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216


Bivalirudin reduces hemorrhagic complications and glycoprotein IIB/IIIA inhibitor usage in coronary intervention: Results from the NYU bivalirudin registry [Meeting Abstract]

Attubato, MJ; Friedman, L; Zinn, AP; Pena-Sing, IR; Schanzer, RJ; Messina, AJ; Mezzafonte, S; Winer, HE; Feit, F
ISI:000181669500021
ISSN: 0735-1097
CID: 37100

Bivalirudin reduces ischemic and hemorrhagic complications of percutaneous coronary intervention: Pooled data from 10 prospective studies in 6,134 patients [Meeting Abstract]

Feit, F; Bitti, JA; Lincoff, AM; Chew, DP; Kleiman, NS; Wallentin, L; White, HD; Orniston, J; Robson, R; Aylward, PE; Attubato, MJ
ISI:000181669500108
ISSN: 0735-1097
CID: 37101

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial

Lincoff, A Michael; Bittl, John A; Harrington, Robert A; Feit, Frederick; Kleiman, Neal S; Jackman, J Daniel; Sarembock, Ian J; Cohen, David J; Spriggs, Douglas; Ebrahimi, Ramin; Keren, Gadi; Carr, Jeffrey; Cohen, Eric A; Betriu, Amadeo; Desmet, Walter; Kereiakes, Dean J; Rutsch, Wolfgang; Wilcox, Robert G; de Feyter, Pim J; Vahanian, Alec; Topol, Eric J
CONTEXT: The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). OBJECTIVE: To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications. DESIGN, SETTING, AND PARTICIPANTS: The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization. RESULTS: Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P =.32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P =.40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001). CONCLUSIONS: Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding
PMID: 12588269
ISSN: 0098-7484
CID: 37076

ACT guided bivalirudin therapy for intracoronary radiation [Meeting Abstract]

Attubato M; Pena-Sing IR; Schanzer RJ; Rill VL; El-Omar MM; Friedman L; Zinn AP; Ellerin BE; Hirsch AE; DeWyngaert JK; Lief EP; Keller NM; Feit F
ORIGINAL:0005265
ISSN: 1522-1946
CID: 56299

The effect of femoral artery closure devices on hemorrhagic events in patients receiving bivalirudin or heparin: an observation study from REPLACE-1 [Meeting Abstract]

Attubato MJ; Feit F; Kleiman NS; Lincoff AM; [The REPLACE-1 Investigators]
ORIGINAL:0005264
ISSN: 1522-1946
CID: 56298

Detection of abdominal aortic aneurysms during cardiac catheterization [Meeting Abstract]

Attubato, M; Simon, DB; Levite, HA; Winer, HE; Keller, NM; Feit, F
ISI:000178077400323
ISSN: 0002-9149
CID: 55582

Clopidogrel plus aspirin was effective but increased bleeding in acute coronary syndromes without ST-segment elevation [Comment]

Kronzon, Ithak; Feit, Frederick
PMID: 11874270
ISSN: 1056-8751
CID: 27279

Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study

Bittl JA; Chaitman BR; Feit F; Kimball W; Topol EJ
BACKGROUND: This study was a reanalysis of the Bivalirudin Angioplasty Study, which compared bivalirudin with high-dose heparin during coronary angioplasty for unstable angina. METHODS: Differences in rates of death, myocardial infarction, or repeat revascularization were compared at 7, 90, and 180 days after angioplasty with intention-to-treat analysis. RESULTS: The combined end point occurred in 135 of 2161 patients (6.2%) in the bivalirudin group and in 169 of 2151 patients (7.9%) in the heparin group at 7 days (P =.039). Differences persisted between the groups at 90 days (P =.012) and 180 days (P =.153). Bleeding occurred in 76 patients (3.5%) in the bivalirudin group versus 199 (9.3%) in the heparin group (P <.001). CONCLUSIONS: This analysis supports the hypothesis that bivalirudin reduces ischemic complications and bleeding after angioplasty. Further trials are needed to evaluate bivalirudin versus heparin in conjunction with platelet-glycoprotein IIb/IIIa inhibitors and for coronary stenting
PMID: 11717596
ISSN: 1097-6744
CID: 37077

Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation (BARI)

Berger PB; Velianou JL; Aslanidou Vlachos H; Feit F; Jacobs AK; Faxon DP; Attubato M; Keller N; Stadius ML; Weiner BH; Williams DO; Detre KM
OBJECTIVES: We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND: Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS: In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS: Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION: In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years
PMID: 11691521
ISSN: 0735-1097
CID: 37078

Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial

Tcheng, JE; O'Shea, JC; Cohen, EA; Pacchiana, CM; Kitt, MM; Lorenz, TJ; Greenberg, S; Strony, J; Califf, RM; Buller, C; Cantor, WJ; Joseph, DM; Kitt, MM; Lincoff, AM; Madan, M; Popma, J; Teirstein, P; Cohen, E; Balleza, L; Parsons, P; Lui, H; Young, J; Fox, R; Labinaz, M; Jelley, J; Williams, J; Cohen, D; Trovato, M; Smith, J; Henry, P; Chisholm, R; O'Donnell, D; Talley, JD; Pacheco, R; Timmis, S; Muraka, A; Mann, T; Cubeddu, G; Tannenbaum, M; Greene, J; Santoian, E; Wash, M; Sheldon, S; Pronesti, L; Jain, A; Alonzo, M; Seidelin, P; Richards, J; Lopez, M; Dittenber, R; Johnson, K; Levine, G; Maresh, K; Ferrando, T; Sarembock, I; Snyder, L; Kieval, J; Herlan, L; Miller, M; Bembridge, D; Nair, R; Hickel, L; Kiernan, F; Murphy, D; Cloutier, J; Conn, E; Beardsley, J; Ritchie, M; Cragen, D; Jafar, MZ; Counihan, P; Rosenfelder, D; Ducas, J; Montebruno, L; Carere, R; Radons, B; Williams, L; Owens, W; Dougal, R; Feldman, R; Audrain, D; Karamali, A; Smith, M; Blankenship, J; Demko, SL; Thompson, M; Gacoich, G; Chiodo, V; Noll, P; Ledley, G; Miller, C; Felten, W; Garner, B; Chandler, AB; Easler, P; Albin, G; Page, A; Maddox, W; Allen, S; Gilchrist, I; Moore, R; Zimmerman, H; Curtis, M; Hildebrand, K; Greene, R; Healy, E; Meengs, W; Carson, D; George, J; Roncevich, T; Aharonian, V; Browning, R; Kostuk, W; Carr, S; Feit, F; Gostomsky, B; Butman, S; Hannah, E; Hassel, CD; Hartley, D; Shook, T; Hiller-Mullin, S; Brill, D; Dillion, M; Armstrong, B; Kerns, D; Pichard, A; Okubagzi, P; Nasser, T; Driver, L; Garrett, J; Boltey, L; Stouffer, G; Potter, M; Amidon, T; Eggert, S; Taussig, A; Potter, K; Natarajan, M; Tartaglia, C; Werner, J; Dunlap, T; Harrold-Runge, P; Davidson, C; Goodreau, L; Herzog, W; Calamunci, N; Slater, A; Tormey, D; Phillips, W; White, D; Sridhar, K; White, J; Goodman, D; Buchbinder, M; Nasser, V; Rapeport, K; Vorman, P; Weiner, B; Borbone, M; Shadoff, N; Paap, C; Rehman, A; Haag, E; Burchenal, J; Kioussopoulos, K; Senior, D; Senior, J; Piana, R; Kirshenbaum, J; Chan, S; Chowdry, A; Kraft, P; Clark, V; Fox, M; Deutsch, E; Shannon, T; Quesada, R; Brotherton, J; Murrin, C; Cinderella, J; Hearne, S; Seefried, V; Farah, T; Pakstis, D; Bartolet, B; Bond, C; Debarardinis, C; Montory, D; Smith, G; Gray, D; Phillips, P; Hathaway, S; Manoukian, S; Patrick, C; Yakubov, S; Brooks, J; Block, P; Block, B; Muhlestein, JB; Kim, S; Shalev, Y; Schmidt, W; Resar, J; Citro, K; Stine, R; Zumbuhl, J; Moreyra, A; Kreiger, S; Berger, P; Cannon, CP; Fisher, L; Hasselblad, V; Foster, A; Joseph, D; Madan, M; McLendon, C; Rund, M; Tillery, N; Wood, F; Mahaffey, KW; Irwin, C; Kulick, D; Johnson, N; Chen, J; Greenberg, S; Hogeboom, C; Lorenz, TJ; Terifay, R; Strony, J; Veltri, E
Background The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention. are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. Methods We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 mug/kg boluses 10 min apart and a continuous infusion of 2.0 mug/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. Findings The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). Interpretation Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment to the bailout situation
ISI:000165994300009
ISSN: 0140-6736
CID: 55267