METHODS: ZERBINI was a multi-country, observational, retrospective/prospective study of subjects receiving evolocumab as part of routine clinical management of their hyperlipidemia. This regional publication reports on adult participants from Saudi Arabia and Kuwait who have had ≥1 dose of evolocumab before enrollment and ≤6 months' prior exposure to evolocumab. Patient characteristics and treatment persistence data were collected in addition to baseline and follow-up data up to 12 months post-evolocumab initiation.
RESULTS: Overall, 225 patients were included from two sites, Saudi Arabia (N = 155) and Kuwait (N = 70). Mean age was comparable across sites and most patients had baseline coronary artery disease and/or hypertension. Baseline LDL-C levels (mean ± SD 3.6 ± 1.4 mmol/L in Saudi Arabia, 3.1 ± 1.4 mmol/L in Kuwait) were reduced by approximately 57%-62% in the first 6 months after evolocumab initiation (1.5 ± 1.2 mmol/L in Saudi Arabia [n = 63], 1.2 ± 0.8 mmol/L in Kuwait [n = 28]). This decrease was maintained over the 12-month follow-up period. Most patients achieved ACC 2018 LDL-C goals (<1.8 mmol/L; 74.6% in Saudi Arabia, 93.1% in Kuwait) and ESC 2019 LDL-C goals (<1.4 mmol/L; 66.7% in Saudi Arabia, 75.9% in Kuwait) in the first 6 months after evolocumab initiation. Medication persistence with evolocumab was high (up to 90.7%). Evolocumab had a favorable safety profile and no treatment-emergent adverse events were observed at either site.
CONCLUSION: Evolocumab is an effective lipid-lowering treatment in local populations. LDL-C goal achievement is increased when evolocumab is added to background lipid-lowering therapy with high tolerability and persistence. Long-term follow-up and large-scale data are needed to further support these observations.
METHODS: This prospective, single-arm, multi-center, observational, real-world registry, included 565 patients with long CAL (length 30 to ≤56 mm) in native coronary arteries (reference vessel diameters: 2.25 mm to 3.50 mm). Based on lesion length, patients were implanted with 30 mm, 40 mm, 50 mm, or 60 mm BioMime™ Morph SES. Primary endpoint was freedom of target lesion failure (TLF) at 6-month and up to 36-month.
RESULTS: Over 65 % of patients had lesions requiring 50 mm and 60 mm stents. The follow-up length was up to 24-month for the whole cohort and up to 36-month only for 211 patients from seven selected centers. The freedom from TLF rate was 97.86 %, 97.26 %, 96.27 %, and 95.15 % at 6-, 12-, 24-, and 36-month follow-ups, respectively. The cumulative rates of major adverse cardiac events (MACE) were 2.74 % at 12-month, 3.73 % at 24-month and 4.85 % at 36-month. Additionally, the rates of ischemia-driven target lesion revascularization were 2.01 % at 12-month, 2.16 % at 24-month, and 3.88 % at 36-month. Lastly, stent thrombosis (ST) was reported in only 2 cases (0.97 %) at 36-month.
CONCLUSION: The lower incidences of MACE and ST up to three-year follow-up indicate BioMime™ Morph SES is an effective and safe option for PCI in long CAL.