Observational Prospective study to esTIMAte the rates of outcomes in patients undergoing PCI with drug-eluting stent implantation who take statins –follow-up (OPTIMA II)

Abstract

Objective: The OPTIMA II study sought to evaluate rates of major adverse cardiac and cerebrovascular events (MACCEs) during the long-term follow-up of chronic statin users who underwent percutaneous coronary intervention (PCI) with implantation of a drug-eluting stent (DES).Research design and methods: OPTIMA II was a non-interventional, observational study conducted at a single center in the Russian Federation. Included patients were aged ≥18 years with stable angina who had received long-term (≥1 month) statin therapy prior to elective PCI with DES implantation and who had participated in the original OPTIMA study. Patients received treatment for stable angina after PCI as per routine study site clinical practice. Study data were collected from patient medical records and a routine visit 4 years after PCI.Clinical trial registration: NCT02099565.Main outcome measures: Rate of MACCEs 4 years after PCI.Results: Overall, 543 patients agreed to participate in the study (90.2% of patients in the original OPTIMA study). The mean (± standard deviation [SD]) duration of follow-up from the date of PCI to data collection was 4.42 ± 0.58 (range: 0.28–5.56) years. The frequency of MACCEs (including data in patients who died) was 30.8% (95% confidence interval: 27.0–34.7); half of MACCEs occurred in the first year of follow-up. After PCI, the majority of patients had no clinical signs of angina. Overall, 24.3% of patients discontinued statin intake in the 4 years after PCI. Only 7.7% of patients achieved a low-density lipoprotein (LDL) cholesterol goal of <1.8 mmol/L. Key limitations of this study related to its observational nature; for example, the sample size was small, the clinical results were derived from outpatients and hospitalized medical records, only one follow-up visit was performed at the end of the study (after 4 years’ follow-up), only depersonalized medical information was made available for statistical analysis, and adherence to statin treatment was evaluated on the basis of patient questionnaire.Conclusions: Long-term follow-up of patients who underwent PCI with DES implantation demonstrated MACCEs in nearly one-third of patients, which is comparable to data from other studies. PCI was associated with relief from angina or minimal angina frequency, but compliance with statin therapy and the achievement of LDL cholesterol targets 4 years after PCI were suboptimal.