Three vs Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents

Abstract

for the OPTIMIZE Trial Investigators IMPORTANCE The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTSThe OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents.INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURESThe primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, −1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short-and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCEIn patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis.

Can Phone-Based Motivational Interviewing Improve Medication Adherence to Antiplatelet Medications After a Coronary Stent Among Racial Minorities? A Randomized Trial

“…However, expert opinion and guidelines, as well as the appropriate length of use of such medications continue to evolve. 52 …”

Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines

“…49 There are a number of on-going trials comparing short duration (3 months) versus standard duration (12 months) of DAPT administration. 50 4. If the patient has received DES for ACS then the recommendations are still that the DAPT (aspirin plus either prasugrel or ticagrelor) be maintained for 12 months, irrespective of DES type; 5.…”

Extended Duration Dual Antiplatelet Therapy and Mortality: A Systematic Review and Meta-Analysis

“…After adding results of the DAPT Study, 14 studies comprising 69,644 subjects were included in our meta-analysis. [1][2][3][11][12][13][14][15][16][17][18][19][20][21] The subject populations enrolled in the trials were as follows: ten trials of subjects with coronary artery disease after percutaneous coronary intervention and/or acute coronary syndrome (1,344 deaths, 42,606 subjects), 3,12,[14][15][16][17][18][19][20][21] one trial of subjects who underwent surgical revascularization for peripheral arterial disease (41 deaths, 851 subjects), 11 one trial of subjects with recent lacunar stroke (190 deaths, 3,020 subjects), 2 one trial of subjects at high risk of atherothrombotic events (745 deaths, 15,603 subjects), 1 and one trial of subjects with atrial fibrillation (1,666 deaths, 7,554 subjects; table 1). 13 All trials were multicenter, randomized, controlled trials with low risk of bias (Appendix, Supplemental Table 5).…”

“…[1][2][3][11][12][13][14][15][16][17][18][19][20][21] All trials evaluated clopidogrel as the sole thienopyridine apart from ARCTIC-Interruption and the DAPT Study, which included both clopidogrel-and prasugreltreated patients (prasugrel use 32% among randomized BMS-and DES-treated subjects in the DAPT Study, and 9% among randomized subjects in ARTIC-Interruption). 2,22 Eight trials compared DAPT to aspirin alone (55,198 subjects), [1][2][3][11][12][13]20,21 of which three trials, DES-LATE, ARCTIC-Interruption, and the DAPT Study compared the continuation of DAPT beyond 12 months to aspirin alone in subjects having already received 12 months or more of DAPT.…”

“…3,20,21 The remaining six trials compared extended duration DAPT to short duration DAPT (12,102 subjects). 12,[14][15][16][17][18] The difference in DAPT duration between study arms in all 14 trials ranged from six months to a median of 43·2 months.…”