• Marius M Hoeper, Friedrich Grimminger, Adam Torbicki, Arno Fritsch, Neil Davie, Pavel Jansa, and Martin Wilkins.
• Chest. 2014 Mar 1;145(3 Suppl):535B.

Session TitleDVT/PE/Pulmonary HypertensionSESSION TYPE: Slide PresentationsPRESENTED ON: Sunday, March 23, 2014 at 12:15 PM - 01:15 PMPURPOSE: The long-term effect of riociguat was compared in patients with CTEPH in FC I/II versus FC III/IV at CHEST-1 baseline.MethodsIn CHEST-1, patients were randomized to riociguat individual-dose titration (up to 2.5 mg tid) or placebo. Patients could enter CHEST-2 after completing CHEST-1 without ongoing riociguat-related SAEs; placebo patients were titrated to their optimum riociguat dose (up to 2.5 mg tid) and riociguat patients continued on their optimum dose.Results91% of CHEST-1 patients (n=237) entered CHEST-2. Of these, 211 (89%) were ongoing in this interim analysis (cut-off March 2013; mean treatment duration 582 days); the numbers of patients in FC I/II/III/IV at CHEST-1 baseline were 3/73/154/6. At CHEST-1 completion, mean±SD 6MWD in the FC I/II subgroup increased by 56±65 m and 20±51 m in riociguat and placebo patients, respectively, versus 47±55 m and 2±68 m in the FC III/IV subgroup. After 12 weeks of CHEST-2, 6MWD in the FC I/II subgroup increased by 70±55 m and 41±61 m in ex-riociguat and ex-placebo patients, versus 51±74 m and 45±78 m in the FC III/IV subgroup. In all patients at 1 year, 6MWD increased by 51±52 m in the FC I/II subgroup (n=61) and 52±68 m in the FC III/IV subgroup (n=110). At CHEST-1 completion in the FC I/II subgroup, FC improved/stablilized/worsened in 16/76/8% and 12/84/4% of riociguat and placebo patients; proportions in the FC III/IV subgroup were 44/55/1% and 18/80/2%, respectively. In all patients at 1 year, proportions were 25/67/8% in the FC I/II subgroup (n=63) and 58/40/1% in the FC III/IV subgroup (n=114; data missing for n=1). At the cut-off, 7 (9%) patients in the FC I/II subgroup had experienced clinical worsening and 4 (5%) had died, versus 31 (19%) and 9 (6%), respectively, in the FC III/IV subgroup.ConclusionsRiociguat increased 6MWD and improved/stabilized FC in most patients in FC I/II and FC III/IV.Clinical ImplicationsLong-term riociguat appears to show benefit in persistent/recurrent and inoperable CTEPH patients in both WHO FC I/II and WHO FC III/IV.DisclosureAndrea M D'Armini: Other Andrea D'Armini received fees for participation in review activities from Bayer: Hossein-Ardeschir Ghofrani: Grant monies (from industry related sources) Hossein-Ardeschir Ghofrani has received grant money paid to his institution by Bayer HealthCare: Friedrich Grimminger: Grant monies (from industry related sources) Friedrich Grimminger has received grant money paid to his institution by Bayer HealthCare: Marius M Hoeper: Consultant fee, speaker bureau, advisory committee, etc. Marius M. Hoeper has received consulting fees, honorarium and/or support for travel from Bayer: Pavel Jansa: Consultant fee, speaker bureau, advisory committee, etc. Pavel Jansa has received consulting fees, honorarium and/or support for travel to meetings from Bayer: Nick H Kim: Consultant fee, speaker bureau, advisory committee, etc. Nick H. Kim has received consulting fees, honorarium and/or support for travel to meetings from Bayer: Gerald Simonneau: Grant monies (from industry related sources) Gerald Simonneau has received grant money paid to his institution from Bayer: Adam Torbicki: University grant monies Adam Torbicki has received university grant monies for statute activities of the university: Martin Wilkins: Consultant fee, speaker bureau, advisory committee, etc. Martin Wilkins has received consulting fees, honorarium and/or support for travel to meetings from Bayer HealthCare: Arno Fritsch: Employee Arno Fritsch is a full-time employee of Bayer HealthCare: Neil Davie: Employee Neil Davie is a full-time employee of Bayer HealthCare: Eckhard Mayer: Consultant fee, speaker bureau, advisory committee, etc. Eckhard Mayer has received consulting fees, honorarium and/or support for travel to meetings from Bayer The following authors have nothing to disclose: Chen WangNo Product/Research Disclosure Information.

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