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Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry

Daugherty, Stacie L; Thompson, Lauren E; Kim, Sunghee; Rao, Sunil V; Subherwal, Sumeet; Tsai, Thomas T; Messenger, John C; Masoudi, Frederick A
OBJECTIVES/OBJECTIVE:This study sought to compared the use and effectiveness of bleeding avoidance strategies (BAS) by sex. BACKGROUND:Women have higher rates of bleeding following percutaneous coronary intervention (PCI). METHODS:Among 570,777 men (67.5%) and women (32.5%) who underwent PCI in the National Cardiovascular Data Registry's CathPCI Registry between July 1, 2009 and March 31, 2011, in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radial approach, and their combinations) were assessed. The relative risk of bleeding for each BAS compared with no BAS was determined in women and men using multivariable logistic regressions adjusted for clinical characteristics and the propensity for receiving BAS. Finally, the absolute risk differences in bleeding associated with BAS were compared. RESULTS:Overall, the use of any BAS differed slightly between women and men (75.4% vs. 75.7%, p = 0.01). When BAS was not used, women had significantly higher rates of bleeding than men (12.5% vs. 6.2%, p < 0.01). Both sexes had similar adjusted risk reductions of bleeding when any BAS was used (women, odds ratio: 0.60, 95% confidence interval [CI]: 0.57 to 0.63; men, odds ratio: 0.62, 95% CI: 0.59 to 0.65). Women and men had lower absolute bleeding risks with BAS; however, these absolute risk differences were greater in women (6.3% vs. 3.2%, p < 0.01). CONCLUSIONS:Women continue to have almost twice the rate of bleeding following PCI. The use of any BAS was associated with a similarly lower risk of bleeding for men and women; however, the absolute risk differences were substantially higher in women. These data underscore the importance of applying effective strategies to limit post-PCI bleeding, especially in women.
PMCID:3667414
PMID: 23524046
ISSN: 1558-3597
CID: 5223672

Ischemia-driven revascularization: demonstrating and delivering a mature procedure in a mature way [Comment]

Patel, Manesh R; Rao, Sunil V
PMID: 23674312
ISSN: 1941-7705
CID: 5223702

Incorporation of bleeding as an element of the composite end point in clinical trials of antithrombotic therapies in patients with non-ST-segment elevation acute coronary syndrome: validity, pitfalls, and future approaches

Subherwal, Sumeet; Ohman, E Magnus; Mahaffey, Kenneth W; Rao, Sunil V; Alexander, John H; Wang, Tracy Y; Alexander, Karen P; Hasselblad, Vic; Roe, Matthew T
With the large number of antithrombotic therapies available and under investigation for the treatment of non-ST-segment elevation acute coronary syndromes (NSTE ACS), practice guidelines now stress the importance of selecting an antithrombotic strategy according to the efficacy and safety profiles of the chosen agent. Contemporary trials have incorporated bleeding along with ischemic end points into a composite end point commonly referred to as net clinical benefit, which allows for simultaneous evaluation of the differences between benefit and harm for an investigational antithrombotic therapy. However, incorporating major bleeding into a composite end point that includes ischemic events is not warranted and is associated with many pitfalls. In this article, we discuss the validity of combining efficacy and safety end points to form a net clinical benefit composite end point with the traditional time-to-event analysis for trials evaluating antithrombotic therapies for NSTE ACS. We describe alternative statistical approaches for concurrent assessment of the safety and efficacy of antithrombotic therapies used to treat patients with NSTE ACS.
PMID: 23622901
ISSN: 1097-6744
CID: 5223692

Acute coronary syndromes: Blood transfusion in patients with acute MI and anaemia

Sherwood, Matthew W; Rao, Sunil V
In a meta-analysis of predominantly observational data, blood transfusion was independently associated with adverse outcomes in patients with myocardial infarction. These findings are consistent with previously published research, but clinical application of these data is hindered by the lack of prospective, randomized trials and the inherent bias in observational studies.
PMCID:3924319
PMID: 23380974
ISSN: 1759-5010
CID: 5223612

Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy

Klutstein, Marc W; Westerhout, Cynthia M; Armstrong, Paul W; Giugliano, Robert P; Lewis, Basil S; Gibson, C Michael; Lutchmedial, Sohrab; Widimsky, Petr; Steg, P Gabriel; Dalby, Anthony; Zeymer, Uwe; Van de Werf, Frans; Harrington, Robert A; Newby, L Kristin; Rao, Sunil V
BACKGROUND:Bleeding is a major limitation of antithrombotic therapy among invasively managed non-ST-segment elevation acute coronary syndromes (NSTE-ACS) patients; therefore, we examined the use of radial access and its association with outcomes among NSTE-ACS patients. METHODS:Clinical characteristics and geographic variation in radial access were examined, as well as its association with bleeding, red blood cell transfusion and ischemic outcomes (96-hour death/myocardial infarction/recurrent ischemic/thrombotic bailout; 30-day death/myocardial infarction; 1-year death) in the EARLY versus delayed, provisional eptifibatide in acute coronary syndromes trial. RESULTS:Of 9126 patients, 13.5% underwent radial-access catheterization. Female sex, age, weight, and prior revascularization were inversely associated with radial access, and its use varied widely by country (2%-97%). There were fewer GUSTO severe/moderate bleeds and red blood cell transfusions in the radial access group; however, it was attenuated after adjustment (odds ratio 0.73, 95% confidence intervals [CI] [0.50-1.06], P = .094 and 1.00 [0.71-1.40] P = .991). Ischemic outcomes did not differ by access site. CONCLUSIONS:In this post hoc analysis of a large clinical trial, there was significant international variation in use of radial access for NSTE-ACS patients undergoing invasive management, and it was preferentially used in those at lower risk for bleeding. Radial approach was not associated with a significant reduction in either bleeding or ischemic outcomes. Further study is needed to determine whether wider application of radial approach to acute coronary syndrome patients at high risk for bleeding improves overall outcomes.
PMID: 23537976
ISSN: 1097-6744
CID: 5223682

Association between bleeding events and in-hospital mortality after percutaneous coronary intervention

Chhatriwalla, Adnan K; Amin, Amit P; Kennedy, Kevin F; House, John A; Cohen, David J; Rao, Sunil V; Messenger, John C; Marso, Steven P
IMPORTANCE/OBJECTIVE:Bleeding is the most common complication after percutaneous coronary intervention (PCI) and is associated with increased morbidity and health care costs. The incidence of bleeding-related mortality after PCI has not been described in a nationally representative population. Furthermore, the relationships among bleeding risk, bleeding site, and mortality are unclear. OBJECTIVES/OBJECTIVE:To describe the association between bleeding events and in-hospital mortality after PCI and to estimate the adjusted population attributable risk (estimated as the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. DESIGN, SETTING, AND PATIENTS/METHODS:Data from 3,386,688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the NNH for bleeding-related mortality, a propensity-matched analysis was performed. MAIN OUTCOME MEASURES/METHODS:In-hospital mortality. RESULTS:There were 57,246 bleeding events (1.7%) and 22,165 in-hospital deaths (0.65%) in 3,386,688 PCI procedures. The adjusted population attributable risk for mortality related to major bleeding was 12.1% (95% CI, 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56,078 procedures with a major bleeding event and 224 312 controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs 1.87%; risk difference, 3.39% [95% CI, 3.20%-3.59%]; NNH = 29 [95% CI, 28-31]; P < .001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs 0.17%; risk difference, 1.45% [95% CI, 1.13%-1.77%], NNH = 69 [95% CI, 57-88], P < .001; intermediate: 3.27% vs 0.71%; risk difference, 2.56% [95% CI, 2.33%-2.79%], NNH = 39 [95% CI, 36-43], P < .001; and high: 8.16% vs 3.45%; risk difference, 4.71% [95% CI, 4.35%-5.07%], NNH = 21 [95% CI, 20-23], P < .001). Although both access-site and non-access-site bleeding were associated with increased in-hospital mortality (2.73% vs 1.87%; risk difference, 0.86% [95% CI, 0.66%-1.05%], NNH = 117 [95% CI, 95-151], P < .001; and 8.25% vs 1.87%; risk difference, 6.39% [95% CI, 6.04%-6.73%], NNH = 16 [95% CI, 15-17], P < .001, respectively), the NNH was lower for nonaccess bleeding. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.
PMID: 23483177
ISSN: 1538-3598
CID: 5223652

Improving outcomes in patients with cardiogenic shock: achieving more through less [Editorial]

Gilchrist, Ian C; Rao, Sunil V
PMID: 23453089
ISSN: 1097-6744
CID: 5223632

TransRadial Education and Therapeutics (TREAT): shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: a report from the Cardiac Safety Research Consortium

Hess, Connie N; Rao, Sunil V; Kong, David F; Miller, Julie M; Anstrom, Kevin J; Bertrand, Olivier F; Collet, Jean-Philippe; Effron, Mark B; Eloff, Benjamin C; Fadiran, Emmanuel O; Farb, Andrew; Gilchrist, Ian C; Holmes, David R; Jacobs, Alice K; Kaul, Prashant; Newby, L Kristin; Rutledge, David R; Tavris, Dale R; Tsai, Thomas T; White, Roseann M; Peterson, Eric D; Krucoff, Mitchell W
Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity and mortality. Periprocedural bleeding also represents the primary safety concern of concomitant antithrombotic therapies essential for PCI success. Use of radial access for PCI reduces procedural bleeding and hence may change the risk profile and net clinical benefit of these drugs. This new drug-device safety interaction creates opportunities to advance the safe and effective use of antithrombotic agents during PCI. In June 2010 and March 2011, leaders from government, academia, professional societies, device manufacturing, and pharmaceutical industries convened for 2 think tank meetings. Titled TREAT I and II, these forums examined approaches to improve the overall safety of PCI by optimizing strategies for antithrombotic drug use and radial artery access. This article summarizes the content and proceedings of these sessions.
PMCID:3886824
PMID: 23453103
ISSN: 1097-6744
CID: 5223642

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; Džavík, Vladimír; 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; Dzavík, Vladimír; 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