Glycoprotein IIb/IIIa Inhibitors May Modulate the Clinical Benefit of Radial Access as Compared to Femoral Access in Primary Percutaneous Coronary Intervention: A Meta-Regression and Meta-Analysis of Randomized Trials.

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.

One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer.

OBJECTIVES: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. BACKGROUND: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. METHODS: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. RESULTS: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%. CONCLUSIONS: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

Radial approach for percutaneous coronary interventions on chronic total occlusions: technical issues and data review.

OBJECTIVE: To overview the scientific data and the technical details regarding percutaneous coronary interventions (PCI) on chronic total occlusions (CTO) by radial approach. BACKGROUND: Trans-femoral approach is commonly regarded as the standard for PCI on CTO. METHODS: A systematic search in Medline and in the main international websites was realized. Key data were extracted and analyzed using standard meta-analytic techniques. Bench test assessment of compatibility between different combinations of interventional devices (required for CTO recanalization techniques) and the following guiding catheters was performed: 5 Fr, Sheathless 6.5 Fr, 6 Fr, Sheathless 7.5 Fr and 8 Fr. RESULTS: No prospective randomized study was found, whereas 13 observational studies on 3,501 CTOs treated by radial approach were identified. Overall, the crossover to femoral access rate ranged between 0 and 5.8%. Access site complications were noted in <1% of cases and in-hospital major adverse events were reported in 0-3.8% of patients. PCI success was significantly influenced by the learning curve: In the five studies comparing the success rates between a first and a later period of practice, a significant improvement was observed (OR, 95% CI: 0.30, 0.39-0.51; P < 0.001). The technical details relevant to approach a CTO by transradial access are discussed, and the original results of bench tests provide details regarding the compatibility of various CTO recanalization techniques with specific guiding catheter sizes. CONCLUSIONS: The transradial access represents a promising alternative to trans-femoral access to treat patients undergoing CTO PCI in high-volume transradial centres. The presented data may be useful to plan transradial PCI attempts on CTO lesions.

Future of left atrial appendage interventions.

Percutaneous left atrial appendage occlusion (LAAO), currently recognized as a procedure with relatively low risk, is increasingly being adopted in clinical practice. However, due to the preventive nature of the procedure and the necessity to compare it with newer and safer oral anticoagulants, further optimization is required to address remaining challenges. These latter include acquiring comprehensive data on safety and efficacy, establishing standardized pre-procedural planning, and simplifying procedural process. Consequently, we have provided an overview that encompasses future opportunities for enhancing procedural safety and efficacy, thereby establishing LAAO as the mainstream strategy for stroke and systemic embolism prevention in patients with atrial fibrillation and absolute contraindications to anticoagulant drugs.

Acute Kidney Injury in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: The Role of Vascular Access Site.

Background: 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. Methods: 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. Results: after propensity score adjustment, radial access was associated with a reduced, albeit statistically not significant, incidence of AKI (14.7% vs. 21.0%; p = 0.06) and major bleeding (12.5% vs. 18.7%; p = 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. Conclusions: 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.

One-year outcomes of consecutive patients treated by Endeavor zotarolimus and Resolute zotarolimus stents: the impact of polymer coating in drug-eluting stent technology.

BACKGROUND: Polymer-coating represents a key component of drug-eluting stent (DES) technology and its possible impact on vessel-wall healing is a matter of debate. The clinical impact of different polymer-coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus-eluting stent (E-ZES) and Resolute Zotarolimus-eluting stent (R-ZES) as they differ in the polymer-coating only. METHODS: At our Institution, E-ZES was available during a first period and then it was substituted by the R-ZES during a second period. Clinical, angiographic, and procedural data were prospectively collected. Clinical follow-up was prospectively obtained up to 1-year. Primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12-month. RESULTS: A total of 467 patients undergoing percutaneous coronary intervention were enrolled: 233 patients treated with E-ZES and 234 with R-ZES. Patients treated by R-ZES had similar clinical characteristics and worse angiographic characteristics compared with those treated by E-ZES. At 12-month follow-up, MACE rate was significantly lower in the R-ZES group compared with E-ZES group (4.2% vs. 14.6%; P < 0.01). This difference was due to nonsignificantly lower rates of death and myocardial infarction and to significant lower rate of target-lesion-revascularization (R-ZES 3.4% vs. E-ZES 10.3%, P < 0.01). CONCLUSIONS: The results of this study suggest that the clinical outcome of patients treated by DES differing for the polymer coating only may be different. Polymer coating is a pivotal, probably underrated, component of DES technology which may influence the clinical performance of DES.

In-hospital outcomes of Portico transcatheter aortic valve replacement with the FlexNav as compared to the first-generation delivery system.

Introduction: 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). Aim: To evaluate the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first-generation device. Material and methods: 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 (1st gen DS). In-hospital outcomes were self-adjudicated according to the Valve Academic Research Consortium-3 definition. Results: Fifty patients were included in this study; 22 were treated with the FlexNav DS and the remaining patients with the 1st gen DS. Clinical characteristics were similar between groups, except for older age (82.6 ±3.6 vs. 80.7 ±3.8; p = 0.07) and higher prevalence of female gender (68.2% vs. 39.3%; p = 0.04) in the FlexNav DS group as compared to the 1st gen DS group, respectively. We observed similar rates of procedural success but higher rate of moderate-to-severe paravalvular leak in the 1st gen DS as compared to FlexNav DS group (28.6% vs. 4.6%; p = 0.03); major vascular complications were reduced, although not significantly, in the FlexNav DS as compared to the 1st gen DS group (4.5% vs. 10.7%; p = 0.64). Conclusions: 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.

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures.

BACKGROUND: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access. METHODS: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL. RESULTS: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time. CONCLUSIONS: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

Feasibility of complex coronary and peripheral interventions by trans-radial approach using large sheaths.

BACKGROUND: Trans-radial approach (TRA) reduces vascular access-site complications but has some technical limitations. Usually, TRA procedures are performed using 5 Fr or 6 Fr sheaths, whereas complex interventions requiring larger sheaths are approached by trans-femoral access. METHODS: During 4 years, at two Institutions with high TRA use, we have attempted to perform selected complex coronary or peripheral interventions by TRA using sheaths larger than 6 Fr. Clinical and procedural data were prospectively collected. Attempt to place a 7 Fr or 8 Fr sheath (according to the planned strategy of the procedure) was performed after 5-6 Fr sheath insertion, administration of intra-arterial nitrates and radial artery angiography. Late (>3 months) patency of the radial artery was checked (by angiography in the case of repeated procedures or by palpation + reverse Allen test). RESULTS: We collected 60 patients in which TRA large sheath insertion was attempted. The large sheath (87% 7 Fr, 13% 8 Fr) was successfully placed in all cases. Most of the procedures were complex coronary interventions (bifurcated or highly thrombotic or calcific chronic total occlusive lesions), whereas 8.3% were carotid interventions. Procedural success rate was 98.3% (1 failure to reopen a chronic total occlusion). No access-site related complication occurred. In 57 (95%) patients, late radial artery patency was assessed and showed patency in 90% of the cases, the remaining patients having asymptomatic collateralized occlusion. CONCLUSIONS: In selected patients, complex percutaneous interventions requiring 7-8 Fr sheaths can be successfully performed by RA approach without access-site clinical consequences.

Impact of radial-to-aorta vascular anatomical variants on risk of failure in trans-radial coronary procedures.

OBJECTIVES: To assess the impact of an "operative" classification of vascular anatomic variants on the feasibility of trans-radial approach. BACKGROUND: Vascular anatomic variants located from the wrist to the aorta may influence the feasibility of trans-radial procedures. Recently, a new "operative" classification of these variants was proposed. METHODS: Consecutive trans-radial diagnostic or interventional catheterizations were considered. Vascular anatomic variants were classified according to 10 categories and sub-grouped according to the ABC classification (A: radial-brachial arterial axis; B: axillary-subclavian-anonymous axis; C: aortic arch). Primary study end-point was failure of trans-radial approach (necessity to cross-over to another approach to complete the procedure). RESULTS: Three thousand four hundred seventy-seven consecutive radial procedures were considered. Anatomic variants were diagnosed in 308 procedures (8.8%): A variants: 7.2%, B variants: 1.9%; C variants: 0.3%. Failure occurred in 2.0% of procedures. Failure rate was 0.7% in the absence of variants vs.15.2% in the presence of any variant (P < 0.0001, OR 27.7, 95%CI 16.3-46.9). Each of the 10 variants was significantly associated with increased failure rate. Each of the three level-subgroups of variants was significantly associated to the risk of failure (failure 14.7% in A level, 13.9% in B level, 33.3% in C level; P < 0.0001 vs. absence of variants). CONCLUSIONS: Failure of trans-radial procedures is associated to anatomic variants located from the wrist to the aorta. The "operative" ABC classification of anatomic variants is useful not only to categorize these anatomic variants, but also to predict the risk of failure of trans-radial approach.

Prospective evaluation of myocardial ischemia related to post-procedural side-branch stenosis in bifurcated lesions treated by provisional approach with drug-eluting stents.

OBJECTIVES: To prospectively assess the impact of post-procedural side-branch (SB) stenosis on inducible myocardial ischemia in patients with bifurcated lesions undergoing percutaneous interventions. BACKGROUND: Provisional-stenting with drug-eluting stents (DES) is the recommended strategy to treat percutaneously bifurcated lesions but is associated to variable degrees of residual SB stenosis. The role of SB residual stenosis on post-procedural myocardial ischemia is uncertain. METHODS: Patients with bifurcations treated by DES according to provisional-stenting technique were enrolled in the study if they had no other untreated lesion. Patients were divided into two groups according to post-procedural 3D-quantitative coronary analysis (3DQCA): group OR (optimal result: stenosis < 50% of SB lumen area at 3DQCA) and group SR, suboptimal result: (stenosis ≥ 50% of SB lumen area at 3DQCA). Treadmill exercise stress test (EST) was performed within 1 week from PCI. The primary study endpoint was myocardial ischemia (≥1 mm ST-segment depression at EST). RESULTS: Sixty patients were enrolled: 49 (81.7%) comprised group OR and 11 (18.3%) group SR. Post-PCI myocardial ischemia at EST was inducible in 17 (34.7%) patients of group OR versus 10 (90.9%) patients of group SR (P = 0.0007). During the follow-up, patients of Group SR (vs. Group OR) had a significantly higher occurrence of inducible myocardial ischemia during late (>8 weeks) stress tests (P < 0.001). CONCLUSIONS: In patients with bifurcated lesions treated by a provisional-stenting technique, residual SB stenosis ≥ 50% at 3DQCA is associated with post-procedural inducible myocardial ischemia at EST.

Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study.

BACKGROUND: most of the studies assessing transradial approach for coronary angiography (CA) have been performed through right radial approach (RRA). Our aim was to evaluate the safety and efficacy of left radial approach (LRA) compared with RRA for coronary procedures. METHODS: from January 2009 to December 2009, in 2 hospitals, 1,540 patients were randomized to RRA (770 patients) or LRA (770 patients) for percutaneous coronary procedures. The primary end point was fluoroscopy time for CA and for percutaneous coronary intervention (PCI) evaluated independently. Prespecified subgroup analyses according to patient age and operator experience were planned. RESULTS: in 1,467 patients (732 RRA and 735 LRA), a CA (diagnostic group) was performed, and in 688 (344 each for RRA and LRA), a PCI. In the diagnostic group, LRA was associated with significantly lower fluoroscopy time (149 seconds, interquartile range [IQR] 95-270 seconds) and dose area product fluoroscopy (10.7 Gy cm(2), IQR 6-20.5 Gy cm(2)) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm(2), IQR 7-23.8 Gy cm(2), P = .004, respectively). In the PCI group, there were no significant differences in fluoroscopy time (614 seconds, IQR 367-1,087 seconds for LRA and 695 seconds, IQR 415-1,235 seconds, P = .087 for RRA) and dose area product fluoroscopy (53.7 Gy cm(2), IQR 29-101 Gy cm(2) for LRA and 63.1 Gy cm(2), IQR 31-119 Gy cm(2), P = .17 for RRA). According to subgroup analyses, the differences between LRA and RRA were confined to older patients (≥ 70 years old) and to operators in training. CONCLUSIONS: left radial approach for coronary diagnostic procedures is associated with lower fluoroscopy time and radiation dose adsorbed by patients compared with the RRA, particularly in older patients and for operators in training.

Pushing the limits forward: transradial superficial femoral artery stenting.

Percutaneous revascularization of superficial femoral artery (SFA) is increasingly carried out to treat patients with peripheral vascular disease and either intermittent claudication or critical limb ischemia. Transradial vascular access is increasingly adopted for invasive procedures due to reduced access-site complications and improved patient's comfort, compared with transfemoral. However, compared with coronary interventions, the adoption of transradial access in peripheral procedures is limited. Concerning SFA interventions, transradial access is usually prevented by the distance between the vascular access and the target lesion, which extends over the length of the currently available devices. Thanks to technical improvements, resulting in specifically dedicated low-profile equipment with adequate shaft length availability, transradial access is now feasible for the treatment of selected SFA lesions. We report the first two cases of SFA stenting performed by transradial access with a new specifically developed self-expanding nitinol stent with extended delivery system length. This report suggests that, with proper technique and specifically dedicated equipment, transradial SFA stenting is feasible. Treatment of SFA disease by transradial route, allowing for immediate post-procedure walking and simultaneous bilateral interventions, may represent an alternative for effective treatment of selected patients with SFA lesions.

Renal artery stenting in patients with chronic ischemic heart disease.

OBJECTIVES: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis. METHODS: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting. RESULTS: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis. CONCLUSIONS: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control.

Transradial approach to treat superficial femoral artery in-stent restenosis.

BACKGROUND: Transradial access reduces the incidence of access site complications of percutaneous revascularization procedures. However, in patients with peripheral vascular disease, the adoption of transradial approach for superficial femoral artery (SFA) angioplasty is usually prevented by the distance between the vascular access and the target lesions; thus, SFA angioplasty is commonly performed by transfemoral approach. Recently, low-profile balloons with extended shaft length became available, allowing to potentially address SFA lesions by transradial approach. As plain balloon angioplasty represents a valuable option for SFA in-stent restenosis treatment, we evaluated the feasibility of transradial approach in this clinical setting. METHODS: Transradial balloon angioplasty of SFA diffuse in-stent restenosis was attempted in 12 patients aged 69.4 +/- 5.1 years. Six-French 125 cm long MP guiding catheters, 300 cm long 0.018'' guidewire, and low-profile 4 Fr compatible 180 cm long shaft balloons (5 and 6 mm in diameter and 80-150 mm in length) were used. RESULTS: The procedural success was 100%, and no complications occurred during the hospital stay. Compared with a matched group of patients in whom angioplasty was performed by trans-femoral approach, main procedural key data resulted similar except for the amount of administered contrast dye, which was slightly but significantly lower in transradial group (170 +/- 59 ml vs. 241 +/- 103, P = 0.03). CONCLUSIONS: In conclusion, with the currently available equipment, the transradial approach is feasible and represents a valuable alternative for treatment of patients with SFA in-stent restenosis.

Transradial renal stenting: why and how.

Transradial vascular access for invasive procedures is gaining increasingly acceptance due to reduced access-site complications and improved patient's comfort compared with transfemoral. However, the adoption of transradial access in peripheral vascular procedures is actually limited by anatomical and technical considerations. Yet, among all the peripheral vascular districts, the renal one seems to be particularly suitable for transradial approach. In this article, we discuss the rationale for preferring the radial approach instead of femoral and review the specific technical issues related to transradial renal artery stenting (RAS).

Safety and feasibility of iliac endovascular interventions with a radial approach. Results from a multicenter study coordinated by the Italian Radial Force.

BACKGROUND: Percutaneous angioplasty of lower limb disease is commonly performed with a transfemoral access. In the coronary field, a transradial approach has shown to reduce access-site bleeding and adverse clinical events. This route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. In this study we sought to evaluate the feasibility and safety of this approach for iliac interventions. METHODS: Multicenter study was performed at high-volume centers with experience in transradial percutaneous interventions. Primary endpoint of the study was procedural success; secondary endpoints included in-hospital bleeding, 1-month freedom from adverse events and the rate of radial occlusion. Feasibility of this technique was evaluated by recording procedural and fluoroscopy time and contrast load. RESULTS: A total of 149 patients from 5 centers were enrolled. The population had a medium risk profile, with 48% of patients having TASC 2 or 3 lesions. Procedural success was achieved in 98.7% of the population, and we did not register in-hospital complications, including both vascular access site and procedural-related complications. An ancillary transfemoral approach was used in 13% of patients. One-month freedom from symptoms was achieved in 97.3% of patients, and the rate of radial occlusion was 2.7%. Major determinants of an unsuccessful procedure were the use of normal 6 or 7-Fr introducer with guiding catheter, TASC D lesion attempt, lesion length>30 mm and total occlusion. CONCLUSIONS: A transradial approach for iliac disease may be a feasible and safe alternative to the transfemoral route in experienced hands, in the light of significant technical improvements and dedicated devices.