Objectives The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 12 months in patients with coronary bifurcation lesions after double kissing double crush ...(DK crush) or provisional stenting (PS) techniques. Background Provisional side branch (SB) stenting is preferable to DK crush because it has been associated with fewer complications. It is unknown which strategy would provide the best results. Methods From April 2007 to June 2009, 370 unselected patients with coronary bifurcation lesions from 7 Asian centers were randomly assigned to either the DK or the PS group. Additional SB stenting in PS was required if final results were suboptimal. The primary end point was the occurrence of MACE at 12 months, including cardiac death, myocardial infarction, or target vessel revascularization (TVR). Secondary end point was the angiographic restenosis at 8 months. Results There were 3 procedural occlusions of SB in the PS group. At 8 months, angiographic restenosis rates in the main vessel and SB were significantly different between the DK (3.8% and 4.9%) and the PS groups (9.7% and 22.2%, p = 0.036 and p < 0.001, respectively). Additional SB stenting in the PS group was required in 28.6% of lesions. TVR was 6.5% in the DK group, occurring significantly less often than in the PS group (14.6%, p = 0.017). There were nonsignificant differences in MACE and definite stent thrombosis between the DK (10.3% and 2.2%) and PS groups (17.3%, and 0.5%, p = 0.070 and p = 0.372, respectively). Conclusions DK crush was associated with a significant reduction of TLR and TVR in this unselected patient population. However, there was no significant difference in MACE between DK and the PS groups. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChicTR-TRC-00000015 )
Abstract Objectives The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold ...compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device. Background The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns. Methods In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post–scaffold implantation at 6 and 12 months. Results Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range IQR: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was −0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm IQR: 1.57 to 2.31 mm vs. 2.29 mm IQR: 1.74 to 2.51 mm, d = −0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% IQR: 21.0% to 40.7% for the Mirage, 18.2% IQR: 13.1% to 31.6% for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups. Conclusions At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.
Abstract Objectives This study aimed to investigate the cutoff of post–drug-eluting stent (DES) fractional flow reserve (FFR) for prediction of 1- to 3-year target vessel failure (TVF). Background ...FFR immediately after a DES implantation correlates with clinical events. However, the cutoff of post-DES FFR for predicting long-term clinical events remains understudied. Methods Between May 2012 and September 2013, a total of 1,476 patients who had FFR <0.8 at maximal and at baseline underwent DES implantation were prospectively studied in 9 centers. Post-DES FFR was repeat measured. The primary endpoint was the 1-year TVF rate after procedures. Receiver-operating characteristic curves were used to calculate the post-DES FFR value for TVF, then patients were classified on the basis of this value and followed up for 3 years. Results By the end of the first year, 88 (6.0%) TVFs were recorded. A post-DES FFR ≤0.88 strongly correlated with TVF. Disease in the left anterior descending coronary artery (LAD), stent length, and stent diameter were independent factors of impaired post-DES FFR, whereas post-procedure FFR ≤0.88 was the only predictor of TVF, with 40 (4.0%) TVFs in the FFR >0.88 and 48 (8.0%) in the FFR ≤0.88 group (p = 0.001), mainly driven by target vessel revascularization (3.8% vs. 8.8%; p = 0.005) and cardiac death (0.2% vs. 1.3%; p = 0.017). The difference in TVF between 2 groups was maintained through 3-year follow-up (p = 0.002). For patients with LAD lesions, a post-DES FFR ≤0.905 predicted 1-year TVF. Conclusions Post-DES FFR strongly correlated with TVF rate. Mechanisms attributed to and treatments for impaired FFR after stenting should be studied in future studies. (Post-DES FFR Predicts the Clinical Outcomes: DK CRUSH-VII, A Prospective, Multicenter, Registry Study DK CRUSH-VII; ChiCTR-PRCH-12001976 )
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