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Duration of Dual Antiplatelet therapy for DES

The following useful summary of recent trial regarding duration of antiplatelet therapy for drug eluting stents. The material has kindly been provided by E Blattman from Abbott Vascular. The information is from peer reviewed literature and is posted as important information. The information is publicly available and from peer reviewed literature.

From E Blattman

Here is a link directly to the published article in the New England Journal of Medicine (Mauri):

http://www.nejm.org/doi/full/10.1056/NEJMoa1409312

Link to associated editorial (Colombo and Cheiffo):

http://www.nejm.org/doi/full/10.1056/NEJMe1413297

Medscape summary:

http://www.medscape.com/viewarticle/835006

The primary results of the largest randomized DAPT study were presented at AHA in a Late-Breaking Clinical Trial Session by Dr. Laura Mauri of the Harvard Clinical Research Institute (HCRI)

The HCIR DAPT study is to be used by the FDA to make policy and the FDA have already reacted to these results with a statement to the press (http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm).

1. HCRI DAPT Study – DES Primary Results, N=9,961 (Mauri)

Trial Design:

· Independent, multi-centre study, patients randomized according to site, thienopyridine drug type, and presence of risk factors for ST

· Objective: To determine the optimal DAPT duration following stent implantation

· 12 Month run in for both arms with people with events in this timeframe excluded from the trial..

· 1:1 randomization of 12 vs. 30 month DAPT; Patients followed for an additional 3 months after DAPT discontinuation (33 months total) to assess possible rebound effect

· DES: XIENCE/Promus (47.2%), Taxus (26.8%), Endeavor (12.7%), Cypher (11.2%)

· Drugs: Plavix (65.3%) or Prasugrel (34.7)

· Co-Primary Effectiveness Endpoints:

o ARC Def/Prob ST at 12-30 months post-procedure

o MACCE (death, MI or stroke) at 12-30 months post-procedure

· Primary Safety Endpoint: Moderate or severe bleeding at 12-30 months post-procedure

· Interruption was allowed for up to 14 days.

Key Results:

All DES Results, n=9,961:

· Primary Safety endpoint results:

o Def/Prob Stent Thrombosis: 0.4% for the 30-month DAPT arm and 1.4% for the 12-month arm, p<0.001

o MACCE:4.3% for the 30-month DAPT arm and 5.9% for the 12-month arm, p <0.001

§ MI: 2.1% for 30-month arm and 4.1% for 12 month arm, p<0.001

§ Death: 2.0% for 30-month arm and 1.5% for 12-month arm, p=0.05

· Primary Efficacy Endpoint results – Rate of Moderate/Severe Bleeding:2.5% for 30-month arm and 1.6% for 12-month arm, p=0.001

· All primary endpoints statically in favour of 30 month DAPT vs 12 month DAPT with the secondary endpoint of bleeding being less with 12 month DAPT as expected but there was no difference in fatal or severe bleeds as a combined endpoint.

· More Deaths in the 30 month DAPT but this was due to play of chance in the randomization with 8 Cancer patients in the 30 month arm and 1 Cancer patient in the 12 month arm.

CoCr EES Results, n=4,703:

· Primary Safety endpoint results:

o Def/Prob Stent Thrombosis: 0.3% for the 30-month DAPT arm and 0.7% for the 12-month arm

o MACCE:4.3% for the 30-month DAPT arm and 4.5% for the 12-month arm

· These subgroup analyses were not powered and between stent comparisons were not adjusted.*

DAPT Study reaffirms that Xience (EES) is the best choice when it comes to metallic stents. Xience has proven, trial after trial, consistently low ST rates, which was shown again in DAPT study.

This study does raise the question that when a patient receives a permanent metallic implant, there is an ongoing benefit of longer-term DAPT for at least 30 months

SECONDARY ANALYSIS – Is BMS safer?

Dr. Dean Kereiakes (co-author of the DAPT trial) also presented data from a secondary analysis of the DAPT trial at AHA. I have included the link to the Medscape summary for you. This analysis focused on the comparison of how the DES patient population compared to the BMS patient population in the DAPT trial and it showed that drug-eluting stents (DES) are not associated with increased rate of stent thrombosis or major ischemic events compared with bare-metal stents, according to the results of a propensity analysis based on the DAPT study.

http://www.medscape.com/viewarticle/835157#vp_1

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