Pendahuluan: Saat ini, pengobatan antiplatelet tunggal menggunakan aspirin atau clopidogrel direkomendasikan untuk pasien penyakit arteri perifer (PAD) pasca-revaskularisasi. Namun, penelitian terbaru menyarankan bahwa kombinasi rivaroxaban dan aspirin lebih menguntungkan. Kami melakukan tinjauan sistematis untuk menentukan efikasi dan keamanan kombinasi rivaroxaban dan aspirin dibandingkan dengan aspirin saja. Metode: Kami melakukan tinjauan sistematis berdasarkan Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). Pencarian dilakukan di Cochrane, PubMed, Scopus, EBSCOHost, dan Google Scholar menggunakan kata kunci. Kriteria inklusi dan eksklusi diterapkan. Studi yang dipilih dinilai menggunakan Cochrane risk of bias tool versi 2 untuk inklusi. Studi yang terpilih diekstraksi untuk karakteristik dan hasil. Hasil dianalisis secara kualitatif dan kuantitatif. Kami menggunakan model efek tetap atau acak untuk menentukan rasio tergabung yang sesuai. Interval kepercayaan 95% dan nilai p kurang dari 0,05 digunakan sebagai indikator signifikansi statistik. Hasil: Dua studi terkontrol acak multicenter dimasukkan setelah pencarian dan penilaian dengan risiko bias rendah. Kedua studi menunjukkan hasil efektivitas primer yang lebih baik dalam kelompok kombinasi dan perbaikan risiko perdarahan mayor. Analisis kuantitatif menemukan tingkat komplikasi PAD yang lebih rendah (OR=0,79; 95% CI=0,66–0,95) termasuk infark miokard, stroke, kematian kardiovaskular, dan iskemia tungkai akut. Kelompok kombinasi memberikan hasil keamanan primer (OR=1,32; 95% CI=1,06–1,67) dan sekunder (OR=1,47; 95% CI=1,19–1,84) yang lebih rendah. Kesimpulan: Kombinasi rivaroxaban dan aspirin memberikan hasil klinis yang lebih baik pada pasien PAD pasca-revaskularisasi. Namun, kombinasi ini harus digunakan dengan hati-hati karena dapat meningkatkan risiko perdarahan pada populasi tersebut.
Introduction: Currently, single antiplatelet treatments using aspirin or clopidogrel were recommended for post-revascularization peripheral artery disease (PAD) patients. However, recent study suggested that combination of rivaroxaban and aspirin was more favorable. We conducted a systematic review to determine efficacy and safety of rivaroxaban and aspirin combination compared to aspirin alone. Method: We conducted a systematic review based on the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. Searching was conducted on Cochrane, PubMed, Scopus, EBSCOHost, and Google Scholar using keywords. Inclusion and exclusion criteria were applied. Selected studies were appraised using Cochrane risk of bias tool v.2 for inclusion. Included studies were extracted for characteristics and outcomes. Outcomes were analyzed qualitatively and quantitatively. We used fixed- or random-effect model to determine pooled ratio per appropriate. A 95% confidence interval and p-value of 0.05 and below were used as indicators of statistical significance. Results: Two multicentered, randomized controlled studies were included after searching and appraisal with low risk of bias. Both studies showed greater primary effectivity outcome in combination group and improvements of major bleeding risk. Quantitative analysis found lower PAD complications rate (OR=0.79; 95% CI=0.66–0.95) which including myocardial infarct, stroke, cardiovascular death, and acute limb ischemia. Combination group provided lesser primary (OR=1.32; 95% CI=1.06–1.67) and secondary (OR=1.47; 95% CI=1.19–1.84) safety outcome. Conclusion: Combination of rivaroxaban and aspirin provided better clinical outcome in postrevascularization PAD patients. However, this combination should be used carefully as this yield larger risk of bleeding in the population. |
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