PARIS: Does DAPT Cessation After PCI Increase Cardiac Risk?

The impact of dual antiplatelet therapy (DAPT) cessation on cardiac risk after PCI is not uniform but varies substantially based on the underlying reasons for cessation, according to the PARIS Study presented on Sept. 1 during the ESC Congress 2013 and simultaneously published in the Lancet.

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The multicenter, multinational, observational study followed 5,031 patients who were discharged on DAPT following implantation of either bare metal or drug-eluting stents for two years. Data show DAPT cessation for any reason increased significantly over the course of two years — from 2.9 percent after 30 days to 57.3 percent at two years. Overall, discontinuation per physician recommendation was the primary reason for cessation (40.8 percent), followed by disruption of DAPT use due to bleeding or non-compliance (14.4 percent) and voluntary, short-term, physician-guided interruption for reasons such as surgery (10.5 percent), respectively. However, study investigators noted that the reasons for cessation varied substantially throughout the two years, with disruption for bleeding or non-compliance the primary reason for cessation during the first 12 months and physician-guided discontinuation taking a substantial lead in the second year.

In terms of major adverse cardiac events (MACE), the overall rate over the two-year period was 11 percent, with most events (74 percent) occurring while patients were taking DAPT. The adjusted hazard ratio (HR) for MACE due to short-term interruption was 1.41 (p=0·10) and to disruption for noncompliance or bleeding was 1.50 (p=0•004). In contrast, patients who discontinued DAPT per their physician had lower MACE risk (0.63). "The overall impact of DAPT cessation on adverse events is modest and may have been mitigated with the introduction of safer stent platforms," the investigators noted.

In a corresponding commentary, Andreas May, MD, from University Hospital Tubingen and Eberhard Karls-University, Germany, writes that the PARIS results on the one hand show "there is adequate safety for patients who complete or temporarily interrupt DAPT in accordance with their physician's recommendation." However, he says, "on the other hand, unanticipated disruptions of antiplatelet therapy put the patient at increased risk and necessitate the best care and alertness by treating physicians."

Moving forward, the study investigators suggest their findings "highlight the need for uniform approaches in classifying DAPT cessation, analogous to those currently used for bleeding and MI."

Keywords: Risk, Drug-Eluting Stents, Patient Discharge, Hemorrhage, Patient Compliance, Stents, Paris

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