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Effect of radial versus femoral access on radiation dose and the importance of procedural volume: a substudy of the multicenter randomized RIVAL trial
Jolly, Sanjit S; Cairns, John; Niemela, Kari; Steg, Philippe Gabriel; Natarajan, Madhu K; Cheema, Asim N; Rao, Sunil V; Cantor, Warren J; DžavÃk, VladimÃr; Budaj, Andrzej; Sheth, Tej; Valentin, Vicent; Fung, Anthony; Widimsky, Petr; Ferrari, Emile; Gao, Peggy; Jedrzejowski, Barbara; Mehta, Shamir R
OBJECTIVES/OBJECTIVE:The authors sought to compare the radiation dose between radial and femoral access. BACKGROUND:Small trials have shown an increase in the radiation dose with radial compared with femoral access, but many were performed during the operators' learning curve of radial access. METHODS:Patients were randomized to radial or femoral access, as a part of the RIVAL (RadIal Vs. femorAL) trial (N = 7,021). Fluoroscopy time was prospectively collected in 5740 patients and radiation dose quantified as air kerma in 1,445 patients and dose-area product (DAP) in 2,255 patients. RESULTS:Median fluoroscopy time was higher with radial versus femoral access (9.3 vs. 8.0 min, p < 0.001). Median air kerma was nominally higher with radial versus femoral access (1,046 vs. 930 mGy, respectively, p = 0.051). Median DAP was not different between radial and femoral access (52.8 Gy-cm(2) vs. 51.2 Gy·cm(2), p = 0.83). When results are stratified according to procedural volume, air kerma was increased only in the lowest tertile of radial volume centers (low 1,425 vs. 1,045 mGy, p = 0.002; middle 987 vs. 958 mGy, p = 0.597; high 652 vs. 621 mGy, p = 0.403, interaction p = 0.026). Multivariable regression showed procedural volume was the greatest independent predictor of lower air kerma dose (ratio of geometric means 0.55; 95% confidence interval 0.49 to 0.61 for highest-volume radial centers). CONCLUSIONS:Radiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators. High-volume centers have the lowest radiation dose irrespective of which access site approach that they use. (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).
PMID: 23517837
ISSN: 1876-7605
CID: 5223662
An international survey of clinical practice during primary percutaneous coronary intervention for ST-elevation myocardial infarction with a focus on aspiration thrombectomy
Russo, Juan J; DzavÃk, VladimÃr; Cairns, John A; Rao, Sunil V; Niemelä, Kari O; Natarajan, Madhu K; Bertrand, Olivier F; Eskola, Markku; Welsh, Robert; Maciejewski, Pawel; Cheema, Asim N; Fung, Anthony; Cantor, Warren J; Lavi, Shahar; Widimsky, Petr; Jolly, Sanjit S
AIMS/OBJECTIVE:Data suggest that there is a variable use of thrombectomy during primary percutaneous coronary interventions (PPCI). We sought to evaluate practices during PPCI for ST-elevation myocardial infarction (STEMI), including the use of aspiration thrombectomy, and to determine the feasibility of conducting a definitive aspiration thrombectomy trial. METHODS AND RESULTS/RESULTS:A 27-item online survey was distributed to 1,607 interventional cardiologists internationally. A total of 461 responses were received. During PPCI, aspiration thrombectomy is used routinely by 36% of respondents, and selectively by 60%. Twenty-five percent of respondents reported experiencing a complication related to thrombectomy including: vessel dissection (13%), bringing thrombus back into left main coronary artery from target vessel (5%), stroke or transient ischaemic attack (2%), and coronary artery perforation (1%). The vast majority of respondents (89%) believe that a confirmatory aspiration thrombectomy trial is needed and 85% would be willing to randomise patients in such a trial. CONCLUSIONS:The majority of interventional cardiologists surveyed are not using thrombectomy routinely during PPCI. The survey results suggest that a large, confirmatory thrombectomy trial is needed and feasible in the current era. The survey also highlights a significant level of variability and underutilisation of other evidence-based therapies during PPCI.
PMID: 23425540
ISSN: 1969-6213
CID: 5223622
Association of systemic lupus erythematosus with angiographically defined coronary artery disease: a retrospective cohort study
Kaul, Mala S; Rao, Sunil V; Shaw, Linda K; Honeycutt, Emily; Ardoin, Stacy P; St Clair, E William
OBJECTIVE:To determine if systemic lupus erythematosus (SLE) is associated with a higher prevalence of coronary artery disease (CAD) in select patients undergoing coronary angiography. We compared the extent of angiographic abnormalities, CAD risk factors, and all-cause mortality in SLE patients with non-SLE controls. METHODS:We identified SLE patients (n = 86) and controls matched by sex and year of cardiac catheterization (n = 258) undergoing cardiac catheterization for the evaluation of CAD (median followup duration of 4.3 years). Multivariable logistic regression was used to determine if SLE was associated with obstructive CAD, defined as ≥70% stenosis in a major epicardial coronary artery. Risk-adjusted survival differences between the 2 groups were assessed using Cox proportional hazards modeling. RESULTS:The SLE patients (85% women) were younger than the non-SLE patients (median age 49 years versus 70 years; P < 0.001) and were less likely to have diabetes mellitus and hyperlipidemia, but had similar rates of hypertension (70% versus 71%; P = 0.892). In unadjusted analyses, SLE and non-SLE patients had similar rates of obstructive CAD by angiography (52% versus 62%; overall P = 0.11). After adjustment for known CAD risk factors, SLE was associated with a significantly increased likelihood of CAD (odds ratio 2.24 [95% confidence interval (95% CI) 1.08-4.67]). SLE was also associated with a nonsignificant increase in all-cause mortality (hazard ratio 1.683 [95% CI 0.98-2.89], P = 0.060). CONCLUSION/CONCLUSIONS:In this selected population, SLE was significantly associated with the presence of CAD as defined by coronary angiography, the gold standard for assessing flow-limiting lesions in this disease. The patients with SLE showed a similar severity of CAD as the controls despite having less than half the rate of diabetes mellitus and being 20 years younger.
PMCID:3496832
PMID: 22745037
ISSN: 2151-4658
CID: 5223502
Same-day discharge compared with overnight hospitalization after uncomplicated percutaneous coronary intervention: a systematic review and meta-analysis
Abdelaal, Eltigani; Rao, Sunil V; Gilchrist, Ian C; Bernat, Ivo; Shroff, Adhir; Caputo, Ronald; Costerousse, Olivier; Pancholy, Samir B; Bertrand, Olivier F
OBJECTIVES/OBJECTIVE:This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON). BACKGROUND:Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent. METHODS:The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI. RESULTS:A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI. CONCLUSIONS:There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (>17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients.
PMID: 23352820
ISSN: 1876-7605
CID: 5223602
The prevalence and outcomes of transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction: analysis from the National Cardiovascular Data Registry (2007 to 2011)
Baklanov, Dmitri V; Kaltenbach, Lisa A; Marso, Steven P; Subherwal, Sumeet S; Feldman, Dmitriy N; Garratt, Kirk N; Curtis, Jeptha P; Messenger, John C; Rao, Sunil V
OBJECTIVES/OBJECTIVE:The purpose of this study was to examine use and describe outcomes of radial access for percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND:Transradial PCI (TRI) is associated with reduced risk of bleeding and vascular complications, as compared with femoral access PCI (FPCI). Studies have suggested that TRI may reduce mortality among patients with STEMI. METHODS:We examined 294,769 patients undergoing PCI for STEMI at 1,204 hospitals in the CathPCI Registry between 2007 and 2011. Patients were grouped according to access site used for PCI. The temporal trend in the rate of radial versus femoral approach was determined. For minimization of confounding, an inverse probability weighting analysis incorporating propensity scores was used to compare procedural success, post-PCI bleeding, door-to-balloon times, and in-hospital mortality between radial and femoral access. RESULTS:Over the 5-year period, the use of TRI versus FPCI in STEMI increased from 0.9% to 6.4% (p < 0.0001). There was no difference in procedural success. TRI was associated with longer median door-to-balloon time (78 vs. 74 min; p < 0.0001) but lower adjusted risk of bleeding (odds ratio [OR]: 0.62; 95% CI: 0.53 to 0.72; p < 0.0001) and lower adjusted risk of in-hospital mortality (OR: 0.76; 95% CI: 0.57 to 0.99; p = 0.0455). CONCLUSIONS:In this large national database, use of radial access for PCI in STEMI increased over the study period. Despite longer door-to-balloon times, the radial approach was associated with lower bleeding rate and reduced in-hospital mortality. These data provide support to execute an adequately powered randomized controlled trial comparing radial and femoral approaches for PCI in STEMI.
PMID: 23265340
ISSN: 1558-3597
CID: 5223592
Radial First: Paradox plus Proficiency=Opportunity [Editorial]
Rao, Sunil V.; Krucoff, Mitchell W.
ISI:000326340100030
ISSN: 2047-9980
CID: 5226362
Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation
Mehta, Shamir R; Jolly, Sanjit S; Cairns, John; Niemela, Kari; Rao, Sunil V; Cheema, Asim N; Steg, Philippe Gabriel; Cantor, Warren J; DžavÃk, VladimÃr; Budaj, Andrzej; Rokoss, Michael; Valentin, Vicent; Gao, Peggy; Yusuf, Salim
OBJECTIVES/OBJECTIVE: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).
PMID: 23103036
ISSN: 1558-3597
CID: 5223582
Short- and long-term outcomes of coronary stenting in women versus men: results from the National Cardiovascular Data Registry Centers for Medicare & Medicaid services cohort
Anderson, Monique L; Peterson, Eric D; Brennan, J Matthew; Rao, Sunil V; Dai, David; Anstrom, Kevin J; Piana, Robert; Popescu, Andra; Sedrakyan, Art; Messenger, John C; Douglas, Pamela S
BACKGROUND:Conflicting evidence exists on sex-based outcomes after coronary stenting. METHODS AND RESULTS/RESULTS:Data on 426 996 patients ≥65 years old (42.3% women) from the National Cardiovascular Data Registry CathPCI Registry (2004-2008) were linked to Medicare inpatient claims to compare in-hospital outcomes by sex and long-term outcomes by sex and stent type. In-hospital complications were more frequent in women than in men: death (3869 [2.2%] versus 3737 [1.6%]; adjusted odds ratio, 1.41; 95% confidence interval [CI], 1.33-1.49), myocardial infarction (2365 [1.3%] versus 2858 [1.2%]; odds ratio, 1.19; 95% CI, 1.11-1.27), bleeding (7860 [4.4%] versus 5627 [2.3%]; odds ratio, 1.86; 95% CI, 1.79-1.93), and vascular complications (2381 [1.3%] versus 1648 [0.7%]; odds ratio, 1.85; 95% CI, 1.73-1.99). At 20.4 months, women had a lower adjusted risk of death (hazard ratio [HR], 0.92; 95% CI, 0.90-0.94) but similar rates of myocardial infarction, revascularization, and bleeding. Relative to bare metal stent use, drug-eluting stent use was associated with similar improved long-term outcomes in both sexes: death (women: adjusted HR, 0.78; 95% CI, 0.76-0.81; men: HR, 0.77; 95% CI, 0.74-0.79), myocardial infarction (women: HR, 0.79; 95% CI, 0.74-0.84; men: HR, 0.81; 95% CI, 0.77-0.85), and revascularization (women: HR, 0.93; 95% CI, 0.90-0.97; men: HR, 0.91; 95% CI, 0.88-0.94). There was no interaction between sex and stent type for long-term outcomes. CONCLUSIONS:In contemporary coronary stenting, women have a slightly higher procedural risk than men but have better long-term survival. In both sexes, use of a drug-eluting stent is associated with lower long-term likelihood for death, myocardial infarction, and revascularization.
PMID: 22988009
ISSN: 1524-4539
CID: 5223562
Clinical update: Remaining challenges and opportunities for improvement in percutaneous transradial coronary procedures
Rao, Sunil V; Bernat, Ivo; Bertrand, Olivier F
The adoption of transradial coronary angiography and coronary intervention is growing because of emerging data on its potential advantages over the femoral approach. As the adoption of radial procedures increases, it is important to understand the remaining challenges of both the technique and its implementation. In this review, we discuss four important issues related to transradial procedures--radial access site bleeding, radial artery injury and occlusion, radiation exposure, and implementation of a successful transradial primary percutaneous coronary intervention (PCI) programme. Although the radial artery is superficial and haemostasis can be achieved readily, access site bleeding can occur that, if left unchecked, can lead to forearm haematoma and, rarely, to compartment syndrome. Radial artery injury and occlusion are consequences of radial access, and randomized trials show that use of smaller diameter sheaths, adequate anticoagulation, and post-procedure 'patent' haemostasis reduce the risk of occlusion. The published literature demonstrates an association between transradial procedures and increased radiation exposure; therefore, reduction of radiation dosing during transradial procedures should be a priority for operators and catheterization laboratories. The potential reduction in mortality seen with transradial primary PCI must be balanced against the clinical imperative of timely reperfusion. Operators and catheterization laboratories should not begin a transradial primary PCI programme until sufficient radial experience has been gained in the elective setting. In addition, a protocol for femoral bailout should be considered to maintain door-to-reperfusion metrics.
PMID: 22815330
ISSN: 1522-9645
CID: 5223532
Clinical expert consensus statement on best practices in the cardiac catheterization laboratory: Society for Cardiovascular Angiography and Interventions
Naidu, Srihari S; Rao, Sunil V; Blankenship, James; Cavendish, Jeffrey J; Farah, Tony; Moussa, Issam; Rihal, Charanjit S; Srinivas, Vankeepuram S; Yakubov, Steven J
PMID: 22434598
ISSN: 1522-726x
CID: 5051942