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PARIS: Incidence and Impact of Dual Antiplatelet Therapy Cessation On Adverse Cardiac Events Following Percutaneous Coronary Intervention: Two-Year Results from the Patterns of Non-Adherence to Anti-Platelet Regimens In Stented Patients (PARIS) Study



 Presenter abstract | Discussant report | All the Scientific resources on ESC Congress 365

 

Presentation

By Roxana Mehran
Other authors: Usman Baber, USA; Giora Weisz, USA; Annapoorna Kini, USA; Bernhard Witzenbichler, Germany; Tim Henry, USA; Cono Ariti, UK; Samantha Sartori, USA; Kristin Falciglia, USA; Michael Gibson, USA; Mitch Krucoff, USA; Antonio Colombo, Italy; Alaide Chieffo, Italy; David Cohen, USA; David Moliterno, USA ; Gabriel Steg, France; Stuart Pocock,UK
Background:
Dual antiplatelet therapy (DAPT) cessation increases the risk for adverse events following percutaneous coronary intervention (PCI). Whether this risk is uniform over time or varies according to the underlying cause of DAPT cessation in the contemporary PCI era is unknown.
 
Methods:
The PARIS Registry (n=5,031) is a multicenter, multinational observational study of patients receiving PCI with stents and discharged on DAPT. Patients were evaluated for adverse events as well as DAPT cessation at 30-day, 6-month, 1-, and 2-year follow-up.
Pre-specified reasons for DAPT cessation included physician-recommended discontinuation, brief interruption (e.g. for surgery) and disruption (e.g. non-compliance or due to bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated.
We examined the incidence and impact of DAPT cessation on major adverse cardiac events (MACE) using time-updated Cox models adjusted for baseline variables.

Results:
At the 2-year follow-up, the overall incidence of any DAPT cessation was 57.3%.The rates of discontinuation, disruption and interruption were 39.9%, 14.2%, and 11.7%, respectively. The overall 2-year MACE rate was 11.6%, with most events (74%) occurring while patients were on DAPT. However, adjusted hazard ratios (HR [95% CI]) for MACE due to interruption and disruption were 1.46 (0.99 – 2.15; P=0.052) and 1.53 (1.17-2.01; P=0.002), respectively. The risk due to disruption varied by time and attenuated after 30 days (Figure 1). Conversely, recommended discontinuations were associated with a significantly lower MACE risk.
Figure 1: 2-year MACE Risk Associated with Modes of DAPT Cessation Using Time-Updated Covariates
Figure 1: 2-year MACE Risk Associated with Modes of DAPT Cessation Using Time-Updated Covariates

Conclusion:
The risk of MACE events after DAPT cessation post PCI is not uniform but varies by mode, circumstance for cessation, and attenuates over time. While most events following PCI occur among patients on DAPT, the relative risk due to brief interruptions or disruption remain substantial.

Discussant Report

Stephan Windecker
Cessation of antiplatelet therapy is associated with impaired outcome owing to a rebound of platelet aggregation and a prothrombotic state among patients undergoing non-cardiac surgery.
Previous studies in the field were limited by selected patient populations, retrospective assessment of DAPT malcompliance, and imprecise definitions of DAPT cessation camouflaging differences in outcome related to DAPT withdrawal as compared to patient-related risks and clinical circumstances.
The investigator-initiated PARIS registry of 5,018 patients undergoing PCI prospectively defined DAPT cessation according to three types, namely physician-recommended discontinuation, interruption related to surgical procedures with resumption of DAPT within 14 days, and disruption due to bleeding or non-compliance and investigated its impact on 2 year cardiac adverse event rates.
Throughout 2 years, the most frequent mode of DAPT cessation was  physician-guided discontinuation in 41% of patients mostly after one year of DAPT, followed by disruption in 14%  and interruption in 11% of patients. Focussing on ischemic outcomes including cardiac death, spontaneous myocardial infarction and definite or probable stent thrombosis, DAPT disruption was associated with a significant 2-3 fold increased risk, which was most pronounced during the first 7 days after disruption and attenuated over time.
Conversely, physician-guided DAPT discontinuation or brief DAPT interruption were not associated with an increased risk of ischemic adverse events.
Finally, sustained DAPT throughout 2 years was not associated with additional benefit compared to physician-guided DAPT discontinuation.
Strengths of the study include the predefined and standardized DAPT cessation categories with adjudication of adverse events and type of DAPT cessation as well as the all-comer patient enrolment with a high proportion of new generation DES representative of contemporary clinical practice.
Limitations of the study are that  patients on DAPT throughout 2 years were arbitrarily defined as reference group although the optimal DAPT duration balancing long-term ischemic versus bleeding risk is not known; the lack of a cause-effect relationship particularly among patients with DAPT interruption in the context of surgery in whom adverse events may represent an epiphenomenon unrelated to DAPT cessation; and the unclear risk of DAPT cessation in relation to the time elapsed after PCI.
As any important study, PARIS gives rise to several important  questions:

  • During which time window after PCI is the risk related to DAPT disruption the highest and when does it become negligible?
  • What is the optimal duration of DAPT after PCI?
  • What are the risks of DAPT cessation depending on whether a single antiplatelet or both antiplatelet drugs are discontinued?

References


706 - Session Title: PARIS: Incidence and Impact of Dual Antiplatelet Therapy Cessation On Adverse Cardiac Events Following Percutaneous Coronary Intervention: Two-Year Results from the Patterns of Non-Adherence to Anti-Platelet Regimens In Stented Patients (PARIS) Study

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.