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Pragmatic Use of Rosuvastatin and DAPT in ACS
Patients Journey
 Place of DAPT in ACS
 Duration of DAPT
 Patient profile for DAPT+Statin
 Benefit of fixed dose combination - DAPT and Statin
 Real-world experience of DAPT+Statin fixed dose combination
 Barriers for optimal management of dyslipidemia
Overview
Guideline recommendation on
antithrombotic drugs in STEMI and NSTEMI
Use of antithrombotic drugs in patients undergoing PCI
Neumann FJ, et al. Eur Heart J. 2019 Jan 7;40(2):87-165.
STEMI
Treatment Indication
(Pre-) Treatment DAPT
Time
1 month
3 months
6 months
12 months
30 months
36 months
DAPT
Duration
A
No Yes
฀
12 months DAPT
A C
A P
A T
or
or
A T or
A P A C
DAPT >12 months
A T
or
A C
6 months DAPT
High Bleeding Risk
A
T
C
Aspirin
Clopidogrel
Prasugrel
Ticagrelor
Antiplatelet drugs :
T P C
STEMI
P
Antithrombotic therapy in non-ST-segment elevation ACS patients
Collet JP, et al.Eur Heart J. 2021 Apr 7;42(14):1289-1367.
NSTE-ACS
NSTE-ACS
Recommendations for duration of DAPT in
patients who undergo elective PCI
Recommendations for duration of DAPT in patients who
undergo elective PCI
Mehta SR, et al. Can J Cardiol. 2018 Mar;34(3):214-233.
Elective PCI
Extend DAPT up
to 3 years
SAPT
SAPT
DAPT for 1 month if BMS,
or 3 months if DES
Not at high risk of bleeding1 High risk of bleeding1
DAPT for 6 months
ASA + clopidogrel
High-risk clinical or angiographic features for
thrombotic CV events2, and not at high risk of
bleeding?1
Yes No
Strongrecommendation
Weak recommendation
Recommendations for duration of DAPT in
patients with ACS who undergo PCI
Recommendations for duration of DAPT in patients with ACS who
undergo PCI
Mehta SR, et al. Can J Cardiol. 2018 Mar;34(3):214-233.
PCI for STEMI or NSTEACS
At 1 year, determine bleeding risk
Strong
recommendation
Weak recommendation
Continue DAPT for up to 3 years
ASA 81 mg once daily +
Ticagrelor 60 mg BID or
Clopidogrel 75 mg once daily2
SAPT
ASA 81 mg once daily
or
Clopidogrel 75 mg once daily
Not at high risk of bleeding1 High risk of bleeding1
DAPT for 1 year
ASA 81 mg once daily +
Ticagrelor 90 mg BID or Prasugrel 10 mg once daily
preferred over Clopidogrel 75 mg once daily
1 Factors associated with increased bleeding risk include:need for OAC in addition to DAPT, advanced age (> 75 years), frailty, anemia with hemoglobin< 110 g/dL,
chronic renal failure (creatinine clearance < 40 mL/min), low body weight (< 60 kg),hospitalization for bleeding within last year, prior stroke/intracranical
bleed, regular need for NSAIDS or prednisone
2 Instead of ticagrelor or clopidogrel,prasugrel 5-10 mg daily is also an option (weak recommendation)
Benefit of DAPT score to assess the
risk and duration of DAPT therapy
DAPT Duration
XX
Standard DAPT: 12 months
Shorter DAPT: 1, 3 or 6 months
Prolonged DAPT: 24 or 36 months
Gargiulo, Giuseppe, et al. "State of the art: duration of dual antiplatelet therapy after ercutaneous coronary intervention and coronary stent implantation-past,
present and future perspectives." EuroIntervention 13.6 (2017): 717-733.
Patient profiles for the extended DAPT
therapy
Clinical characteristics that may benefit from extended duration of DAPT
Howard CE, et al. J Am Heart Assoc. 2019;8(20):e012639.
• ACS presentation/prior ACS event
• Peripheral arterial disease
• Diabetes mellitus
• Renal dysfunction
• Current cigarette use
• Left ventricular ejection fraction
<30%
• Congestive heart failure
• Increased procedure complexity
• Stent diameter <3 mm
• Vein graft PCI
• High CAD burden
• Older‐generation stents
Patient profiles for the statin therapy
ESC 2019Treatmentgoals for (LDL-C) across categories of
total CV diseaserisk
2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (European Heart Journal 2019 -doi: 10.1093/eurheartj/ehz455)
Low
Moderate
High
Very-High
116mg/dL)
Treatmentgoal
forLDL-C
100mg/dL)
70mg/dL)
55mg/dL
& ≥50%
reduction
frombaseline
Low Moderate High very-High CVRisk
•SCORE<1%
Young patients(T1DM<35years;T2DM<50years) with
DMduration <10years without otherrisk factors
•SCORE≥5%and<10%
•Markedlyelevatedsingleriskfactors,inparticular TC>8mmol/L(310
mg/dL)orLDL-C>4.9mmol/L(190mg/dL)orBP≥180/110mmHg
•FHwithoutothermajorrisk factors
•ModerateCKD(eGFR30–59mL/min)
•DMw/otargetorgandamage,withDMduration≥10
yearsorotheradditional riskfactor
•ASCVD
•FHwithASCVDorwithanother majorriskfactor
•SevereCKD(eGFR<30mL/min)
•DM&targetorgandamage:≥3 majorriskfactors;
orearlyonsetof T1DMoflongduration(>20years)
New LDL-C and non-HDL-C treatment goals & Risk Category – LAI 2022
Non-adherence to DAPT + Statin and increase CV
mortality
Benefit of fixed dose combination therapy in ACS
Clinical benefit of DAPT + Statin
combination in long term survival benefit
J Vasc Surg 2018;67:279-86
ASPIRIN, CLOPIDOGREL, AND STATIN COMBINATIONS
PROVIDES LONG TERM SURVIVAL BENEFIT
DAPT plus statin therapy had improved survival
79% compared with those receiving non-
combination or no therapy
Indian data on patient profile, preference
of fixed dose combination DAPT plus Stain
and duration in ACS
•1548 patients with mean age of 57.4
years
Total no. of subjects:
•HTN 1395 (90.1)
•DM 847 (54.7)
•Heart failure 562 (36.3)
•Recurrent ACS 256 (16.5)
•Stroke 113 (7.3)
Percentage of
patient with ACS
& comorbidities
The Majority of the ACS patient were in the age group of
40-60 years
Heart India 2021;9:161-8.
The Majority of the ACS patient were on Triple Drug Therapy of
Rosuvastatin ,Clopidogrel,Aspirin for 6-12 Months and >12 month
78.8% and 78.1% of patients were receiving triple FDC
of rosuvastatin, clopidogrel, and aspirin
Heart India 2021;9:161-8.
Barriers for optimal management of
dyslipidemia post ACS
Barriers to optimal dyslipidaemia management post ACS
Reda A, et al. Adv Ther. 2020;37(5):1754-1777.
• Dyslipidemia control post ACS is suboptimal.
• High prevalence of CVD risk factors confers a higher risk of CVD.
• ACS onset is often earlier in these patients, and they may be more
challenging to treat
•Low awareness of the value of intensive lipid lowering
•Patients non-adherence to given medication
•Fear of side effect
•
• Lack of follow-up of patients with ACS
•Poor access to intensive medications
•Economical factors
Factors which limit the effective use of
statin
Factors That limits the effective use of Statin
Data on file - In Publication
Ø Combination of DAPT and statins was effective and well-tolerated and may improve
treatment compliance and tolerability.
Ø Triple fixed-dose combination therapy of aspirin, clopidogrel, and rosuvastatin was the
most preferred choice of physicians, for optimal management post-ACS patient in Indian
setting.
Ø Rosuvastatin was preferred statin choice with DAPT.
Heart India 2021;9:161-8.
Conclusion
Thank you

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DAPT & Statin Fixed dose combination.pptx

  • 1. Pragmatic Use of Rosuvastatin and DAPT in ACS Patients Journey
  • 2.  Place of DAPT in ACS  Duration of DAPT  Patient profile for DAPT+Statin  Benefit of fixed dose combination - DAPT and Statin  Real-world experience of DAPT+Statin fixed dose combination  Barriers for optimal management of dyslipidemia Overview
  • 3. Guideline recommendation on antithrombotic drugs in STEMI and NSTEMI
  • 4. Use of antithrombotic drugs in patients undergoing PCI Neumann FJ, et al. Eur Heart J. 2019 Jan 7;40(2):87-165. STEMI Treatment Indication (Pre-) Treatment DAPT Time 1 month 3 months 6 months 12 months 30 months 36 months DAPT Duration A No Yes ฀ 12 months DAPT A C A P A T or or A T or A P A C DAPT >12 months A T or A C 6 months DAPT High Bleeding Risk A T C Aspirin Clopidogrel Prasugrel Ticagrelor Antiplatelet drugs : T P C STEMI P
  • 5. Antithrombotic therapy in non-ST-segment elevation ACS patients Collet JP, et al.Eur Heart J. 2021 Apr 7;42(14):1289-1367. NSTE-ACS NSTE-ACS
  • 6. Recommendations for duration of DAPT in patients who undergo elective PCI
  • 7. Recommendations for duration of DAPT in patients who undergo elective PCI Mehta SR, et al. Can J Cardiol. 2018 Mar;34(3):214-233. Elective PCI Extend DAPT up to 3 years SAPT SAPT DAPT for 1 month if BMS, or 3 months if DES Not at high risk of bleeding1 High risk of bleeding1 DAPT for 6 months ASA + clopidogrel High-risk clinical or angiographic features for thrombotic CV events2, and not at high risk of bleeding?1 Yes No Strongrecommendation Weak recommendation
  • 8. Recommendations for duration of DAPT in patients with ACS who undergo PCI
  • 9. Recommendations for duration of DAPT in patients with ACS who undergo PCI Mehta SR, et al. Can J Cardiol. 2018 Mar;34(3):214-233. PCI for STEMI or NSTEACS At 1 year, determine bleeding risk Strong recommendation Weak recommendation Continue DAPT for up to 3 years ASA 81 mg once daily + Ticagrelor 60 mg BID or Clopidogrel 75 mg once daily2 SAPT ASA 81 mg once daily or Clopidogrel 75 mg once daily Not at high risk of bleeding1 High risk of bleeding1 DAPT for 1 year ASA 81 mg once daily + Ticagrelor 90 mg BID or Prasugrel 10 mg once daily preferred over Clopidogrel 75 mg once daily 1 Factors associated with increased bleeding risk include:need for OAC in addition to DAPT, advanced age (> 75 years), frailty, anemia with hemoglobin< 110 g/dL, chronic renal failure (creatinine clearance < 40 mL/min), low body weight (< 60 kg),hospitalization for bleeding within last year, prior stroke/intracranical bleed, regular need for NSAIDS or prednisone 2 Instead of ticagrelor or clopidogrel,prasugrel 5-10 mg daily is also an option (weak recommendation)
  • 10. Benefit of DAPT score to assess the risk and duration of DAPT therapy
  • 11. DAPT Duration XX Standard DAPT: 12 months Shorter DAPT: 1, 3 or 6 months Prolonged DAPT: 24 or 36 months Gargiulo, Giuseppe, et al. "State of the art: duration of dual antiplatelet therapy after ercutaneous coronary intervention and coronary stent implantation-past, present and future perspectives." EuroIntervention 13.6 (2017): 717-733.
  • 12. Patient profiles for the extended DAPT therapy
  • 13. Clinical characteristics that may benefit from extended duration of DAPT Howard CE, et al. J Am Heart Assoc. 2019;8(20):e012639. • ACS presentation/prior ACS event • Peripheral arterial disease • Diabetes mellitus • Renal dysfunction • Current cigarette use • Left ventricular ejection fraction <30% • Congestive heart failure • Increased procedure complexity • Stent diameter <3 mm • Vein graft PCI • High CAD burden • Older‐generation stents
  • 14. Patient profiles for the statin therapy
  • 15. ESC 2019Treatmentgoals for (LDL-C) across categories of total CV diseaserisk 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (European Heart Journal 2019 -doi: 10.1093/eurheartj/ehz455) Low Moderate High Very-High 116mg/dL) Treatmentgoal forLDL-C 100mg/dL) 70mg/dL) 55mg/dL & ≥50% reduction frombaseline Low Moderate High very-High CVRisk •SCORE<1% Young patients(T1DM<35years;T2DM<50years) with DMduration <10years without otherrisk factors •SCORE≥5%and<10% •Markedlyelevatedsingleriskfactors,inparticular TC>8mmol/L(310 mg/dL)orLDL-C>4.9mmol/L(190mg/dL)orBP≥180/110mmHg •FHwithoutothermajorrisk factors •ModerateCKD(eGFR30–59mL/min) •DMw/otargetorgandamage,withDMduration≥10 yearsorotheradditional riskfactor •ASCVD •FHwithASCVDorwithanother majorriskfactor •SevereCKD(eGFR<30mL/min) •DM&targetorgandamage:≥3 majorriskfactors; orearlyonsetof T1DMoflongduration(>20years)
  • 16. New LDL-C and non-HDL-C treatment goals & Risk Category – LAI 2022
  • 17. Non-adherence to DAPT + Statin and increase CV mortality Benefit of fixed dose combination therapy in ACS
  • 18.
  • 19. Clinical benefit of DAPT + Statin combination in long term survival benefit
  • 20. J Vasc Surg 2018;67:279-86 ASPIRIN, CLOPIDOGREL, AND STATIN COMBINATIONS PROVIDES LONG TERM SURVIVAL BENEFIT DAPT plus statin therapy had improved survival 79% compared with those receiving non- combination or no therapy
  • 21. Indian data on patient profile, preference of fixed dose combination DAPT plus Stain and duration in ACS
  • 22. •1548 patients with mean age of 57.4 years Total no. of subjects: •HTN 1395 (90.1) •DM 847 (54.7) •Heart failure 562 (36.3) •Recurrent ACS 256 (16.5) •Stroke 113 (7.3) Percentage of patient with ACS & comorbidities The Majority of the ACS patient were in the age group of 40-60 years Heart India 2021;9:161-8.
  • 23. The Majority of the ACS patient were on Triple Drug Therapy of Rosuvastatin ,Clopidogrel,Aspirin for 6-12 Months and >12 month 78.8% and 78.1% of patients were receiving triple FDC of rosuvastatin, clopidogrel, and aspirin Heart India 2021;9:161-8.
  • 24. Barriers for optimal management of dyslipidemia post ACS
  • 25. Barriers to optimal dyslipidaemia management post ACS Reda A, et al. Adv Ther. 2020;37(5):1754-1777. • Dyslipidemia control post ACS is suboptimal. • High prevalence of CVD risk factors confers a higher risk of CVD. • ACS onset is often earlier in these patients, and they may be more challenging to treat •Low awareness of the value of intensive lipid lowering •Patients non-adherence to given medication •Fear of side effect • • Lack of follow-up of patients with ACS •Poor access to intensive medications •Economical factors
  • 26. Factors which limit the effective use of statin
  • 27. Factors That limits the effective use of Statin Data on file - In Publication
  • 28. Ø Combination of DAPT and statins was effective and well-tolerated and may improve treatment compliance and tolerability. Ø Triple fixed-dose combination therapy of aspirin, clopidogrel, and rosuvastatin was the most preferred choice of physicians, for optimal management post-ACS patient in Indian setting. Ø Rosuvastatin was preferred statin choice with DAPT. Heart India 2021;9:161-8. Conclusion