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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.

Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

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Background-The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation. Methods and Results-This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], nϭ15, and fast release [FR], nϭ15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28Ϯ0.4 mm) than in the SR group (Ϫ0. 09Ϯ0.23 mm, Pϭ0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had Յ35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33Ϯ0.42 mm [FR] and 0.13Ϯ0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FRϭ 9.90Ϯ9 mm 3 and SRϭ10.35Ϯ9.3 mm 3 ). Conclusions-This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population. Key Words: stents Ⅲ angiography Ⅲ ultrasonics Ⅲ restenosis A new generation of drug-eluting coronary stents designed to limit restenosis has been developed recently. The clinical success of these novel technologies will depend on a complex interaction between stent, coating matrix, drug, and the vessel wall. Stents coated with sirolimus, a natural macrocyclic lactone with immunosuppressive and antiinflammatory action, represented the first successful attempt to abolish restenosis in human coronary arteries. 1-3 A virtual absence of neointimal proliferation was observed 1 year after implantation of sirolimus-eluting Bx Velocity stents in a pilot study. 2 Subsequently, the RAVEL (a RAndomized comparison of a sirolimus-eluting Bx VELocity stent with a standard stent for coronary revascularization) investigators reported an absence of both angiographic restenosis at 6 months and target-lesion revascularization 1 year after the implantation of sirolimus-eluting stents in a multicenter randomized trial. 3 Although encouraging, potential late side effects of these drug-eluting coronary stents may pose limitations. Lessons from intracoronary brachytherapy include the development of late thrombosis and neointimal proliferation that may occur beyond the first year after treatment. 4 -6 In the present study, we evaluated the clinical...

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Background-Despite the proven superiority of sirolimus-eluting stents (SESs) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation. Methods and Results-The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; nϭ15] and fast release [FR; nϭ15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2-and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41Ϯ0.49 mm) than the SR group (0.09Ϯ0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FRϭ9.1% and SRϭ5.7%). Conclusions-This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimuseluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation). Key Words: angiography Ⅲ restenosis Ⅲ stents D rug-eluting stent (DES) implantation is rapidly becoming the prime revascularization strategy for obstructive coronary artery disease because of reduced incidence of in-stent restenosis. 1-3 Despite much enthusiasm, only a few DES devices have proven clinical effectiveness, and longterm data are lacking.Most bioactive agents of DESs alter cell cycle division and have unpredictable long-term effects in the vessel wall. 4 These cellular effects, which may resemble the mechanism of action of radiation therapy, have raised concerns about the safety of the DES beyond the initial years after implantation. In addition, nonbiodegradable polymer coatings, as well as residual medication in some devices, remain on the stent surface in close contact with arterial wall structures and represent a potential source for late inflammation, restenosis, or other side effects. The present study provides a unique opportunity to evaluate clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with sirolimus-eluting stents (SESs) 4 years after implantation. MethodsThe study sample and study protocol have been described previously. 1 In brief, 30 consecutive patients were implanted with a single sirolimus-eluting Bx Velocity stent fro...