IMPORTANCE Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option. OBJECTIVE To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events. DESIGN, SETTING, AND PARTICIPANTS Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019. INTERVENTIONS Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522). MAIN OUTCOMES AND MEASURES The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding. RESULTS Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, −1.34% [95% CI, −2.57% to −0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, −0.55% [95% CI, −1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, −1.13% [95% CI, −1.84% to −0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority). CONCLUSIONS AND RELEVANCE Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations.

Background-We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year. Methods and Results-Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (nϭ30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the Ն50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2Ϯ5% obstruction volume, GIII) and at 12 months (GIϭ2Ϯ5% and GIIϭ2Ϯ3%). Key Words: angiography Ⅲ drugs Ⅲ stents Ⅲ restenosis Ⅲ ultrasonics D espite major technological advances in the past decades, of which the coronary stent is one of the most important, the percutaneous treatment of coronary artery disease is still hampered by a 20% to 30% incidence of restenosis. The list of candidate therapies and devices for prevention of restenosis after angioplasty is long and ever expanding. However, few if any have substantially improved the result of stenting for the treatment of de novo lesions. Intracoronary radiation has so far proven to be effective for the treatment of in-stent restenosis but not for the treatment of de novo lesions. 1 As a result of their ability to deliver prolonged and sufficient intramural drug concentrations to the target coronary segment, drug-eluting stents have emerged as a potential solution for restenosis. Our group has recently reported an almost complete absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting Bx VELOCITY stents. 2 The local release of sirolimus (rapamycin, Rapamune), a natural macrocyclic lactone with potent immunosuppressive action, 3 resulted in elimination of restenosis in this first series of patients. Comparable results have only been observed after the implantation of high-activity ␤-emitting stents (9 mm 3 of neointimal hyperplasia at 6-month follow-up). 4 However, a worrying late progression of in-stent neointimal hyperplasia was observed between 6 months and 1 year after implantation of radioactive stents. 5 Conclusions-This See p 1996The aim of the present investigation was to determine whether sirolimus-eluting stents produce a sustained suppression of the neointimal proliferation over a period of 1 year or merely delay the restenosis process. Methods Study PopulationForty-five patients with nati...

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ClinicalTrials.gov, number NCT01844284.

The results of this prospective multicenter study demonstrate that FD-OCT provides accurate and reproducible quantitative measurements of coronary dimensions in the clinical setting.