Skip to main content

Advertisement

Log in

Incidence, predictors, and outcomes of DAPT disruption due to non-compliance vs. bleeding after PCI: insights from the PARIS Registry

  • Original Paper
  • Published:
Clinical Research in Cardiology Aims and scope Submit manuscript

Abstract

Background

The disruption of dual antiplatelet therapy (DAPT) due to non-compliance or bleeding is known to significantly increase the risk of adverse outcomes after percutaneous coronary intervention (PCI). However, it is currently unknown if there are differences in the predictors and clinical impact of disruption due to non-compliance compared with bleeding.

Methods

The patterns of non-adherence to antiplatelet regimens in stented patients (PARIS) registry was an international, multicenter prospective study of PCI patients discharged on DAPT (aspirin + a P2Y12 receptor). We analyzed the incidence, patient characteristics, predictors, and outcomes in patients with DAPT disruption due to non-compliance as compared to DAPT disruption due to bleeding in the PARIS registry. Predictors of non-recommended disruption and bleeding disruption were assessed using logistic regression. Risks associated with disruption on major adverse cardiac events (MACE, a composite of cardiac death, definite or probable stent thrombosis, spontaneous myocardial infarction, and target lesion revascularization) were analyzed using time-updated Cox regression over 2-year follow-up.

Results

Out of 5018 patients, the rate of non-compliant DAPT disruption was 1.6% at 30 days (n = 79), 6.5% at 12 months (n = 328), and 9.1% at 2 years from PCI (n = 457). The rate of bleeding DAPT disruption was 0.6% at 30 days (n = 32), 3.1% at 12 months (n = 156), and 4.6% at 2 years (n = 229). Multivariate predictors of non-compliant disruption included female gender, history of smoking, acute coronary syndrome, and US patients which were associated with greater risk; and dyslipidemia and discharge PPI which were associated with lower risk. Multivariate predictors of bleeding disruption included older age, prior MI, and discharge warfarin which were associated with greater risk; and US region and intervention to the LAD which were associated with lower risk. Non-compliant disruption was associated with a significantly greater risk for MACE (HR 1.73, 95% CI 1.17–2.54, p = 0.006) and spontaneous myocardial infarction (HR 2.93, 95% CI 1.85–4.65, p < 0.001). Bleeding disruption was associated with a significantly greater risk for all-cause death (HR 1.93, 95% CI 1.22–3.08, p = 0.005).

Conclusion

Approximately 1 in 10 patients disrupts DAPT due to non-compliance and 1 in 20 disrupts DAPT due to bleeding. Disruption due to non-compliance resulted in higher risk for ischemic events and disruption due to bleeding had higher subsequent mortality. These data warrant efforts to focus on patient education in those at high risk of non-compliance.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Brown MT, Bussell JK (2011) Medication adherence: WHO cares? Mayo Clin Proc 86:304–314

    Article  PubMed  PubMed Central  Google Scholar 

  2. De Geest S, Sabate E (2003) Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs 2:323

    Article  PubMed  Google Scholar 

  3. Lee JK, Grace KA, Taylor AJ (2006) Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA 296:2563–2571

    Article  CAS  PubMed  Google Scholar 

  4. Osterberg L, Blaschke T (2005) Adherence to medication. N Engl J Med 353:487–497

    Article  CAS  Google Scholar 

  5. Tarn DM, Heritage J, Paterniti DA, Hays RD, Kravitz RL, Wenger NS (2006) Physician communication when prescribing new medications. Arch Intern Med 166:1855–1862

    Article  PubMed  Google Scholar 

  6. Duerschmied D, Brachmann J, Darius H, Frey N, Katus HA, Rottbauer W, Schäfer A, Thiele H, Bode C, Zeymer U (2018) Antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: should we change our practice after the PIONEER AF-PCI and RE-DUAL PCI trials? Clin Res Cardiol 107(7):533–538. https://doi.org/10.1007/s00392-018-1242-2 PMID: 29679144

    Article  CAS  PubMed  Google Scholar 

  7. Lee SY, Hong MK, Shin DH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kim HS, Valgimigli M, Palmerini T, Stone GW (2017) Clinical outcomes of dual antiplatelet therapy after implantation of drug-eluting stents in patients with different cardiovascular risk factors. Clin Res Cardiol 106(3):165–173. https://doi.org/10.1007/s00392-016-1035-4 PMID: 27631821

    Article  CAS  PubMed  Google Scholar 

  8. Airoldi F, Colombo A, Morici N et al (2007) Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation 116:745–754

    Article  CAS  PubMed  Google Scholar 

  9. Giustino G, Baber U, Sartori S et al (2015) Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol 65:1298–1310

    Article  CAS  PubMed  Google Scholar 

  10. Mehran R, Baber U, Steg PG et al (2013) Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet 382:1714–1722

    Article  PubMed  Google Scholar 

  11. Cutlip DE, Windecker S, Mehran R et al (2007) Clinical end points in coronary stent trials—a case for standardized definitions. Circulation 115:2344–2351

    Article  Google Scholar 

  12. Thygesen K, Alpert JS, White HD et al (2007) Universal definition of myocardial infarction. Eur Heart J 28:2525–2538

    Article  PubMed  Google Scholar 

  13. Mehran R, Rao SV, Bhatt DL et al (2011) Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the bleeding academic research consortium. Circulation 123:2736–2144

    Article  PubMed  Google Scholar 

  14. Stone GW, McLaurin BT, Cox DA et al (2006) Bivalirudin for patients with acute coronary syndromes. New Engl J Med 355:2203–2216

    Article  CAS  PubMed  Google Scholar 

  15. Biondi-Zoccai G, Frati G, Abbate A (2015) Noncompliance and cessation of dual antiplatelet therapy after coronary stenting looking at the speck rather than noticing the log? Jacc-Cardiovasc Inte 8:411–413

    Article  Google Scholar 

  16. Mauri L, Kereiakes DJ, Yeh RW et al (2014) Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. New Engl J Med 371:2155–2166

    Article  CAS  PubMed  Google Scholar 

  17. McFadden EP, Stabile E, Regar E et al (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 364:1519–1521

    Article  CAS  PubMed  Google Scholar 

  18. Dauerman H, Stoler R, Kereiakes D, Mauri L, Cutlip D, Grp ES (2013) Thrombosis, bleeding and DAPT non-adherence in the EDUCATE registry. Eur Heart J 34:877–877

    Article  Google Scholar 

  19. Grines CL, Bonow RO, Casey DE et al (2007) Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents. J Am Coll Cardiol 49:734–739

    Article  CAS  PubMed  Google Scholar 

  20. Yu AP, Yu YF, Nichol MB, Gwadry-Sridhar F (2008) Delay in filling the initial prescription for a statin: a potential early indicator of medication nonpersistence. Clin Ther 30:761–774

    Article  PubMed  Google Scholar 

  21. Prochaska JH, Göbel S, Nagler M, Knöpfler T, Eggebrecht L, Lamparter H, Panova-Noeva M, Keller K, Coldewey M, Bickel C, Lauterbach M, Hardt R, Espinola-Klein C, Ten Cate H, Rostock T, Münzel T, Wild PS (2018) Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure. Clin Res Cardiol. https://doi.org/10.1007/s00392-018-1293-4 (PMID: 29948286; epub ahead of print)

    Article  PubMed  Google Scholar 

  22. Richardt G, Maillard L, Nazzaro MS, Abdel-Wahab M, Carrié D, Iñiguez A, Garot P, Abdellaoui M, Morice MC, Foley D, Copt S, Stoll HP, Urban P (2018) Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. Clin Res Cardiol. https://doi.org/10.1007/s00392-018-1308-1 (PMID:29951803; epub ahead of print)

    Article  PubMed  Google Scholar 

  23. Benner JS, Chapman RH, Petrilla AA, Tang SSK, Rosenberg N, Schwartz JS (2009) Association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy. Am J Health-Syst Ph 66:1471–1477

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Roxana Mehran.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Moalem, K., Baber, U., Chandrasekhar, J. et al. Incidence, predictors, and outcomes of DAPT disruption due to non-compliance vs. bleeding after PCI: insights from the PARIS Registry. Clin Res Cardiol 108, 643–650 (2019). https://doi.org/10.1007/s00392-018-1392-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-018-1392-2

Keywords

Navigation