Summary Background It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. Methods We did a ...randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov , number NCT01433627. Findings We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio RR 0·85, 95% CI 0·74–0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73–0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49–0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53–0·99; p=0·045). Interpretation In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. Funding The Medicines Company and Terumo.
Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome.
We randomly ...assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events.
The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval CI, 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34).
In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
COVID‐19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID‐19 and, in the meantime safety and ...protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019‐nCoV infection accessing in cath‐lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).
Technological advancements in transcatheter heart valve platforms are essential in order to achieve high standards of efficacy and safety in transcatheter aortic valve replacement (TAVR).
To evaluate ...the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first-generation device.
In this single-center, observational study consecutive patients undergoing Portico valve implantation with the new FlexNav delivery system (DS) were compared with patients treated with the first-generation delivery system (1
gen DS). In-hospital outcomes were self-adjudicated according to the Valve Academic Research Consortium-3 definition.
Fifty patients were included in this study; 22 were treated with the FlexNav DS and the remaining patients with the 1
gen DS. Clinical characteristics were similar between groups, except for older age (82.6 ±3.6 vs. 80.7 ±3.8;
= 0.07) and higher prevalence of female gender (68.2% vs. 39.3%;
= 0.04) in the FlexNav DS group as compared to the 1
gen DS group, respectively. We observed similar rates of procedural success but higher rate of moderate-to-severe paravalvular leak in the 1
gen DS as compared to FlexNav DS group (28.6% vs. 4.6%;
= 0.03); major vascular complications were reduced, although not significantly, in the FlexNav DS as compared to the 1
gen DS group (4.5% vs. 10.7%;
= 0.64).
Our data suggest that the FlexNav DS, thanks to its lower profile and enhanced stability during valve deployment, might be associated with reduced rates of vascular complications and moderate to severe paravalvular leak, thus improving procedural results.
Background Radiation exposure is an important issue for interventional cardiologists that is often underevaluated. Our aim was to evaluate determinants of operator radiation exposure during ...percutaneous coronary procedures. Methods The RADIANT ( NCT01974453 ) is a prospective, single centre observational study involving four expert operators and two fellows performing percutaneous coronary procedures. The operator radiation dose was evaluated using dedicated electronic dosimeters in 2028 procedures: 1897 transradial access (TRA) (1120 right and 777 left TRA) and 131 transfemoral access (TFA). Results In the whole population operator radiation dose at thorax did not differ between TFA (9 μSv interquartile range 5–18 μSv) and TRA (9 μSv 4–21 μSv) but after propensity score matching analysis, TFA showed lower dose (9 μSv 5–18 μSv) compared to TRA (17 μSv 9–28 μSv, P < .001). In the whole transradial group, left TRA (5 μSv 2–12 μSv) was associated with significant lower operator dose compared to right TRA (13 μSv 6–26 μSv, P < .001).The use of adjunctive protective pelvic drapes was significantly associated with lower radiation doses compared to procedures performed without drapes ( P < .001). Among the operators, an inverse relation between height and dose was observed. Finally, left projections, the use of angiographic systems not dedicated for coronary and high frame rates were all associated with a significant higher operator radiation exposure. Conclusions In a high volume centre for transradial procedures, TFA is associated with lower operator radiation dose compared to TRA. The use of adjunctive anti-rx drapes seems a valuable tool to reduce the higher operator radiation exposure associated with TRA.
Transradial approach currently represents the preferred arterial access approach for percutaneous coronary procedures primarily due to the reduced access-site complications compared with femoral ...access (1). However, because of its thinner caliber and higher sensitivity to mechanical and humoral stresses than other somatic vessels, radial artery is prone to spasm (2). In general, spasm is a benign complication that can be resolved with nitrates or Ca2+-channel blockers, but in some rare cases, the spasm is so severe and prolonged that it may lead to radial sheath entrapment, with documented rare cases of radial avulsion (3). We retrospectively evaluated the diagnostic or interventional percutaneous coronary procedures performed by us in 2018 to evaluate the rate of radial sheath entrapment due to severe spasm and to describe the effect of papaverine use.
in patients undergoing percutaneous coronary interventions (PCI), radial access should be favoured over femoral access as it reduces the risk of vascular complications and bleeding. Furthermore, a ...preventive role of radial access in the occurrence of acute kidney injury (AKI), mainly mediated by the reduction of bleeding and cholesterol crystal embolization into renal circulation, has been investigated in several studies, yielding conflicting results.
we designed a retrospective study to appraise the effect of the use of a vascular access site on the occurrence of AKI in a cohort of 633 patients with acute myocardial infarction treated by PCI at our centre from 2018 to 2020.
after propensity score adjustment, radial access was associated with a reduced, albeit statistically not significant, incidence of AKI (14.7% vs. 21.0%;
= 0.06) and major bleeding (12.5% vs. 18.7%;
= 0.04) as compared to femoral access. At multivariate analysis, femoral access was an independent predictor of AKI, together with in-hospital occurrence of BARC 3-5 bleeding, Killip class >1 at presentation, female gender, baseline eGFR <60 mL/min, and baseline haemoglobin <12 g/dL.
although limited by the observational design, our study supports the hypothesis that radial access may exert a protective role on the occurrence of AKI in patients with acute myocardial infarction undergoing PCI.
Objectives. Several randomized controlled trials (RCTs) consistently reported better clinical outcomes with radial as compared to femoral access for primary percutaneous coronary intervention (PCI). ...Nevertheless, heterogeneous use of potent antiplatelet drugs, such as Gp IIb/IIIa inhibitors (GPI), across different studies could have biased the results in favor of radial access. We performed an updated meta-analysis and meta-regression of RCTs in order to appraise whether the use of GPI had an impact on pooled estimates of clinical outcomes according to vascular access. Methods. We computed pooled estimates by the random-effects model for the following outcomes: mortality, major adverse cardiovascular events (death, myocardial infarction, stroke, and target vessel revascularization), and major bleedings. Additionally, we performed meta-regression analysis to investigate the impact of GPI use on pooled estimates of clinical outcomes. Results. We analyzed 14 randomized controlled trials and 11090 patients who were treated by radial (5497) and femoral access (5593), respectively. Radial access was associated with better outcomes for mortality (risk difference 0.01 (0.00, 0.01), p=0.03), MACE (risk difference 0.01 (0.00, 0.02), p=0.003), and major bleedings (risk difference 0.01 (0.00, 0.02), p=0.02). At meta-regression, we observed a significant correlation of mortality with both GPI use (p=0.011) and year of publication (p=0.0073), whereas no correlation was observed with major bleedings. Conclusions. In this meta-analysis, the use of radial access for primary PCI was associated with better clinical outcomes as compared to femoral access. However, the effect size on mortality was modulated by GPI rate, with greater benefit of radial access in studies with larger use of these drugs.
Objectives. To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background. Gp IIb/IIIa inhibitors (GPI) use during pPCI has ...declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods. Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results. A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions. In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.
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