Expert Consensus Survey: Prostacyclin Pathway Agent Use in Pulmonary Arterial Hypertension - Pulmonology Advisor
Expert Consensus Survey: Prostacyclin Pathway Agent Use in Pulmonary Arterial Hypertension - Pulmonology Advisor |
| Posted: 05 Dec 2019 04:30 AM PST  A new consensus survey of expert opinions was published regarding the use of oral prostacyclin pathway agents in patients with various forms of pulmonary arterial hypertension (PAH) who received dual endothelin receptor antagonist (ERA)/phosphodiesterase type 5 inhibitor (PDE5i) therapy. The opinions were published in CHEST. Researchers used MEDLINE to perform a systematic literature review of studies between 2008 and 2018 comprising adult patients with connective tissue disease (CTD)-associated PAH and function class (FC) 2 or 3 idiopathic, heritable, repaired congenital heart defect, or drug- or toxin-induced PAH (the latter was considered one etiologic grouping, IPAH+) who were treated with oral prostacyclin pathway agents. Pivotal trials for oral treprostinil and selexipag were also included if they focused on IPAH+ or CTD-associated PAH and FC 1 or 2 symptoms with background ERA/PDE5i therapy. A series of clinical scenarios centered on 1 or the 3 etiologic groups (IPAH, CTD-associated PAH, and portopulmonary hypertension) were presented to the panelists for the development of the consensus. To create the consensus statements, the panel used the RAND/University of California Los Angeles Appropriateness Method, which incorporates the Delphi method and the nominal group technique. A total of 458 case scenarios were accepted by Delphi 2. Based on the available data, the panelists agreed that selexipag may be considered for patients with IPAH+ and low- or intermediate-risk hemodynamic parameters who receive dual oral ERA/PDE5i therapy. This was specific to patients in FC 2 who had not been hospitalized for PAH in the past 6 months but had moderate to severe right ventricular dysfunction. The panelists also agreed that intravenous or subcutaneous prostacyclin should be the treatment of choice in patients with IPAH+ or CTD-associated PAH who receive dual oral therapies and have high-risk hemodynamic parameters. Overall, a total of 14 consensus statements on the use of oral prostacyclin pathway agents that included 13 clinical scenarios where selexipag may be considered were discussed by the panelists. A limitation of the survey included the paucity of evidence (only 5 clinical trials) regarding the use of selexipag and oral treprostinil. Because of these limitations, the authors concluded that the "expert opinions must be validated with rigorous prospective studies, and this document may serve as a template for future investigations." Disclosure: This clinical trial was supported by Actelion Pharmaceuticals. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors' disclosures. Reference McLaughlin VV, Channick R, De Marco T, et al. Results of an expert consensus survey on the treatment of pulmonary arterial hypertension with oral prostacyclin pathway agents [published online November 16, 2019]. CHEST. doi:10.1016/j.chest.2019.10.043  |
| Posted: 21 Nov 2019 12:00 AM PST  Dive Brief:
Dive Insight:Pulmonary hypertension is an established prognostic factor in conventional mitral valve surgery, with research linking the condition to increased short and long-term mortality. However, there is a lack of data on the association between pulmonary hypertension and outcomes in patients who undergo transcatheter mitral valve repair using Abbott's MitraClip. To assess whether a link exists, cardiologists from institutions including Massachusetts General Hospital used the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry to analyze outcomes in more than 4,000 patients treated with MitraClip at 232 U.S. sites between 2013 and 2017. Those patients were put in four groups based on their pulmonary arterial pressure. The one-year mortality rate in the patients who were free from pulmonary hypertension was 16.3%. In the subgroup with severe pulmonary hypertension, the one-year mortality rate was 27.8%. The mortality rate ticked up as the extent of pulmonary hypertension went from mild to moderate to severe. A similar trend was observed when one-year mortality was combined with readmissions for heart failure in a composite endpoint. The rate of patients experiencing one of those outcomes rose from 27.8% in patients without pulmonary hypertension to 45.2% in their counterparts with a severe form of the condition. While the data suggest MitraClip is associated with worse outcomes in some patients than in others, the researchers see the findings as a reason to explore using the device differently, rather than limit its use. The researchers state the data show "transcatheter mitral valve repair was safe and effective and resulted in improved functional capacity" even in patients with severe pulmonary hypertension. To ensure more people get MitraClip when it appears to be most effective, the researchers propose intervening sooner in the progression of mitral regurgitation when patients are less likely to have developed pulmonary hypertension. More research is needed to show if that proposal will lead to improved outcomes. The study comes weeks after another group of researchers published a research letter in JAMA Internal Medicine examining reports of injury and device malfunction linked to MitraClip in FDA's adverse event database. The analysis identified underreporting of deaths related to MitraClip. Among the 5,323 injury and malfunction reports, researchers found 97 reports describing patient deaths not grouped with the 295 properly identified cases of death.  |
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