Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

OBJECTIVES: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis. BACKGROUND: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%. METHODS: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs. RESULTS: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001). CONCLUSIONS: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Temporal trends, safety, and efficacy of bivalirudin in elective percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

OBJECTIVE: To evaluate the safety and efficacy of bivalirudin based therapy among patients undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease in a large multicenter registry. BACKGROUND: The REPLACE I trial demonstrated the non-inferiority of a strategy of bivalirudin compared with heparin and glycoprotein (GP) IIbIIIa inhibition in patients undergoing PCI. There is a paucity of outcome data with bivalirudin use in the setting of real-world PCI practice. METHODS: We evaluated the outcome of 11,719 patients who underwent elective PCI for stable coronary artery disease (CAD) from 2002 to 2004 in a large regional consortium, and who were treated with bivalirudin (n = 2051) or with heparin and GP IIbIIIa inhibitors (n = 9,668). The primary endpoints were transfusion and in-hospital major adverse cardiovascular events (MACE) defined as the composite of death, MI, stroke, and any coronary artery bypass grafting (CABG) or target lesion revascularization. RESULTS: Compared with patients who received heparin plus GP IIbIIIa inhibitors, patients who received bivalirudin had a similar incidence of post-procedural MI, stroke, in-hospital death, MACE (2.88 vs. 2.48, P = 0.30), or transfusion (2.83% vs. 2.41%, P = 0.27). Patients at greater risk of bleeding were more likely to be treated with bivalirudin. After adjusting for the propensity to receive bivalirudin and for baseline co-morbidities, there was no difference in the odds of MACE or the need for transfusion between the two groups. CONCLUSION: Compared with heparin plus GP IIbIIIa inhibition, use of bivalirudin in patients undergoing PCI for stable CAD is associated with similar ischemic and bleeding complications. Given the ease of administration and lower cost, bivalirudin provides an attractive treatment option in this patient population.