Tesis

Pengaruh Pemberian Statin pada Pasien Chronic Limb Threatening Ischemia terhadap Insiden Amputasi Mayor hingga Pengamatan Satu Tahun: Analisis Stratifikasi dengan Skor Wound, Ischemia, Foot Infection = The role of Statin Consumption on Chronic Limb Threatening Ischemia Patients to Major Amputation Incidence until 1 year Obeservation: Stratification Analysis based on Skor Wound, Ischemia, Foot Infection Score.

Pendahuluan: Chronic Limb Threatening Ischemia (CLTI) adalah stadium lanjut penyakit arteri perifer (PAD). The society for Vascular Surgery Lower Extremity Guidelines Committee menciptakan sistem klasifikasi yang lebih komprehensif untuk stratifikasi risiko amputasi pada pasien di seluruh spektrum CLTI. Sistem ini didasarkan pada nilai objektif Wound (W), Ischemia (I) dan Foot Infection (fI) untuk menghitung stadium klinis tungkai terancam dari 1 hingga 4 yang telah divalidasi dalam beberapa penelitian untuk dapat sangat memprediksi risiko amputasi ekstremitas mayor dalam satu tahun. Berbagai pedoman profesional saat ini merekomendasikan terapi statin untuk semua individu dengan PAD. Temuan para peneliti tentang hubungan yang kuat dan bergantung pada intensitas antara terapi statin dan amputasi serta mortalitas di antara individu dengan insiden PAD adalah hal yang penting secara klinis, baik untuk pasien maupun dokter yang merawat mereka. Namun demikian, protokol pemberian statin masih bervariasi di Indonesia. Penelitian ini bertujuan untuk mengetahui peran konsumsi statin pada pasien CLTI dengan berbagai skor WIfI terhadap amputasi mayor yang diamati hingga satu tahun di Rumah Sakit Cipto Mangunkusumo (RSCM) berdasarkan skor CLTI. Metode: Dilakukan studi kohort retrospektif dari data pasien yang didiagnosis CLTI di RSCM pada tahun 2010-2019. Subjek dibagi menjadi grup statin dan non statin. Dilakukan Uji bivariat dengan chi-square untuk melihat bagaimana pengaruh pemberian statin, komorbid dan skor WIFI pada subjek CLTI terhadap amputasi mayor. Kemudian dilakukan analisis stratifikasi untuk melihat pengaruh statin pada subjek CLTI dengan berbagai spektrum. Dilakukan pula analisis bagaimana kecendrungan statin bekerja jika diberikan pada pasien dengan berbagai jumlah komorbid. Uji multivariat dilakukan menggunakan regresi logistik menghadirkan nilai p dengan adjusted relative risk (RR). Hasil: Mayoritas pasien adalah laki-laki (59,5%). Sebanyak 83,2% subjek penelitian menderita diabetes melitus, 70,5% subjek mengalami hipertensi, 47,7% subjek mengalami gagal ginjal kronis, dan 26,4% subjek menderita penyakit jantung. Selain itu, hampir setengah dari total subjek penelitian memiliki skor WIfI yang parah (45,5%). Subjek yang diberi statin berpeluang menjalani amputasi mayor sebesar 0,562 kali dibandingkan subjek yang tidak diberikan statin (95% CI 0,407 - 0,777). Dengan kata lain, pemberian statin mampu mencegah amputasi mayor pada pasien CLTI. Namun hal tersebut hanya dapat diterapkan pada subjek CLTI dengan skor WifI yang rendah, karena semakin tinggi skor WifI pasien memiliki faktor komorbid yang lebih banyak (p < 0,05; 95% CI 0,008 - 0,783). Amputasi mayor pada subjek CLTI secara statistik signifikan dengan diabetes komorbid (p = 0,001), penyakit jantung (p < 0,001), skor WIfI (p = 0,001) dan penggunaan statin (p < 0,001). Simpulan: Penelitian ini menunjukkan bahwa pemberian statin dapat mencegah kejadian amputasi mayor pada pasien CLTI dengan skor WIfI rendah meskipun terdapat faktor komorbid.
Kata kunci: Chronic limb threatening ischemia, peripheral arterial disease, WIfI score, statin, amputasi mayor


Background : Chronic limb threatening ischemia (CLTI) is an advanced stage of peripheral artery disease (PAD). The society for Vascular Surgery Lower Extremity Guidelines Committee created a more comprehensive threatened limb classification system intended to stratify amputation risk in patients across the spectrum of CLTI. The system is based on objective grades Wound (W), Ischemia (I) and Foot Infection (FI) to calculate a threatened limb clinical stage from 1 to 4 has been validated in multiple studies to be highly predictive of 1-year major limb amputation risk. Current professional society guidelines recommend statin therapy for all individuals with PAD. The investigators’ finding of a strong and intensity- dependent association between statin therapy and both amputation and mortality among individuals with incident PAD is of considerable clinical importance, both to patients and the physicians who care for them. Yet, there is no study available for this and statin protocol vary in our country. This study aims on revealing the role of statin consumption prior to major amputation on CLTI patients in Cipto Mangunkusumo based on CLTI score. Methods: We performed retrospective cohort study from a database of CLTI patients diagnosed at Cipto Mangunkusumo Hospital in 2010-2019. Subjects were divided into statin and nonstatin groups. A bivariate test with chi-square was performed to see how the effect of statin, comorbid and WIFI scores on CLTI subjects on major amputations. Then a stratification analysis was performed to see the effect of statins on CLTI subjects with various spectra. An analysis of how the statin likelihood of working when given to subjects with varying amounts of comorbidities was also conducted. Multivariate tests was performed used logistic regression presenting p values with adjusted relative risk (RR). We performed cohort retrospective analysis study from a database of CLTI patients diagnosed at Cipto Mangunkusumo Hospital in 2010- 2019. Subjects were divided into 2 groups, the CLTI patients with statin and without statin based on their database. We also analyse comorbid factors (diabetes mellitus, hypertension, chronic renal failure and heart disesase) related to CLTI and WIfI score to major amputation incidence Results: Majority of the patients were male (59.5%). A total of 83.2% of study subjects suffered from diabetes mellitus, 70.5% of subjects had hypertension, 47.7% of subjects had chronic kidney failure, and 26.4% of subjects had heart disease. In addition, almost half of the total study subjects had a severe WIfI score (45.5%). Subjects who were given statins had a chance to undergo major amputation by 0.562 times compared to subjects who were not given statins (95% CI 0.407 - 0.777). In other words, statin administration was able to prevent major amputation in CLTI patients. However, it only can be applied to CLTI subjects with low WifI score, as higher WifI score patients have more comorbid factors (p < 0,05; 95%CI 0,008 – 0,783). Major amputation in CLTI subjects was statistically significant with comorbid diabetes (p = 0.001), heart disease (p < 0.001), WIfI score (p = 0.001) and statin use (p < 0.001). Conclusion: This study shows that statin administration can prevent the incidence of major amputation in CLTI patients with low WIfI scores despite the presence of comorbid factors.
Keywords: Chronic limb threatening ischemia, WIfI score, statin, major amputation