Key Takeaway

This interim analysis of PERI-DYS study* conducted in Germany compared 1-year outcomes of patients with dyslipidemia and very high CV risk, who received PCSK9i treatment vs those eligible for but did not receive PCSK9i, and showed that:

Median LDL-C
LDL-C at goal <55 mg/dL		 PCSK9i
64.4 mg/dL 40.4%		 No PCSK9i
76.6 mg/dL 21.2%

 

Low achievement of LDL-C goals was due to infrequent LLT intensification

 

Why This Matters

  • PERI-DYS study compared patients at very high CV risk treated with PCSK9i vs those eligible for but did not receive PCSK9i, exploring differences and subsequent treatment patterns
  • Interim analysis reported changes in LDL-C levels and factors associated with treatment intensification 12 months after patient enrollment

Study Design

STUDY TYPE

  • Prospective, open-label, noninterventional study (NCT03110432; at 70 sites in Germany)

STUDY POPULATION

  • Patients with dyslipidemia and very high CV risk (N = 1,713)

Key Results

Mean age
63.4 years (± 11.5)

Sex
35% women

Baseline characteristics

Parameter PCSK9i
(n = 810)		 No PCSK9i
(n = 903)
Age, years 62 ± 10 64 ± 12
CHD, % 74 68
Untreated LDL-C, mg/dL 201 179
Statin intolerance, % 67.3 15.3

Patients treated with PCSK9i vs not treated with PCSK9i were:

  • Younger
  • More likely to have:
    – CHD
    – Higher untreated LDL-C
    – Statin intolerance

Median LDL-C at 1 year:
PCSK9i vs no PCSK9i


Lower median LDL-C level was seen in patients on PCSK9i vs those not on PCSK9i

LDL-C at goal <55 mg/dL
at 1 year: PCSK9i vs no PCSK9i


LDL-C at goal <55 mg/dL in more patients on PCSK9i vs those not on PCSK9i

LDL-C (<55 mg/dL) goal achievement in patients receiving PCSK9i + statin
at baseline vs PCSK9i only vs statin only at 1 year

Patients on PCSK9i + statin at baseline showed highest LDL-C goal achievement (<55 mg/dL) vs patients only on PCSK9i or only on statin

Proportion of patients having unchanged LLT
vs those having modified therapy at 1 year

PATIENTS WITH MODIFIED THERAPY
  PCSK9i No PCSK9i
Intensification of therapy 7% 19%
PCSK9i
Add-on
Discontinuation
0%
6%
4%
0%
Statin
Add-on
Discontinuation
4%
3%
3%
4%
Statin intensity increase 2% 8%
Ezetimibe
Add-on
Discontinuation
3%
4%
7%
3%

Results from multivariate model

High LDL-C (e.g., 100–119 mg/dL) was significantly associated with LLT intensification (OR = 2.3)

Conversely, following were statistically significant factors with less likelihood for LLT intensification:

Older age
60+ years; OR = 0.7

Ezetimibe at baseline
OR = 0.7

Statin intolerance at baseline
OR = 0.7

*Prospective, open-label, non-interventional.

ABBREVIATIONS:
CHD, coronary heart disease; CV, cardiovascular; LDL-C, low-density lipoprotein-cholesterol; LLT, lipid-lowering therapy; OR, odds ratio; PCSK9, proprotein convertase subtilisin/kexin type 9; PCSK9i, protein convertase subtilisin/kexin type 9 inhibitor.

    Parhofer KG, et al. Management of patients with very high cardiovascular risk eligible for PCSK9 inhibitor treatment: 1-year outcomes of the PERI-DYS study (Poster number: SS119/#332). Presented at the 91st European Atherosclerosis Society Congress (EAS 2023) on May 23, 2023.

MAT-KW-2300338/V1/OCT2023