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.

Keywords:

• Angina; drug-eluting stents; low-density lipoprotein cholesterol; medication non-adherence; percutaneous coronary intervention; statins

Transparency

Declaration of funding

The OPTIMA and OPTIMA II studies were funded by AstraZeneca Russia.

Declaration of financial/other relationships

Y.Kh. and N.L. have disclosed that they are employees of AstraZeneca Russia. Y.Ka. has disclosed that he has received investigator and lecture fees from AstraZeneca and research grants from Servier and Takeda. D.T. and V.B. have received research grants from AstraZeneca.

CMRO peer reviewer 1 has disclosed that he has received personal fees from AstraZeneca and Pfizer; he has received grants and fees from MDS; personal fees and non-financial support from Abbott, Boehringer Ingelheim, and Eli Lilly, and non-financial support and other fees from GSK. CMRO peer reviewers 2 and 3 have no relevant financial relationships to disclose.

Acknowledgments

The authors would like to acknowledge Kerry Acheson PhD CMPP™ of iMed Comms, an Ashfield Company, part of UDG Healthcare plc for medical writing support that was funded by AstraZeneca Russia. The authors thank the investigators and patients who participated in this study.

Previous presentation: Karpov Yu, Logunova N, Buza V, Tomilova D. The incidence and severity of angina pectoris in patients after elective percutaneous coronary intervention (OPTIMA II). Accepted for poster presentation at the 84th European Atherosclerosis Society Congress, Innsbruck, Austria, 29 May–1 June 2016. Karpov Yu, Logunova N, Buza VV, Tomilova DI. The 4-year follow-up of medications compliance in patients after elective percutaneous coronary intervention (PCI) with drug-eluting stent (DES) (data from OPTIMA II study). Accepted for oral presentation at the symposium of the International Atherosclerosis society, Anitschkow days, St. Petersburg, 2016. Karpov Yu, Logunova N, Buza VV, Tomilova DI. Adherence to lipid-lowering therapy in patients who took statins after elective percutaneous coronary intervention (OPTIMA II). Accepted for poster presentation at the EuroPrevent Congress 2016, Sophia Antipolis, France, 14–15 June 2016. Karpov Yu, Khomitskaya Yu, Buza VV, Tomilova DI. Long-term outcomes after elective percutaneous coronary intervention in patients with stable coronary artery disease who took statins (OPTIMA II). Submitted for presentation at American Heart Association’s scientific session, New Orleans, USA, 12–16 November 2016.