Objectives The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with ...non–ST-segment elevation acute coronary syndrome (NSTEACS). Background The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI. Methods We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed. Results Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non–coronary artery bypass graft–related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio HR: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041). Conclusions In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives This study sought to evaluate the feasibility of performing contemporary bifurcation techniques with the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular, Santa ...Clara, California) (BVS). Background The feasibility of using the BVS in bifurcation lesions is unknown. Methods We performed bifurcation stenting procedures including main-vessel stenting with ballooning of the side branch through the BVS struts, T-stenting and crush and culotte procedures, in a synthetic arterial model. Low-pressure final kissing balloon (FKB) inflation was performed to complete the procedures. Results Single-stent procedures optimally opened the side-branch ostium without deforming the main vessel BVS. T-stenting completely covered the side-branch ostium. In crush cases, we could easily re-cross the crushed BVS with the wire and balloon and achieve good results after deployment of the main-vessel BVS and FKB inflation. A 2-BVS culotte resulted in good paving of the main vessel. Disruption of 1 BVS strut was observed after FKB inflation with the 2 balloons inflated beyond the recommended limit of the BVS, as calculated by Finet's law. Conclusions Intervention of bifurcation lesions using the Absorb BVS using modern bifurcation techniques appears feasible in a coronary bifurcation model. Provisional stenting is recommended in the majority, with sequential balloon inflations and FKB inflation only when necessary. T or T-stenting and small protrusion stenting with a metal drug-eluting stent is preferable in case of crossover. A 2-BVS, T-stent technique can be performed in a high-angle bifurcation; otherwise, crush or culotte should be considered, using metal DES in the side branch. Two-BVS crush and culotte require careful evaluation, and should only be considered in patients with large-caliber main vessels.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy ...and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization. Methods and Results The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients <75 years of age (1.0% vs 3.2%; P < .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P < .001) and <75 (6.7% vs 1.9%; P < .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3). Conclusions Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to ...embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Studies evaluating the efficacy and safety of the transradial approach for percutaneous coronary intervention (PCI) were carried out mainly before the widespread use of stents and ...glycoprotein (GP) IIb/IIIa inhibitors. We sought to determine the association between the choice of the vascular access site and procedural complications after PCI performed with routine stenting and GP IIb/IIIa inhibition. Methods The data source was a prospective registry of 13,499 consecutive cases of PCI at the University Health Network, Toronto, Canada, from April 2000 to September 2006. Logistic regression was used to calculate the probability of selection to the radial access group. Using propensity score methodology, 3,198 patients with femoral access were randomly matched to 3,198 patients with radial access based on clinical, angiographic, and procedural characteristics. Multivariable logistic regression analysis was used to identify the independent predictors of access site–related complications. Major adverse cardiac event was defined as death, myocardial infarction, abrupt vessel closure, or coronary artery bypass surgery. Results Use of the transradial approach was associated with fewer vascular access complications (1.5% vs 0.6%, P < .001) and a shorter length of hospital stay. Multivariable analysis revealed transradial access (OR 0.39, 95% CI 0.2-0.7) to be an independent predictor of lower risk, whereas primary PCI (OR 4.36, 95% CI 1.4, 13), recent myocardial infarction (OR 2.0 95% CI 1.2, 3.4), age (per 10 years increase: OR 1.37, 95% CI 1.1-1.7) and female gender (0R 2.78 95% CI 1.7, 4.6) were independent predictors of a higher risk of access site complications. Conclusions Use of transradial access for PCI is safe and is independently associated with a reduced rate of in-hospital access site complications and reduced length of hospital stay.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting ...stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES). Methods The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non–insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year. Results Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; Psuperiority = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES ( P = .11). Conclusion In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Benchmarking the performance of providers is an increasing priority in many health care economies. In-hospital mortality represents an important and uniformly assessed measure on which to ...examine the outcome of percutaneous coronary intervention (PCI). Most existing prediction models of in-hospital mortality after PCI were derived from 1990s data, and their current relevance is uncertain. Methods From consecutive PCIs performed during 2000-2008, derivation and validation cohorts of 10,694 and 5,347 patients, respectively, were analyzed. Logistic regression for in-hospital death yielded integer risk weights for each independent predictor variable. These were summed for each patient to create the Toronto PCI risk score. Results Death occurred in 1.3% of patients. Independent predictors with associated risk weights in parentheses were as follows: age 40 to 49 y (1), 50 to 59 y (2), 60 to 69 y (3), 70 to 79 y (4), and ≥80 y (5); diabetes (2); renal insufficiency (2); New York Heart Association class 4 (3); left ventricular ejection fraction <20% (3); myocardial infarction in the previous month (3); multivessel disease (1); left main disease (2); rescue or facilitated PCI (3); primary PCI (4); and shock (6). The model had a receiver operator curve of 0.96 and Hosmer-Lemeshow goodness-of-fit P = .16 in the validation set. Four previously published external models were tested in the entire data set. Three models had ROC curves significantly less than the Toronto PCI score, and all 4 showed significant levels of imprecision. Conclusions The Toronto PCI mortality score is an accurate and contemporary predictive tool that permits evaluation of risk-stratified outcomes and aids counseling of patients undergoing PCI.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Pol ish B ifurcation O ptimal S tenting I (POLBOS I) trial was to compare ...bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes. Methods Between October 2010 and January 2013 patients with stable coronary artery disease or non–ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. Results The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% ( P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05). Conclusions MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background Radial artery occlusion occurs after transradial cardiac catheterization or percutaneous coronary intervention. Although use of a sheath larger than the artery is a risk factor ...for radial artery occlusion, radial artery size is not routinely measured. We aimed to identify bedside predictors of radial artery diameter. Methods Using ultrasound, we prospectively measured radial, ulnar, and brachial artery diameters of 130 patients who presented for elective percutaneous coronary intervention or diagnostic angiography. Using prespecified candidate variables we used multivariable linear regression to identify predictors of radial artery diameter. Results Mean internal diameters of the right radial, ulnar, and brachial arteries were 2.44 ± 0.60, 2.14 ± 0.53, and 4.50 ± 0.88 mm, respectively. Results for the left arm were similar. The right radial artery was larger in men than in women (2.59 vs 1.91 mm; P < 0.001) and smaller in patients of South Asian descent (2.00 vs 2.52 mm; P < 0.001). Radial artery diameter correlated with wrist circumference ( r2 = 0.26; P < 0.001) and shoe size ( r2 = 0.25; P < 0.001) and weakly correlated with height ( r2 = 0.14; P < 0.001), weight ( r2 = 0.18; P < 0.001), body mass index ( r2 = 0.07; P = 0.002), and body surface area ( r2 = 0.22; P < 0.001). The independent predictors of a larger radial artery were wrist circumference ( r2 = 0.26; P < 0.001), male sex ( r2 = 0.06; P < 0.001), and non-South Asian ancestry ( r2 = 0.05; P = 0.006; final model r2 = 0.37; P < 0.001). A risk score using these variables predicted radial artery diameter (c-statistic, 0.71). Conclusions Wrist circumference, male sex, and non-South Asian ancestry are independent predictors of increased radial artery diameter. A risk score using these variables can identify patients with small radial arteries.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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