No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial.

BACKGROUND: The optimal strategy to prevent no-reflow in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) is unknown. AIMS: We aimed to examine the effect of thrombectomy on the outcome of no-reflow in key subgroups and the adverse clinical outcomes associated with no-reflow. METHODS: We performed a post hoc analysis of the TOTAL Trial, a randomised trial of 10,732 patients comparing thrombectomy versus PCI alone. This analysis utilised the angiographic data of 1,800 randomly selected patients. RESULTS: No-reflow was diagnosed in 196 of 1,800 eligible patients (10.9%). No-reflow occurred in 95/891 (10.7%) patients randomised to thrombectomy compared with 101/909 (11.1%) in the PCI-alone arm (odds ratio [OR] 0.95, 95% confidence interval [CI]: 0.71-1.28; p-value=0.76). In the subgroup of patients who underwent direct stenting, those randomised to thrombectomy compared with PCI alone experienced less no-reflow (19/371 [5.1%] vs 21/216 [9.7%], OR 0.50, 95% CI: 0.26-0.96). In patients who did not undergo direct stenting, there was no difference between the groups (64/504 [12.7%] vs 75/686 [10.9%)], OR 1.18, 95% CI: 0.82-1.69; interaction p-value=0.02). No-reflow patients had a significantly increased risk of experiencing the primary composite outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA Class IV heart failure) at 1 year (adjusted hazard ratio 1.70, 95% CI: 1.13-2.56; p-value=0.01). CONCLUSIONS: In patients with STEMI treated by PCI, thrombectomy did not reduce no-reflow in all patients but may be synergistic with direct stenting. No-reflow is associated with increased adverse clinical outcomes.

Superficial temporal artery access for carotid artery stenting: A case report.

Percutaneous intervention of patients who suffer from generalized vascular disease is often a great challenge due to the limited accessibility of the access gates. We discuss the case of a 66-year-old man who presented with critical right internal carotid artery (ICA) stenosis after previous hospitalization due to stroke. In addition to arteria lusoria, the patient had known bilateral femoral amputation, occlusion of the left ICA and significant three-vessel coronary artery disease. After unsuccessful common carotid artery (CCA) cannulation from the right distal radial artery access, we successfully performed the diagnostic angiography and the planned right ICA-CCA intervention using superficial temporal artery (STA) puncture. We showed that STA access can be used as an alternative and additional access site for diagnostic carotid artery angiography and intervention when standard access sites alone are insufficient.

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.

Distal Radial Artery Access for Recanalization of Radial Artery Occlusion and Repeat Intervention: A Single Center Experience.

Background: Once occluded, the radial artery becomes unsuitable for repeat interventions and obligates the need for alternative vascular access, such as the femoral approach, which is not encouraged by current guidelines. With the dissemination of distal radial access (DRA), which allows the cannulation of the artery in its distal segment and which remains patent even in the case of radial artery occlusion (RAO), the option to perform angioplasty at this level becomes feasible. Methods: Thirty patients with RAO were enrolled in this pilot study. Recanalization was performed through DRA using hydrophilic guidewires. The feasibility endpoint was procedural success, namely the successful RAO recanalization, the efficacy endpoint was patency of the artery at 30 days, and the safety endpoint was the absence of periprocedural vascular major complications or major adverse cardiac and cerebrovascular events. Results: The mean age of the patients was 63 ± 11 years, and 15 patients (50%) were men. Most patients had asymptomatic RAO (n = 28, 93.3%), and only two (6.6%) reported numbness in their hands. The most common indication for the procedure was PCI (19, 63.2%). Total procedural time was 41 ± 22 min, while the amount of contrast used was 140 ± 28 mL. Procedural success was 100% (n = 30). Moreover, there were no major vascular complications (0%); only two small hematomas were described (10%) and one had an angiographically visible perforation (3%). One case of periprocedural stroke was reported (3%), with onset immediately after the procedure and recovering 24 h later. Twenty-seven radial arteries (90%) remained patent at the one-month follow-up. Conclusions: RAO recanalization is feasible and safe, and by using dedicated hydrophilic guidewires, the success rate is high without significantly increasing procedural time or the amount of used contrast.

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.

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 Secondary Access for Transcatheter Aortic Valve Implantation: The Minimalistic Approach.

BACKGROUND: Although not yet recommended by the guidelines, distal radial access, a new site for cardiovascular interventions, has been rapidly acknowledged and adopted by many centers due to its high rate of success, safety and fewer complications. We present our experience using secondary distal radial access during transcatheter aortic valve implantation (TAVI), proposing a new, even more minimal approach. METHODS: As of November 2020, a systematic distal radial approach as secondary access site for TAVI was adopted in our center. Primary endpoints were technical success and major adverse events (MAEs). Secondary endpoints: the access site complication rate, hemodynamic and clinical results of the intervention, procedural related factors, crossover rate to the femoral access site, and hospitalization duration (in days). RESULTS: From November 2020, 41 patients underwent TAVI using this strategy. Patients had a mean age of 76 ± 11.2 years, 41% were male. Six (14.63%) patients received a balloon-expandable valve and 35 (85.37%) received a self-expandable valve. TAVI was successful in all cases. No complications occurred due to transradial access. Puncture success, defined as completed sheath placement was maximum (N = 41/41,100%) and emergent transfemoral secondary access was not required in any case. Primary transfemoral vascular access site complications occurred in 7 cases (17%) of which 4 (13.63%) were resolved through distal radial access: one occlusion, two flow-limiting stenoses and four perforations of the common femoral artery. There were no additional major vascular complications at 30 days. Overall MACE rate was 2.4%. CONCLUSION: The use of the distal radial approach for secondary access in TAVI is safe, feasible and has several advantages over old access sites.

Distal Radial Artery Access for Coronary and Peripheral Procedures: A Multicenter Experience.

INTRODUCTION: Distal radial access (dRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. The aim of this large multicenter registry was to demonstrate the feasibility and safety of dRA in a wide variety of routine procedures in the catheterization laboratory, ranging from coronary angiography and percutaneous coronary intervention to peripheral procedures. METHODS: The study comprised 1240 patients who underwent coronary angiography, PCI or noncoronary procedures through dRA in two Hungarian centers from January 2019 to April 2021. Baseline patient characteristics, number and duration of arterial punctures, procedural success rate, crossover rate, postoperative compression time, complications, hospitalization duration, and different learning curves were analyzed. RESULTS: The average patient age was 66.4 years, with 66.8% of patients being male. The majority of patients (74.04%) underwent a coronary procedure, whereas 25.96% were involved in noncoronary interventions. dRA was successfully punctured in 97% of all patients, in all cases with ultrasound guidance. Access site crossover was performed in 2.58% of the patients, mainly via the contralateral dRA. After experiencing 150 cases, the dRA success rate plateaued at >96%. Our dedicated dRA step-by step protocol resulted in high open radial artery (RA) rates: distal and proximal RA pulses were palpable in 99.68% of all patients at hospital discharge. The rate of minor vascular complications was low (1.5%). A threshold of 50 cases was sufficient for already skilled radial operators to establish a reliable procedural method of dRA access. CONCLUSION: The implementation of distal radial artery access in the everyday routine of a catheterization laboratory for coronary and noncoronary interventions is feasible and safe with an acceptable learning curve.

Superficial temporal artery access for percutaneous coronary artery stenting during the COVID-19 pandemic: a case report.

BACKGROUND: The COVID-19 pandemic creates new challenges for healthcare, including invasive cardiology. CASE SUMMARY: We discuss the case of a 65-year-old man who presented with non-ST segment elevation myocardial infarction combined with bilateral pneumonia. The patient had known severe iliac artery lesions with prior interventions and bilateral subclavian artery occlusions. After unsuccessful femoral artery access, the diagnostic angiography and the right coronary artery percutaneous coronary intervention were successfully performed from ultrasound-guided lower superficial temporal artery access. DISCUSSION: We showed that superficial temporal access can be used as an alternate access site for diagnostic coronary angiography and intervention when standard wrist and femoral access sites are not readily accessible.

Safety and feasibility of transradial aortic valve valvuloplasty (TRAV study).

INTRODUCTION: The importance of balloon aortic valvuloplasty (BAV) in the transcatheter aortic valve implantation (TAVI) era emerged in the past decades, but the access site related complication rate remained significant. AIM: To establish the safety and technical success of transradial balloon aortic valvuloplasty (trBAV). The secondary objective was to determine the effectiveness and appropriate role of trBAV. MATERIAL AND METHODS: Between 2017 and 2019, 36 consecutive patients with symptomatic aortic stenosis (AoS) were treated with trBAV in this prospective, single-center study. During the procedure, the efficacy and the aortic valve insufficiency were controlled by hemodynamic measurements and later by echocardiography. The primary end-points were technical success and major adverse events (MAE). Secondary end-points were the access site complication rate, hemodynamic and clinical result of the intervention, procedure-related factors, crossover rate to the femoral access site and hospitalization duration. RESULTS: Clinical and technical success was achieved in all cases. Invasively measured peak-to-peak gradient decreased from 76.8 ±27.2 to 54.7 ±21.1 mm Hg (p = 0.001), and the aortic-valve area increased from 0.69 ±0.2 to 0.91 ±0.3 cm2 (p = 0.001). No major adverse cardiac or cerebrovascular events or vascular complications (according to VARC 2 criteria) occurred during the procedures. The perioperative death rate was 2.7% (n = 1). CONCLUSIONS: According to our study, radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis.

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.

Clinical Impact of Weight-Loss Pharmacotherapy in Patients with Atherosclerotic Cardiovascular Disease.

Obesity is associated with the development and progression of multiple cardiovascular risk factors, such as hypertension, dyslipidemia, and type 2 diabetes mellitus, and is an important contributor to the global burden of atherosclerotic cardiovascular disease (CVD). Guidelines suggest that clinicians provide lifestyle counseling and promote lifestyle modifications before considering weight-loss surgery. However, despite lifestyle modifications and increased physical activity, most patients with obesity will not lose significant weight or will experience weight regain. Weight-loss pharmacotherapy added to lifestyle modification has long been perceived as a bridge between lifestyle modifications alone and weight-loss surgery. However, since its inception, weight-loss pharmacotherapy has been plagued by variable efficacy and concern about cardiovascular safety. Following requirements from regulatory authorities, efficacy and cardiovascular safety trials have been conducted for the currently available weight-loss pharmacotherapeutic agents. Overall, these trials have shown that weight-loss pharmacotherapy is only modestly efficient for the inducement of weight loss. Recent trials have also demonstrated the cardiovascular safety of some of these agents. We review these trials with a focus on the clinical impact of these weight-loss pharmacotherapeutic agents in patients with atherosclerotic CVD.

Development of a micro-scale method to assess the effect of corrosion on the mechanical properties of a biodegradable Fe-316L stent material.

The application of biodegradable materials to stent design has the potential to transform coronary artery disease treatment. It is critical that biodegradable stents have sustained strength during degradation and vessel healing to prevent re-occlusion. Proper assessment of the impact of corrosion on the mechanical behaviour of potential biomaterials is important. Investigations within literature frequently implement simplified testing conditions to understand this behaviour and fail to consider size effects associated with strut thickness, or the increase in corrosion due to blood flow, both of which can impact material properties. A protocol was developed that utilizes micro-scale specimens, in conjunction with dynamic degradation, to assess the effect of corrosion on the mechanical properties of a novel Fe-316L material. Dynamic degradation led to increased specimen corrosion, resulting in a greater reduction in strength after 48 h of degradation in comparison to samples statically corroded. It was found that thicker micro-tensile samples (h > 200 µm) had a greater loss of strength in comparison to its thinner counterpart (h < 200 µm), due to increased corrosion of the thicker samples (203 MPa versus 260 MPa after 48 h, p = 0.0017). This investigation emphasizes the necessity of implementing physiologically relevant testing conditions, including dynamic corrosion and stent strut thickness, when evaluating potential biomaterials for biodegradable stent application.

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.

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.

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.