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.

Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.

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.

Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.

BACKGROUND: Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis. METHODS: We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed. RESULTS: A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03). CONCLUSIONS: Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).

TRIACCESS Study: Randomized Comparison Between Radial, Femoral, and Pedal Access for Percutaneous Femoro-popliteal Artery Angioplasty.

BACKGROUND: The aim of this randomized study was to compare the success and complication rates of different access sites for the treatment of superficial artery stenosis. METHODS AND RESULTS: A total of 180 consecutive patients were randomized in a prospective study to treat symptomatic superficial femoral artery stenosis via radial (RA), femoral (FA), or pedal artery (PA) access. Technical success was achieved in 96.7%, 100%, and 100% of the patients in the RA, FA, and PA groups, respectively (p=0.33). Secondary access sites were used in 30%, 3.3%, and 30% of the patients in the RA, FA, and PA access groups, respectively (p=0.0002). Recanalization for chronic total occlusion was performed in 34/36 (94.4%), 30/30 (100%), and 46/46 (100%) patients in the RA, FA, and PA groups, respectively (p=0.17). The X-ray dose was significantly lower in the PA group than that in the RA and FA access groups (63.1 vs 162 vs 153 Dyn, p=0.0004). The cumulative rates of access site complications in the RA, FA, and PA groups were 3.3% (0% major and 3.3% minor), 16.7% (3.3% major and 13.3% minor), and 3.3% (3.3% major and 0% minor) (p=0.0085), respectively. The cumulative incidence of MACEs at 6 months in the RA, FA, and PA groups was 5%, 6.7%, and 1.7%, respectively. The cumulative incidence of MALEs at 6 months in the RA, FA, and PA groups was 20%, 16.7%, and 9.2%, respectively (p=0.54). CONCLUSION: Femoral artery intervention can be safely and effectively performed using radial, femoral, and pedal access, but radial and pedal access is associated with a lower access site complication rate and hospitalization. Pedal access is associated with a lower X-ray dose than that with radial and femoral access.

Distal Radial Artery Access for Superficial Femoral Artery Interventions.

PURPOSE: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. MATERIALS AND METHODS: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. RESULTS: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8). CONCLUSION: SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.

Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT).

AIMS: The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether time-to-treatment initiation (TTI) influences the beneficial impact of colchicine. METHODS AND RESULTS: In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4-7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32-0.84], in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53-1.75) or > Day 8 (HR = 0.82, 95% CI 0.61-1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05). CONCLUSION: Patients benefit from early, in-hospital initiation of colchicine after MI. TRIAL REGISTRATION: COLCOT ClinicalTrials.gov number, NCT02551094.

A novel fiber-optic based 0.014″ pressure wire: Designs of the OptoWire™, development phases, and the O2 first-in-man results.

OBJECTIVES: To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O2 pilot study results. BACKGROUND: Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire. METHODS AND RESULTS: The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed. CONCLUSION: The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.

Direct transpedal pressure measurement during transpedal below-the-knee interventions in critical limb ischemia.

AIM: The aim of this study was to assess the feasibility of the distal pressure measurement during transpedal below-the-knee interventions in chronic limb-threatening ischemia (CLTI) and to assess the hemodynamic response after percutaneous transluminal angioplasty. METHODS: The clinical and angiographic data of 137 consecutive patients treated via transpedal access in CLTI (Rutherford 4-6) were evaluated. Distal pedal pressure (PP) at the end of the pedal sheath was measured and the pedal-to-aortic pressure index (PAPI) was also calculated before and after the intervention. RESULTS: Good angiographic results was achieved in 131 patients (95.6%) in the femoro-popliteal and at least in one below-the-knee artery. Significant differences were found in PP and PAPI between before- and after-intervention values (103.2 ± 41.6 mmHg vs. 138.2 ± 37.8 mmHg and 0.74 ± 0.29 vs. 1.03 ± 0.34), respectively. Post-procedural PP and PAPI were significantly higher in patients who underwent good and borderline/unsuccessful intervention 141.7 [135.8-147.6] versus 82.6 [33.8-131.5] mmHg and 1.05 [1-1.1] versus 0.53 [0.2-0.8], respectively. PP's are significantly different in various Rutherford classification groups. Among the studied parameters, postprocedural PAPI was found to have the best discriminatory power to predict 3-month amputation (c-statistic: 0.749, 95% CI: 0.546-0.952, p = .016, sensitivity: 57.1%, specificity: 92.3% using the cut-off criterion ≤0.58). Major adverse event was detected in 17 patients at 3 months follow up (12.4%), including 7 major amputations (5.1%). CONCLUSION: Transpedal pressure and pedal-to-aortic pressure index significantly increased during transpedal below-the-knee angioplasty and final pressure and index correlates significantly with limb salvage.

A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion-The RESCUE-RAO Trial.

BACKGROUND: Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO). OBJECTIVE: We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods. Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) (n = 495) or prolonged (8 hours) (n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery. RESULTS: One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group (p < 0.001). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group (p < 0.001). CONCLUSION: Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.

Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial.

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.

Effect of PPARγ agonist on aerobic exercise capacity in relation to body fat distribution in men with type 2 diabetes mellitus and coronary artery disease: a 1-yr randomized study.

Targeting metabolic determinants of exercise performance with pharmacological agents that would mimic/potentiate the effects of exercise represents an attractive clinical alternative to counterbalance the poor exercise capacity in patients with type 2 diabetes mellitus (T2DM). We examined the effect of 1-yr treatment with the insulin sensitizer peroxisome proliferator-activated receptor (PPAR)γ agonist rosiglitazone on aerobic exercise capacity and body fat composition/distribution in men with T2DM and stable coronary artery disease (CAD). One-hundred four men (age: 64 ± 7 yr; body mass index: 30.0 ± 4.4 kg/m2) with T2DM and CAD were randomized to receive rosiglitazone or placebo for 1 yr. Aerobic exercise capacity (exercise duration) was assessed with a maximal treadmill test, and body composition/distribution were assessed by dual-energy X-ray absorptiometry/computed tomography scans. At 1 yr, patients with T2DM under PPARγ agonist treatment showed a reduction in aerobic exercise capacity compared with the control group (exercise duration change, -31 ± 8 versus 7 ± 11 s, P = 0.009). Significant increases in body fat mass (3.1 ± 0.4 kg, 12%), abdominal and mid-thigh subcutaneous adipose tissue (AT) levels, and mid-thigh skeletal muscle fat were found (all P < 0.01), whereas no effect on visceral AT levels was observed (P > 0.05) under treatment. Subcutaneous fat mass gained under PPARγ agonist was the strongest predictor of the worsening in aerobic exercise capacity (P > 0.0001); no association was found with skeletal muscle fat infiltration nor visceral AT. Treatment with the insulin sensitizer PPARγ agonist rosiglitazone in patients with T2DM and CAD is associated with a worsening in aerobic exercise capacity, which seems to be mainly attributable to weight gain and subcutaneous fat mass expansion.

Transradial left gastric artery embolization to treat severe obesity: A pilot study.

BACKGROUND: Bariatric surgery is currently the only effective treatment with long-lasting results to treat severe obesity. OBJECTIVES: We performed a pilot study to evaluate the feasibility, safety and efficacy of percutaneous distal embolization of the left gastric artery (LGA) using a transradial approach. METHODS AND RESULTS: We recruited seven severely obese male patients (mean age 48 ± 7 years) referred for diagnostic coronary angiography. Mean baseline weight was 160 ± 27 kg and body mass index was of 52 ± 8 kg/m2 . We successfully injected 300-500 µm polyvinyl alcohol particles using 5Fr catheters and all distal LGA were occluded at the end of procedures. Mean procedure duration was 24 ± 13 min and mean fluoroscopy time was 10 ± 5 min. Six patients reported mild transient epigastric discomfort, which resolved with proton pump inhibitors. At 2 months, the average weight loss was of 7 ± 6 kg (median loss: -10 kg [-2, -11]), 6 ± 12 kg (median loss: -9 kg [-16, +4]) at 6 months and 13 ± 17 kg (median loss: -11 kg [0, -25]) up to 12 months after index procedures. CONCLUSION: Percutaneous transradial LGA embolization appears to be a promising technique to reduce the obesity burden. Randomized trials are required to further delineate the risk/benefit ratio, potential clinical indications and long term results.

Benefit of routine preprocedural radial artery angiography in STEMI patients.

AIMS: To assess the benefit of routine preprocedural radial artery (RA) angiography in patients with ST segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: All consecutive STEMI patients, in the period from January 2010 until December 2016 were included in the study. Preprocedural radial artery angiography was performed in all patients since March 2011. We compared clinical and procedure characteristics, access site bleeding complications and failure of primary chosen TRA between two groups of STEMI patients before and after we started performing routine RA angiography. We compared 762 STEMI patients from 2010 until March 2011 and 4306 STEMI patients after March 2011 until December 2016. Mean age of patients was 60 ± 11 years with 73% males. The latter group had more elderly and obese patients (P < .0001 both). Prior percutaneous coronary interventions was present in 7% of patients and 0, 1% had prior coronary bypass surgery. Procedure duration (38 ± 16 vs. 32 ± 20 min) was significantly longer in the first group (P value < .0001), but contrast volume (120 ± 33 vs. 110 ± 35 ml), and fluoroscopy time (8.6 ± 6 vs. 8.7 ± 8 min) were similar in both groups. Access crossover from primary TRA was 4, 6% in the first group, with a significant decrease to 3, 1% in the second (P < .0001), after introducing preprocedural RA angiography. Access site bleeding complications were significantly higher in the first group 6.8% vs. 4.3% in the second (p < .0001). CONCLUSION: Routine preprocedural radial artery angiography in STEMI patients is associated with lower rate of access site bleeding complications and reduced overall procedural time and TRA crossover rate.

Transpedal vs. femoral access for peripheral arterial interventions-A single center experience.

OBJECTIVE: To compare the transpedal approach to established femoral approach for endovascular treatment of infrainguinal peripheral arterial disease. BACKGROUND: Endovascular treatment of infrainguinal peripheral arterial disease is on the rise. Femoral approach is widely used but has significant complications. Recently the primary transpedal approach has been described for endovascular interventions. We hypothesized that transpedal approach could reduce access site related complications. We compared the two approaches in a retrospective cross-sectional study at a single center. METHODS: We analyzed demographics, procedural parameters, and complications in patients who underwent a primary transpedal approach for infrainguinal intervention and compared to patients with a traditional femoral approach in our outpatient based endovascular lab. RESULTS: The success rate for access was lower in transpedal group compared to femoral (94% vs. 100%, p = .0002). The contrast dose (44 ± 11 mL vs. 68 ± 13 mL, p < .0001), radiation dose (25 mGy [16-43] vs. 48 mGy [36-67], p < .0001) and fluoroscopy time (5.48 min [3.48-11.71] vs. 9.35 min [6.63-14.11], p < .0001) were significantly lower in transpedal group. CONCLUSION: The transpedal approach for infrainguinal revascularization appears to be a reasonable primary approach with high success and low complication rate with significant reduction in radiation and contrast dose. These findings should be further studied in a randomized controlled trial.

Short- and long-term results with a percutaneous treatment in critical hand ischaemia.

BACKGROUND: The aim of this prospective registry was to determine the feasibility, safety, and outcomes of percutaneous transluminal angioplasty and thrombolysis in the treatment of critical hand ischemia (CHI). METHODS: One-hundred one patients (aged 60.6 ± 15.3 years) were treated for CHI between 2012 and 2016 in three cardiovascular centers. Anatomically, the upper arm was divided into three segments (I-subclavian, II-brachial, and III-forearm). We examined the rates of technical and clinical success, major adverse events (MAEs), and vascular complications at 1 year and at long-term follow-up. RESULTS: Nineteen patients (18.8%) were treated for acute CHI, and 82 (81.2%) for chronic CHI. Median follow-up was 36.9 (19.6-68.3) months. Clinical symptoms were isolated rest pain in 91 patients (90.1%) and digital ulcer or gangrene in 10 patients (9.9%). The technical and clinical success rate of intervention was 96.0% (97/101) and 84.2% (85/101) at 1 year. Angioplasty was performed in Segments I, II, and III in 28 (27.7%), in 29 (28.7%), and 44 (43.5%) patients. Stent implantation was necessary in 47 patients (46.8%). Vascular access site complications were found in 2.1% of the sample. After 1 year, MAEs occurred in 27 patients (26.9%), and the target lesion revascularization rate was 11.9%. In two patients (1.9%), thoracic sympatectomy was necessary, and two patients (1.9%) underwent minor finger amputations. CONCLUSIONS: Angioplasty of hand vessels for CHI is a feasible and safe procedure with acceptable rates of technical success and hand healing. MAEs are frequent because the rate of severe comorbidities is high.

Contemporary transradial access practices: Results of the second international survey.

OBJECTIVES: To gain insight into current practice of transradial angiography and intervention in the United States and around the world. BACKGROUND: Transradial access (TRA) has grown worldwide. In a prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators. METHODS: We used an internet-based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent-level comparisons were made with the prior survey to assess for temporal changes in practice. RESULTS: Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts. CONCLUSIONS: There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes.

Randomized trial of primary PCI with or without routine manual thrombectomy.

BACKGROUND: During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. METHODS: We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. RESULTS: The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02). CONCLUSIONS: In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

Transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion.

BACKGROUND: Improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (SFA) chronic total occlusions (CTO). A change in access site to radial (TRA) or tibiopedal (TPA) artery for the treatment of these SFA CTO has been reported. The feasibility, efficacy and safety of these two access sites for treatment of SFA CTO have not been reported. METHODS: We performed an as treated analysis of 184 SFA CTO interventions in 161 patients from 01/2014 to 09/2016 using either primary TRA or TPA (operator discretion) at two institutions. Primary end point was 30 day major adverse event (MAE) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. RESULTS: Primary TRA was used in 46 patients with 47 CTO lesions .Primary TPA was used in 115 patients with 137 CTO lesions. Primary crossing success rate was higher with TRA compared to TPA (74% vs 54%, P = 0.01). Dual TRA-TPA was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30 day MAE was 5% in TRA arm, 0% in TPA arm and 2% in dual TRA-TPA arm, P = 0.08. All access sites were patent, confirmed by ultrasound. CONCLUSION: The treatment of SFA CTO is feasible and safe using both TRA or TPA approach providing high success rates and no access site complications.

Rosiglitazone lowers resting and blood pressure response to exercise in men with type 2 diabetes: A 1-year randomized study.

AIMS: We aimed to determine the effect of 1-year treatment with the insulin sensitizer peroxisome proliferator-activated receptor (PPAR)-γ agonist rosiglitazone on exercise capacity and blood pressure (BP) response to exercise in men with coronary artery disease (CAD) and type 2 diabetes (T2D). MATERIALS AND METHODS: A total of 116 men (age, 64 ± 7 years; body mass index, 30.0 ± 4.4 kg/m2 ) with CAD and T2D were randomized to receive rosiglitazone or placebo for 1 year. Exercise capacity (VO2peak ) and BP response to exercise were assessed with a maximal treadmill test, prior to the intervention and at 1-year follow-up. Exercise-induced hypertension (EIH) was defined as maximal systolic BP ≥ 220 mm Hg and/or diastolic BP ≥ 100 mm Hg. RESULTS: PPAR-γ agonist-treated patients showed improvements in fasting glucose, HbA1c and insulin sensitivity (Homeostasis model assessment of insulin resistance [HOMA-IR]) (all P < .05). Resting BPs, maximal exercise diastolic BP and resting rate-pressure product (RPP) were all reduced in the PPAR-γ agonist group (P < .05). Maximal exercise duration was unchanged. T2D patients who displayed the greatest improvement in insulin sensitivity (HOMA-IR) under PPAR-γ agonist treatment experienced a greater reduction in exercise BP and RPP (P < .05). The proportion of men with EIH decreased in the PPAR-γ agonist group during follow-up (39.00% ± 0.06% vs 21.00% ± 0.05%). In the subgroup with EIH that was treated with a PPAR-γ agonist, resting and exercise diastolic BP, as well as resting RPP, were all reduced at 1-year follow-up (P < .05). CONCLUSIONS: The insulin sensitizer rosiglitazone has a beneficial effect on resting and BP response to exercise in men with CAD and T2D, especially in those with an exaggerated BP response to exercise.

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial.

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.