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Objectives The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up. Background The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up. Methods The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion–related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat. Results Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031). Conclusions Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486)

The aim of this study was to investigate the optimal strategy for antiplatelet therapy in patients with lower extremity peripheral artery disease (PAD) after endovascular revascularization.The optimal strategy for antiplatelet therapy in patients with PAD after endovascular revascularization has not been established.From March 2008 to February 2013, 693 patients with lower extremity PAD treated with different antiplatelet therapies, such as mono-antiplatelet therapy (MAPT) and dual-antiplatelet therapy (DAPT), of various durations after endovascular revascularization were analyzed. They were classified into 2 groups (DAPT 6 months or MAPT vs. DAPT ≥6 months). The primary outcomes were major adverse cardiovascular events and major adverse limb events. The safety outcome was major bleeding.During 5-year follow-up, major adverse cardiovascular events occurred less frequently in the DAPT ≥6-month group than the DAPT 6-month or MAPT group (17.3% vs. 31.3%; hazard ratio: 0.44; 95% confidence interval: 0.30 to 0.65; p 0.001). Major adverse limb events also occurred less frequently in the DAPT ≥6-month group than the DAPT 6-month or MAPT group (21.5% vs. 43.7%; hazard ratio: 0.42; 95% CI: 0.30 to 0.58; p 0.001). However, major bleeding events were infrequent, with no signal toward harm with DAPT ≥6 months. Results were consistent after inverse probability-weighted adjustment and propensity score matching.Following endovascular revascularization for lower extremity PAD, DAPT ≥6 months was associated with decreased 5-year major adverse cardiovascular events and major adverse limb events.

Objectives This study sought to assess the impact of intravascular ultrasound (IVUS) guidance on clinical outcomes following drug-eluting stent implantation when treating long lesions. Background The role of IVUS guidance when treating long lesions has been tested during bare-metal stent, but not during drug-eluting stent, implantation. Methods A total of 543 patients treated with stents ≥28 mm in length were randomly assigned to IVUS guidance (n = 269) versus angiography guidance (n = 274). The primary endpoint was a composite of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at 1 year following intervention. Results In the intention-to-treat analysis, total stent length was 32.4 mm in the IVUS-guided arm versus 32.3 mm in angiography-guided arm (p = 0.84). Adjunct post-dilation was more frequently performed in the IVUS-guided arm (54.6% vs. 44.5%, p = 0.03); post-intervention minimal lumen diameters were similar (2.55 vs. 2.55 mm, respectively, p = 0.50); and MACE occurred in 12 (4.5%) patients in IVUS-guided arm and in 20 (7.3%) patients in the angiography-guided arm (p = 0.16). However, among the 269 patients assigned to IVUS guidance, IVUS was not used in 13 patients (4.8%); conversely, in 274 patients assigned to angiography alone, 41 patients (15.0%) were treated with IVUS guidance. Therefore, in a per-protocol analysis according to actual IVUS usage, minimum lumen diameter was larger (2.58 vs. 2.51 mm, p = 0.04), and MACE rates were lower: 4.0% in the IVUS-guided arm versus 8.1% in the angiography-guided arm (p = 0.048). Conclusions A strategy of routine IVUS for drug-eluting stent implantation in long lesions did not improve the 1-year MACE rates. The IVUS use per operator decision was associated with improved results. (A New Strategy Regarding Discontinuation of Dual Antiplatelet; NCT01145079 )

Objectives This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an “all-comer” group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. Background DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Methods Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Results Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p Conclusions After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.