- Title
- 2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF: Results From REDUCE LAP-HF II
- Creator
- Gustafsson, Finn; Petrie, Mark C.; Fail, Peter S.; Chung, Eugene S.; Lurz, Philipp; Lilly, Scott; Kaye, David M.; Cleland, John G. F.; Cikes, Maja; Leon, Martin B.; Cutlip, Donald E.; van Veldhuisen, Dirk J.; Komtebedde, Jan; Solomon, Scott D.; Shah, SJ; Swarup, Vijendra; Winkler, Sebastian; Hasenfuß, Gerd; Borlaug, Barry A.; Mohan, Rajeev C.; Flaherty, James D.; Sverdlov, Aaron L.
- Relation
- JACC: Heart Failure Vol. 12, Issue 8, p. 1425-1438
- Publisher Link
- http://dx.doi.org/10.1016/j.jchf.2024.04.011
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2024
- Description
- Background: The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, "responders" (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified. Objectives: This study sought to determine: 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt. Methods: The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status. Results: In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio: 1.36 [95% CI: 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio: 0.73 [95% CI: 0.54-0.98]). Conclusions: At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033).
- Subject
- heart failure with preserved ejection fraction; interventional cardiology; responder analysis; sham control; SDG 3; Sustainable Development Goal
- Identifier
- http://hdl.handle.net/1959.13/1513943
- Identifier
- uon:56788
- Identifier
- ISSN:2213-1779
- Rights
- n/a
- Language
- eng
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