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An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention

Shah, Rahman; Rogers, Kelly C; Matin, Khalid; Askari, Raza; Rao, Sunil V
BACKGROUND:Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI. METHODS AND RESULTS/RESULTS:Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P = .800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P = .089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P = .122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P = .069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P = .041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P = .009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P < .001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P = .012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P = .009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P = .252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P = .114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P = .049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P = .226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P = .018). CONCLUSIONS:In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.
PMID: 26699596
ISSN: 1097-6744
CID: 5224552

A Call for Comprehensive Forearm Access? [Comment]

Sawlani, Neal; Rao, Sunil V; Bhatt, Deepak L
PMID: 26716588
ISSN: 1557-2501
CID: 5224562

Post-procedural/pre-hemostasis intra-arterial nitroglycerin after transradial catheterization: A gender based analysis

Dharma, Surya; Kedev, Sasko; Patel, Tejas; Sukmawan, Renan; Gilchrist, Ian C; Rao, Sunil V
BACKGROUND:We analyzed the effect of nitroglycerin on radial artery occlusion (RAO) in women undergoing transradial catheterization. METHODS:A total of 1706 patients undergoing transradial catheterization were randomized to receive either 500μg intra-arterial nitroglycerin or placebo at the end of the radial procedure. We explored the gender-based analysis between women (n=539) and men (n=1167). The primary outcome was the incidence of RAO as confirmed by absence of antegrade flow at one day after the transradial procedure evaluated by duplex ultrasound of the radial artery. RESULTS:The use of nitroglycerin, as compared with placebo, did not significantly reduce the risk of RAO in women patients [odds ratio, 0.69; 95% confidence interval (CI), 0.38 to 1.26; P=0.147]. The risk of RAO was higher in women age <60years as compared with women age ≥60years [5.6% vs. 3.5%; odds ratio, 2.16; 95% CI, 1.18 to 3.94; P=0.008]. In women age <60years (n=237), both counter puncture technique and a duration of hemostasis ≥4h were associated with a similar enhanced risk of developing RAO (odds ratio, 3.51; 95% CI, 1.59 to 7.72; P<0.001). CONCLUSIONS:The administration of nitroglycerin at the end of a transradial catheterization in women did not reduce the risk of RAO as determined by ultrasound one day after the radial procedure. Age <60years was associated with a higher risk of RAO compared with age ≥60years in women. Further strategies to reduce RAO in women are needed.
PMID: 26797427
ISSN: 1878-0938
CID: 5224582

Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention

Perez, Alberto E. Barria; Rao, Sunil V.; Jolly, Sanjit J.; Pancholy, Samir B.; Plourde, Guillaume; Rimac, Goran; Poirier, Yann; Costerousse, Olivier; Bertrand, Olivier F.
ISI:000373968500010
ISSN: 0002-9149
CID: 5226512

Initial Report From an Emergency-Department-Based Registry of NSTEMI Patients Given Upstream Advanced Oral Antiplatelet Therapy [Meeting Abstract]

Pollack, Charles V.; Bhandary, Durgesh D.; Frost, Alex; Peacock, W. Frank; Diercks, Deborah B.; Silber, Steven H.; Rao, Sunil V.; Bangalore, Sripal; Reicher, Barry; Burke, Lea M.; DeRita, Renato; Khan, Naeem D.
ISI:000396815301071
ISSN: 0009-7322
CID: 5226592

Patterns of Use and Outcomes of Antithrombotic Therapy in End Stage Renal Disease Patients Undergoing PCI: Observations From NCDR [Meeting Abstract]

Washam, Jeffrey B.; Mccoy, Lisa A.; Wojdyla, Daniel M.; Patel, Manesh R.; Klein, Andrew J.; Abbott, J. D.; Rao, Sunil V.
ISI:000396815604090
ISSN: 0009-7322
CID: 5226612

Sex-related differences in outcomes after percutaneous coronary intervention (PCI) in patients with diabetes presenting with acute coronary syndrome (ACS): Results from the PROMETHEUS study [Meeting Abstract]

Vogel, Birgit; Baber, Usman; Sartori, Samantha; Chandrasekhar, Jaya; Aquino, Melissa; Farhan, Serdar; Kini, Annapoorna; Weintraub, William; Rao, Sunil; Kapadia, Samir; Weiss, Sandra; Strauss, Craig; Toma, Catalin; Muhlestein, J. Brent; DeFranco, Anthony; Effron, Mark; Keller, Stuart; Baker, Brian; Pocock, Stuart; Henry, Timothy; Mehran, Roxana
ISI:000397332900268
ISSN: 0735-1097
CID: 5488532

The Multidimensionality of Cardiovascular Procedures [Comment]

Rao, Sunil V
PMID: 26477636
ISSN: 1558-3597
CID: 5224462

Proficiency With Vascular Access: Don't Rob Peter to Pay Paul [Editorial]

Rao, Sunil V; Nolan, Jim
PMID: 26604057
ISSN: 1876-7605
CID: 5224502

Transradial Versus Transfemoral Access in Patients Undergoing Rescue Percutaneous Coronary Intervention After Fibrinolytic Therapy

Kadakia, Mitul B; Rao, Sunil V; McCoy, Lisa; Choudhuri, Paramita S; Sherwood, Matthew W; Lilly, Scott; Kobayashi, Taisei; Kolansky, Daniel M; Wilensky, Robert L; Yeh, Robert W; Giri, Jay
OBJECTIVES/OBJECTIVE:The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes. BACKGROUND:Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI. METHODS:Patients in the National Cardiovascular Data Registry's CathPCI Registry undergoing rescue PCI for STEMI between 2009 and 2013 were studied. Patients were divided on the basis of access site. Patterns of access use and baseline demographics were noted. Unadjusted and propensity-matched analyses were performed comparing in-hospital bleeding, vascular complications, and mortality outcomes among transradial and transfemoral access patients. The falsification endpoint of gastrointestinal bleeding was specified to assess for persistent unmeasured confounding. RESULTS:Transradial access was used in 14.2% of cases. In propensity-matched analyses, transradial rescue PCI was associated with significantly less bleeding than transfemoral access (odds ratio [OR]: 0.67; 95% confidence interval [CI]: 0.52 to 0.87; p = 0.003), but not mortality (OR: 0.81; 95% CI: 0.53 to 1.25; p = 0.35). Gastrointestinal bleeding was less frequent in the radial group (OR: 0.23; 95% CI: 0.05 to 0.98; p = 0.05). CONCLUSIONS:In a large, "real-world" registry, transradial access was used in a minority of cases and was associated with significantly less bleeding than transfemoral access in patients undergoing rescue PCI. However, given persistent differences in a falsification endpoint, the influence of treatment-selection bias on these results cannot be ruled out. Further studies are needed to determine predictors of bleeding and mortality in this understudied high-risk group.
PMID: 26718516
ISSN: 1876-7605
CID: 5224572