{"schemaVersion":"wpf-profile-export-v1","exportedAt":"2026-09-18T15:17:46.579Z","profile":{"slug":"bivalirudin","name":"Bivalirudin","aliases":[],"category":"Direct thrombin inhibitor peptide"},"synthesis":{"mechanism":"Bivalirudin is a synthetic 20-residue peptide anticoagulant derived conceptually from the thrombin-binding properties of hirudin. Its N-terminal D-phenylalanine-containing sequence binds the catalytic site of thrombin while a C-terminal region engages thrombin’s fibrin-recognition exosite; thrombin can subsequently cleave the molecule, contributing to reversible inhibition. It acts directly on circulating and clot-bound thrombin without requiring antithrombin. The molecule is established in percutaneous coronary intervention, while use in extracorporeal membrane oxygenation, cardiopulmonary bypass, pediatric procedures, and other settings has a different and often off-label evidence and regulatory context.","evidence":"The governed corpus spans the pivotal REPLACE-2, ACUITY, HORIZONS-AMI, EUROMAX, HEAT-PPCI, MATRIX, VALIDATE-SWEDEHEART, and BRIGHT-4 evidence families; post-procedure infusion research; early angioplasty studies; pediatric catheterization and ECMO investigations; modern systematic reviews and individual-patient or aggregate meta-analyses; laboratory monitoring research; and comparative real-world work. Source identities, titles, authorship, publication metadata, DOI/PMID links, bivalirudin identity, and duplication were checked against PubMed. Evidence ratings preserve differences among large PCI trials, pediatric pilot studies, ECMO cohorts, meta-analyses, and in-vitro assays. Claim-level interpretation, bias, applicability, and changing background antiplatelet or access-site practice remain for accountable Owner review.","safety":"The evidence base spans two decades of changing PCI technique, radial-access adoption, antiplatelet therapy, heparin dosing, glycoprotein IIb/IIIa use, and stent technology, limiting direct comparison across trials. Open-label designs and treatment crossovers occur in parts of the literature. Composite outcomes and bleeding definitions vary. Meta-analyses inherit comparator heterogeneity and cannot erase trial-level differences. Evidence for ECMO, cardiopulmonary bypass, neurointervention, and children is smaller and often observational. Renal clearance, critical illness, assay limitations, extracorporeal-circuit conditions, and concomitant antithrombotic drugs affect exposure and bleeding or thrombosis risk. Current official labeling—not this profile—controls indications, contraindications, monitoring, and clinical use.","observationalBoundary":"Randomized PCI trials establish that bivalirudin is an effective procedural anticoagulant, but its balance against heparin depends on the comparator regimen, glycoprotein IIb/IIIa inhibitor strategy, vascular access, post-PCI infusion, ischemic-risk profile, and era of practice. Across major trial programs, reduced bleeding in some comparisons must be considered alongside acute stent-thrombosis signals and differences in ischemic outcomes. Later evidence, including BRIGHT-4 and pooled analyses, evaluates whether high-dose post-PCI infusion and contemporary practice alter that balance. ECMO, cardiopulmonary-bypass, pediatric, and HIT-associated uses are clinically important but supported by smaller, heterogeneous, and frequently nonrandomized evidence; they are not interchangeable with the FDA PCI indication. Monitoring research also shows that assay choice and patient physiology can affect interpretation of anticoagulant effect.","openQuestions":"Which contemporary PCI populations derive a net clinical advantage from bivalirudin over modern heparin strategies? What infusion duration and intensity best balance bleeding and acute stent thrombosis after primary PCI? Which anticoagulation assay most reliably reflects exposure in ECMO, renal dysfunction, and critical illness? Can adequately powered randomized trials define outcomes in adult and pediatric ECMO or cardiopulmonary bypass? How should HIT history, circuit adsorption, inflammatory state, organ failure, and concurrent antiplatelet therapy change interpretation? What explains discordance among major trials, and which findings remain transferable to current devices and access techniques?"},"completion":{"version":"wpf-profile-v1.0","complete":false,"checks":[{"key":"overview","passed":true,"actual":715,"required":100,"severity":"blocking"},{"key":"evidence_summary","passed":true,"actual":833,"required":100,"severity":"blocking"},{"key":"safety_summary","passed":true,"actual":832,"required":100,"severity":"blocking"},{"key":"archive_boundary","passed":true,"actual":942,"required":75,"severity":"blocking"},{"key":"open_questions","passed":true,"actual":707,"required":75,"severity":"blocking"},{"key":"verified_sources","passed":true,"actual":25,"required":25,"severity":"blocking"},{"key":"reviewed_sources","passed":false,"actual":0,"required":1,"severity":"blocking"},{"key":"chemistry","passed":true,"actual":true,"required":true,"severity":"blocking"},{"key":"regulatory_context","passed":true,"actual":2,"required":2,"severity":"blocking"},{"key":"claims","passed":false,"actual":0,"required":1,"severity":"blocking"},{"key":"claim_traceability","passed":true,"actual":0,"required":0,"severity":"blocking"},{"key":"regulatory_freshness","passed":true,"actual":0,"required":0,"severity":"warning"}],"failures":["reviewed_sources","claims"]},"chemistry":{"id":"32b47ffb67135de3f0a23dde65a109a0","peptideId":"1b71a102-4ca8-4627-91da-174a06298fc2","molecularFormula":"C98H138N24O33","molecularWeight":2180.3,"aminoAcidSequence":"[D-Phe]PRPGGGGNGDFEEIPEEYL","smiles":null,"inchi":null,"inchikey":"OIRCOABEOLEUMC-GEJPAHFPSA-N","structureImageUrl":"https://pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/16129704/PNG","createdAt":"2026-09-09T21:47:39.847Z","updatedAt":"2026-09-09T21:47:39.847Z"},"evidence":[{"id":"767f4326d4bd4751ede7c3faf5ab025a","peptideId":"1b71a102-4ca8-4627-91da-174a06298fc2","title":"Evaluation of a Bivalirudin Dosing and Monitoring Protocol in Pediatric Extracorporeal Membrane Oxygenation.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/40717748/","evidenceTier":"observational","summary":"Bivalirudin is a direct thrombin inhibitor used off-label for systemic anticoagulation in extracorporeal membrane oxygenation (ECMO).","authors":"Layne M Smith, Francis L Casey Iii, Dhaval Chauhan, Christopher E Mascio, Margaret Mathewson, Jai Udassi","publishingOrg":"The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG","publicationYear":2025,"doi":"10.5863/1551-6776-30.2.218","pubmedId":"40717748","jurisdiction":null,"dateAccessed":"2026-09-09T21:46:05.208Z","editorialNotes":"Identity and metadata verified against the NCBI PubMed record; 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