Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional ...heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio OR 0.03, 95% confidence interval CI 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p <0.0001) were independent predictors of late RAO, whereas heparin was not (OR 0.45 95% CI 0.13 to 1.54, p = 0.20). In conclusion, our results suggest that maintenance of radial artery patency during hemostasis is the most important parameter to decrease the risk of RAO. In selected cases, provisional use of heparin appears feasible and safe when patent hemostasis is maintained.
Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest ...randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov , number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio HR 1·00 95% CI 0·87–1·15, p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 95% CI 0·76–1·14, p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 95% CI 1·10–2·51, p=0·015). Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. Funding Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
Aims
We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double‐layer micromesh stent using wrist approach in patients with significant carotid ...disease.
Materials and Methods
Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow‐up assessments included neurological exams, duplex ultrasound (DUS), and 12‐lead ECG. The primary endpoint was the 30‐day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in‐stent restenosis evaluated with DUS. Long‐term outcomes up to 72 months of follow‐up were assessed in all eligible patients.
Results
The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high‐risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30‐day major adverse event rate of 0.9% (1/105). Up to 72 months of follow‐up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in‐stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient.
Conclusion
Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long‐term follow‐up.
IMPORTANCE: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. OBJECTIVE: To evaluate e-cigarettes with individual counseling for smoking cessation. DESIGN, SETTING, AND ...PARTICIPANTS: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. INTERVENTIONS: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. MAIN OUTCOMES AND MEASURES: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. RESULTS: Among 376 randomized participants (mean age, 52 years; 178 women 47%), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference RD, 12.8 95% CI, 4.0 to 21.6) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 95% CI, –1.2 to 15.7). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 95% CI, –0.1 to 16.6), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 95% CI, 1.8 to 19.4). Adverse events were common (nicotine e-cigarette with counseling: 120 94%; nonnicotine e-cigarette with counseling: 118 93%; counseling only: 88 73%), with the most common being cough (64%) and dry mouth (53%). CONCLUSIONS AND RELEVANCE: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02417467
Transradial access (TRA) is increasingly used worldwide for percutaneous interventional procedures and associated with lower bleeding and vascular complications than transfemoral artery access. ...Radial artery occlusion (RAO) is the most frequent post-procedural complication of TRA, restricting the use of the same radial artery for future procedures and as a conduit for coronary artery bypass graft. The authors review recent advances in the prevention of RAO following percutaneous TRA diagnostic or interventional procedures. Based on the available data, the authors provide easily applicable and effective recommendations to prevent periprocedural RAO and maximize the chances of access in case of repeat catheterization or coronary artery bypass grafting surgery.
The aim of this study was to evaluate practice of transradial approach (TRA).
TRA has been adopted as an alternative access site for coronary procedures.
A questionnaire was distributed worldwide ...with Internet-based software.
The survey was conducted from August 2009 to January 2010 among 1,107 interventional cardiologists in 75 countries. Although pre-TRA dual hand circulation testing is not uniform in the world, >85% in the U.S. perform Allen or oximetry testing. Right radial artery is used in almost 90%. Judkins catheters are the most popular for left coronary artery angiographies (66.5%) and right coronary artery angiographies (58.8%). For percutaneous coronary intervention (PCI), 6-F is now standard. For PCI of left coronary artery, operators use standard extra back-up guiding catheters in >65% and, for right coronary artery 70.4% use right Judkins catheters. Although heparin remains the routine antithrombotic agent in the world, bivalirudin is frequently used in the U.S. for PCI. The incidence of radial artery occlusion before hospital discharge is not assessed in >50%. Overall, approximately 50% responded that their TRA practice will increase in the future (68.4% in the U.S.).
TRA is already widely used across the world. Diagnostic and guiding-catheters used for TRA remain similar to those used for traditional femoral approach, suggesting that specialized radial catheters are not frequently used. However, there is substantial variation in practice as it relates to specific aspects of TRA, suggesting that more data are needed to determine the optimal strategy to facilitate TRA and optimize radial artery patency after catheterization.
Radial artery occlusion (RAO) can result from transradial catheterization. We compared the incidence of RAO with 2 heparin dosage regimens after transradial coronary angiography, and we evaluated the ...efficacy and safety of transient homolateral ulnar artery compression to achieve acute radial artery recanalization. Patients referred for coronary angiography were randomized to very-low-dose heparin (2,000 IU) or low-dose heparin (5,000 IU). On sheath removal, hemostasis was obtained using the TR band with a plethysmography-guided patent hemostasis technique. In the case of RAO as assessed by duplex ultrasonography 3 to 4 hours after hemostasis, immediate 1-hour ulnar artery compression was applied. Hematomas >15 cm2 were also assessed. We randomized 465 patients, 222 in the 2,000-IU group and 243 in the 5,000-IU group. The baseline and procedural characteristics were comparable in both groups. The incidence of initial RAO was 5.9% in the 2,000-IU group and 2.9% in the 5,000-IU group (p = 0.17), with a compression time of 2.10 ± 0.78 hours and 2.25 ± 0.82 hours, respectively (p = 0.051). After ulnar artery compression, the final incidence of RAO was 4.1% in the 2,000-IU group and 0.8% in the 5,000-IU group (p = 0.03). The incidence of local hematoma was 2.3% and 3.7% in the 2,000- and 5,000-IU groups, respectively (p = 0.42). In conclusion, acute RAO after transradial catheterization can be recanalized by early 1-hour homolateral ulnar artery compression. This simple nonpharmacologic method was effective and safe in patients with very-low- and low-dose heparin. Nevertheless, the incidence of final RAO remained significantly lower after a higher anticoagulation level.
Periprocedural bleeding complications after percutaneous coronary intervention (PCI) are associated with increased short- and long-term morbidity and mortality. Although clinical trials have ...primarily assessed pharmacological strategies for reducing bleeding risk, there is a mounting body of evidence suggesting that adoption of a transradial rather than a transfemoral approach to PCI may permit greater reductions in bleeding risk than have been achieved with pharmacological strategies alone. However, despite a long history of use, a lack of widespread uptake by physicians coupled with the technological limitations of available devices has in the past confined transradial PCI to the status of a niche procedure, and many operators lack experience in this technique. In this review, we examine the history of the transradial approach to PCI and discuss some of the circumstances that have hitherto limited its appeal. We then review the current state of the peer-reviewed literature supporting its use and summarize the unresolved issues affecting broader application of this technique, including lack of operator familiarity and an insufficient evidence base for guiding practice. Finally, we describe potential directions for future investigation in the transradial realm.
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