Tejas Patel

Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization.

Objective: The objective of this study was to evaluate the efficacy of hemostasis with patency in avoiding radial artery occlusion after transradial catheterization. Background: Radial artery occlusion is an infrequent but discouraging complication of transradial access. It is related to factors such as sheath to artery ratio and is less common in patients receiving heparin. Despite being clinically silent in most cases, it limits future transradial access. Patients and Methods: Four hundred thirty‐six consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. Two hundred nineteen patients were randomized to group I, and underwent conventional pressure application for hemostasis. Two hundred seventeen patients were randomized to group II and underwent pressure application confirming radial artery patency using Barbeaus test. Radial artery patency was studied at 24 hr and 30 days using Barbeaus test. Results: Thirty‐eight patients had evidence of radial artery occlusion at 24 hr. Twenty patients had persistent evidence of radial artery occlusion at 1 month. Group II, with documented patency during hemostatic compression, had a statistically and clinically lower incidence of radial artery occlusion (59% decrease at 24 hr and 75% decrease at 30 days, P < 0.05), compared with patients in group I. Low body weight patients were at significantly higher risk of radial artery occlusion. No procedural variables were found to be associated with radial artery occlusion. Conclusion: Patent hemostasis is highly effective in reducing radial artery occlusion after radial access and guided compression should be performed to maintain radial artery patency at the time of hemostasis, to prevent future radial artery occlusion.

Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology

Radial access use has been growing steadily but, despite encouraging results, still varies greatly among operators, hospitals, countries and continents. Twenty years from its introduction, it was felt that the time had come to develop a common evidence-based view on the technical, clinical and organisational implications of using the radial approach for coronary angiography and interventions. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) has, therefore, appointed a core group of European and non-European experts, including pioneers of radial angioplasty and operators with different practices in vascular access supported by experts nominated by the Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology (ESC). Their goal was to define the role of the radial approach in modern interventional practice and give advice on technique, training needs, and optimal clinical indications.

Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI.

In response to growing U.S. interest, the Society for Coronary Angiography and Interventions recently formed a Transradial Committee whose purpose is to examine the utility, utilization, and training considerations related to transradial access for percutaneous coronary and peripheral procedures. With international partnership, the committee has composed a comprehensive overview of this subject presented herewith.

The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled.

AIMS The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population. METHODS AND RESULTS ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year. CONCLUSIONS This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Best practices for transradial angiography and intervention: a consensus statement from the society for cardiovascular angiography and intervention's transradial working group.

Duke University Medical Center, Durham, North Carolina Stanford University Medical Center, Palo Alto, California Penn State Hershey Medical Center, Hershey, Pennsylvania Brigham and Women’s Hospital, Boston, Massachusetts Mayo Clinic, Rochester, Minnesota University of Illinois at Chicago/Jesse Brown VA Medical Center, Chicago, Illinois First Coast Heart and Vascular Center, Jacksonville, Florida G.V. (Sonny) Montgomery VA Medical CenterJackson, Mississippi. Stern Cardiovascular Foundation, Memphis, Tennessee Reid Heart Center at FirstHealth of the Carolinas, Pinehurst, North Carolina Deborah Heart & Lung Institute, Browns Mills, New Jersey Duke University Medical Center, Durham, North Carolina Lahey Clinic, Burlington, Massachusetts Geisinger Medical Center, Danville, Pennsylvania Apex Heart Institute, Seth N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India The Wright Center for Graduate Medical Education, The Commonwealth Medical College, Scranton, Pennsylvania

Effect of duration of hemostatic compression on radial artery occlusion after transradial access

To evaluate the effect of duration of hemostatic compression on the incidence of radial artery occlusion (RAO) after transradial coronary intervention. Background: RAO occurs in 2–10% of patients after transradial access. The effect of duration of hemostatic compression on occurrence of RAO is unknown.

Radiation exposure in relation to the arterial access site used for diagnostic coronary angiography and percutaneous coronary intervention: a systematic review and meta-analysis

BACKGROUND Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). METHODS We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. FINDINGS Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference [WMD], fixed effect: 1·04 min, 95% CI 0·84-1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96-1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm(2), 95% CI -0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm(2), 95% CI 0·08-1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 μSv (SD 110) with transradial access and 74 μSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 μSv (17) with transradial access and 46 μSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs. INTERPRETATION Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. FUNDING None.

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

BACKGROUND The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. METHODS We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. RESULTS At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). CONCLUSIONS In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Histopathologic changes of the radial artery wall secondary to transradial catheterization

Objective: The immediate effects of transradial access on the radial artery wall are unknown. In this study we sought to assess the histological changes induced by catheterization on the radial artery. Methods: Thirty-four patients undergoing coronary artery bypass grafting (CABG) had radial arteries harvested to serve as bypass conduits. The proximal and distal ends of the radial artery conduits were sectioned and embedded in paraffin. Both ends of all specimens were evaluated by a blinded pathologist for intimal hyperplasia, medial inflammation, medial calcification, periarterial tissue or fat necrosis, adventitial inflammation, adventitial necrosis, and adventitial neovascularization. Fisher’s exact test was used for statistical analysis. Results: Fifteen previously catheterized radial arteries (TRA group) were compared with 19 noncatheterized arteries (NCA group). The distal ends of the TRA group showed significantly more intimal hyperplasia (73.3% vs 21.1%; p = 0.03), periarterial tissue or fat necrosis (26% vs 0%; p = 0.02), and more adventitial inflammation (33.3% vs 0%; p = 0.01) than the distal ends of the NCA group. The distal ends of the TRA group also showed significantly more intimal hyperplasia (73.3% vs 26.6%; p = 0.03) and adventitial inflammation (33.3% vs 0%; p = 0.01) than the proximal ends of the same arteries. There were no histological differences in the proximal ends of the two groups. Conclusion: Transradial catheterization induces significant histological changes suggestive of radial artery injury limited to the puncture site in the form of intimal hyperplasia, medial inflammation, and tissue necrosis. Both the proximal and distal ends of the radial artery show a spectrum of atherosclerotic changes independent of its use for transradial catheterization.

Comparison of door-to-balloon times for primary PCI using transradial versus transfemoral approach.

Objectives: The objective of this study was to compare door‐to‐balloon times and other variables in ST‐segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) using transfemoral or transradial approaches. Background: Transradial PCI has been shown to lower the risk of access site complications but the procedure is not applied to STEMI patients, due to concerns of procedural complexity adversely affecting prompt reperfusion. There is paucity of real‐world data comparing TRI with TFI in patients with STEMI. Methods: Three hundred sixteen consecutive patients with STEMI undergoing primary PCI were studied. Patients were divided in two groups, Group I (n = 204) undergoing PCI transfemorally and Group II (n = 109) patients transradially. Demographic data, door‐to‐balloon times, procedural variables, predischarge adverse events, access site complications, and 1 year follow‐up major adverse cardiac events (MACE) were recorded. Results: Door‐to‐balloon time was 72 ± 14 min in Group I compared with 70 ± 17 min in Group II, the difference was not statistically significant (t = 1.096, P > 0.27). Group II patients had significantly fewer access site complications compared with Group I (20 vs. 1 patient, χ2 = 10.8, P < 0.05). Demographics, predischarge adverse events, and MACE at 1 year follow‐up were comparable between the two groups. Conclusions: Transradial approach to primary PCI provides similar door‐to‐balloon times to transfemoral approach, and significantly lowers access site related complications, in patients presenting with STEMI.