Managing Nonagenarians with Acute Myocardial Infarction: Invasive versus Conservative Treatment.

BACKGROUND: Limited data are available to support an invasive treatment strategy in nonagenarians with acute myocardial infarction (AMI). We aimed to investigate whether percutaneous coronary intervention (PCI) is beneficial in this frail population. METHODS: We retrospectively analyzed 41 nonagenarians with AMI (both ST-segment-elevation and non-ST-segment-elevation MI) between 2006 and 2015 in a single center. We assessed 30-day and one-year mortality rates according to the treatment strategy. RESULTS: Among study subjects, 24 (59%) were treated with PCI (PCI group) and 17 (41%) were treated with conservative management (medical treatment group) per the clinician's discretion. The median follow-up duration was 30 months (0-74 months). Thirty-day mortality was lower in the PCI group than in the medical treatment group (17% vs. 65%; P < 0.001). One-year mortality was also lower in the PCI group than in the medical treatment group (21% vs. 76%; P < 0.001). The PCI group presented a 73% decreased risk of death (adjusted hazard ratio: 0.269; 95% confidence interval: 0.126-0.571; P < 0.001). In the Killip class 1 through 3 subgroups (n = 36), 30-day and one-year mortality were still higher among those in the medical treatment group (13% vs. 54% at 30 days; P < 0.001 and 17% vs. 69% at one year; P < 0.001). Landmark analysis after 30 days revealed no significant difference in the cumulative mortality rate between the two groups, indicating that the mortality difference was mainly determined within the first 30 days after AMI. CONCLUSION: Mortality after AMI was decreased in correlation with the invasive strategy relative to the conservative strategy, even in nonagenarians. Regardless of age, PCI should be considered in AMI patients. However, large-scale randomized controlled trials are needed to support our conclusion.

Comparison of three-dimensional quantitative coronary angiography and intravascular ultrasound for detecting functionally significant coronary lesions.

BACKGROUND: Three-dimensional quantitative coronary angiography (3D-QCA) can provide more accurate measurement of true vessel size and may be comparable to intravascular ultrasound (IVUS) in identifying functionally significant coronary stenosis, as determined by fractional flow reserve (FFR). This study aimed to evaluate the diagnostic accuracy of 3D-QCA for predicting FFR <0.8. METHODS: We assessed 175 lesions in 175 patients by FFR, IVUS, and 3D-QCA. Correlations between 3D-QCA values, IVUS values, and FFR values were analyzed. Receiver operating characteristic (ROC) curves were used to evaluate diagnostic accuracy of 3D-QCA for predicting FFR <0.8 and to determine the appropriate cut-off value. RESULTS: Upon evaluating 3D-QCA values, minimum lumen area (MLA) correlated with FFR value (r=0.48, P<0.001). Considering IVUS values, MLA correlated with FFR value (r=0.43, P<0.001). Also, 3D-QCA MLA was well correlated with IVUS MLA (r=0.61, P<0.001). The area under the ROC curve (AUC) for 3D-QCA MLA was 0.77, and the best cut-off value was 2.37 (sensitivity: 73%, specificity: 71%). The AUC for IVUS MLA was 0.73, and the best cut-off value was 3.01 (sensitivity: 71%, specificity: 65%). There was no significant difference in AUC for 3D-MLA and IVUS-MLA (P=0.27). CONCLUSIONS: 3D-QCA is not inferior to IVUS for functional assessment of intermediate coronary lesions. We can consider 3D-QCA as a suitable substitute for IVUS or FFR in determining coronary intervention.

Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial.

BACKGROUND: Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. TRIAL DESIGN: Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective, randomized clinical trial. A total of 1,700 consecutive patients with intermediate stenosis (40%-70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the predefined criteria for revascularization; FFR ≤ 0.80 in the FFR-guided group and Minimal Lumen Area (MLA) ≤3 mm2 (or 3 mm270%) in the IVUS-guided group. The primary end point is the patient-oriented composite outcome, which is a composite of all-cause death, myocardial infarction, and any repeat revascularization at 24months after randomization. We will test noninferiority of current standard FFR-guided PCI strategy compared with IVUS-guided decision for PCI and stent optimization strategy. CONCLUSION: The FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis.

Effects of a psychoeducational intervention for secondary prevention in Korean patients with coronary artery disease: a pilot study.

This intervention study was designed to examine whether a 12-week psychoeducational intervention influenced recurrent cardiac events, symptom experience and treatment adherence of patients with coronary artery disease. Fifty-eight patients were randomized to either the intervention or the control group. Measures were taken at baseline, after intervention, and at 6-month follow-up. Recurrent cardiac events included revascularization, rehospitalization, emergency room visits and mortality. Symptom experiences were measured using the Seattle Angina Questionnaire-Korean and Hospital Anxiety and Depression Scale. Treatment adherence included health behaviours, routine check-up and medication adherence. At 6-month follow-up, the intervention group had significantly better physical functions and lower anxiety and depressive symptoms. Treatment adherence was also significantly higher in the intervention group than the control group. No significant difference was noticed in the incidence of recurrent cardiac events between the groups. A longer follow-up study is needed to determine the long-term effects on the prevention of recurrent cardiac events.

Efficacy of clotinab in acute myocardial infarction trial-ST elevation myocardial infarction (ECLAT-STEMI).

BACKGROUND: This study investigated the efficacy and the safety of the upstream glycoprotein (Gp) IIb/IIIa inhibitor (clotinab; ISU ABXIS, Seoul, Republic of Korea) under 600-mg clopidogrel pretreatment compared with provisional use in ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: A total of 786 STEMI patients were randomized to upstream use in the emergency room (ER) (n = 392) or provisional use during percutaneous coronary intervention (PCI) (n = 394). All patients were prescribed 600-mg clopidogrel in the ER. The primary endpoint was the 30-day incidence of composite events including death, nonfatal myocardial infarction, target vessel revascularization, and stroke. There was no significant difference in the events that occurred in 40 patients (10.2%) in the upstream arm and 55 patients (14.0%) in the provisional arm during the 30 days (odds ratio 0.70, 95% confidence interval 0.45-1.08). Major bleeding was higher in the upstream arm (1.5% vs. 0%, P = 0.02). However, there was a significant reduction in 30-day composite events in the upstream arm in the high-risk population (Killip class ≥II or GRACE score >140). CONCLUSIONS: The upstream use of clotinab under a 600-mg clopidogrel loading may not significantly reduce cardiac events following primary PCI but may improve the clinical outcome in high-risk patients.

Fractional flow reserve versus angiography in left circumflex ostial intervention after left main crossover stenting.

BACKGROUND AND OBJECTIVES: Discrepancy between angiographic percent (%) diameter stenosis and fractional flow reserve (FFR) exists in non-left main bifurcation lesions. The aim of this study was to compare angiographic stenosis severity and FFR in jailed ostial left circumflex artery (LCX) lesions after left main (LM)-to-left anterior descending artery (LAD) crossover stenting. SUBJECTS AND METHODS: Twenty-nine (n=29) patients with distal LM or ostial LAD lesions treated by LM-to-LAD crossover stenting were consecutively enrolled. After successful stenting, FFR was measured at the jailed LCX. Additional intervention was performed in lesions with FFR <0.8. RESULTS: The mean reference diameter of LCX was 3.1±0.4 mm, and percent diameter stenosis after crossover stenting was 56±21%. Angiographically significant stenosis (>50%) at the ostial LCX occurred in 59% (17/29) of cases. Among them, only five (29%) lesions had functional significance, and underwent additional procedure. During follow-up, three patients in the deferral group and two patients in the additional intervention group had target lesion revascularization. CONCLUSION: There was a discrepancy between angiographic percent diameter stenosis and FFR in jailed LCX lesions after LM crossover stenting.

Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided.

OBJECTIVES: This study sought to evaluate the long-term clinical outcomes of a fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) strategy compared with intravascular ultrasound (IVUS)-guided PCI for intermediate coronary lesions. BACKGROUND: Both FFR- and IVUS-guided PCI strategies have been reported to be safe and effective in intermediate coronary lesions. METHODS: The study included 167 consecutive patients, with intermediate coronary lesions evaluated by FFR or IVUS (FFR-guided, 83 lesions vs. IVUS-guided, 94 lesions). Cutoff value of FFR in FFR-guided PCI was 0.80, whereas that for minimal lumen cross sectional area in IVUS-guided PCI was 4.0 mm(2). The primary outcome was defined as a composite of major adverse cardiac events including death, myocardial infarction, and ischemia-driven target vessel revascularization at 1 year after the index procedure. RESULTS: Baseline percent diameter stenosis and lesion length were similar in both groups (51 +/- 8% and 24 +/- 12 mm in the FFR group vs. 52 +/- 8% and 24 +/- 13 mm in the IVUS group, respectively). However, the IVUS-guided group underwent revascularization therapy significantly more often (91.5% vs. 33.7%, p < 0.001). No significant difference was found in major adverse cardiac event rates between the 2 groups (3.6% in FFR-guided PCI vs. 3.2% in IVUS-guided PCI). Independent predictors for performing intervention were guiding device: FFR versus IVUS (relative risk [RR]: 0.02); left anterior descending coronary artery versus non-left anterior descending coronary artery disease (RR: 5.60); and multi- versus single-vessel disease (RR: 3.28). CONCLUSIONS: Both FFR- and IVUS-guided PCI strategy for intermediate coronary artery disease were associated with favorable outcomes. The FFR-guided PCI reduces the need for revascularization of many of these lesions.

Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using fractional flow reserve.

AIMS: This study was performed to evaluate the functional outcomes of fractional flow reserve (FFR)-guided jailed side-branch (SB) intervention strategy. METHODS AND RESULTS: One hundred and ten patients treated by provisional strategy were consecutively enrolled and SB FFR was measured in 91 patients. SB intervention was allowed when FFR was <0.75. FFR measurement was repeated after SB intervention and at 6-month follow-up angiography. In 26 of 28 SB lesions with FFR <0.75, balloon angioplasty (SB balloon/artery ratio = 0.84 +/- 0.14) was performed and FFR >or=0.75 was achieved in 92% of the lesions although the mean residual stenosis was 69 +/- 10%. During follow-up, there were no changes in SB FFR in lesions with (0.86 +/- 0.05 to 0.84 +/- 0.01, P = 0.4) and without SB angioplasty (0.87 +/- 0.06 to 0.89 +/- 0.07, P = 0.1). Functional restenosis (FFR <0.75) rate was only 8% (5/65). When clinical outcomes of these patients were compared with 110 patients with similar bifurcation lesions treated without FFR-guidance, there was no difference in 9-month cardiac event rates (4.6 vs. 3.7%, P = 0.7) between the two groups. CONCLUSION: In conclusion, FFR-guided SB intervention strategy resulted in good functional outcomes.

Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions.

OBJECTIVE: This study compared the efficacy of the sirolimus-eluting stent (SES), the paclitaxel-eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. BACKGROUND: The outcome of drug-eluting stent (DES) implantation in long coronary lesions remains unclear. METHODS: The study involved 527 patients with de novo long coronary lesions (> or = 24 mm), which were treated with long (> or = 28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). RESULTS: Lesions in the SES (36.0 +/- 14.9 mm, P < 0.001) and PES (36.3 +/- 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 +/- 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six-month angiographic follow-up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in-segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in-segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. CONCLUSIONS: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use.

Physiologic assessment of jailed side branch lesions using fractional flow reserve.

OBJECTIVES: This study was performed to evaluate the feasibility of the physiologic assessment of jailed side branches using fractional flow reserve (FFR) and to compare the measured FFR with the stenosis severity assessed by quantitative coronary angiography (QCA). BACKGROUND: It is not well-known which side branches should be treated after stent implantation at main branches and how to assess the functional significance of these lesions. METHODS: Ninety-seven jailed side branch lesions (vessel size > 2.0 mm, percent stenosis > 50% by visual estimation) after stent implantation at main branches were consecutively enrolled. The FFR was measured using a pressure wire at 5 mm distal and proximal to the ostial lesion of the jailed side branch. RESULTS: The FFR measurement was successful in 94 lesions. Mean FFRs were 0.94 +/- 0.04 and 0.85 +/- 0.11 at the main branches and jailed side branches, respectively. There was a negative correlation between the percent stenosis and FFR (r = -0.41, p < 0.001). However, no lesion with < 75% stenosis had FFR < 0.75. Among 73 lesions with > or = 75% stenosis, only 20 lesions were functionally significant. CONCLUSIONS: The FFR measurement in jailed side branch lesions is both safe and feasible. Quantitative coronary angiography is unreliable in the assessment of the functional severity of jailed side branch lesions, and measurement of FFR suggests that most of these lesions do not have functional significance.

Intracoronary continuous adenosine infusion.

BACKGROUND: Various methods are used to induce maximal hyperemia for physiologic studies, but the feasibility and efficacy of continuous intracoronary (IC) infusion of adenosine for measurement of fractional flow reserve (FFR) has not been well-defined. METHODS AND RESULTS: Patients with intermediate coronary artery stenosis were consecutively enrolled. In the phase I study, FFR was measured after 3 dosages of IC adenosine infusion (180, 240 and 300 microg/min) in 30 patients. The phase II study was performed to compare the hyperemic efficacy of IC infusion (240 microg/min) with IC bolus injection (40, 80 microg) and intravenous (IV) infusion (140 microg x kg (-1) x min(-1)) of adenosine in 20 patients. In the phase I study, no significant differences in FFR were observed with the 3 different doses of IC infusion (p = 0.06). In the phase II study, FFR after an IC bolus injection (0.83+/-0.06) was significantly higher than with IV (0.79+/-0.07) or IC (0.78+/-0.09) infusion (p < 0.01). However, no difference in FFR was observed for IC and IV infusions. CONCLUSION: IC infusion of adenosine seems to be a safe and effective method of inducing maximal hyperemia for FFR measurement.