Original title: 6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug. Reference: Eluting Stents in Patients Nonresistant to Aspirin The Randomized, Multicenter ITALIC Trial. JACC.VOL. 65, NO. 8, 2015
Current recommendations on dual antiplatelet therapy (DAPT) are under review, particularly in acute coronary events due largely to the advent of second-generation stents. This work studied the hypothesis that DAPT for 6 months (brief) will be non-inferior to 24 months (long) in terms of results and safety. A randomize, multicenter study with 1850 patients (2031 enrolled less 181 excluded) in any clinical situation except when primary TCA and TCA of LCA was performed. They were divided into two branches: those receiving the brief DAPT versus those received for 24 months. Patients showing resistance to ASA (6.8%) were excluded according to various methods. Also the only stent used was the Xience V.
The primary endpoint was a composite of death, MI, urgent target vessel revascularization, stroke, and major bleeding until 12 months after angioplasty. The secondary endpoints were the analysis of the above events between 24 and 36 months as well as the individual analysis of all events used in the primary endpoint, incidence of minor and minimal bleeding at 12, 24 and 3 months.
There were no significant differences in the characteristics of the randomized population or procedures. It was possible to demonstrate noninferiority of brief DAPT versus long as there was no significant difference in the primary endpoint (24 months: 1.5% versus 6 months: 1.6% p = 0.85). There were no differences regarding stent thrombosis or bleeding. Also these results were independent of the clinical situation (44% of ACS).
Conclusion
The rates of bleeding or thrombotic complications were statistically similar for brief DAPT versus long in patients who respond to ASA.
Editorial comment
This study supports the conclusions in several randomized studies and positions the treatment of DAPT for 6 months both in patients with stable coronary disease and STSEACS (stands that were up 24.2% of patients in the DAPT for 6 months branch who abandoned treatment before the deadline). Unfortunately patients with STEMI and TCA of LCA were not included, probably because they could have acted as confounding factors as dual antiplatelet therapy would be indicated by the mere fact of AMI, ej., prevention of recurrent ischemic spontaneous events (plus thrombosis intrastent) and the lack of evidence in the lesions of TCA. Moreover, this study was strict rule AAS resistance, then what happens to patients real life in which no routine is tested resistance to it?
Courtesy Dr. Santiago Alonso and Dr. Pablo Vazquez.
Centro Cardiológico Americano. Sanatorio Americano.
Montevideo, Uruguay.
Dr. Santiago Alonso y Dr. Pablo Vázquez.