BARCELONA, SPAIN — Participation in a comprehensive educational program that took advantage of modern electronic communications as well as more conventional approaches in a randomized trial was followed by a significant jump in the rate at which patients with atrial fibrillation (AF) were properly on oral anticoagulation (OAC) a year later[1].
The educational intervention, which use web-based instruction and podcasts as well as more standard reading materials, videos, and interviews, was aimed at both patients and providers and tailored to the individual needs of the five developing countries participating in the study: Argentina, Brazil, China, India, and Romania.
In adjusted analysis, patients randomized to participate in the education program were more than three times as likely to be on their prescribed OAC regimen 1 year later compared with nonparticipants.
The intervention seemed to encourage patients already on OAC to stay on it, but it also helped those not on OAC at baseline to start taking the meds properly, according to Dr Christopher B Granger (Duke University Medical Center, Durham, NC), who presented the study here at the European Society of Cardiology (ESC) 2017 Congress.
Of the about one-third of patients who were not on OAC when they enrolled in the study, he said, those randomized to the education intervention were more than four times as likely to be on OAC at 1 year (P<0.0001). “This may the single most important finding in our study,” according to Granger.
There was a suggestion of fewer strokes among those in the education intervention, a sharp but only nominally significant decrease of 52% (P=0.043) at 1 year in the trial, which wasn’t powered for clinical outcomes.
Granger was senior author on the Improve Treatment With Oral Anticoagulants in Atrial Fibrillation (IMPACT-AF) study’s publication in the Lancet, with lead author Dr Dragos Vinereanu (University and Emergency Hospital, Bucharest, Romania), released about the same time as his ESC presentation.
OAC in AF Varies Worldwide
The group points out the shortfalls in OAC use in AF around the world, which they say was only 58% in the 46-country RE-LY registry, 40% in Eastern Europe and South America, and 38% in Asia. Variation in healthcare systems and resources may be a cause, but so probably is “insufficient education of patients and physicians,” they write.
In the current study, OAC use was “higher than expected,” Granger said, possibly because of selection bias toward centers with an interest in anticoagulation and quality improvement. Over a year it increased from 68% at baseline to 80% in the intervention group but from 64% at baseline to only 67% in the control group.
Of note, of the patients not on OAC at baseline, 78% were instead on antiplatelets. Granger explained to theheart.org | Medscape Cardiology that patients on aspirin but not OAC for their AF received special attention from the education program. In the five countries, especially China, he said, aspirin “is still frequently used, and simply changing aspirin to an anticoagulant was something we strongly promoted.”
In some regions, he said, “Doctors and patients still have a reluctance to use treatments that may cause bleeding. It’s almost an irrational reluctance. It is a real concern, especially in frail elderly patients, and seems to be one of the main reasons patients are not being treated [with OAC], even though the net effect of treatment is clearly beneficial.”
In an accompanying editorial[2], Dr Michael D Ezekowitz (Thomas Jefferson University, Philadelphia, PA) and Dr Anthony P Kent (Yale New Haven Health, Bridgeport, CT) agree. “Evidence shows that physicians considering anticoagulation treatments for patients are more influenced by the events they induce (bleeds) than the events potentially prevented, in this case devastating strokes. We suspect that patients and their families might have the same attitude to anticoagulation,” they write.
“Integrated AF Care”
IMPACT-AF, according to Prof Paulus Kirchhof (University of Birmingham, UK), an author of the ESC guidelines for AF[3], “confirms the value of integrated AF care.” The intervention “offers the patients better access to understanding why they need treatment, better access to their treatment, and improved access to healthcare professionals who can explain to them why they need to be treated,” said Kirchhof, who was the appointed discussant following Granger’s presentation.
The trial enrolled 2281 patients with AF at 48 centers in the five developing countries; each center’s patients represented a cluster, and randomization was carried out on the 48 clusters, not at the patient level. Patients were assigned about equally to the educational intervention or care that was standard for each location and were followed for a median of 12 months (interquartile range [IQR] 11.8–12.2 months).
As Granger described the intervention, it was based on two major components: education for providers and patients, and “auditing and feedback.” Educational tools included a website, clinical monographs, webinars, and “monthly calls with the sites with the national coordinating centers, with focus on common reasons for withholding anticoagulation and also for promoting adherence for patients already on treatment,” Granger said.
The audit and feedback component “seems to be critically important,” he said when interviewed. “The sites, the principal investigator, and healthcare providers reviewed their patients with an expert to look for opportunities to improve care.” The process focused on patients’ reasons for not being on OAC.
Secondary Anticoagulation Outcomes, Intervention Group (n=1184) v Control Group (n=1092)
| End points | At 6 mo, adjusted OR (95% CI); P | At 1 y, adjusted OR (95% CI); P |
|---|---|---|
| On OAC at baseline and at follow-up | 1.81 (0.79–412); 016 | 1.68 (0.90–3.12); 0.10 |
| Not on OAC at baseline but on OAC at follow-up | 3.94 (2.11–7.37); <0.0001 | 4.60 (2.20–9.63); <0.0001 |
OAC=oral anticoagulation
Use of OAC rose from 68% at baseline to 80% in the intervention group at 1 year and from 64% to 67% in the standard-care group. Adjusted for clusters, countries, baseline OAC use, and other variables, the 1-year adjusted odds ratio being on OAC at 1 year was 3.28 (95% CI 1.67–6.44, P=0.0002) in the intervention group vs controls. The hazard ratio for stroke at 1 year was 0.48 (95% CI 0.23–0.99) for the intervention vs controls, but Granger acknowledged that not much could be made of the finding, due to the trial’s statistical limitations.
The risk of major bleeding was similar in the two groups at about 1% in each, where the rate of clinically relevant nonmajor bleeding was marginally higher in the intervention group, although still low overall. There were no significant differences in clinical outcomes like death, stroke, or systemic embolism.
The educational intervention was designed to be tailored to the needs, practices, and sensitivities of individual countries, Granger said when interviewed. For example, “In India, it’s really hard for many people to travel the distances to get to a healthcare center, so we used nonphysician health workers to actually go to the patients.”
And the countries had different approaches for how frequently and intensively they reviewed each patient with the site’s principal investigators, he said. “But each country had a benefit, regardless of exactly how they followed the general principles of these interventions.”
IMPACT-AF was supported by Bayer Pharmaceuticals, Boehringer Ingelheim, and Daiichi Sankyo, and educational grants from Bristol-Myers Squibb, Pfizer, and Boehringer Ingelheim SA Argentina. Vinereanu reports grants and speaker fees from Novartis Pharma Services, Pfizer, Servier Pharma, Johnson & Johnson, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Berlin Chemie Menarini, and Abbott/ Mylan; and consulting fees from AstraZeneca, Gedeon Richter, and Terapia. Granger discloses grants and personal fees from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo; grants from Bayer and Janssen; personal fees from AbbVie, Boston Scientific, Eli Lilly, Gilead, Hoffmann-La Roche, NIH, Sirtex, and Verseon; and grants and personal fees from Armetheon, AstraZeneca, GlaxoSmithKline, the Medicines Company, Medtronic, and Novartis. Disclosures for the coauthors are listed in the paper. Ezekowitz reports receiving consulting fees from Boehringer Ingelheim, Pfizer, Bristol-Myers Squibb, Portola, Daiichi-Sankyo, and Armetheon and grant support from Boehringer Ingelheim and Pfizer for research in thrombosis. Kent reports that he has no relevant financial relationships. Kirchhof discloses receiving consulting fees or honoraria from 3M, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardiome, Daiichi Sankyo, Johnson & Johnson, MEDA Pharma, Medtronic, Merck, Osuka, Pfizer, Sanofi, Servier, and Siemens.
Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
Tidak ada komentar:
Posting Komentar