Abstract Objectives The goal of this study was to assess the real-world clinical utility of fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRCT ) for ...decision-making in patients with stable coronary artery disease (CAD). Background FFRCT has shown promising results in identifying lesion-specific ischemia. The real-world feasibility and influence on the diagnostic work-up of FFRCT testing in patients suspected of having CAD are unknown. Methods We reviewed the complete diagnostic work-up of nonemergent patients referred for coronary computed tomography angiography over a 12-month period at Aarhus University Hospital, Denmark, including all patients with new-onset chest pain with no known CAD and with intermediate-range coronary lesions (lumen reduction, 30% to 70%) referred for FFRCT . The study evaluated the consequences on downstream diagnostic testing, the agreement between FFRCT and invasively measured FFR or instantaneous wave-free ratio (iFR), and the short-term clinical outcome after FFRCT testing. Results Among 1,248 patients referred for computed tomography angiography, 189 patients (mean age 59 years; 59% male) were referred for FFRCT , with a conclusive FFRCT result obtained in 185 (98%). FFRCT was ≤0.80 in 31% of patients and 10% of vessels. After FFRCT testing, invasive angiography was performed in 29%, with FFR measured in 19% and iFR in 1% of patients (with a tendency toward declining FFR-iFR guidance during the study period). FFRCT ≤0.80 correctly classified 73% (27 of 37) of patients and 70% (37 of 53) of vessels using FFR ≤0.80 or iFR ≤0.90 as the reference standard. In patients with FFRCT >0.80 being deferred from invasive coronary angiography, no adverse cardiac events occurred during a median follow-up period of 12 (range 6 to 18 months) months. Conclusions FFRCT testing is feasible in real-world symptomatic patients with intermediate-range stenosis determined by coronary computed tomography angiography. Implementation of FFRCT for clinical decision-making may influence the downstream diagnostic workflow of patients. Patients with an FFRCT value >0.80 being deferred from invasive coronary angiography have a favorable short-term prognosis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Summary Background Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty. We tested the hypothesis that remote ischaemic conditioning during evolving ...ST-elevation myocardial infarction, and done before primary percutaneous coronary intervention, increases myocardial salvage. Methods 333 consecutive adult patients with a suspected first acute myocardial infarction were randomly assigned in a 1:1 ratio by computerised block randomisation to receive primary percutaneous coronary intervention with (n=166 patients) versus without (n=167) remote conditioning (intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff). Allocation was concealed with opaque sealed envelopes. Patients received remote conditioning during transport to hospital, and primary percutaneous coronary intervention in hospital. The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention, measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment; analysis was per protocol. This study is registered with ClinicalTrials.gov , number NCT00435266. Findings 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria, 32 were lost to follow-up, and 77 did not complete the follow-up with data for salvage index. Median salvage index was 0·75 (IQR 0·50–0·93, n=73) in the remote conditioning group versus 0·55 (0·35–0·88, n=69) in the control group, with median difference of 0·10 (95% CI 0·01–0·22; p=0·0333); mean salvage index was 0·69 (SD 0·27) versus 0·57 (0·26), with mean difference of 0·12 (95% CI 0·01–0·21; p=0·0333). Major adverse coronary events were death (n=3 per group), reinfarction (n=1 per group), and heart failure (n=3 per group). Interpretation Remote ischaemic conditioning before hospital admission increases myocardial salvage, and has a favourable safety profile. Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes. Funding Fondation Leducq.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions Lisette Okkels Jensen, Michael Mæng, Anne Kaltoft, Per Thayssen, Hans Henrik Tilsted ...Hansen, Morten Bøttcher, Jens Flensted Lassen, Lars Romer Krussel, Klaus Rasmussen, Knud Nøerregaard Hansen, Lars Pedersen, Søren Paaske Johnsen, Henrik Toft Sørensen, Leif Thuesen We compared rates of stent thrombosis (ST), myocardial infarction (MI), death, and target lesion revascularization after implantation of drug-eluting stents (DES) and bare-metal stents (BMS), with population-based medical databases in Denmark. The DES were implanted in 3,548 patients, and BMS were implanted in 8,847 patients. The risk of definite ST was similar in the 2 groups. Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES. The MI and mortality were similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Summary Background In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9–12 months. However, the optimum timepoint for this assessment ...remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents. Methods We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events—cardiac death, myocardial infarction, and target vessel revascularisation—at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov , number NCT00660478. Findings We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 17·0% vs sirolimus-eluting stents 182/1170 15·6%; odds ratio OR 1·10, 95% CI 0·88–1·37; p=0·40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 8·0% vs sirolimus 46/1170 3·9%; OR 2·13, 95% CI 1·48–3·07; p<0·0001) compared with those at follow-up between 1 and 5 years (104 9·0% vs 136 11·6%; OR 0·78, 95% CI 0·59–1·02; p=0·071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 1·1%) than the sirolimus-eluting stent (4/1170 0·3%; OR 3·34, 95% CI 1·08–10·3; p=0·036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 0·1% vs sirolimus-eluting stent 21/1170 1·8%, OR 0·05, 95% CI 0·01–0·36; p=0·003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period. Interpretation The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation. Funding Cordis and Medtronic.
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Summary Background In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and ...safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were receiving routine clinical care with no direct follow-up. Methods We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial is registered with ClinicalTrials.gov , number NCT00660478. Findings 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow-up. All randomly assigned patients were included in analyses at 9-month follow-up; 2200 patients (94%) had completed 18-month follow-up by the time of our assessment. At 9 months, the primary endpoint had occurred in a higher proportion of patients treated with the zotarolimus-eluting stent than in those treated with the sirolimus-eluting stent (72 6% vs 34 3%; HR 2·15, 95% CI 1·43–3·23; p=0·0002). At 18-month follow-up, this difference was sustained (113 10% vs 53 5%; 2·19, 1·58–3·04; p<0·0001). For patients receiving the zotarolimus-eluting stent and those receiving the sirolimus-eluting stent, all cause-mortality was similar at 9-month follow-up (25 2% vs 18 2%; 1·40, 0·76–2·56; p=0·28), but was significantly different at 18-month follow-up (51 4% vs 32 3%; 1·61, 1·03–2·50; p=0·035). Interpretation The sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care. Funding Cordis and Medtronic.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Objectives This study sought to determine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) (FFRCT ) for the ...diagnosis of lesion-specific ischemia in nonculprit vessels of patients with recent in ST-segment elevation myocardial infarction (STEMI). Background In patients with stable angina, FFRCT has high diagnostic performance in identification of ischemia-causing lesions. The potential value of FFRCT for assessment of multivessel disease in patients with recent STEMI has not been evaluated. Methods Coronary CTA with calculation of FFRCT and invasive coronary angiography with FFR were performed 1 month after STEMI in patients with multivessel disease. Coronary CTA and invasive coronary angiography stenosis >50% were considered obstructive. Lesion-specific ischemia was assumed if FFRCT was ≤0.80. FFR ≤0.80 was the reference standard. To evaluate the influence of vessel size, the total coronary vessel lumen volume relative to left ventricular mass (volume-to-mass ratio) was calculated and compared with that of patients with stable angina. Results The study evaluated 124 nonculprit vessels from 60 patients. Accuracy, sensitivity, and specificity of FFRCT were 72%, 83%, and 66% versus 64% (p = 0.033), 93% (p = 0.15), and 49% (p < 0.001) for CTA and 72% (p = 1.00), 76% (p = 0.46), and 70% (p = 0.54) for invasive coronary angiography. Following STEMI, median volume-to-mass ratio was lower than in patients with stable angina, 53 versus 65 mm3 /g (p = 0.009). In patients with volume-to-mass ratio ≥65 mm3 /g (upper tertile) accuracy, sensitivity, and specificity of FFRCT were all 83% versus 56% (p = 0.009), 75% (p = 0.61), and 44% (p = 0.003) in patients with <49 mm3 /g (lower tertile). Conclusions The diagnostic performance of FFRCT for staged detection of ischemia in STEMI patients with multivessel disease is moderate. STEMI patients have a smaller vessel volume than do patients with stable angina. The diagnostic performance of FFRCT is influenced by the volume-to-mass ratio. This study does not support routine use of FFRCT in the post-STEMI setting. (Assessment of Coronary Stenoses Using Coronary CT-Angiography and Noninvasive Fractional Flow Reserve; NCT01739075 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives This study sought to evaluate the platelet response to aspirin and the immature platelet fraction in patients with previous stent thrombosis (ST). Background ST is a potentially fatal ...complication of coronary stenting. A reduced platelet response to aspirin increases the risk of cardiovascular events. Methods We included 117 patients previously undergoing percutaneous coronary intervention. A total of 39 patients had suffered ST and 78 patients served as controls matched at a 1:2 ratio with respect to age, sex, stent type, and percutaneous coronary intervention indication. All patients were treated with aspirin 75 mg once daily. Platelet function was assessed by multiple electrode aggregometry in citrated and hirudinized blood and by VerifyNow Aspirin Assay (Accumetrics, San Diego, California). Flow cytometric determination of the immature platelet fraction was performed to evaluate platelet turnover. Platelet activation was evaluated by soluble serum P-selectin. Compliance was confirmed by serum thromboxane B2. Results All patients were fully compliant, which was confirmed by suppressed levels of serum thromboxane B2 . Platelet aggregation was increased in patients with previous ST when assessed by multiple electrode aggregometry induced by collagen (pcitrated blood = 0.003; phirudinized blood < 0.0001) and by arachidonic acid (pcitrated blood = 0.16; phirudinized blood = 0.04), respectively. Similarly, platelet aggregation assessed by VerifyNow was higher in ST cases (p = 0.12). A trend toward an increased immature platelet fraction among cases was seen (p = 0.13), whereas P-selectin levels (p = 0.56) did not differ between groups. Conclusions Overall, patients with previous ST had a reduced antiplatelet effect of aspirin, which might be explained by an increased platelet turnover.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare ...clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio HR 2.08, 95% confidence interval CI 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, ...myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval CI 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. Objectives This study compared 5-year outcomes for ...EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial. Methods Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis. Results At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio HR: 0.80, 95% confidence interval CI: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72). Conclusions At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease SORT OUT IV; NCT00552877 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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