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Background This study sought to investigate the safety of 3‐month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus‐eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART‐CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti‐ platelet Therapy in Patients Undergoing Implantation of Coronary Drug‐Eluting Stents) randomized trial compared 3‐month DAPT followed by P2Y12 inhibitor monotherapy with 12‐month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus‐eluting stents were also done among patients receiving 3‐month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3‐month DAPT and 491 to 12‐month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3‐month DAPT group and in 14 patients (2.9%) in the 12‐month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24–1.39; P =0.22). In whole population who were randomly assigned to receive 3‐month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus‐eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41–2.22; P =0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3‐month DAPT followed by P2Y12 inhibitor monotherapy and 12‐month DAPT strategies. With 3‐month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus‐eluting stents. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02079194.

Background/objectives The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Methods This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100mg and clopidogrel 75mg once daily as separate formulations for >6months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4weeks later. Results A total of 648 patients (the full-analysis population; age, 63.6±9.0years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, −0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4weeks of FDC treatment. Conclusions This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES.

A novel design and assembly technology is developed for a three-dimensional (3-D) flexible thermal flow sensor based on convective heat transfer to reduce detection error caused by position variation of a sensor inside the flow of narrow and curved geometries, such as coronary artery. The 3-D sensor has three independent sensing elements equally distributed around the catheter tube. This arrangement introduces three independent information channels, and cross-comparisons are used to provide accurate flow measurement. The resistance of the sensing elements is measured at ~ 1-1.2 kΩ with the temperature coefficient of resistance at 0.086%/°C. Using a constant-current circuit, the three sensing elements are heated to ~ 10°C above ambient temperature. Flow testing is implemented in a pipe channel at two positions: on the wall and along the center line. Experimental results from these two positions are discussed and computational fluid dynamic simulation based on Newtonian fluid properties is implemented, showing comparable results within an acceptable range of experimental to simulation errors. Therefore, we demonstrate the capability of 3-D thermal flow sensor for detecting the position of the catheter in the flow channel, thereby providing an accurate flow measurement.

Most studies evaluating the benefit and risk of additional ballooning (AB) after stent implantation have involved patients (pts) with stable angina. However, its safety and efficacy may be questionable in the context of pts presenting with acute myocardial infarction (AMI). We evaluated the 12-month

A novel design and assembly technology was developed for a three-dimensional (3-D) thermal flow sensor based on convective heat transfer to reduce detection error caused by position variation of a sensor inside the flow of narrow and curved geometries, such as coronary artery. The 3-D sensor has three independent sensing elements equally distributed around the catheter tube. This arrangement introduces three independent information channels, and cross-comparisons were utilized to provide accurate flow measurement. The resistance of the sensing elements was measured at approximately 1-1.2 KΩ with the temperature coefficient of resistance (TCR) at 0.086 %/°C. Using a constant-current circuit, the three sensing elements were heated to about 10 °C above ambient temperature. Flow testing was implemented in a pipe channel at two positions: on the wall or along the center line. When the sensor was in contact with the pipe, output voltage of the sensing element facing the pipe wall changed less than 0.6 mV. Meanwhile, other two sensing elements which were facing the flow field had a maximum output change of 3.3-3.5 mV. Placing the sensors at the center line of the pipe resulted in an almost equal output voltage change for all sensing elements. Therefore, we demonstrated the capability of 3-D thermal flow sensor for detecting the position of the catheter in the flow channel, thereby providing an accurate flow measurement.

Background and Objectives:The clinical impact of an intrapulmonary right to left shunt, without hypoxia (subclinical IPS), has not been sufficiently evaluated. We investigated the prevalence and clinical impact of a subclinical IPS in patients with end stage hepatic disease. Subjects and Methods:Contrast echocardiography, with hand-agitated saline, was performed in 72 consecutive candidates for a liver transplantation between April 2001 and November 2001. A positive contrast echocardiography indicated an intrapulmonary right to left shunt, and was defined as the delayed appearance of microbubbles in the left side of the heart (3 to 6 beats after the initial appearance in the contrast in the right side of the heart). We compared the clinical events of the patients both with and without a shunt, i.e. death, spontaneous bacterial peritonitis, sepsis, hepatic encephalopathy or variceal bleeding. Results:A subclinical IPS was detected in 19 of the 72 candidates for a liver transplantation (26.3%). All these candidates were Child class C liver cirrhosis. There were no differences in the baseline characteristics between the patients and those without a shunt in the Child class C (n=57). The mean PaO2 value of the patients with at least a 3+ left ventricular opacification (3 to 4+, n=6) was significantly lower than those with a 1+ to 2+ left ventricular opacification (n=13) (76±10 mmHg vs. 103±13 mmHg, p< 0.05). The mortality was not significantly difference between the patients with (5%, 1/19) or without (21%, 8/38, p=0.24) a shunt. Also, there were no significant differences in the clinical events during the mean follow-up period of 7±3 months (68.4% vs. 83.5% p=0.12). Conclusion:Subclinical IPS's are not uncommon in patients with end stage hepatic disease. The extent of shunting correlates with the level of arterial 논문접수일:2002년 10월 21일 수정논문접수일:2002년 11월 5일 심사완료일:2002년 11월 28일 교신저자:송재관, 138-736 서울 송파구 풍납동 388-1 울산대학교 의과대학 서울아산병원 내과학교실 전화:(02) 3010-3150·전송:(02) 486-5918·E-Mail:jksong@amc.seoul.kr