies are necessary to confirm these findings.

Rationale and Design of the Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion Trial (CAPITAL-RAPTOR)

IntroductionTransradial access (TRA) has rapidly emerged as the preferred vascular access site for coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) remains as an important complication of TRA...

Peri- and Post-procedural Anticoagulation with Left Atrial Appendage Occlusion Devices.

In patients with atrial fibrillation and high stroke risk, anticoagulation with direct oral anticoagulants or vitamin K antagonists is the standard of care for stroke prevention. The benefit of anticoagulation is driven by attenuating the risk of thrombus formation in the left atrial appendage. Percutaneous left atrial appendage occlusion offers an alternative therapeutic strategy for stroke prevention in patients with high bleeding risk or contraindications for long-term anticoagulation. This review of the current literature delineates the standard protocols of peri- and post-procedural anticoagulation/antithrombotic therapy after left atrial appendage occlusion, the complications of the procedure, and the risk of device-related thrombosis and of incomplete occlusion of the appendage. Finally,the limitations and gaps in the literature are identified.

Prospective randomized trial of antithrombotic strategies following great saphenous vein ablation using injectable polidocanol endovenous microfoam (Varithena)

ObjectivePostablation deep vein thrombosis (DVT) represents a potentially serious complication after Varithena polidocanol endovenous microfoam (PEM) ablation. The following primary outcomes were assessed: whether (1) adjunctive apixaban anticoagulation or (2) mechanical deep venous system (DVS) saline flushing could decrease saphenofemoral junction (SFJ) thrombus extension (postablation superficial thrombus extension [PASTE]) and/or DVT compared with compression alone, after great saphenous vein (GSV) PEM ablation. MethodsVarithena 1% PEM ablation patients were randomized to (1) SFJ compression, (2) compression and DVS saline flushing, or (3) compression, DVS saline flushing, and 5 days of postprocedural 5 mg oral apixaban anticoagulation twice daily. Duplex imaging was obtained 7 to 10 days after PEM ablation and PASTE/DVT incidence (primary end point) was compared between groups at this time point. ResultsWe treated 304 limbs in 257 patients with PEM. Overall, 103 limbs received SFJ compression (group C, 33.8%), 101 received compression and deep venous flushing (group D, 32.9%), and 100 received compression, deep flush, and anticoagulation (group A, 33.2%). Mean ultrasound follow-up time was 9.7 days (all patients) with a primary GSV closure rate of 92.4%. SFJ PASTE (II-IV) occurred in 0.9%, 1.0%, and 0% (groups C, D, and A, respectively). DVT occurred in 16.7%, 14.7%, and 1.98% (groups C, D, and A; χ2, P = .002). Patients in group A receiving apixaban anticoagulation had a significant reduction in DVT compared with patients in group C (1.98% vs 16.7%, χ2; P < .001); likewise, patients in group A had a significantly decreased DVT occurrence compared with group D (14.7% vs 1.98%; χ2, P = .00162), whereas patients in groups C and D were not statistically different (16.7% vs 14.7%; χ2, P = .60). Conclusions(1) Neither adjunctive DVS flushing nor anticoagulation decreased clinically relevant SFJ PASTE (II-IV) incidence, which remained similarly low across all groups and ranged between 0% and 1%, regardless of adjunctive DVS flushing or anticoagulation. This rate was significantly lower than prior reports (2.3%-4.1%). (2) DVS flushing had no influence on the rate of DVT. Observed PEM-induced DVT incidence using SFJ compression alone or compression with DVS flushing (16.7% and 14.7%, respectively) was significantly higher than prior reports (2.5%-9.6%). This finding may relate to the greater extent of AK/BK GSV territory treated in the present study. (3) Five days of postprocedural oral apixaban anticoagulation, 5 mg given twice daily, significantly decreased DVT occurrence to 1.98%, compared with nonanticoagulated patients (16.7%). This finding is comparable with the DVT rates reported after endovenous thermal ablation (0.7-1.7%). (4) Postprocedural apixaban anticoagulation may have a significant preventive role in decreasing DVT occurrence after PEM ablation.

What is known in pre-, peri-, and post-procedural anticoagulation in micro-axial flow pump protected percutaneous coronary intervention?

Interest in the use of percutaneous left ventricular assist devices (p-LVADs) for patients undergoing high-risk percutaneous coronary intervention (PCI) is growing rapidly. The Impella™ (Abiomed Inc.) is a catheter-based continuous micro-axial flow pump that preserves haemodynamic support during high-risk PCI. Anticoagulation is required to counteract the activation of the coagulation system by the patient's procoagulant state and the foreign-body surface of the pump. Excessive anticoagulation and the effect of dual antiplatelet therapy (DAPT) increase the risk of bleeding. Inadequate anticoagulation leads to thrombus formation and device dysfunction. The precarious balance between bleeding and thrombosis in patients with p-LVAD support is often the primary reason that patients' outcomes are jeopardized. In this chapter, we will discuss anticoagulation strategies and anticoagulant management in the setting of protected PCI. This includes anticoagulant therapy with unfractionated heparin, direct thrombin inhibitors, DAPT, purge blockage prevention by bicarbonate-based purge solution, and monitoring by activated clotting time, partial thromboplastin time, as well as anti-factor Xa levels. Here, we provide a standardized approach to the management of peri-interventional anticoagulation in patients undergoing protected PCI.

Bayesian Meta-analysis of Direct Oral Anticoagulation Versus Vitamin K Antagonists With or Without Concomitant Antiplatelet After Transcatheter Aortic Valve Implantation in Patients With Anticoagulation Indication.

Patients undergoing transcatheter aortic valve implantation (TAVI) commonly have co-morbidities requiring anticoagulation. However, the optimal post-procedural anticoagulation regimen is not well-established. This meta-analysis investigates safety and efficacy outcomes of direct oral anticoagulants (DOACs) and Vitamin K Antagonist (VKA), with or without concomitant antiplatelet therapy. We searched EMBASE and MEDLINE for appropriate studies. Subgroup analyses were performed for anticoagulant monotherapy and combined therapy with antiplatelet agents. Eleven studies (6359 patients) were included. Overall, there were no differences between DOACs and VKA for all-cause mortality (Odds Ratio [OR]: .69; Credible Interval [CrI]: .40-1.06), cardiovascular-related mortality (OR: .76; Crl: .13-3.47), bleeding (OR: .95; CrI: .75-1.17), stroke (OR: 1.04; CrI: .65-1.63), myocardial infarction (OR: 1.51; CrI: .55-3.84), and valve thrombosis (OR: .29; CrI: .01-3.54). For DOACs vs VKA monotherapy subgroup, there were no differences in outcomes. For the combined therapy subgroup, there was decreased odds of all-cause mortality in the DOACs group compared with the VKA group (OR: .13; CrI: .02-.65), but no differences for bleeding and stroke. DOACs and VKA have similar safety and efficacy profiles for post-TAVI patients with anticoagulation indication. However, if concomitant antiplatelet therapy is required, DOACs were more favorable than VKA for all-cause mortality.

Abstract 14883: Non-Vitamin K Oral Anticoagulants versus Warfarin After Watchman Device Implantation: A Systematic Review and Meta-Analysis

Introduction: Postprocedural anticoagulation is indicated for at least 45 days in patients who undergo percutaneous left atrial appendage occlusion with the Watchman device. The relative efficacy and safety of non-vitamin K oral anticoagulants (NOACs) to warfarin for postprocedure anticoagulation in this setting is not well known. Methods: We conducted a systematic review and meta-analysis to compare NOACs with warfarin in patients who underwent left atrial appendage occlusion with Watchman. PubMed, Cochrane, and EMBASE were systematically searched. We included randomized and observational studies with at least 45 days of follow-up following Watchman implantation comparing anticoagulation with NOACs vs. warfarin for thrombotic and hemorrhagic outcomes. Results: We included 11 studies with 2,325 patients who underwent Watchman device implantation and were anticoagulated with NOACs (n=1,194; 51.35%) or warfarin (n=1,131; 48.65%). NOACs were associated with a lower incidence of major bleeding (OR 0.49; 95% CI 0.28-0.89; p=0.02; Fig. 1A) and device-related thrombosis (OR 0.44; 95% CI 0.21-0.93; p=0.03; Fig. 1B). There was no significant difference between NOACs and warfarin with regards to stroke or transient ischemic attack (OR 0.43; 95% CI 0.15-1.28; p=0.13; Fig. 2). Conclusions: In this meta-analysis, NOACs were associated with lower risks of device-related thrombosis and major bleeding relative to warfarin in patients who undergo Watchman implantation.

Anticoagulation in orthopaedic practice

Venous thromboembolism is a known complication following fractures and surgery. The incidence in orthopaedic surgeries is higher than in other specialities. Proper post procedural anticoagulation will help prevent most thromboembolic events. Several guidelines have been published directing the use of anticoagulation, most optimal agent to use and duration. The decision to anticoagulated must be based on a case-by-case basis considering patient factors as well. The following review article attempts to address these issues regarding anticoagulation in orthopaedic practice.

Left Atrial Appendage Ligation Using the AtriClip Device: Single-Center Study of Device Safety and Efficacy

Objective: Left atrial appendage (LAA) occlusion at the time of cardiac surgery in patients with atrial fibrillation has been shown to reduce the incidence of postoperative embolic stroke. However, the optimal method for LAA occlusion is not universally accepted. We sought to examine the safety and effectiveness of LAA occlusion with the AtriClip epicardial occlusion device. Methods: Cardiac surgical patients with atrial fibrillation who underwent LAA AtriClip placement were evaluated prospectively. Clip placement and clinical outcomes were examined after 1 year of follow-up with transesophageal echocardiography (TEE). The presence of a 10 mm or greater residual pouch, presence of flow into the LAA, or device-related thrombus (DRT) were considered failures. Results: Ninety-seven patients were analyzed. The mean CHA2DS2-VASc score was 2.4 ± 1.4. The postoperative follow-up period ranged from 366 to 1,693 days (mean 685 days or 1.87 years). Seventy-four AtriClips were placed with video-assisted thoracic surgery, whereas 23 were placed via sternotomy or thoracotomy. Successful closure was found in 96% (93 of 97) of patients at follow-up. Failure occurred in 4 patients. No clip migration or DRT was seen on 3-dimensional imaging. Of all 97 patients, 76 (78%) were on presurgical oral anticoagulation, whereas 5 (5.1%) were on postprocedure oral anticoagulation. There were no postoperative thromboembolic events at the time of the study TEE. Conclusions: The AtriClip epicardial surgical occlusion device can provide an excellent rate of successful closure of the LAA during surgical ablation procedures without DRT.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN. This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September 2020). We compared the outcomes of patients who were discharged on DOACs versus warfarin after the WATCHMAN procedure. The primary outcome was the composite of any bleeding, thromboembolism, or cardiovascular death through 7​days and 45​days after the procedure. The final analysis included 301 patients, of whom 82.4% (248/301) were discharged on DOACs and 17.6% (53/301) were discharged on warfarin. The mean CHA2DS2-VASc and HAS-BLED scores were 4.9​±​1.6 and 2.9​±​0.9, respectively. The primary composite outcome was similar between the DOAC and warfarin groups through 7​days (3.2% vs 5.6%; adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.13-3.17; P​=​.59) and 45 days after procedure (10.1% vs 11.3%; adjusted OR, 1.18; 95% CI, 0.41-3.45; P​=​.76). Major bleeding (5.2% vs 9.5%; P​=​.34) and all-cause readmission (12.5% vs 16.9%; P​=​.85) at 45​days were comparable between the DOAC and warfarin groups. The overall incidence of device-related thrombus and significant peri-device flow at 45​days were low (<0.5%). In high-risk patients with atrial fibrillation, the primary composite outcome of any bleeding, thromboembolism, or cardiovascular death through 7​days and 45​days following WATCHMAN implantation was similar in patients receiving DOACs versus warfarin.

Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial.

Adequate procedural anticoagulation is crucial for radial artery occlusion (RAO) prevention in patients undergoing transradial access coronary catheterization, although the effect of postprocedural anticoagulation lack thorough investigation. The aim of this study was to evaluate the clinical value of short-term postoperative anticoagulation with rivaroxaban for 24 hours and 1-month RAO prevention in patients who received transradial coronary procedures. A total of 382 patients were randomized to receive either placebo (control group) or rivaroxaban 10 mg once daily for a period of 7 days (rivaroxaban group) to evaluate the effect of the rivaroxaban in the prevention of 24 hours and 1-month RAO assessed by Doppler ultrasound. There was no significant difference in the incidence of 24-hour RAO (8.9% versus 11.5%; P=0.398) between the rivaroxaban group and control group (odds ratio, 0.75 [95% CI, 0.39-1.46]; P=0.399). In contrast, the 1-month RAO (3.8% versus 11.5%; P=0.011) was significantly reduced in patients who received rivaroxaban as compared with those who did placebo (odds ratio, 0.22 [95% CI, 0.08-0.65]; P=0.006). For patients with 24-hour RAO, the rivaroxaban group was associated with higher recanalization rate of the radial artery (69.2% versus 30.0%; P=0.027) compared with the control group. No significant differences can be observed between the 2 groups for access-site complications or bleeding events. Short-term postoperative anticoagulation with rivaroxaban did not reduce the rate of 24-hour RAO but improved 1-month RAO, because of higher recanalization of the radial artery. However, larger clinical trials are needed to prove our results. URL: https://www.chictr.org.cn; Unique identifier: ChiCTR1900026974.

Analysis of a New Ultrasound Classification System following Ablation of the Great Saphenous Vein

Ablation of truncal vein reflux, whether by thermal or nonthermal techniques, may be associated with thrombus extension into the deep system and deep venous thrombosis (DVT) in a small number of patients. To assess for this, most patients undergo a follow-up ultrasound examination within 24 to 72 hours after the procedure. Two prior classification systems for describing thrombus extension and managing postprocedure anticoagulation therapy have been widely used. Recently, a new classification system, arteriovenous fistula (AVF) consensus, was published that combined the two in an effort to establish one universal system. In this study, our objective was to use all three classifications in a cohort of patients to determine the impact of consolidating systems in the management of patients with different levels of great saphenous vein (GSV) closure. We performed a retrospective cohort review of consecutive patients who underwent GSV ablation with mechanochemical or thermal techniques at two associated medical centers during years 2015-2017 and 2018-2019. Only patients who underwent postprocedure duplex ultrasound at 24 to 72 hours were included. Ultrasounds were independently assigned to each of the classification systems based on the level of closure (Table). Patient charts were also reviewed to identify treatment. A total of 223 patients were analyzed (150 underwent radiofrequency ablation and 73 ClariVein ablation). The mean age was 58.5 with 49% females and 51% males. Of the patients, 52% underwent concomitant phlebectomies. Two patients required anticoagulation post treatment. Another two underwent a follow-up ultrasound examination with one patient who had unchanged findings and one with improvement of the level of closure. The rest did not require any further follow-up. This was consistent with recommendations by all three classifications. GSV ablation at a level that requires anticoagulation or repeat ultrasound examination is rare, occurring in <1% of patients. The previous systems and AVF consensus system are similar enough that applying either one for the purpose of postprocedure management results in no change in treatment. Based on this data, the AVF classification system may be applied when clinically indicated in the postablation period, to standardize the reporting of this infrequent but important complication.TableNumber of patients by level of closureKabnick class (n = 223)Lawrence class (n = 223)AVF consensus class (n = 223)I (210)I (195)Ia (195)II (12)II (5)Ib (15)III (0)III (10)II (12)Iv (1)IV (11)III (0)V (1)IV (1)VI (1) Open table in a new tab

Postprocedure Anticoagulation in Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

This study sought to assess the association between postprocedural anticoagulation (PPAC) use and several clinical outcomes. PPAC after primary percutaneous coronary intervention (pPCI) in patients with ST-segment elevation myocardial infarction (STEMI) may prevent recurrent ischemic events but may increase the risk of bleeding. No consensus has been reached on PPAC use. Using data from the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome registry, conducted between 2014 and 2019, we stratified all STEMI patients who underwent pPCI according to the use of PPAC or not. Inverse probability of treatment weighting and a Cox proportional hazards model with hospital as random effect were used to analyze differences in in-hospital clinical outcomes: the primary efficacy endpoint was mortality and the primary safety endpoint was major bleeding. Of 34,826 evaluable patients, 26,272 (75.4%) were treated with PPAC and were on average younger, more stable at admission with lower bleeding risk score, more likely to have comorbidities and multivessel disease, and more often treated within 12 hours of symptom onset than those without PPAC. After inverse probability of treatment weighting adjustment for baseline differences, PPAC was associated with significantly reduced risk of in-hospital mortality (0.9% vs 1.8%; HR: 0.62; 95%CI: 0.43-0.89; P< 0.001) and a nonsignificant difference in risk of in-hospital major bleeding (2.5% vs 2.2%; HR: 1.05; 95%CI: 0.83-1.32; P = 0.14). PPAC in STEMI patients after pPCI was associated with reduced mortality without increasing major bleeding complications. Dedicated randomized trials with contemporary STEMI management are needed to confirm these findings.

Immediate postprocedure anticoagulation with factor Xa inhibitors of venous stents for nonthrombotic venous lesions does not increase stent patency

BackgroundMany clinicians will prescribe anticoagulation therapy for patients after iliac vein stenting to prevent early or late stent thrombosis. At present, it is unknown whether therapeutic anticoagulation has any effect on stent patency. Thus, we assessed the role of short-term anticoagulation on iliac vein stent patency in patients with nonthrombotic iliac vein lesions (NIVLs). MethodsWe performed a retrospective medical record review of all iliac vein stents placed for NIVLs at the Center for Vascular Medicine from January 2018 to December 2019. We compared the stent patency in the two groups. The anticoagulation (AC) group had received rivaroxaban or apixaban postoperatively for a minimum of 90 days and were compared with a group that had received no postoperative anticoagulation (NAC). Stent patency was assessed using transabdominal ultrasound at 3, 6, 12, 18, 24, and 30 months. At the discretion of the treating physician, the patients who demonstrated thrombus layering on surveillance ultrasound scanning continued rivaroxaban or apixaban until thrombus resolution was observed. The demographics and stent location, diameter, and length were assessed. Stent patency was analyzed using life table analyses. Differences in stent patency were analyzed using GraphPad Prism, version 8, statistical software (GraphPad Software Inc, La Jolla, Calif) and the log-rank (Mantel-Cox) test. ResultsThe number of patients and stents in each group were as follows: AC group, 299 patients and 308 stents; and NAC group, 77 patients and 90 stents. The average age was 52.24 ± 13.44 years and 55.63 ± 14.49 years in the AC and NAC groups, respectively (P ≤ .065). Women constituted 76% of the patients in the AC group and 72% in the NAC group. The average stent diameter and length for the AC group was 20 ± 2 mm and 77 ± 13 mm and for the NAC group was 19 ± 2 mm and 82 ± 9 mm, respectively. The stents had been placed in the right common iliac vein, bilaterally, or left common iliac vein territory in 15%, 3%, and 82% in the AC group and 18%, 2%, and 80% in the NAC group, respectively. The cumulative stent patency at 30 months was 98.7% and 94.6% for the NAC and AC groups, respectively (P ≤ .83). All the stents placed were Wallstents (Boston Scientific, Marlborough, Mass). A total of eight insertion site thromboses occurred that did not affect stent patency: five in the AC group (1.6%) and three in the NAC group (4.5%; P = .15). In addition, 19 patients demonstrated evidence of thrombus layering, with 6 receiving extended anticoagulation. ConclusionsOur data indicate that perioperative stent thrombosis in patients with NIVLs is uncommon. Thus, anticoagulation for perioperative stent thrombosis prophylaxis is not necessary. Anticoagulation should only be used for patients with insertion site thromboses and should be considered if thrombus layering is observed on surveillance scanning.