Drug-eluting stents (DES) were developed to overcome in-stent restenosis (ISR), which has long been considered the main complication limiting the long-term efficacy of coronary stenting. ...New-generation DES which composed of advanced stent design with and without specific biocompatible polymer contributes a reduction of the incidence of ISR to rate ranging from 5 to 10%. The precise reasons of DES restenosis are still controversial and not fully understood. Angiographic and coronary images at the index procedure, systemic status of patients, medications, and intracoronary imaging at ISR site are all considered to find the possible mechanisms of DES restenosis. Multiple biological, genetic, mechanical, and technical factors might intricately contribute to DES restenosis. Biological and genetic factors of ISR are not able to be sufficiently modified by the current medical approaches. Tailored treatments avoiding mechanical and technical factors of ISR are required to reduce DES restenosis. Elucidation of DES restenosis leads to further improvement in the current DES system and finds the optimal approach to treat DES restenosis. The possible mechanisms of DES restenosis are discussed in this review.
Percutaneous coronary intervention (PCI) has become a standard-of-care procedure in patients with acute and chronic coronary syndrome. Adjunctive antithrombotic therapy following PCI is the ...cornerstone of pharmacological treatment to prevent ischemic events. Dual antiplatelet therapy, a combination of aspirin and a P2Y12 inhibitor, has been proven as an initial antithrombotic regimen to reduce thrombotic events in patients undergoing PCI. However, the optimal antithrombotic strategy such as appropriate duration of dual antiplatelet therapy and the safe and effective combination of oral anticoagulation with antiplatelet therapy remains under debate. Since Japanese patients have different risk profiles for both thrombotic and bleeding events compared with Western population, optimal antithrombotic regimen may be different. Recently, the evidence in this field has been rapidly evolving and the antithrombotic strategy varies widely in clinical practice. In this clinical expert consensus document, we provide an in-depth review concerning antithrombotic strategies after PCI from Japanese perspective.
Quantitative coronary angiography (QCA) remains to play an important role in clinical trials and post-marketing surveillance related to the safety and efficacy of new PCI devices. In this document, ...the current standard methodology of QCA is summarized. In addition, its history, recent development and future perspectives are also reviewed.
Background:Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) ...for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction MI, and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.Conclusions:Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).
Background: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) ...implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 91.4% lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations.Conclusions: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.
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