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Reply: The Hidden Players [Comment]

Shah, Rahman; Rao, Sunil V
PMID: 27659579
ISSN: 1876-7605
CID: 5224802

SCAI expert consensus statement: 2016 best practices in the cardiac catheterization laboratory: (Endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologia intervencionista; Affirmation of value by the Canadian Association of interventional cardiology-Association canadienne de cardiologie d'intervention)

Naidu, Srihari S; Aronow, Herbert D; Box, Lyndon C; Duffy, Peter L; Kolansky, Daniel M; Kupfer, Joel M; Latif, Faisal; Mulukutla, Suresh R; Rao, Sunil V; Swaminathan, Rajesh V; Blankenship, James C
PMID: 27137680
ISSN: 1522-726x
CID: 5052282

A team-based approach to patients in cardiogenic shock

Doll, Jacob A; Ohman, E Magnus; Patel, Manesh R; Milano, Carmelo A; Rogers, Joseph G; Wohns, David H; Kapur, Navin K; Rao, Sunil V
Cardiogenic shock is a common clinical condition with high in-hospital mortality. Early application of appropriate interventions for cardiogenic shock-including medical therapies, revascularization, temporary hemodynamic support devices, and durable mechanical circulatory support-may improve outcomes. The number and complexity of therapies for cardiogenic shock are increasing, making time-dependent decision-making more challenging. A multidisciplinary cardiogenic shock team is recommended to guide the rapid and efficient use of these available treatments. © 2015 Wiley Periodicals, Inc.
PMID: 26526563
ISSN: 1522-726x
CID: 5224472

Blood Transfusion and the Risk of Acute Kidney Injury Among Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Karrowni, Wassef; Vora, Amit Navin; Dai, David; Wojdyla, Daniel; Dakik, Habib; Rao, Sunil V
BACKGROUND:Acute kidney injury (AKI) complicating percutaneous coronary intervention (PCI) is associated with adverse clinical outcomes. To date, no studies have evaluated the association of blood transfusion with AKI in patients undergoing PCI. METHODS AND RESULTS:We used a retrospective cohort study of all patients with acute coronary syndrome undergoing PCI from CathPCI Registry (n=1 756 864). The primary outcome was AKI defined as the rise in serum creatinine post procedure ≥0.5 mg/dL or ≥25% above baseline values. AKI developed in 9.0% of study sample. Patients with AKI were older, more often women, and had high prevalence of comorbidities, including diabetes mellitus, hypertension, and advanced stages of chronic kidney disease at baseline. Blood transfusion was utilized in 2.2% of patients. In the overall sample, AKI developed in 35.1% of patients who received transfusion versus 8.4% of patients without transfusion (adjusted odds ratio, 4.87 [4.71-5.04]). In the subgroup of patients who sustained bleeding event and received transfusion, the rate of AKI was significantly increased across all preprocedure hemoglobin levels versus no blood transfusion. Similar findings were seen in the subgroup of patients with no bleeding event. CONCLUSIONS:Blood transfusion is strongly associated with AKI in patients with acute coronary syndrome undergoing PCI. Further investigation is needed to determine whether a restrictive blood transfusion strategy might improve PCI outcomes by reducing the risk of AKI.
PMID: 27582110
ISSN: 1941-7632
CID: 5224772

Characteristics, treatment and in-hospital outcomes of patients with STEMI in a metropolitan area of a developing country: an initial report of the extended Jakarta Acute Coronary Syndrome registry

Dharma, Surya; Andriantoro, Hananto; Purnawan, Ismi; Dakota, Iwan; Basalamah, Faris; Hartono, Beny; Rasmin, Ronaly; Isnanijah, Herawati; Yamin, Muhammad; Wijaya, Ika Prasetya; Pratama, Vireza; Gunarto, Tjatur Bagus; Juwana, Yahya Berkahanto; Suling, Frits R W; Witjaksono, A M Onny; Lasanudin, Hengkie F; Iskandarsyah, Kurniawan; Priatna, Hardja; Tedjasukmana, Pradana; Wahyumandradi, Uki; Kosasih, Adrianus; Budhiarti, Imelda A; Pribadi, Wisnoe; Wirianta, Jeffrey; Lubiantoro, Utojo; Pramesti, Rini; Widowati, Diah Retno; Aminda, Sissy Kartini; Basalamah, M Abas; Rao, Sunil V
OBJECTIVE:We studied the characteristics of patients with ST segment elevation myocardial infarction (STEMI) after expansion of a STEMI registry as part of the STEMI network programme in a metropolitan city and the surrounding area covering ∼26 million inhabitants. DESIGN:Retrospective cohort study. SETTING:Emergency department of 56 health centres. PARTICIPANTS:3015 patients with acute coronary syndrome, of which 1024 patients had STEMI. MAIN OUTCOME MEASURE:Characteristics of reperfusion therapy. RESULTS:The majority of patients with STEMI (81%; N=826) were admitted to six academic percutaneous coronary intervention (PCI) centres. PCI centres received patients predominantly (56%; N=514) from a transfer process. The proportion of patients receiving acute reperfusion therapy was higher than non-reperfused patients (54% vs 46%, p<0.001), and primary PCI was the most common method of reperfusion (86%). The mean door-to-device (DTD) time was 102±68 min. In-hospital mortality of non-reperfused patients was higher than patients receiving primary PCI or fibrinolytic therapy (9.1% vs 3.2% vs 3.8%, p<0.001). Compared with non-academic PCI centres, patients with STEMI admitted to academic PCI centres who underwent primary PCI had shorter mean DTD time (96±44 min vs 140±151 min, p<0.001), higher use of manual thrombectomy (60.2% vs13.8%, p<0.001) and drug-eluting stent implantation (87% vs 69%, p=0.001), but had similar use of radial approach and intra-aortic balloon pump (55.7% vs 67.2%, and 2.2% vs 3.4%, respectively). In patients transferred for primary PCI, TIMI risk score ≥4 on presentation was associated with a prolonged door-in to door-out (DI-DO) time (adjusted OR 2.08; 95% CI 1.09 to 3.95, p=0.02). CONCLUSIONS:In the expanded JAC registry, a higher proportion of patients with STEMI received reperfusion therapy, but 46% still did not. In developing countries, focusing the prehospital care in the network should be a major focus of care to improve the DI-DO time along with improvement of DTD time at PCI centres. TRIAL REGISTRATION NUMBER:NCT02319473.
PMID: 27580835
ISSN: 2044-6055
CID: 5224762

Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction

Rao, Sunil V; Zeymer, Uwe; Douglas, Pamela S; Al-Khalidi, Hussein; White, Jennifer A; Liu, Jingyu; Levy, Howard; Guetta, Victor; Gibson, C Michael; Tanguay, Jean-Francois; Vermeersch, Paul; Roncalli, Jérôme; Kasprzak, Jaroslaw D; Henry, Timothy D; Frey, Norbert; Kracoff, Oscar; Traverse, Jay H; Chew, Derek P; Lopez-Sendon, Jose; Heyrman, Reinilde; Krucoff, Mitchell W
BACKGROUND:Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES:This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months. METHODS:In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months. RESULTS:In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37). CONCLUSIONS:Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563).
PMID: 27515331
ISSN: 1558-3597
CID: 5224732

The Fuzzy Math of Anticoagulation and Access Site: When 1 + 1 Does Not Always Equal 2 [Comment]

Rao, Sunil V; Shah, Rahman
PMID: 27491602
ISSN: 1876-7605
CID: 5224722

Arterial access site and outcomes in patients undergoing percutaneous coronary intervention with and without vorapaxar

Déry, Jean-Pierre; Mahaffey, Kenneth W; Tricoci, Pierluigi; White, Harvey D; Podder, Mohua; Westerhout, Cynthia M; Moliterno, David J; Harrington, Robert A; Chen, Edmond; Strony, John; Van de Werf, Frans; Ziada, Khaled M; Held, Claes; Aylward, Philip E; Armstrong, Paul W; Rao, Sunil V
OBJECTIVES/OBJECTIVE:We evaluated outcomes associated with transradial vs. transfemoral approaches and vorapaxar in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in the TRACER trial. BACKGROUND:Vorapaxar reduces ischemic events but increases the risk of major bleeding. METHODS:We compared 30-day and 2-year major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization) and noncoronary artery bypass graft (CABG)-related bleedings in 2,192 transradial and 4,880 transfemoral patients undergoing PCI after adjusting for confounding variables, including propensity for transradial access. RESULTS:Overall, 30-day GUSTO moderate/severe and non-CABG TIMI major/minor bleeding occurred less frequently in transradial (0.9% vs. 2.0%, P = 0.001) vs. transfemoral (1.1% vs. 2.5%, P = 0.005) patients. A similar reduction was seen at 2 years (3.3% vs. 4.7%, P = 0.008; 3.3% vs. 4.9%, P < 0.001, respectively). Transradial was associated with an increased risk of ischemic events at 30 days (OR 1.38, 95% CI 1.11-1.72; P = 0.004), driven primarily by increased periprocedural myocardial infarctions. At 2 years, rates of MACE were comparable (HR 1.14, 95% CI 0.98-1.33; P = 0.096). Although bleeding rates were higher with vorapaxar in transfemoral vs. transradial patients, there was no significant treatment interaction. Also, the access site did not modulate the association between vorapaxar and MACE. CONCLUSIONS:Transradial access was associated with lower bleeding rates and similar long-term ischemic outcomes, suggesting transradial access is safer than transfemoral access among ACS patients receiving potent antiplatelet therapies. Because of the nonrandomized allocation of arterial access, these results should be considered exploratory. © 2015 Wiley Periodicals, Inc.
PMID: 26698636
ISSN: 1522-726x
CID: 5224542

Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials

Ferrante, Giuseppe; Rao, Sunil V; Jüni, Peter; Da Costa, Bruno R; Reimers, Bernhard; Condorelli, Gianluigi; Anzuini, Angelo; Jolly, Sanjit S; Bertrand, Olivier F; Krucoff, Mitchell W; Windecker, Stephan; Valgimigli, Marco
OBJECTIVES:The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD). BACKGROUND:Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD. METHODS:The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed. RESULTS:Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p = 0.001, number needed to treat to benefit [NNTB] = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints. CONCLUSIONS:Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD.
PMID: 27372195
ISSN: 1876-7605
CID: 5224702

Effect of Post-Primary Percutaneous Coronary Intervention Bivalirudin Infusion on Acute Stent Thrombosis: Meta-Analysis of Randomized Controlled Trials

Shah, Rahman; Rogers, Kelly C; Ahmed, Agha J; King, Bryan J; Rao, Sunil V
OBJECTIVES:The aim of this study was to evaluate the efficacy of various doses of post-primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis (AST). BACKGROUND:In several recent randomized controlled trials, bivalirudin infusion was continued post-PCI as either a full PCI dose (Biv-Full) or a reduced dose (Biv-Low) to reduce the risk for AST. The results of these trials varied, so the authors performed a meta-analysis of RCTs to determine whether the risk for AST is dose dependent. METHODS:Scientific databases and Web sites were searched for RCTs. A traditional meta-analysis was performed using moderator analyses and network meta-analysis using mixed-treatment comparison models to compare the efficacy of various bivalirudin doses in reducing AST. RESULTS:Data from 5 trials including 16,294 patients were analyzed. Compared with heparin, bivalirudin increased AST risk 2-fold, but this was ameliorated by continuing Biv-Full (risk ratio: 0.90, 95% confidence interval: 0.32 to 2.54; p = 0.852). This effect was not seen with Biv-Low. Similarly, in mixed-treatment models, no difference in AST rate was found between heparin and Biv-Full (odds ratio: 0.97; 95% confidence interval: 0.36 to 2.21). After 30 days, bivalirudin decreased the risk for major bleeding by 47% compared with heparin; this benefit persisted even with continued Biv-Full post-PCI (risk ratio: 0.29; 95% confidence interval: 0.16 to 0.53; p < 0.001). CONCLUSIONS:Although bivalirudin is associated with a greater risk for AST than heparin post-primary PCI, this limitation may be mitigated by continuing Biv-Full (not Biv-Low) 3 to 4 h post-operatively. The decrease in bleeding risk with bivalirudin compared with heparin is not compromised by this strategy.
PMID: 27318846
ISSN: 1876-7605
CID: 5224692