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Analysis of Medtronic's Resolute Stent Shows Safety with Only Six Months of Antiplatelet Therapy
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sMedtronic's Resolute Integrity Drug-Eluting Stent
Medtronic's Resolute Integrity Drug-Eluting Stent
May 31, 2012 -- An analysis of the RESOLUTE US trial, with additional data from the pooled Resolute global clinical program, concluded that there was no sign that patients who stopped taking clopidogrel/ticlopidine and aspirin at six months had any increased risk of clinical safety events or stent thrombosis, when compared to patients who continued on the drugs for 12 and 24 months.

Although the sample size was relatively small, only 158 patients went off Dual AntiPlatelet Therapy (DAPT) at six months vs. 2,419 who stayed on, there were no stent thromboses at all in the short duration cohort.

Thaddeus R. Tolleson, MD, FACC
Thaddeus R. Tolleson, MD, FACC

The study was presented earlier this month at SCAI 2012, the annual meeting of the Society for Cardiovascular Angiography and Interventions, by Thaddeus R. Tolleson, MD, FACC of Tyler Cardiovascular Consultants in Tyler, Texas. The presentation, titled "Clinical Outcomes with 6 Months vs. 12 Months vs. 24 Months Dual Antiplatelet Therapy in Patients Treated With the Resolute Zotarolimus Eluting Stent: Insights from the RESOLUTE US Trial", looked first at patients in the RESOLUTE US Trial. The research team, having found no signal that early cessation of DAPT had any negative effect, expanded the patient population to the entire pooled Resolute program.

However, and this is important, patients with complex anatomy or multiple lesions, long lesions, bifurcation lesions, etc. were excluded -- because it is assumed that these patients are more thrombogenic and would benefit from a full one year course of DAPT.

Although the patient numbers for this analysis are not powered to definitively show a difference in stent thrombosis, it is most interesting that the only stent thromboses in the entire cohort of over 2,000 patients occurred in the patients who were still on DAPT at one year.

The question of how long is "long enough" for dual antiplatelet therapy after drug-eluting stent implantation is one of the major issues affecting both patients and physicians. The concerns over late stent thrombosis with the first generation of drug-eluting stents (Taxus and Cypher) generated a recommendation in 2006 to extend DAPT to one year (the original guideline was for 6 months).

Perhaps, with the second and third generation devices, an entire year of DAPT is not necessary. This change has significant implications for patients because in the Resolute pooled study, fully 90% of patients who discontinued DAPT early did so because of surgical or medical procedures or tests that needed to be performed and that required cessation of blood thinners.

Reported by Burt Cohen, May 31, 2012