No abstract

Background: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. Methods: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. Results: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P =0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P =0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. Conclusions: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)

During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

A ccording to a previous pathological study using directional coronary atherectomy specimens, the components of neointimal tissue in drug-eluting stent (DES) in-stent restenosis were similar to those of bare-metal stent in-stent restenosis at 4 to 36 months after implantation, and the components were mainly composed of smooth muscle cells.1 Recently, neoatherosclerosis, the atherosclerotic change within neointima, has been introduced as an important variable in both ex-and in-vivo studies. [2][3][4][5][6][7] Neoatherosclerosis is observed more frequently and occurs significantly earlier in DEStreated lesions when compared with bare-metal stent-treated lesions.2-7 Furthermore, compared with patients without neoatherosclerosis, those with neoatherosclerosis have more severe coronary artery disease, such as acute coronary syndrome or stent thrombosis. 5,8 Accordingly, neoatherosclerosis has been regarded as a primary mechanism for late stent failure after DES implantation.9 From recent registry studies with large study populations, the second-generation DES showed similar efficacy, but lower incidence of stent thrombosis compared with the first-generation DES.10,11 However, the development of neoatherosclerosis in second-generation DESs has not been sufficiently evaluated. Although the previous studies suggested several predictors for neoatherosclerosis, it did not compare first-with second-generation DESs or included Background-Despite the enhanced properties of the second-generation drug-eluting stent (DES), its association with neoatherosclerosis has not been sufficiently evaluated. Therefore, we sought to evaluate and compare neoatherosclerosis in second-generation DESs to first-generation DESs. Methods and Results-A total of 212 DES-treated patients with >50% percent neointimal cross-sectional area stenosis were retrospectively enrolled from the Korean multicenter optical coherence tomography (OCT) registry.