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Impact of Sex and Contact-to-Device Time on Clinical Outcomes in Acute ST-Segment Elevation Myocardial Infarction-Findings From the National Cardiovascular Data Registry
Roswell, Robert O; Kunkes, Jordan; Chen, Anita Y; Chiswell, Karen; Iqbal, Sohah; Roe, Matthew T; Bangalore, Sripal
BACKGROUND: Emergent myocardial reperfusion via primary percutaneous coronary intervention is optimal care for patients presenting with ST-segment elevation myocardial infarction (STEMI). Delays in such interventions are associated with increases in mortality. With the shift in focus to contact-to-device (C2D) time as a new perfusion metric, this study was designed to examine how sex affects C2D time and mortality in STEMI patients. METHODS AND RESULTS: Clinical data on male and female STEMI patients were extracted and analyzed from the National Cardiovascular Data Registry from July 1, 2008 to December 31, 2014. A total of 102 515 patients were included in the final analytic cohort. The median C2D time in female patients with STEMI was delayed when compared to male patients (80 [65-97] versus 75 [61-90] minutes; P<0.001). The unadjusted mortality was higher in female patients when compared to male patients with STEMI (4.1% versus 2.0%; P<0.001). For every 5-minute increase in C2D time, the adjusted odds ratio for mortality was 1.04 (95% CI, 1.03-1.06) for female patients with STEMI and 1.07 (95% CI, 1.06-1.09) for male patients (P for sex by C2D interaction=0.003). CONCLUSIONS: To date, this is the largest analysis of STEMI patients that measures the impact of the new recommended C2D reperfusion metric on in-hospital mortality. Female STEMI patients have longer C2D times and increased mortality. The disparity can be improved and survival can increase in this high-risk patient cohort by decreasing systems issues that cause increased reperfusion times in female STEMI patients.
PMCID:5523636
PMID: 28077385
ISSN: 2047-9980
CID: 2400742
Revascularization strategies in chronic kidney disease: Percutaneous coronary intervention versus coronary artery bypass graft surgery
Chapter by: Patel, AV; Bangalore, S
in: Cardio-Nephrology: Confluence of the Heart and Kidney in Clinical Practice by
pp. 317-327
ISBN: 9783319560427
CID: 3527812
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease [Letter]
Bangalore, Sripal
PMID: 28032959
ISSN: 1533-4406
CID: 2402432
A meta-analysis and meta-regression of long-term outcomes of transcatheter versus surgical aortic valve replacement for severe aortic stenosis
Villablanca, Pedro A; Mathew, Verghese; Thourani, Vinod H; Rodes-Cabau, Josep; Bangalore, Sripal; Makkiya, Mohammed; Vlismas, Peter; Briceno, David F; Slovut, David P; Taub, Cynthia C; McCarthy, Patrick M; Augoustides, John G; Ramakrishna, Harish
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (>/=1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS. METHODS: A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016. RESULTS: Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome. CONCLUSION: TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity.
PMID: 27732927
ISSN: 1874-1754
CID: 2278412
Use and Effectiveness of Bivalirudin Versus Unfractionated Heparin for Percutaneous Coronary Intervention Among Patients with ST-Segment Elevation Myocardial Infarction in the United States
Secemsky, Eric A; Kirtane, Ajay; Bangalore, Sripal; Jovin, Ion S; Shah, Rachit M; Ferro, Enrico G; Wimmer, Neil J; Roe, Matthew; Dai, Dadi; Mauri, Laura; Yeh, Robert W
OBJECTIVES: The purpose of this study was to describe temporal trends and determine the comparative effectiveness of bivalirudin versus unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Several clinical trials have compared the safety and effectiveness of bivalirudin versus UFH during PCI for STEMI, but results have been conflicting. METHODS: Trends in anticoagulant use were examined among 513,775 PCIs for STEMI from July 2009 through December 2014 within the National Cardiovascular Data Registry CathPCI Registry. We conducted an instrumental variable analysis comparing bivalirudin with UFH, using operator preference for bivalirudin as the instrument. We used a test of mediation to determine the extent to which differences in outcomes between anticoagulants were due to differences in use of glycoprotein IIb/IIIa inhibitors (GPI). Primary outcomes were in-hospital bleeding and mortality. RESULTS: Bivalirudin use increased from 2009 through 2013, followed by a new decline. GPIs were used in 74.7% of UFH PCIs versus 26.5% of bivalirudin PCIs. In unadjusted analyses, bivalirudin was associated with decreased bleeding (risk difference [RD]: -4.2%; p < 0.001) and mortality (RD: -0.84%; p < 0.001). After instrumental variable analyses, bivalirudin remained associated with less bleeding (RD: -3.75%; p < 0.001), but not mortality (RD: -0.10%; p = 0.280). The higher rate of GPI use with UFH was responsible for more than one-half of bivalrudin's bleeding reduction (GPI-adjusted RD: -1.57%; p < 0.001). Bleeding reductions were negligible for transradial PCI (RD: -0.11%; p = 0.842). CONCLUSIONS: The use of bivalirudin during STEMI has decreased. Bivalirudin was associated with reduced bleeding and no mortality difference. The bleeding reduction with bivalirudin was largely explained by the greater use of GPIs with UFH.
PMID: 27838271
ISSN: 1876-7605
CID: 2310812
Cognitive Decline, Blood Pressure Control and Variability: A Relentless Downward Spiral? [Letter]
Messerli, Franz H; Bangalore, Sripal
PMID: 27751802
ISSN: 1538-9375
CID: 2279882
Optimal Treatment Strategies in Patients with Chronic Kidney Disease and Coronary Artery Disease
Volodarskiy, Alexander; Kumar, Sunil; Amin, Shyam; Bangalore, Sripal
BACKGROUND: Chronic kidney disease is an independent risk factor for coronary artery disease and is associated with an increase in adverse outcomes. However, the optimal treatment strategies for patients with chronic kidney disease and coronary artery disease are yet to be defined. METHODS: MEDLINE, EMBASE and CENTRAL were searched for studies including at least 100 patients with chronic kidney disease (defined as estimated glomerular filtration rate = 60 mL/min/1.73 m2 or on dialysis) and coronary artery disease treated with medical therapy, percutaneous coronary intervention or coronary artery bypass surgery and followed for at least 1 month and reporting outcomes. The outcome evaluated was all-cause mortality. Meta-analysis was performed to evaluate the outcomes with revascularization (percutaneous coronary intervention or coronary artery bypass surgery) when compared with medical therapy alone. In addition, outcomes with percutaneous coronary intervention vs. coronary artery bypass surgery were evaluated. RESULTS: The search yielded 38 non-randomized studies that enrolled 85,731 patients. Revascularization (percutaneous coronary intervention or coronary artery bypass surgery) was associated with lower long-term mortality (mean 4.0 years) when compared with medical therapy alone (RR=0.73; 95% CI 0.62-0.87), driven by lower mortality with percutaneous coronary intervention vs. medical therapy and coronary artery bypass surgery vs. medical therapy. Coronary artery bypass surgery was associated with a higher upfront risk of death (RR=1.81; 95% CI 1.47-2.24) but a lower long-term risk of death (RR=0.94; 95% CI 0.89-0.98) when compared to percutaneous coronary intervention. CONCLUSIONS: In chronic kidney disease patients with coronary artery disease, the current data from non-randomized studies indicate lower mortality with revascularization, via either coronary artery bypass surgery or percutaneous coronary intervention, when compared with medical therapy. These associations should be tested in future randomized trials.
PMID: 27476086
ISSN: 1555-7162
CID: 2199322
Complete vs Culprit-Only Percutaneous Coronary Intervention in STEMI With Multivessel Disease: A Meta-analysis and Trial Sequential Analysis of Randomized Trials
Bainey, Kevin R; Welsh, Robert C; Toklu, Bora; Bangalore, Sripal
BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) most commonly are treated with culprit-only percutaneous coronary intervention (PCI). However, this has been recently challenged, suggesting benefit with complete revascularization (CR). Still, these latest findings are largely based on clinical trials powered for composite outcomes that frequently include "softer" end points. We performed a meta-analysis comparing routine culprit-only PCI vs CR in STEMI, with an emphasis on "hard" clinical end points. METHODS: MEDLINE, EMBASE, ISI Web of Science, and CENTRAL were searched from 1996-May 2015. Studies included patients with STEMI and MVD who received primary PCI. The primary end point was long-term death/myocardial infarction (MI). Data were combined using a fixed-effects model. RESULTS: Seven randomized trials (2004 patients: 1065 CR and 939 culprit-only PCI procedures) were included. Compared with culprit-only PCI, CR reduced the composite of death/MI (odds ratio [OR], 0.71; 95% confidence interval [CI], 0.52-0.96) but not death (OR, 0.78; 95% CI, 0.53-1.15) or recurrent MI (OR, 0.85; 95% CI, 0.58-1.24) alone. If CR was performed during the index catheterization, a reduction in death/MI was observed (death/MI: OR, 0.41; 95% CI, 0.25-0.65; death: OR, 0.59; 95% CI, 0.34-1.00; recurrent MI: OR, 0.35; 95% CI, 0.18-0.69). If staged, no benefits were noted (death/MI: OR, 0.99; 95% CI, 0.67-1.45; death: OR, 0.95; 95% CI, 0.56-1.61; recurrent MI: OR, 1.02; 95% CI, 0.61-1.70). However, when trial sequential analysis was performed for the overall population, the cumulative z-curve did not cross the monitoring boundary, suggesting a lack of evidence for reducing death/MI with CR (similar for index catheterization). CONCLUSIONS: In STEMI with MVD, there is insufficient evidence to support a reduction in death/MI with CR. Our results reinforce the need for larger clinical trials powered for robust clinical end points.
PMID: 27378594
ISSN: 1916-7075
CID: 2357292
Outcomes of </=6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation: A meta-analysis and meta-regression
Villablanca, Pedro A; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schupke, Stefanie; Briceno, David F; Bortnick, Anna E; Garcia, Mario J; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish
BACKGROUND: The benefit of </=6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of =6-month versus 12-month DAPT in patients undergoing PCI with DES placement. METHODS: We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I) > 40 was identified, effects were obtained with random models. RESULTS: Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between =6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69-1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66-1.21), non-CV mortality (OR 0.85; 95% 0.58-1.24), myocardial infarction (OR 1.10; 95% CI: 0.89-1.37), stroke (OR 0.97; 95% CI: 0.67-1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89-2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77-1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49-1.05) was observed, though the all-bleeding event rate was significantly lower in the </=6-month DAPT group (OR 0.76; 95% CI: 0.59-0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with </=6-month DAPT. CONCLUSION: DAPT for </=6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.
PMCID:5207602
PMID: 28033306
ISSN: 1536-5964
CID: 2429992
Meta-Analysis of Randomized Trials on the Efficacy and Safety of Angiotensin-Converting Enzyme Inhibitors in Patients >/=65 Years of Age
Bavishi, Chirag; Ahmed, Mohammed; Trivedi, Vrinda; Khan, Abdur Rahman; Gongora, Carlos; Bangalore, Sripal; Messerli, Franz H
The comparative efficacy and safety of angiotensin-converting enzyme inhibitors (ACEIs) with other agents in patients >/=65 years of age with cardiovascular diseases or at-risk are unknown. Electronic databases were systematically searched to identify all randomized controlled trials that compared ACEIs with control (placebo or active) and reported long-term cardiovascular outcomes. We required the mean age of patients in the studies to be >/=65 years. Random-effects model was used to pool study results. Sixteen trials with 104,321 patients and a mean follow-up of 2.9 years were included. Compared with placebo, ACEIs significantly reduced all outcomes except stroke. Compared with active controls, ACEIs had similar effect on all-cause mortality (relative risk [RR] 0.99, 95% confidence interval [CI] 0.95 to 1.03), cardiovascular mortality (RR 0.99, 95% CI 0.93 to 1.04), heart failure (RR 0.97, 95% CI 0.91 to 1.03), myocardial infarction (RR 0.94, 95% CI 0.88 to 1.00), and stroke (RR 1.07, 95% CI 0.99 to 1.15). ACEIs were associated with an increased risk of angioedema (RR 2.79, 95% CI 1.05 to 7.42), whereas risk for hypotension and renal insufficiency was similar compared with active controls. Meta-regression analysis showed that the effect of ACEIs on outcomes remained consistent with age increasing >/=65 years. Sensitivity analysis excluding trials comparing ACEIs with angiotensin receptor blockers and heart failure trials yielded similar results, except for reduction in myocardial infarction. In conclusion, the efficacy of ACEIs was similar to active controls for mortality outcomes. Compared with placebo, there was evidence for reduction in cardiovascular outcomes; however, ACEIs failed to prevent stroke and increased the risk of angioedema, hypotension, and renal failure.
PMID: 27692594
ISSN: 1879-1913
CID: 2273832