Preoperative intra-aortic balloon pump in patients with ST-elevation myocardial infarction undergoing urgent cardiac bypass surgery.

BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI), either with or without cardiogenic shock, mechanical circulatory support with an intra-aortic balloon pump (IABP) is not associated with lower mortality. However, in STEMI patients undergoing urgent coronary artery bypass grafting (CABG), preoperative insertion of an IABP has been suggested to reduce mortality. In this study, the effect of preoperative IABP use on mortality in STEMI patients undergoing urgent CABG was investigated. METHODS: All consecutive STEMI patients undergoing urgent CABG in a single centre between 2000 and 2018 were studied. The primary outcome, 30-day mortality, was compared between patients with and without a preoperative IABP. Subgroup analysis and multivariable analysis using a propensity score and inverse probability treatment weighting were performed to adjust for potential confounders. RESULTS: A total of 246 patients were included, of whom 171 (69.5%) received a preoperative IABP (pIABP group) and 75 (30.5%) did not (non-pIABP group). In the pIABP group, more patients suffered from cardiogenic shock, persistent ischaemia and reduced left ventricular function. Unadjusted 30-day mortality was comparable between the pIABP and the non-pIABP group (13.3% vs 12.3%, p = 0.82). However, after correction for confounders and inverse probability treatment weighting preoperative IABP was associated with reduced 30-day mortality (relative risk 0.52, 95% confidence interval 0.30-0.88). CONCLUSION: In patients with STEMI undergoing urgent CABG, preoperative insertion of an IABP is associated with reduced mortality.

The incremental value of coronary artery calcium score in predicting long-term prognosis and defining the warranty period of normal adenosine stress-only myocardial perfusion imaging using CZT SPECT.

BACKGROUND: Normal stress-only (SO) myocardial perfusion imaging (MPI) using SPECT reduces imaging time and radiation dose with a good prognosis. However, the long-term prognostic value of combining coronary artery calcium score (CACS) with SO MPI to determine the warranty period remains unknown. Hence, we assessed the incremental prognostic value of CACS and its impact on the warranty period of normal SO MPI using SPECT. METHODS: We retrospectively included 1375 symptomatic patients without a history of coronary artery disease (CAD) and a normal SO MPI using adenosine who underwent simultaneous CAC scoring. Annual major adverse cardiac events (MACE) rates were calculated for CACS categories: 0, 1-399, 400-999, and ≥1000. RESULTS: The mean age was 60.0 ± 11.8 years (66.9% female) with a median follow-up of 10.3 [IQR 9.6-10.9] years. The warranty period for annual MACE rate for normal SO SPECT extended the total follow-up time in years. MACE rate categorized by CAC categories demonstrated an increase in MACE rates with increasing CACS; CACS 0 and CACS 1-399 were associated with a 10-year warranty period, CACS 400-999 had a warranty period of 4 years and no warranty period could be given for CACS≥1000 (5.9 % at 1 year). CONCLUSIONS: CACS as an adjunct to normal pharmacological SO MPI provides additional prognostic information and aids in determining a warranty period.

Impact of vomiting on P2Y12 platelet inhibition in patients with ST-elevation myocardial infarction: A prespecified subanalysis of the ON-TIME 3 trial.

Vomiting is associated with lower levels of ticagrelor concentration and higher platelet reactivity in the early hours of ST-elevation myocardial infarction. These results support reloading with a ticagrelor loading dose and/or treatment with intravenous platelet inhibitors when patients vomit.

Mortality Reduction After a Preincision Safety Check Before Cardiac Surgery: Is It the Aorta?

OBJECTIVES: The introduction and use of a preincision safety check were associated with lower mortality after mixed adult cardiac surgery; however, an explanatory mechanism is lacking. Stroke, one of the most severe complications after cardiac surgery, with high mortality, may be reduced by adapting the surgical handling of the ascending aorta. This study assessed the prevalence and predictors of this adaptation after a preincision safety check and the subsequent effect on outcome. DESIGN: A prospective, single-center, observational study comparing adaptation with no-adaptation. The primary outcome measure was 30-day mortality. Multivariate analyses were performed to determine independent predictors of adaptation. To study the effect of adaptation on outcome, a propensity score-matched cohort was constructed in a 1:3 intervention:control ratio. SETTING: At Isala Zwolle (NL), a large, nonacademic teaching hospital. PARTICIPANTS: All consecutive cardiac surgery procedures from 2012 until 2015, including 4,752 surgeries. INTERVENTIONS: The adaptation of surgical handling of the ascending aorta. MEASUREMENTS AND MAIN RESULTS: In 283 cardiac surgeries (5.9%), adaptation was indicated. The most important independent predictors for adaptation were extracardiac atherosclerosis, current smoking, and increasing age. In the propensity score-matched cohort consisting of 1,069 procedures, there were no significant differences in outcome. After correction for propensity score, the hazard ratio of adaptation for 30-day mortality was 1.8 (0.85-3.79). CONCLUSIONS: The adaptation of aortic surgical handling after a preincision safety check was necessary for 5.9% of cardiac surgeries, with extracardiac atherosclerosis as the strongest predictor. Outcome was not significantly different between patients with and without adaptation. Although promising, it remains unclear whether adaptation may fully explain mortality reduction after the use of a preincision safety check.

Specific recommendations (or lack thereof) for older patients with cardiovascular disease in the current European Society of Cardiology guidelines : From the Dutch Working Group of Geriatric Cardiology of the Netherlands Society of Cardiology (NVVC) and Special Interest Group Geriatric Cardiology of the Netherlands Society for Clinical Geriatrics (NVKG).

Due to population ageing, the number of older and frail patients with cardiovascular disease is increasing. In the current guidelines of the European Society of Cardiology specific recommendations for this older population are missing or scarce, probably due to limited evidence concerning diagnosis and treatment of cardiovascular disease in older patients. Moreover, recommendations on shared decision making, palliative care and advanced care planning are also essential in these guidelines. In this article we evaluate the current European of Society of Cardiology guidelines (2013-2020) to determine whether specific recommendations for older patients have been included.

NT-proBNP level before primary PCI and risk of poor myocardial reperfusion: Insight from the On-TIME II trial.

BACKGROUND: N-terminal fragment of the brain natriuretic peptide prohormone (NT-proBNP), a marker for neurohumoral activation, has been associated with adverse outcome in patients with myocardial infarction. NT-proBNP levels may reflect extensive ischemia and microvascular damage, therefore we investigated the potential association between baseline NT-proBNP level and ST-resolution (STR), a marker of myocardial reperfusion, after primary percutaneous coronary intervention (pPCI). METHODS: we performed a post-hoc analysis of the On-TIME II trial (which randomized ST-elevation myocardial infarction (STEMI) patients to pre-hospital tirofiban administration vs placebo). Patients with measured NT-proBNP before angiography were included. Multivariate logistic-regression analyses was performed to investigate the association between baseline NTproBNP level and STR one hour after pPCI. RESULTS: Out of 984 STEMI patients, 918 (93.3%) had NT-proBNP values at baseline. Patients with STR <70% had higher NT-proBNP values compared to patients with complete STR (>70%) [Mean ±SD 375.2 ±1021.7 vs 1007.4 ±2842.3, Median (IQR) 111.7 (58.4-280.0) vs 168.0 (62.3-601.3), P <.001]. At multivariate logistic regression analysis, independent predictors associated with higher risk of poor myocardial reperfusion (STR <70%) were: NT-proBNP (OR 1.17, 95%CI 1.04-1.31, P = .009), diabetes mellitus (OR 1.87, 95%CI 1.14-3.07, P = .013), anterior infarct location (OR 2.74, 95% CI 2.00-3.77, P <.001), time to intervention (OR 1.06, 95%CI 1.01-1.11, P = .021), randomisation to placebo (OR 1.45, 95%CI 1.05-1.99, P = .022). CONCLUSIONS: In STEMI patients, higher baseline NT-proBNP level was independently associate with higher risk of poor myocardial reperfusion, supporting the potential use of NT-proBNP as an early marker for risk stratification of myocardial reperfusion after pPCI in STEMI patients.

Does fractional flow reserve overestimate severity of LAD lesions?

BACKGROUND: Fractional Flow Reserve (FFR) is increasingly used to estimate the severity of coronary stenoses, prior to coronary revascularization. However, it has been suggested that FFR overestimates the severity of Left Anterior Descending (LAD) lesions. Our aim was to verify whether in patients without ischemia on Myocardial Perfusion Imaging, FFR of the LAD is more often abnormal in comparison to FFR of other coronary arteries. METHODS: Prospective cohort study of consecutive patients who underwent FFR measurement because of persistent or worsening of angina complaints, within 6 months after normal Myocardial Perfusion Imaging. FFR measurements of a graft or diagonal branch were excluded. A FFR ≤ 0.80 denoted a functionally relevant stenosis. RESULTS: In 133 patients, 167 FFR measurements were performed, of which 85 in the LAD. Mean age of the patients was 64.8 ± 10.5 years, 40% were women. There were no differences in baseline characteristics between patients undergoing LAD and non-LAD measurements. An abnormal FFR was observed in 35.3% of the LAD measurements, compared to 9.8% in the non-LAD measurements (P = 0.001). Also after adjusting for age and gender, the FFR remained more frequently abnormal in the LAD with OR 5.2 (95% CI 2.2 to 12.3). Of the abnormal FFR LAD measurements, 70% were visually considered non-obstructive on invasive angiography. CONCLUSIONS: In selected patients without ischemia on MPI, FFR measurement of the LAD is significantly more often abnormal. The majority of these patients has no obstructive lesions on invasive angiography. Possibly, FFR overestimates severity of LAD lesions, with risk of unnecessary revascularization.

Accuracy of pre-hospital HEART score risk classification using point of care versus high sensitive troponin in suspected NSTE-ACS.

INTRODUCTION: Pre-hospital risk classification by the HEART score is performed with point of care troponin assessment. However, point of care troponin is less sensitive than high sensitive troponin measurement which is used in the hospital setting. In this study we compared pre-hospital HEART-score risk classification using point of care troponin versus high sensitive troponin. METHODS: In 689 consecutive patients with suspected NSTE-ACS, point of care troponin and laboratory high-sensitive troponin were measured in pre-hospital derived blood. For every patient the HEART score with both point of care troponin (HEART-POC) and high sensitive troponin (HEART-hsTnT) was determined. Endpoint was MACE within 45 days. RESULTS: Mean age was 64 (SD ±â€¯14), 163 (24%) patients were considered low-risk by HEART-hsTnT and 170 (25%) by HEART-POC. MACE was observed in 17%. Although high sensitive versus POC troponin scoring was different in 130 (19%) of patients, in 678 (98%) patients risk classification in low versus intermediate-high risk was similar. The predictive values of HEART-POC versus HEART-HsTnT was similar (AUC 0.75 versus 0.76, p = 0.241). CONCLUSION: Although high sensitive versus POC troponin scoring was dissimilar in one fifth of patients, this resulted in different patient risk classification in only 2 percent of patients. Therefore POC troponin measurement suffices for pre-hospital risk stratification of suspected NSTE-ACS.

Effect of early tirofiban administration on N-terminal pro-B-type natriuretic peptide level in patients treated with primary percutaneous coronary intervention.

OBJECTIVES: To investigate the potential association between early tirofiban treatment and N-terminal pro-B-type natriuretic peptide (NT-proBNP) level after primary percutaneous coronary intervention (PCI). BACKGROUND: Whether the use of adjunctive early glycoprotein IIb/IIIa inhibitors (GPIs) therapy, may affect the level of NT-proBNP after primary PCI is poorly studied. METHODS: Nine hundred and eighty four ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI were randomized to either pre-hospital tirofiban administration or placebo. NT-proBNP levels were evaluated on admission before angiography (baseline) and 18-96 hr after PCI. RESULTS: There were 918 (93.3%) patients with NT-proBNP values available at baseline and 865 (87.9%) post-PCI. Post-PCI NT-proBNP level dichotomized with median value as cut-off (968.8 pg/mL, IQR 430.9-1970.0) was significantly lower in patients treated with early tirofiban as compared to placebo (45.5% vs. 54.2% P = 0.011). At multivariate logistic regression analysis, independent predictors of post-PCI NT-proBNP level above the median were: NT-proBNP baseline level (OR 5.19; 95% CI, 2.92-9.25, P < 0.001), Killip class>I (OR 4.07; 95% CI 1.24-13.36, P = 0.021), anterior infarct location (OR 2.61; 95% CI 1.84-3.70, P < 0.001), age (years) (OR 1.04; 95% CI 1.03-1.06, P < 0.001), male gender (OR 0.38; 95% CI 0.26-0.57, P < 0.001), prior PCI (OR 0.49; 95% CI 0.27-0.90, P = 0.021) and tirofiban administration (OR 0.71; 95% CI 0.51-0.99; P = 0.045). CONCLUSIONS: In a large cohort of STEMI patients, pre-hospital tirofiban administration was independently associate with a lower risk of high NT-proBNP level after primary PCI, supporting the potential benefit of early antithrombotic treatment administration in STEMI patients. The trial is registered under No. ISRCTN06195297.

Coronary calcium score influences referral for invasive coronary angiography after normal myocardial perfusion SPECT.

BACKGROUND: In patients with normal SPECT but persistent complaints, invasive angiography may exclude obstructive coronary disease. We assessed whether high coronary artery calcium (CAC) scores are associated with increased referral for invasive angiography following normal SPECT. METHODS AND RESULTS: 2286 consecutive patients (mean age 60 ± 12, 39% male) with normal SPECT were assessed. All patients underwent simultaneous CAC scoring. Patients were categorized into four groups based on their CAC score: CAC = 0 (n = 694), CAC 1 to 100 (n = 891), CAC 101 to 400 (n = 368), and CAC >400 (n = 333). The decision to perform angiography was left to the discretion of treating physician. Follow-up angiography was confined to the first 60 days after SPECT. Occurrence of MACE (late revascularization, myocardial infarction or death) was recorded. Overall, 100 patients (4.4%) underwent early angiography with increasing rates in higher CAC score groups (1.0%, 2.6%, 8.4%, and 11.7%), respectively, P < .001). A CAC score >400 (OR 3.56, 95% CI 2.19 to 5.77, P < .001) was independently associated with referral to angiography. Similarly, CAC score >400 was an independent predictor for MACE (HR 9.26, 95% CI 5.06 to 16.93). Early angiography did not influence prognosis (HR 1.57, 95% CI 0.91 to 2.73). CONCLUSIONS: CAC scoring impacts clinical decision-making and increases referral rates for invasive angiography after normal SPECT.

Value of automatic patient motion detection and correction in myocardial perfusion imaging using a CZT-based SPECT camera.

BACKGROUND: Correction of motion has become feasible on cadmium-zinc-telluride (CZT)-based SPECT cameras during myocardial perfusion imaging (MPI). Our aim was to quantify the motion and to determine the value of automatic correction using commercially available software. METHODS AND RESULTS: We retrospectively included 83 consecutive patients who underwent stress-rest MPI CZT-SPECT and invasive fractional flow reserve (FFR) measurement. Eight-minute stress acquisitions were reformatted into 1.0- and 20-second bins to detect respiratory motion (RM) and patient motion (PM), respectively. RM and PM were quantified and scans were automatically corrected. Total perfusion deficit (TPD) and SPECT interpretation-normal, equivocal, or abnormal-were compared between the noncorrected and corrected scans. Scans with a changed SPECT interpretation were compared with FFR, the reference standard. Average RM was 2.5 ± 0.4 mm and maximal PM was 4.5 ± 1.3 mm. RM correction influenced the diagnostic outcomes in two patients based on TPD changes ≥7% and in nine patients based on changed visual interpretation. In only four of these patients, the changed SPECT interpretation corresponded with FFR measurements. Correction for PM did not influence the diagnostic outcomes. CONCLUSION: Respiratory motion and patient motion were small. Motion correction did not appear to improve the diagnostic outcome and, hence, the added value seems limited in MPI using CZT-based SPECT cameras.

Changes in cardiovascular medication after coronary artery calcium scanning and normal single photon emission computed tomography myocardial perfusion imaging in symptomatic patients.

The impact of coronary artery calcium (CAC) scoring on subsequent changes in cardiovascular medication use in symptomatic patients with normal myocardial perfusion imaging (MPI) findings is not well established. The aim of the current study was to evaluate changes in aspirin and statin use in patients suspected for coronary artery disease after CAC scoring and normal single photon emission computed tomography (SPECT) MPI. METHODS: In the current study, 1,033 stable symptomatic patients without a known history of coronary artery disease with normal SPECT MPI who underwent concomitant CAC scoring were included. All patients had a clinical indication for imaging, mainly atypical chest pain and dyspnea, and were referred from the outpatient clinic of our hospital. Data regarding posttest medication change (either starting or discontinuation of aspirin and statin therapy at the subsequent outpatient visit) were retrospectively collected. Patients were categorized into 4 groups based on their CAC score. RESULTS: Mean age of the patients was 61±11 years and 39% were male. At baseline, 35% of the patients used aspirin and 39% used statin. In patients with CAC scores 0, 1-99, 100-399, and ≥400, aspirin was started in 1%, 4%, 9%, and 9%, respectively, and statin was started in 0%, 7%, 18%, and 24% of the patients, respectively (P<.001). Aspirin was discontinued in 19%, 11%, 7%, and 1% and statin was discontinued in 8%, 6%, 2%, and 0% (P<.001) of the patients in these respective CAC score categories. After correction for differences in risk factors and baseline medication use, increased CAC was independently associated with posttest aspirin (odds ratio 4.6, 11.2, and 27.1 for CAC scores 1-99, 100-399, and ≥400, respectively; P<.001) and statin use (odds ratio 4.4, 19.4, and 60.9 for CAC scores 1-99, 100-399, and ≥400, respectively; P<.001). CONCLUSIONS: Higher CAC scores are associated with the initiation of aspirin and statin therapy in patients with normal SPECT MPI. In patients with lower CAC scores, discontinuation of cardioprotective medication is more likely. CAC score is independently associated with posttest statin and aspirin use.

Factors associated with deferred lesion failure following fractional flow reserve assessment in patients with diabetes mellitus.

OBJECTIVE: To explore the predictors of deferred lesion failure (DLF) in patients with diabetes mellitus (DM) and lesions with a fractional flow reserve (FFR) >0.80 and to examine whether a predictive relationship between negative FFR values (>0.80-1.00) and DLF exists. BACKGROUND: DM is associated with rapidly progressive atherosclerosis and predictors of DLF in FFR negative lesions in this high-risk group are unknown. METHODS: All DM patients who underwent FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients carrying ≥1 FFR negative lesion(s) were assessed for DLF, and multivariate models used to identify independent factors associated with DLF. RESULTS: A total of 205 patients with 252 FFR >0.80 lesions were identified. At a mean follow-up of 3.1 ± 1.4 years, DLF occurred in 29/205 (14.1%) patients, 31/252 (12.3%) lesions. Using marginal Cox regression multivariate analysis, insulin requiring DM [HR 2.24 (95%CI; 1.01-4.95), P = 0.046] and prior revascularization [HR 2.70 (95%CI 1.21-6.01), P = 0.015] were identified as being associated with a higher incidence of DLF. Absolute FFR values in FFR negative lesions in DM patients are not predictive of DLF (receiver operating characteristics curve analysis: area under the curve: 0.57 ± 0.06, 95%CI 0.46-0.69). CONCLUSIONS: In DM patients with FFR negative lesions, insulin requiring DM and prior revascularization are predictors for DLF. In contrast to non-DM patients, no predictive relationship between absolute negative FFR values (ranging >0.80-1.00) and the risk of DLF exists in DM patients. © 2017 Wiley Periodicals, Inc.

Sequential SPECT/CT imaging starting with stress SPECT in patients with left bundle branch block suspected for coronary artery disease.

OBJECTIVES: To investigate the impact of left bundle branch block (LBBB) on sequential single photon emission computed tomography (SPECT)/ CT imaging starting with stress-first SPECT. METHODS: Consecutive symptomatic low- to intermediate-risk patients without a history of coronary artery disease (CAD) referred for SPECT/CT were included from an observational registry. If stress SPECT was abnormal, additional rest SPECT and, if feasible, coronary CT angiography (CCTA) were acquired. RESULTS: Of the 5,018 patients, 218 (4.3 %) demonstrated LBBB. Patients with LBBB were slightly older than patients without LBBB (65±12 vs. 61±11 years, p<0.001). Stress SPECT was more frequently abnormal in patients with LBBB (82 % vs. 46 %, p<0.001). After reviewing stress and rest images, SPECT was normal in 43 % of the patients with LBBB, compared to 77 % of the patients without LBBB (p<0.001). Sixty-four of the 124 patients with LBBB and abnormal stress-rest SPECT underwent CCTA (52 %), which could exclude obstructive CAD in 46 of the patients (72 %). CONCLUSIONS: Sequential SPECT/CT imaging starting with stress SPECT is not the optimal imaging protocol in patients with LBBB, as the majority of these patients have potentially false-positive stress SPECT. First-line testing using CCTA may be more appropriate in low- to intermediate-risk patients with LBBB. KEY POINTS: • Stress-first SPECT imaging is attractive if many patients demonstrate normal stress perfusion. • The majority of left bundle branch block patients have abnormal stress-first SPECT. • Coronary CT excluded obstructive CAD in many LBBB patients with abnormal SPECT. • Stress-first SPECT imaging is not the optimal imaging protocol in LBBB patients. • In LBBB patients imaging with initial coronary CT may be more appropriate.

Sequential SPECT/CT imaging for detection of coronary artery disease in a large cohort: evaluation of the need for additional imaging and radiation exposure.

BACKGROUND: Performing both single photon emission computerized tomography (SPECT) and coronary computed tomography angiography (CCTA) in patients suspected for coronary artery disease (CAD) leads to increased radiation exposure. We evaluated the need for additional imaging and following implications for radiation exposure of a sequential SPECT/computed tomography (CT) algorithm. METHODS AND RESULTS: 5018 consecutive patients without history of CAD were referred for stress-first SPECT and coronary artery calcium (CAC) scoring. If stress SPECT was abnormal, additional rest SPECT and, if feasible, CCTA were acquired. Stress SPECT was normal in 2617 patients (52%). CCTA was not performed in 1289 of the 2401 patients referred for additional imaging (54%), mainly because of severe CAC (47%) or fast/irregular heart rate (22%). 642 patients with abnormal SPECT underwent CCTA, which excluded significant CAD in 378 patients (59%). Mean radiation dose was 4.5 ± 0.3 mSv for stress-only imaging and 13.2 ± 3.3 mSv for additional imaging (P < 0.001). CONCLUSIONS: Half of the patients do not require additional imaging in our sequential SPECT/CT algorithm, which is accompanied with low radiation exposure. CCTA cannot be performed in half of the patients who undergo additional imaging because of (relative) contra-indications. CCTA is able to correct for false-positive SPECT findings in our algorithm.

Shock Index More Sensitive Than Cardiogenic Shock in ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention.

BACKGROUND: Cardiogenic shock (CS) is a strong predictor of mortality in patients with ST-elevation myocardial infarction (STEMI), but there is evidence that shock index (SI), taking into account both blood pressure and heart rate, is a more sensitive and powerful predictor. We investigated the independent impact of SI and CS on 30-day and 1-year mortality in patients with STEMI, treated by primary percutaneous coronary intervention (PCI).Methods and Results:In 7,412 consecutive patients with STEMI treated with primary PCI, the predictive value of either SI or CS on 1-year mortality was assessed. Best cut-off value of SI, determined using receiver operating characteristic (ROC) curve, was 0.7, with an ROC AUC of 0.66 (95% CI: 0.65-0.67), compared with an ROC AUC of 0.60 (95% CI: 0.59-0.61) for CS (P<0.001). At admission, 387 patients (5.2%) had CS and 1,567 patients (21.1%) had SI ≥0.7. The adjusted hazard ratio of mortality in patients with SI ≥0.7 and in CS patients was, respectively, 3.3 (95% CI: 2.4-4.6) and 3.1 (95% CI: 2.1-4.6) after 30 days, and 2.3 (95% CI: 1.8-2.9) and 3.1 (95% CI: 2.2-4.2) after 1 year. CONCLUSIONS: SI identifies more patients with increased risk of mortality, and seems to be a more sensitive prognostic predictor than CS in patients with STEMI treated by primary PCI.

Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design.

BACKGROUND: Fractional flow reserve (FFR) is a widely used tool for the identification of ischaemia-generating stenoses and to guide decisions on coronary revascularisation. However, the safety of FFR-based decisions in high-risk subsets, such as patients with Diabetes Mellitus (DM) or vulnerable stenoses presenting thin-cap fibro-atheroma (TCFA), is unknown. This study will examine the impact of optical coherence tomography (OCT) plaque morphological assessment and the identification of TCFA, in combination with FFR to better predict clinical outcomes in DM patients. METHODS: COMBINE (OCT-FFR) is a prospective, multi-centre study investigating the natural history of DM patients with ≥1 angiographically intermediate target lesion in three subgroups of patients; patients with FFR negative lesions without TCFA (group A) and patients with FFR negative lesions with TCFA (group B) as detected by OCT and to compare these two groups with each other, as well as to a third group with FFR-positive, PCI-treated intermediate lesions (group C). The study hypothesis is that DM patients with TCFA (group B) have a worse outcome than those without TCFA (group A) and also when compared to those patients with lesions FFR ≤0.80 who underwent complete revascularisation. The primary endpoint is the incidence of target lesion major adverse cardiac events (MACE); a composite of cardiac death, myocardial infarction or rehospitalisation for unstable/progressive angina in group B vs. group A. CONCLUSION: COMBINE (OCT-FFR) is the first prospective study to examine whether the addition of OCT plaque morphological evaluation to FFR haemodynamic assessment of intermediate lesions in DM patients will better predict MACE and possibly lead to new revascularisation strategies. Trial Registration Netherlands Trial Register: NTR5376.

Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus.

OBJECTIVE: Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. METHODS: All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). RESULTS: A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed. CONCLUSIONS: This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.

Prognostic value of normal stress-only myocardial perfusion imaging: a comparison between conventional and CZT-based SPECT.

PURPOSE: Single photon emission computed tomography (SPECT) myocardial perfusion imaging has proven to have prognostic importance in patients with suspected stable coronary artery disease (CAD). The recently introduced ultrafast cadmium zinc telluride (CZT)-based gamma cameras have been associated with less equivocal findings and more normal interpretations, allowing stress-only imaging to be performed more often. However, it is yet unclear whether normal stress-only CZT SPECT has comparable prognostic value as normally interpreted stress-only conventional SPECT. METHODS: The study population consisted of 1,650 consecutive patients without known CAD with normal stress-only myocardial perfusion results with either conventional (n = 362) or CZT SPECT (n = 1,288). The incidence of major adverse cardiac events (MACE, all-cause death, non-fatal myocardial infarction and/or coronary revascularization) was compared between the conventional SPECT and CZT SPECT groups. Multivariable analyses using the Cox model were used to adjust for differences in baseline variables. RESULTS: Patients scanned with CZT were less often male (33 vs 39 %), had less often hypercholesterolaemia (41 vs 50 %) and had more often a family history of CAD (57 vs 49 %). At a median follow-up time of 37 months (interquartile range 28-45 months) MACE occurred in 68 patients. The incidence of MACE was 1.5 %/year in the CZT group, compared to 2.0 %/year in the conventional group (p = 0.08). After multivariate analyses, there was a trend to a lower incidence of MACE in the CZT SPECT group (hazard ratio 0.61, 95 % confidence interval 0.35-1.04, p = 0.07). CONCLUSION: The prognostic value of normal stress-only CZT SPECT is at least comparable and may be even better than that of normal conventional stress SPECT.