The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701).
n developed countries, the incidence of end-stage renal disease (ESRD) is increasing at a dramatic rate. 1 Cardiac diseases are responsible for almost 50% of allcause mortality in patients with ESRD, with approximately 20% of all cardiac deaths stemming from fatal outcomes of acute coronary syndrome. 2 Previous studies 3-5 have shown high in-hospital and long-term adverse cardiac event rates after percutaneous coronary intervention (PCI) and coronary artery bypass grafting in patients with ESRD.Recent randomized trials 6,7 have demonstrated that drugeluting stents (DES) substantially reduce in-stent restenosis compared with bare metal stents (BMS), but patients with ESRD were excluded. Thus it remains unclear whether DES has an advantage over BMS in this patient subset. The present study evaluated clinical and angiographic outcomes of PCI with sirolimus-eluting stents (SES) in dialysis patients. Methods PatientsBetween and Asahi Chuo Hospital) were enrolled. All patients had established ESRD and had already been on hemodialysis before PCI. A control group for comparison was composed of the same number of consecutive patients (n=54) on hemodialysis from each hospital who underwent PCI using BMS both during the same time period (n=25) and before the introduction of SES (n=29). Some patients had multivessel stenting. Thus there were 69 and 58 lesions treated with SES and BMS, respectively. This study was approved by the local council on human research at each hospital. PCI was performed after written informed consent was given. All patients underwent stenting according to current guidelines. 8 Glycoprotein IIb/IIIa inhibitors was not used because they are not available in Japan. Rotational atherectomy was used at the operator's discretion. SES was usually used after the introduction of SES unless difficulty in delivery was anticipated, non-cardiac surgery had been planned, or there was a contraindication to SES. Operators tried to fully cover the angiographic lesion, especially when a SES was implanted. After stent implantation, angiographic optimization was performed using high-pressure balloon dilation to achieve an acceptable angiographic result with <20% residual stenosis by visual estimate. All patients received aspirin 100 mg daily before the procedure and continued on it indefinitely. Patients were treated concomitantly with ticlopidine 100 mg twice daily at least 3 months, 9 because clopidogrel had not been available in Japan. Angiographic follow-up was performed at 9 months or earlier if noninva- Impact of Drug-Eluting Stents on Clinical and Angiographic Outcomes in Dialysis PatientsNaoki Ishio, MD; Yoshio Kobayashi, MD; Hideo Takebayashi, MD*; Yoshihiro Iijima, MD**; Junji Kanda, MD † ; Takashi Nakayama, MD; Nakabumi Kuroda, MD; Joseph De Gregorio, MD † † ; Yukinori Kouno, MD**; Masaru Suzuki, MD † ; Seiichi Haruta, MD*; Issei Komuro, MD Background It remains unclear whether sirolimus-eluting stents (SES) have an advantage over bare metal stents (BMS) in patients on dialysis. Methods and ResultsPercutane...
Background The balance between ischemic and bleeding events and their association with platelet reactivity in patients receiving antiplatelet therapy after percutaneous coronary intervention ( PCI ), which differs among regions, is not fully evaluated for East Asians. We examined ischemic/bleeding events and platelet reactivity in Japanese patients undergoing PCI and determined associations between high/low platelet reactivity and clinical outcomes. Methods and Results PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) is a prospective, multicenter registry of Japanese patients with PCI . Primary end points were incidence of first major adverse cardiac and cerebrovascular events ( MACCE ) and first major bleeding events at 12 months post‐ PCI . Platelet reactivity (P2Y 12 reaction unit [PRU ] value) was measured at 12 to 48 hours post‐ PCI ; patients were grouped as having high PRU (>208), optimal PRU (>85 to ≤208), and low PRU (≤85). MACCE and major bleeding occurred in 4.4% and 2.8% of 6267 patients, respectively. The mean±SD PRU value was 182.1±77.1. MACCE was significantly higher in the high PRU (5.7%; n=2227) versus the optimal PRU group (3.6%; n=3002). The hazard ratio (HR) for high PRU versus optimal PRU level was significantly higher for MACCE (adjusted HR, 1.53; 95% CI, 1.14–2.06 [ P =0.004]); stent thrombosis followed the same trend. Incidence of major bleeding did not differ significantly between groups. A high PRU level was significantly associated with MACCE in both patients with and patients without acute coronary syndrome. Conclusions These real‐world data suggest an association between high platelet reactivity and cardiovascular events in Japanese patients undergoing PCI . The trend was the same in both patients with and patients without acute coronary syndrome. REGISTRATION URL : https://www.umin.ac.jp/ctr . Unique identifier: UMIN 000020332.
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