Effectiveness of a Prostacyclin IP Receptor Agonist in Patients With Pulmonary Arterial Hypertension in the Real-world Andalusian Setting: The RAMPHA Study.

PURPOSE: The pillar for therapeutic decisions in the evolution of pulmonary arterial hypertension (PAH) is the patients' prognostic stratification. METHODS: A retrospective cohort study was conducted in a Spanish real-world setting to assess the clinical improvement of PAH patients treated with selexipag measured as changes in the risk profile. Secondary objectives were to describe their baseline characteristics, initial risk status, and variables used to assess patient survival and adverse events. FINDINGS: Total 42 patients (mean age 52.36 [SD: 15.09] years) were included. All had received initial endothelin receptor antagonist treatment and 95.2% dual therapy with phosphodiesterase-5 inhibitor or riociguat. At 6 to 12 months from baseline, patients risk stratification tripled the percentage of patients with low risk, and a trend towards improved risk stratification (P = 0.122). World Health Organization functional class changed, with more patients in milder classes (P = 0.003), and symptom progression slowed down (P < 0.0001). At 3-years, survival was 85.7% and the estimated median survival time was 2.73 years (SD: 1.351; 95% CI: 2.51-2.95). IMPLICATIONS: Selexipag did not achieve a significant improvement in risk profile, although it did show an excellent survival rate, effectively improved functional class, and delayed symptom progression in real life. Selexipag was well tolerated and showed a favorable safety profile, supporting a clinical benefit for PAH patients.

Drug persistence and outcomes in a cohort of patients with nonvalvular atrial fibrillation treated with rivaroxaban after 2 years of follow-up in clinical practice.

AIM: To evaluate medication persistence and outcomes in patients with atrial fibrillation after 2 years of treatment with rivaroxaban in routine practice. METHODS: Retrospective study of atrial fibrillation patients in whom rivaroxaban was prescribed during the first quarter of 2014 in the healthcare area of Costa del Sol (Málaga). RESULTS: A total of 111 patients (mean age 74.9 ± 10.9 years; 52.3% men; CHA2DS2-VASc 3.6 ± 1.3; HAS-BLED 1.3 ± 0.6) were included. A total of 96.3 and 90.6% of patients remained on rivaroxaban therapy after 1 and 2 years of treatment, respectively. During this period, stroke, net clinical benefit outcome (thromboembolic events, myocardial infarction, cardiovascular death and major bleeding) and cardiovascular death occurred in 3.6, 5.4 and 1.8% of patients, respectively. CONCLUSION: In routine practice, medication persistence with rivaroxaban was high. Rates of major cardiac events were low.

Discrepancies between the use of MDRD-4 IDMS and CKD-EPI equations, instead of the Cockcroft-Gault equation, in the determination of the dosage of direct oral anticoagulants in patients with non-valvular atrial fibrillation. / Discrepancias entre el empleo de las ecuaciones MDRD-4 IDMS y CKD-EPI en vez de la de Cockcroft-Gault en la determinación de la posología de los anticoagulantes orales directos en pacientes con fibrilación auricular no valvular.

BACKGROUND AND OBJECTIVE: Direct oral anticoagulants (DOACs) require dose adjustment according to estimated clearance creatinine (eClCr) using the Cockcroft-Gault (CG) equation. There are discrepancies with the equations that estimate glomerular filtration rate (eGFR). We analyse how the use of the CKD-EPI and MDRD-4 IDMS equations affect the recommended dosage for ACODs. PATIENTS AND METHODS: Retrospective study of patients with non-valvular atrial fibrillation seen at a cardiology clinic between November 2012 and August 2014. Patients were reclassified according to the recommended dosage for dabigatran, rivaroxaban, apixaban and edoxaban, based on the eGFR equation used. Other clinical factors are taken into account, according to the product label. We analysed the percentage of discordance. RESULTS: Four hundred and fifty-four patients, 53.3% men, with a mean age of 68.7±13.8 years were studied. The mean intra-individual differences recorded for the CG equation were 3.9ml/min/1.73m2 with MDRD-4 IDMS (95% CI 1.4-6.4, P=.003) and 11.3ml/min/1.73m2 with CKD-EPI (95% CI 8.9-13.7, P<.001). A gradient is observed in the discordance of the posology (apixaban 1.1%, dabigatran 3.5%, edoxaban 5.7%, rivaroxaban 8.4% with MDRD-4 IDMS). Differences were limited to patients with eClCr<60ml/min and were more evident in≥75 years in which the eGFR equations overestimate renal function. CONCLUSIONS: In patients with non-valvular atrial fibrillation, especially with renal failure and in the elderly, eGFR equations tend to overestimate renal function relative to CG and therefore suggest an overdose of DOACs.

TIMI-AF score and cardiovascular events in vitamin K antagonists-naïve outpatients with atrial fibrillation.

BACKGROUND: The TIMI-AF score predicts poor outcomes in patients with atrial fibrillation (AF) and guides selection of anticoagulant therapy by identifying clinical benefit of direct oral anticoagulants (DOACs) or vitamin K antagonists (VKA). HYPOTHESIS: Our objective was to determine the ability to predict cardiovascular events according to the TIMI-AF score in a real-world population. METHODS: Retrospective observational study of VKA-naïve patients with AF was seen at a cardiology outpatient clinic in Spain between November 2012 and August 2014. We recorded adverse events (myocardial infarction, systemic embolism or stroke, major bleeding, and death). RESULTS: The study population comprised of 426 patients (50.7% men, mean age, 69 ± 14 years). The TIMI-AF score identified 372 patients (87.3%) with a low risk, 50 patients (11.7%) with an intermediate risk, and 4 patients (0.9%) with a high risk. After a mean follow-up of 423.4 ± 200.1 days, 37 patients (9%) experienced an adverse event. Patients with a TIMI-AF score ≥ 7 had a poorer cardiovascular prognosis (HR, 6.1; 95%CI, 3.2-11.7; P < 0.001). The area under the ROC curve of TIMI-AF was 0.755 (95%CI, 0.669-0.840; P < 0.001), which was greater than that of CHA2 DS2 VASc (0.641; 95%CI, 0.559-0.724; P = 0.004), HAS-BLED (0.666; 95%CI, 0.578-0.755; P < 0.001), and SAMeTT2 R2 (0.529; 95%CI, 0.422-0.636; P = 0.565). Similar results were obtained in relation to the net clinical outcome (life-threatening bleeding, disabling stroke, or all-cause mortality). CONCLUSIONS: The TIMI-AF risk score can identify patients who are at greater risk of cardiovascular events and a poor net clinical outcome with a better diagnostic yield than CHA2 DS2 VASc, HAS-BLED, and SAMeTT2 R2 .