Patient-oriented Composite Outcome Research Articles

Clinical Outcomes of Deferred Lesions by IVUS Versus FFR-Guided Treatment Decision.

There are limited data regarding the safety of deferral of percutaneous coronary intervention based on intravascular ultrasound (IVUS) findings. The current study sought to compare the prognosis between deferred lesions based on IVUS and fractional flow reserve (FFR)-guided treatment decision. This study is a post hoc analysis of the FLAVOUR randomized trial (Fractional Flow Reserve and Intravascular Ultrasound for Clinical Outcomes in Patients With Intermediate Stenosis) that compared 2-year clinical outcomes between IVUS- and FFR-guided treatment decision on intermediate coronary artery lesions using predefined criteria. In both IVUS and FFR groups, vessels were classified into deferred or revascularized vessels, and patients were classified as those with or without deferred lesions. Vessel-oriented composite outcomes (cardiac death, target vessel myocardial infarction, or target vessel revascularization) in deferred vessels and patient-oriented composite outcomes (death, myocardial infarction, or any revascularization) in patients with deferred lesions were compared between the IVUS and FFR groups. A total of 1682 patients and 1820 vessels were analyzed, of which 922 patients and 989 vessels were deferred. At 2 years, there was no difference in the cumulative incidence of vessel-oriented composite outcomes in deferred vessels between IVUS (n=375) and FFR (n=614) groups (3.8% versus 4.1%; hazard ratio, 0.91 [95% CI, 0.47-1.75]; P=0.77). The risk of vessel-oriented composite outcomes was comparable between deferred and revascularized vessels following treatment decision by IVUS (3.8% versus 3.5%; hazard ratio, 1.09 [95% CI, 0.54-2.19]; P=0.81) and FFR (4.1% versus 3.6%; hazard ratio, 1.14 [95% CI, 0.56-2.32]; P=0.72). In comparison of patient-oriented composite outcomes in patients with deferred lesions, there was no significant difference between the IVUS (n=357) and FFR (n=565) groups (6.2% versus 5.9%; hazard ratio, 1.05 [95% CI, 0.61-1.80]; P=0.86). In patients with intermediate coronary artery stenosis, deferral of percutaneous coronary intervention based on IVUS-guided treatment decision showed comparable risk of clinical events with FFR-guided treatment decision. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02673424.

Discordance between quantitative coronary angiography and fractional flow reserve or intravascular ultrasound: a substudy of the FLAVOUR trial

Abstract Background Discrepancies between quantitative coronary angiography (QCA) and fractional flow reserve (FFR) or intravascular ultrasound (IVUS) are often observed in coronary lesions with intermediate stenosis. Objectives We investigated the impact of physiology- or intracoronary imaging-directed revascularization strategies on clinical outcomes in patients with discordant coronary lesions between QCA and FFR or IVUS. Methods This study was a post hoc analysis of the FLAVOUR study, an investigator-initiated, prospective, randomized, open-label, multinational trial performed at 18 sites in Korea and China. In the FLAVOUR study, 200 patients with ≥60% diameter stenosis (DS) deferred percutaneous coronary intervention (PCI) according to FFR > 0.8 (n=141) or a minimal lumen area > 3 mm2 or 3-4 mm2 with a plaque burden <70% on IVUS whereas 351 patients with <60% DS performed PCI according to positive FFR (n=118) or positive IVUS (n=233) results. The primary outcome was a patient-oriented composite outcome (POCO), a composite of death, myocardial infarction, or revascularization. Results The incidence of discordance was 28.1% in the FFR group and 32.4% in the IVUS group. At 24 months, among patients with ≥60% DS, the incidence of POCO was similar between FFR-guided and IVUS-guided deferral strategies (4.4% vs. 3.4%, p=0.757). Among patients with <60% DS, FFR-directed or IVUS-directed PCI did not differ in the POCO incidence (5.2% vs. 2.6%, p=0.207). However, FFR-guided PCI showed a higher incidence of periprocedural myocardial infarction than IVUS-guided PCI in <60% DS lesions (2.6% vs. 0.0%, p=0.014). Conclusions In patients with discordant intermediate stenosis between QCA and FFR or IVUS, physiology- and imaging-directed revascularization strategies are comparable concerning POCO at 24 months.

Clinical outcomes of deferred lesions by IVUS versus FFR-guided treatment decision: the FLAVOUR trial substudy

Abstract Background There is limited data regarding the safety of deferral of percutaneous coronary intervention (PCI) based on intravascular ultrasound (IVUS) findings. Current study sought to compare the prognosis between deferred lesions based on IVUS and FFR (fractional flow reserve)-guided treatment decision. Methods Study population was derived from FLAVOUR trial which is a multinational, open-label, randomized, and non-inferiority trial that compared 2-year clinical outcomes between IVUS and FFR-guided treatment decision using predefined criteria. In both IVUS and FFR groups, vessels were classified into deferred or revascularized vessels, and patients into those with or without deferred lesion. Vessel-oriented composite outcomes (VOCO) (cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) in deferred vessels and patient-oriented composite outcomes (POCO) (death, myocardial infarction, or any revascularization) in patients with deferred lesion were compared between IVUS and FFR group. Results A total of 1682 patients and 1820 vessels were analyzed. At 2 years, there is no difference in cumulative incidence of VOCO in deferred vessels between IVUS and FFR groups (3.8% vs. 4.1%; hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.47-1.75; P=0.771). The risk of VOCO was comparable between deferred and revascularized vessels following both IVUS (3.8% vs. 3.5%; HR 1.09; 95% CI 0.54-2.19; P=0.813) and FFR-guided treatment decision (4.1% vs. 3.6%; HR 1.14; 95% CI 0.56-2.32; P=0.715). In comparison of POCO in patients with deferred lesion, there was no significant difference between IVUS and FFR groups (6.2% vs. 5.9%; HR 1.05; 95% CI 0.61-1.80; P=0.856). Conclusion In patients with intermediate coronary artery stenosis, deferral of PCI based on IVUS-guided treatment decision showed comparable risk of clinical events with FFR-guided treatment decision.

Angiotensin converting enzyme inhibitors versus angiotensin II type 1 receptor blockers in patients with acute myocardial infarction and prediabetes after successful implantation of newer-generation drug-eluting stents.

Because limited data are available, the present study investigated 2-year major clinical outcomes after angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II type 1 receptor blockers (ARBs) therapy in patients with acute myocardial infarction (AMI) and prediabetes after successful implantation of newer-generation drug-eluting stents (DESs). Overall, 2932 patients with AMI and prediabetes were classified into two groups - the ACEIs group (n = 2059) and the ARBs group (n = 873). The primary endpoint was the occurrence of patient- -oriented composite outcome (POCO), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat revascularization. The secondary endpoint was definite or probable stent thrombosis (ST). The cumulative incidences of POCO (adjusted hazard ratio [aHR]: 1.020; 95% confidence interval [CI]: 0.740-1.404; p = 0.906), all-cause death (aHR: 1.394; 95% CI: 0.803-2.419; p = 0.238), Re-MI (aHR: 1.210; 95% CI: 0.626-2.340; p = 0.570), any repeat revascularization (aHR: 1.150; 95% CI: 0.713-1.855; p = 0.568), and ST (aHR: 1.736; 95% CI: 0.445-6.766; p = 0.427) were similar between the groups. These results were confirmed after propensity score-adjusted analysis. In this study, patients with AMI and prediabetes who received ACEIs or ARBs showed comparable clinical outcomes during the 2-year follow-up period.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Abstract 12393: Two-Year Clinical Outcome of Mid-Range Ejection Fraction at Admission in Patients With Acute Myocardial Infarction

Introduction: The American Heart Association and European Society of cardiology guidelines reclassified heart failure according to left ventricular ejection fraction, recognizing patients with mid-range EF (mrEF; 40% to 49%) as a distinct group. However, studies on the clinical characteristics of mid-range EF patients and the occurrence of cardiovascular events in acute MI patients are insufficient. Methods: We categorized 6,553 patients with acute myocardial infarction (AMI) from the Korea AMI-National Institutes of Health between November 2011 and December 2015 into three groups (reduced EF ; LVEF < 40% at admission, mild-reduced EF ; LVEF 40 to 49%, preserved EF ;LVEF ≥50%). The primary endpoint was defined as any death at two-year. Secondary endpoints were defined as any myocardial infarction, any revascularization, patient-oriented composite outcome(POCE). Results: Compared to patients with other two groups, the reduced EF group had a highest overall mortality, POCE, and any MI (24.7% vs 8.3% vs 4.6%, p < 0.0001, 33.0% vs 15.6% vs 12.4%, p<0.0001, 3.9% vs 2.7% vs 2.6%, p<0.0046). When mid-range EF group was designated as a reference, in multivariate analysis including all variables, significant differences with HFrEF group was found. (Hazard ratio ). When compared with HFpEF, only Model 1 and Model 2 showed a significant statistical difference (Model 1 ; 0.65 (0.53-0.81), Model 2 ; 0.56 (0.56-0.86). Conclusions: Followed up for two years, significant differences in survival rates were observed between the mid-range EF, reduced EF, and preserved EF group. After adjusting for common prognostic factors affecting the overall mortality rate, the reduced EF group had a significantly higher mortality rate than mid-range EF group, but no significant difference was observed between the preserved EF and the mid-range EF group.

Angiographic complete revascularization versus incomplete revascularization in patients with diabetes mellitus

BackgroundConsidering the nature of diabetes mellitus (DM) in coronary artery disease, it is unclear whether complete revascularization is beneficial or not in patients with DM. We investigated the clinical impact of angiographic complete revascularization in patients with DM.MethodsA total of 5516 consecutive patients (2003 patients with DM) who underwent coronary stenting with 2nd generation drug-eluting stent were analyzed. Angiographic complete revascularization was defined as a residual SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) score of 0. The patient-oriented composite outcome (POCO, including all-cause death, any myocardial infarction, and any revascularization) and target lesion failure (TLF) at three years were analyzed.ResultsComplete revascularization was associated with a reduced risk of POCO in DM population [adjusted hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.52–0.93, p = 0.016], but not in non-DM population (adjusted HR 0.90, 95% CI 0.69–1.17, p = 0.423). The risk of TLF was comparable between the complete and incomplete revascularization groups in both DM (adjusted HR 0.75, 95% CI 0.49–1.16, p = 0.195) and non-DM populations (adjusted HR 1.11, 95% CI 0.75–1.63, p = 0.611). The independent predictors of POCO were incomplete revascularization, multivessel disease, left main disease and low ejection fraction in the DM population, and old age, peripheral vessel disease, and low ejection fraction in the non-DM population.ConclusionsThe clinical benefit of angiographic complete revascularization is more prominent in patients with DM than those without DM after three years of follow-up. Relieving residual disease might be more critical in the DM population than the non-DM population.Trial registration The Grand Drug-Eluting Stent registry NCT03507205.

Effects of stent generation on clinical outcomes after acute myocardial infarction compared between prediabetes and diabetes patients

We investigated the effects of stent generation on 2-year clinical outcomes between prediabetes and diabetes patients after acute myocardial infarction (AMI). A total of 13,895 AMI patients were classified into normoglycemia (group A: 3673), prediabetes (group B: 5205), and diabetes (group C: 5017). Thereafter, all three groups were further divided into first-generation (1G)-drug-eluting stent (DES) and second-generation (2G)-DES groups. Patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization were the primary outcome. Stent thrombosis (ST) was the secondary outcome. In both prediabetes and diabetes groups, the cumulative incidences of POCOs, any repeat revascularization, and ST were higher in the 1G-DES than that in the 2G-DES. In the diabetes group, all-cause death and cardiac death rates were higher in the 1G-DES than that in the 2G-DES. In both stent generations, the cumulative incidence of POCOs was similar between the prediabetes and diabetes groups. However, in the 2G-DES group, the cumulative incidences of Re-MI and all-cause death or MI were significantly higher in the diabetes group than that in the prediabetes group. To conclude, 2G-DES was more effective than 1G-DES in reducing the primary and secondary outcomes for both prediabetes and diabetes groups.

Prognostic and Practical Validation of ESC/EACTS High Ischemic Risk Definition on Long-Term Thrombotic and Bleeding Events in Contemporary PCI Patients.

Aims: The ESC/EACTS myocardial revascularization guidelines recently standardized the definition of patients at high ischemic risk (HIR). However, the ability of ESC/EACTS–HIR criteria to stratify ischemic and bleeding risk in a contemporary real-world East Asian cohort remains unexplored. Methods: A total of 10,167 consecutive patients undergoing PCI from prospective Fuwai PCI Registry (January 2013 to December 2013) were reviewed. ESC/EACTS–HIR features was defined as having at least one of the eight clinical and angiographic characteristics. The primary ischemic endpoint was target vessel failure (cardiac death, target vessel myocardial infarction [MI], or target vessel revascularization [TVR]); bleeding outcome was assessed using the BARC type 2, 3, or 5 bleeding. Median follow-up was 29 months. Results: Compared with non-HIR patients, HIR patients ( n =5,149, 50.6%) were associated with increased risk for target vessel failure (adjusted hazard ratio [HR adjust ]: 1.48 [1.25–1.74]) and patient-oriented composite outcome (HR adjust : 1.44 [1.28–1.63]), as well as cardiac death, MI, and TVR. By contrast, the risk of clinically relevant bleeding was not significantly different between the two groups. (HR adjust : 0.84 [0.66–1.06]). Greater than or equal to three implanted stents and diabetic patients with diffuse multivessel coronary disease emerged as independent predictors for long-term adverse outcomes. There was no significant interaction between high bleeding risk (HBR) status and clinical outcomes associated with ESC/EACTS–HIR criteria (all P interaction ＞0.05). Conclusion: The ESC/EACTS–HIR features identified patients at increased risk of thrombotic events, including cardiac death, but not for clinically relevant bleeding. Importantly, HBR did not modify cardiovascular risk subsequent to patients with ESC/EACTS–HIR features, suggesting its potential clinical applicability in tailoring antithrombotic therapy.

Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial.

Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, -1.2%; Pnoninferiority<0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46-0.98]; P=0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P=0.513 and 0.1% versus 0.4%; P=0.174, respectively). In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov; Unique identifier: NCT02193971.

Impact of complete revascularization for acute myocardial infarction with multivessel coronary artery disease in diabetes mellitus patients

Abstract Background Clinical benefits of complete revascularization (CR) in acute myocardial infarction (AMI) patients are unclear. Moreover, the benefit of CR is unknown in AMI with Diabetes Mellitus (DM) patient. Objectives We sought to compare prognosis of CR and incomplete revascularization (IR) in patients with AMI and multivessel disease, according to the presence of DM. Methods A total of 2,150 AMI patients with multivessel coronary artery disease were analyzed. CR was defined based on angiographic image. The primary endpoints of this study was patient oriented composite outcome (POCO) defined as a composite of all cause death, any myocardial infarction, and any revascularization within 3 years. Results Overall, 3-year POCO were significantly lower in patients receiving angiographic CR (985 patients, 45.8%) compared with IR (1165 patients, 54.2%). When divided into subgroups according to the presence of DM, CR reduced 3-year clinical outcomes in the non-DM group but not in the DM group (POCO: 11.7% vs. 23.2%, p&amp;lt;0.001, any revascularization: 7.2% vs. 10.8%, p=0.024 in the non-DM group, POCO: 24.3% vs. 27.8%, p=0.295, any revascularization: 13.3% vs. 11.3%, p=0.448 in the DM group, for CR vs. IR). Multivariate analysis showed that CR significantly reduced 3-year POCO (HR 0.52, 95% CI 0.38–0.71) only in the non-DM group. Conclusion In AMI patients with multivessel disease, CR may be ineffective in improving clinical outcomes in patients with DM. Funding Acknowledgement Type of funding source: None

Implicaciones pronósticas de los índices fisiológicos coronarios en pacientes con diabetes mellitus

Introduction and objectivesNo thorough investigation has been performed of the prognostic value of coronary physiological indices in patients with diabetes mellitus (DM) after coronary revascularization deferral. MethodsWe analyzed 714 patients (235 with DM) with deferred revascularization according to fractional flow reserve (> 0.80). A comprehensive physiological evaluation including coronary flow reserve (CFR), index of microcirculatory resistance, and fractional flow reserve was performed at the time of revascularization deferral. The median values of the CFR (2.88), fractional flow reserve (0.88), and index of microcirculatory resistance (17.85) were used to classify patients into high- or low-index groups. The primary outcome was the patient-oriented composite outcome (POCO) at 5 years, comprising all-cause death, any myocardial infarction, and any revascularization. ResultsCompared with the non-DM population, the DM population showed higher risk of POCO (HR, 2.49; 95%CI, 1.64-3.78; P<.001). In the DM population, the low-CFR group had a higher risk of POCO than the high-CFR group (HR, 3.22; 95%CI, 1.74-5.97; P <.001). In contrast, CFR values could not differentiate the risk of POCO in the non-DM population. There was a significant interaction between CFR and the presence of DM regarding the risk of POCO (P for interaction=.025). Independent predictors of POCO were a low CFR and family history of coronary artery disease in the DM population and percent diameter stenosis and multivessel disease in the non-DM population. ConclusionsThe association between coronary physiological indices and clinical outcomes differs according to the presence of DM. In deferred patients, CFR is the most important prognostic factor in patients with DM, but not in those without DM.

Influence of Anatomical and Clinical Characteristics on Long-Term Prognosis of FFR-Guided Deferred Coronary Lesions

ObjectivesThe aim of this study was to evaluate the clinical and anatomical features to predict the long-term outcomes in patients with fractional flow reserve (FFR)–guided deferred lesions, verified by intravascular ultrasound (IVUS). BackgroundDeferral of nonsignificant lesion by FFR is associated with a low risk of clinical events. However, the impact of combined information on clinical and anatomical factors is not well known. MethodsThe study included 459 patients with 552 intermediate lesions who had deferred revascularization on the basis of a nonischemic FFR (>0.80). Grayscale IVUS was examined simultaneously. The primary endpoint was patient-oriented composite outcome (POCO) (a composite of all-cause death, myocardial infarction, and any revascularization) during 5-year follow-up. ResultsThe rate of 5-year POCO was 9.8%. Diabetes mellitus (hazard ratio: 3.50; 95% confidence interval [CI]: 1.86 to 6.57; p < 0.001), left ventricular ejection fraction ≤40% (hazard ratio: 4.80; 95% CI: 1.57 to 14.63; p = 0.006), and positive remodeling (hazard ratio: 2.04; 95% CI: 1.03 to 4.03; p = 0.041) were independent predictors for POCO. When the lesions were classified according to the presence of the adverse clinical characteristics (diabetes, left ventricular ejection fraction ≤40%) or adverse plaque characteristics (positive remodeling, plaque burden ≥70%), the risk of POCO was incrementally increased (4.3%, 13.6%, and 21.3%, respectively; p < 0.001). ConclusionsIn patients with FFR-guided deferred lesions, 5-year clinical outcomes were excellent. Lesion-related anatomical factors from intravascular imaging as well as patient-related clinical factors could provide incremental information about future clinical risks.

Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with Acute Myocardial Infarction and Prediabetes Based on the Hemoglobin A1c Level.

Objective To compare major clinical outcomes after successful percutaneous coronary intervention (PCI) with first-generation (1G) drug-eluting stents (DES) and second-generation (2G) DES in patients with acute myocardial infarction (AMI) and prediabetes. Background Patients with prediabetes are associated with an increased incidence of coronary artery disease. The relative superiority of 1G- and 2G-DES in these patients is not well established. Methods A total of 4997 patients with AMI and prediabetes were divided into two groups: the 1D-DES group (n = 726) and the 2G-DES group (n = 4271). The primary outcomes were the patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any disease revascularization at 2-year follow-up. The secondary outcome was probable or definite stent thrombosis (ST). Results After propensity score-matching (PSM) analysis, two PSM groups (698 pairs, n = 1396, C-statistics = 0.725) were generated. The cumulative incidence rates of POCOs (hazard ratio (HR): 1.467; 95% confidence interval (CI): 1.068–2.015; p = 0.018), any disease revascularization (HR: 2.259; 95% CI: 1.397–3.654; p = 0.001), and ST (HR: 4.361; 95% CI: 1.243–15.30; p = 0.021) in the 1G-DES group were significantly higher than those in the 2G-DES group. However, the cumulative incidence rates of all-cause death, cardiac death, and Re-MI were similar between the two groups. Conclusions In patients with AMI and prediabetes, 2G-DES implantation was more efficacious than 1G-DES implantation over a 2-year follow-up period. However, further studies are needed to confirm these results.

Prognostic implications of coronary physiological indices in patients with diabetes mellitus

Introduction and objectivesHas been performed of the prognostic value of coronary physiological indices in patients with diabetes mellitus (DM) after coronary revascularization deferral. MethodsWe analyzed 714 patients (235 with DM) with deferred revascularization according to fractional flow reserve (> 0.80). A comprehensive physiological evaluation including coronary flow reserve (CFR), index of microcirculatory resistance, and fractional flow reserve was performed at the time of revascularization deferral. The median values of the CFR (2.88), fractional flow reserve (0.88), and index of microcirculatory resistance (17.85) were used to classify patients into high- or low-index groups. The primary outcome was the patient-oriented composite outcome (POCO) at 5 years, comprising all-cause death, any myocardial infarction, and any revascularization. ResultsCompared with the non-DM population, the DM population showed higher risk of POCO (HR, 2.49; 95%CI, 1.64-3.78; P<.001). In the DM population, the low-CFR group had a higher risk of POCO than the high-CFR group (HR, 3.22; 95%CI, 1.74-5.97; P <.001). In contrast, CFR values could not differentiate the risk of POCO in the non-DM population. There was a significant interaction between CFR and the presence of DM regarding the risk of POCO (P for interaction=.025). Independent predictors of POCO were a low CFR and family history of coronary artery disease in the DM population and percent diameter stenosis and multivessel disease in the non-DM population. ConclusionsThe association between coronary physiological indices and clinical outcomes differs according to the presence of DM. In deferred patients, CFR is the most important prognostic factor in patients with DM, but not in those without DM.

Prognostic Implications of Resistive Reserve Ratio in Patients With Coronary Artery Disease

BackgroundResistive reserve ratio is a thermodilution‐based index which integrates both coronary flow and pressure. Resistive reserve ratio represents the vasodilatory capacity of interrogated vessels including both epicardial coronary artery and microvascular circulation. We evaluated the prognostic potential of resistive reserve ratio compared with pressure‐derived index (fractional flow reserve [FFR]) or flow‐derived index (coronary flow reserve [CFR]).Methods and ResultsA total of 1245 patients underwent coronary pressure and flow measurement using pressure‐temperature wire. Resistive reserve ratio was calculated by CFR adjusted using the ratio between resting and hyperemic distal coronary pressure ([resting mean transit time/hyperemic mean transit time]×[resting distal coronary pressure/hyperemic distal coronary pressure]). Clinical outcome was assessed by patient‐oriented composite outcome (POCO), a composite of any death, myocardial infarction, and revascularization at 5 years. At 5 years, the cumulative incidence of POCO was significantly different according to quartiles of resistive reserve ratio (9.9%, 11.3%, 17.2%, and 22.7% in quartiles 1 to 4, respectively, log rank P<0.001). Among patients with deferred revascularization, those with depressed resistive reserve ratio (<3.5) showed a significantly higher risk of POCO than those with preserved resistive reserve ratio (≥3.5) in patients with FFR>0.80 or patients with CFR>2.0. (FFR>0.80 group: 14.8% versus 6.0%; log rank P=0.001; CFR>2.0 group: 13.5% versus 7.1%; log rank P=0.045). Adding resistive reserve ratio into the model for 5‐year POCO showed significantly higher global Chi square value than FFR or CFR (P<0.001, respectively, for FFR and CFR). Resistive reserve ratio <3.5 was significantly associated with the risk of POCO at 5 years in multivariable model (adjusted hazard ratio 1.597, 95% CI, 1.098–2.271, P=0.014).ConclusionsResistive reserve ratio, which integrated both coronary flow and pressure, showed incremental prognostic implications in patients with coronary artery disease undergoing elective percutaneous coronary intervention guided by invasive physiologic evaluation.Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03690713.

Prognostic implication of global myocardial blood flow in patients with ST-segment elevation myocardial infarction.

The prognostic implications of cardiovascular magnetic resonance imaging (CMR)-derived hyperemic myocardial blood flow (MBF) in patients with ST-elevation myocardial infarction (STEMI) are unknown. This study sought to investigate the incremental prognostic value of hyperemic MBF over conventional CMR markers to identify patients with high risk of future incidence of patient-oriented composite outcomes (POCO) and major adverse cardiac events (MACE) after STEMI. A total of 237 patients who presented with STEMI were prospectively enrolled. The CMR protocol included left-ventricular ejection fraction (LVEF), late gadolinium enhancement (LGE) and microvascular obstruction (MVO) measurement, and volumetric MBF assessment. During a median follow-up of 2.6years, 47 patients experienced POCO (primary outcome) and 21 patients had MACE. In a multivariable model, multivessel disease, LGE, MVO, and hyperemic MBF were independently associated with POCO. Addition of hyperemic MBF to the model consisting of GRACE score, multivessel disease, LVEF, LGE, and MVO significantly improved the predictive efficacy (integrated discrimination improvement 0.020, p = 0.021). Patients with low hyperemic MBF had significantly higher incidence of MACE compared to those with high hyperemic MBF inpropensity score matching analysis (p = 0.018). In conclusion, CMR-derived hyperemic MBF could provide independent and incremental prognostic value over LVEF, LGE, and MVO in patients with STEMI.

Complete Revascularization of Multivessel Coronary Artery Disease Does Not Improve Clinical Outcome in ST-Segment Elevation Myocardial Infarction Patients with Reduced Left Ventricular Ejection Fraction

The benefit of complete revascularization (CR) in ST-segment elevation myocardial infarction (STEMI) patients with left ventricular (LV) dysfunction is uncertain. A total of 1314 STEMI patients with multivessel coronary artery disease were analyzed. CR was defined angiographically and by a residual Synergy between PCI with Taxus and Cardiac Surgery trial (SYNTAX) score (SS) <8. Patients with a left ventricular ejection fraction (LVEF) <40% were classified as the reduced LVEF group. The major study endpoints were patient-oriented composite outcome (POCO) and cardiac death during three-year follow-up. Overall, patients that received angiographic CR (579 patients, 44.1%) had significantly lower three-year clinical events compared with incomplete revascularization (iCR). CR reduced three-year POCO and cardiac death rates in the preserved LVEF group (POCO: 13.2% vs. 21.9%, p < 0.001, cardiac death: 1.8% vs. 6.5%, p < 0.001, respectively) but not in the reduced LVEF group (POCO: 26.0% vs. 33.1%, p = 0.275, cardiac death: 15.1% vs. 19.0%, p = 0.498, respectively). Multivariate analysis showed that CR significantly reduced three-year POCO (hazard ration (HR) 0.59, 95% confidence interval (CI) 0.43–0.82) and cardiac death (HR 0.34, 95% CI 0.14–0.80), only in the preserved LVEF group. Additionally, the results were corroborated using the SS-based CR definition. In STEMI patients with multivessel disease, CR did not improve clinical outcomes in those with reduced LVEF.

Long-term Patient Prognostication by Coronary Flow Reserve and Index of Microcirculatory Resistance: International Registry of Comprehensive Physiologic Assessment.

Background and ObjectivesRecent guideline recommends evaluation using of coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients with functionally insignificant stenosis. We evaluated clinical implications of CFR and IMR in patients with high fractional flow reserve (FFR) and deferred revascularization.MethodsA total of 867 patients (1,152 vessels) consigned to deferred revascularization who underwent comprehensive physiologic assessments were enrolled. Patients with high FFR (>0.80) were categorized by CFR (≤2) and IMR (≥23 U). Clinical outcome was assessed by patient-oriented composite outcome (POCO), a composite of any death, myocardial infarction (MI), and revascularization at 5 years.ResultsPatients with low CFR (≤2) showed significantly greater risk of POCO than those with high CFR (>2) in both high-FFR (p=0.024) and low-FFR (p=0.034) groups. In patients with high FFR, those with low CFR and high IMR (overt microvascular disease) displayed the greatest risk of POCO overall (p=0.015), surpassing those with high CFR and low IMR (HR, 2.873; 95% CI, 1.476–5.594; p=0.002) and showing significantly greater risk of cardiac death or MI (HR, 5.662; 95% CI, 1.984–16.154; p=0.001). Overt microvascular disease was independently associated with POCO in the high-FFR population (HR, 2.282; 95% CI, 1.176–4.429; p=0.015).ConclusionAmong patients with deferred revascularization, those with low CFR showed significantly greater risk of POCO than those with high CFR, regardless of FFR. In patients with high FFR, those with overt microvascular disease showed significantly greater risk of POCO and cardiac death or MI at 5-year, compared with the others.Trial RegistrationClinicalTrials.gov Identifier: NCT03690713

Effects of prediabetes on long-term clinical outcomes of patients with acute myocardial infarction who underwent PCI using new-generation drug-eluting stents

AimsWe investigated the 2-year clinical outcomes of patients with acute myocardial infarction (AMI) and prediabetes after new-generation drug-eluting stents implantation. MethodsA total of 11,962 patients with AMI were classified into normoglycemia (group A; 3,080), prediabetes (group B; 3,709), and diabetes (group C; 5,173) groups. The primary outcomes were the patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization. Secondary outcomes were the individual components of POCOs and stent thrombosis (ST). ResultsPOCOs in groups B and C were significantly higher than those in group A. Cardiac death (adjusted hazard ratio [aHR]: 1.957, 95% confidence interval [CI]: 1.126–3.402; p = 0.017) and any repeat revascularization (aHR: 1.597, 95% CI: 1.052–2.424; p = 0.028) rates were significantly higher in group B than in group A. Re-MI (aHR: 1.884, 95% CI: 1.201–2.954; p = 0.006) and death or MI (aHR: 1.438, 95% CI: 1.098–1.884; p = 0.008) were significantly higher in group C than in group B. ConclusionsIn this study, prediabetes showed bad clinical outcomes post AMI. However, larger randomized controlled studies including ethnically diverse population are needed to confirm these harmful cardiovascular effects of prediabetes in the future.