Trials Of Coronary Artery Bypass Grafting Research Articles

Treatment recommendation based on SYNTAX score 2020 derived from coronary computed tomography angiography and invasive coronary angiography

The diagnostic performance of the SYNTAX score 2020 (SS-2020) when calculated using CCTA remains unknown. This study aimed to compare treatment recommendations based on the SS-2020 derived from coronary computed tomography angiography (CCTA) versus invasive coronary angiography (ICA). This interim analysis included 57 of the planned 114 patients with de-novo three-vessel disease, with or without left main coronary artery disease, enrolled in the ongoing FASTTRACK CABG trial. The anatomical SYNTAX scores derived from ICA or CCTA were evaluated by two separate teams of blinded core-lab analysts. Treatment recommendations were based on a maximal individual absolute risk difference in all-cause mortality between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) of 4.5% ([predicted PCI mortality] – [predicted CABG mortality]). The level of agreement was evaluated with Bland–Altman plots and Cohen’s Kappa. The mean age was 66.2 ± 9.2 years and 89.5% of patients were male. Mean anatomical SYNTAX scores derived from ICA and CCTA were 35.1 ± 11.5 and 35.6 ± 11.4 (p = 0.751), respectively. The Bland–Altman analysis showed mean differences of − 0.26 and − 0.93, with standard deviation of 3.69 and 5.23, for 5- and 10-year all-cause mortality, respectively. The concordance in recommended treatment for 5- and 10-year mortalities were 84.2% (48/57 patients) and 80.7% (46/57 patients), with Cohen’s κ coefficients of 0.672 and 0.551. There was moderate to substantial agreement between treatment recommendations based on the SS-2020 derived using CCTA and ICA, suggesting that CCTA could be used as an alternative to ICA when making decisions regarding the modality of revascularization.

Surgical or percutaneous coronary revascularization for heart failure: an in silico model using routinely collected health data to emulate a clinical trial.

The choice of revascularization with coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in people with ischaemic left ventricular dysfunction is not guided by high-quality evidence. A trial of CABG vs. PCI in people with heart failure (HF) was modelled in silico using routinely collected healthcare data. The in silico trial cohort was selected by matching the target trial cohort, identified from Hospital Episode Statistics in England, with individual patient data from the Surgical Treatment for Ischemic Heart Failure (STICH) trial. Allocation to CABG vs. complex PCI demonstrated random variation across administrative regions in England and was a valid statistical instrument. The primary outcome was 5-year all-cause mortality or cardiovascular hospitalization. Instrumental variable analysis (IVA) was used for the primary analysis. Results were expressed as average treatment effects (ATEs) with 95 confidence intervals (CIs). The target population included 13 519 HF patients undergoing CABG or complex PCI between April 2009 and March 2015. After matching, the emulated trial cohort included 2046 patients. The unadjusted primary outcome rate was 51.1 in the CABG group and 70.0 in the PCI group. IVA of the emulated cohort showed that CABG was associated with a lower risk of the primary outcome (ATE 16.2, 95 CI 20.6 to 11.8), with comparable estimates in the unmatched target population (ATE 15.5, 95 CI 17.5 to 13.5). In people with HF, in silico modelling suggests that CABG is associated with fewer deaths or cardiovascular hospitalizations at 5 years vs. complex PCI. A pragmatic clinical trial is needed to test this hypothesis and this trial would be feasible.

Appropriateness of the modality of revascularization according to the SYNTAX 2020 in the FASTTRACK CABG study

Abstract Objectives To compare the modality of revascularization selected by the local heart team to the one recommended by the core laboratory according to the SYNTAX score 2020 amongst patients with three-vessel disease (3VD) with or without left main disease (LMCAD), who were allocated to CABG planned and solely guided by coronary computerized tomographic angiography in the FASTTRACK CABG trial. Background Personalized long term vital prognosis plays a key role in deciding between PCI and coronary artery bypass grafting (CABG) in patients with complex coronary artery disease. Methods In an interim analysis requested by the Data Safety Monitoring Board the treatment recommendations according to the SYNTAX 2020 were prospectively assessed in 57 consecutive patients (half of the planned population in this First in Man) by a core laboratory and compared to the decision of the “on site” heart team. Results According to SS-2020, the predicted absolute risk difference (ARD) in mortality between the virtual PCI treatment population and the CABG treatment group, which can be considered a virtual surrogate for the average treatment effect, increased with the duration of follow up, from 4.8±3.5% at 5 years to 8.8±5.1% at 10 years (Table 1). The ARD of less than 0% in mortality at 5-year in favour of PCI was only documented in two patients while the 55 remaining patients had a predicted survival benefit over PCI if receiving CABG. However, based on a novel threshold of equipoise (ARD <4.5%) recently validated in a contemporary registry of 3VD and LMCAD, CABG was mandatory in 26 (45.6%) patients, whereas PCI or CABG could have been equally selected in 31 (54.4%) patients (Figure 1). Conclusions According to the SYNTAX Score 2020 there was a strict observance of the CABG treatment recommendation in the first 57 consecutive patients with 3VD or LMCAD, screened on site in the FAST TRACK CABG trial. The more lenient selection criteria derived from the contemporary regitry will have to be tested propectively. Application of artificial intelligence with expanded collection of baseline characteristics, scientific endorsement and regulatory enforcement as well as further prospective evaluation are the challenges of future decision-making scores, that should be ultimately shared with the patients. Funding Acknowledgement Type of funding sources: None.

Comparison of the SYNTAX score 2020 based on Coronary Artery Computed Tomography (CCTA) with Invasive Coronary Angiography (ICA)

Abstract Introduction The SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) based on coronary artery computed tomography (CCTA) and predicting four years mortality according to the SYNTAX score II had a high agreement with the treatment decision derived from invasive coronary angiography (ICA). The agreement of the novel SYNTAX score 2020 (SS-2020) based on CCTA and ICA has not yet been evaluated in a prospective fashion. Methods This study included 54 consecutive patients in the ongoing FASTTRACK CABG trial that investigates decision making, planning and procedural CABG guidance based solely on CCTA and FFRct. All the patients underwent CCTA and ICA, and SS-2020 was calculated based on the results of anatomical SYNTAX score derived from either CCTA or ICA, and the respective scores were compared by using paired t-test. Results The mean age was 67.3±9.7, and 48 were men (88.9%). Anatomical SYNTAX score derived from CCTA was assessed in the 54 cases (analysability 100%). Anatomical SYNTAX scores based on CCTA and ICA were 34.3±9.3, and 35.5±11.3, respectively (P=0.480). As shown in the table predicted 5 years major adverse cardiac and cerebrovascular events (MACCE) following either PCI or CABG, as well as predicted 10 years mortality following CABG differed significantly. However the absolute risk differences (ARD) in 5 years MACCE and 10 years mortality following either PCI or CABG, were comparable. Conclusions High agreements were confirmed in the calculations of anatomical SYNTAX scores with CCTA and ICA. Despite significant differences in predicted MACCE rates at 5 years and mortalities at 10 years, the ARD in MACCE rates and mortality were comparable. In terms of treatment decision-making, SS-2020 calculations based on CCTA is a non-invasive predictive tool comparable to the one based on ICA. Funding Acknowledgement Type of funding sources: None.

Endoscopic vs Open Vein Harvest in Drug-Eluting Stents or Bypass Surgery for Left Main Disease Trial

BackgroundWe investigated outcomes of coronary artery bypass grafting (CABG) with endoscopic vein harvest (EVH) vs open vein harvest (OVH) within the Evaluation of XIENCE Versus CABG (EXCEL) trial. MethodsAll patients in EXCEL randomized to CABG were included in this study. For this analysis, the primary end points were ischemia-driven revascularization (IDR) and graft stenosis or occlusion at 5 years. Additional end points were as follows: a composite of death from any cause, stroke, or myocardial infarction; bleeding; blood product transfusion; major arrhythmia; and infection requiring antibiotics. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. ResultsOf the 957 patients randomized to CABG, 686 (71.7%) received at least 1 venous graft with 257 (37.5%) patients in the EVH group and 429 (62.5%) patients in the OVH group. At 5 years, IDR was higher (11.5% vs 6.7%; P = .047) in the EVH group. At 5 years, rates of graft stenosis or occlusion (9.7% vs 5.4%; P = .054) and the primary end point (17.4% vs 20.9%; P = .27) were similar. In-hospital bleeding (11.3% vs 13.8%; P = .35), in-hospital blood product transfusion (12.8% vs 13.1%; P = .94), and infection requiring antibiotics within 1 month (13.6% vs 16.8%; P = .27) were similar between EVH and OVH patients. Major arrhythmia in the hospital (19.8% vs 13.5%; P = .03) and within 1 month (21.8% vs 15.4%; P = .03) was higher in EVH patients. ConclusionsIDR at 5 years was higher in the EVH group. EVH and OVH patients had similar rates of graft stenosis or occlusion and the composite of death, stroke, or myocardial infarction at 5 years.

Blood loss after coronary artery bypass by aspirin responsiveness assessed with preoperative VerifyNow aspirin testing

BackgroundAspirin is important for preventing thrombotic events but also increases bleeding complications. Minimizing bleeding while preventing thrombotic events remains challenging in patients undergoing coronary artery bypass grafting (CABG). Establishing the patient's preoperative aspirin response could distinguish patients at risk for perioperative blood loss. ObjectiveAim was to compare 12‐h blood loss after CABG between aspirin‐sensitive and aspirin‐resistant patients. Patients/MethodsThe primary analysis of this substudy of the POPular CABG trial (NCT02352402) included patients that used aspirin monotherapy preoperatively. A preoperative platelet function test by the VerifyNow aspirin assay was performed before CABG and patients were classified as aspirin‐sensitive or aspirin‐resistant based on an aspirin reaction units cutoff value of 550. The primary end point was 12‐hour blood loss after CABG. The secondary end point was, among others, clinical bleeding events after CABG. ResultsA total of 128 patients were included in the primary analysis. Of these, 116 patients were aspirin sensitive and 12 were aspirin resistant. Mean blood loss 12 hours after CABG was 555 ± 278 mL in aspirin‐sensitive patients and 406±110 mL in aspirin‐resistant patients (P= .04). All bleeding events (n = 15; 11.7%) occurred in aspirin‐sensitive patients. ConclusionsIn patients who are on aspirin preoperatively, aspirin sensitivity was associated with 12‐hour blood loss after CABG, suggesting that preoperative VerifyNow aspirin testing could identify patients undergoing CABG at high risk for perioperative bleeding.

Sex differences in outcomes after coronary artery bypass grafting: a pooled analysis of individual patient data.

Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men. The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04-1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94-1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11-1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04-1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90-1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes. Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.

Comparison of SYNTAX score strata effects of percutaneous and surgical revascularization trials: A meta-analysis

ObjectivesThe evidence supporting the use of the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score for risk stratification is controversial. We performed a systematic review and meta-analysis of all the randomized controlled trials comparing percutaneous coronary intervention versus coronary artery bypass grafting that reported their outcomes stratified by SYNTAX score, focusing on between-strata comparisons. MethodsA systematic review of MEDLINE, EMBASE, Cochrane Library databases was performed. Incidence rate ratios were pooled with a random effect model. Between-group statistical heterogeneity according to accepted SYNTAX score tertiles was computed in the main analysis. Ratios of incidence rate ratios were computed to appraise between-strata effect, as sensitivity analysis. Primary and secondary outcomes were major adverse cardiac and cerebrovascular events and all-cause mortality, respectively. Separate sub-analyses were performed for left main and multivessel disease. ResultsFrom 425 citations, 6 trials were eventually included (8269 patients [4134 percutaneous coronary interventions, 4135 coronary artery bypass graftings]; mean follow-up: 6.2 years [range: 3.8-10]). Overall, percutaneous coronary intervention was associated with a significant increase in major adverse cardiac and cerebrovascular events (incidence rate ratio, 1.39, 95% confidence interval, 1.27-1.51) and nonsignificant increase in all-cause mortality (incidence rate ratio, 1.17, 95% confidence interval, 0.98-1.40). There was no significant statistical heterogeneity of treatment effect by SYNTAX score for major adverse cardiac and cerebrovascular events or mortality (P = .40 and P = .34, respectively). Results were consistent also for patients with left main and multivessel disease (major adverse cardiac and cerebrovascular events: P = .85 in left main, P = .78 in multivessel disease 0.78; mortality: P = .12 in left main; P = .34 in multivessel disease). Results of analysis based on ratios of incidence rate ratios were consistent with the main analysis. ConclusionsNo significant association was found between SYNTAX score and the comparative effectiveness of percutaneous coronary intervention and coronary artery bypass grafting. These findings have implications for clinical practice, future guidelines, and the design of percutaneous coronary intervention versus coronary artery bypass grafting trials.

Death and Myocardial Infarction Following Initial Revascularization Versus Optimal Medical Therapy in Chronic Coronary Syndromes With Myocardial Ischemia: A Systematic Review and Meta-Analysis of Contemporary Randomized Controlled Trials.

BackgroundIn chronic coronary syndromes, myocardial ischemia is associated with a greater risk of death and nonfatal myocardial infarction (MI). We sought to compare the effect of initial revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) plus optimal medical therapy (OMT) with OMT alone in patients with chronic coronary syndrome and myocardial ischemia on long‐term death and nonfatal MI.Methods and ResultsOvid Medline, Embase, Scopus, and Cochrane Library databases were searched for randomized controlled trials of PCI or CABG plus OMT versus OMT alone for patients with chronic coronary syndromes. Studies were screened and data were extracted independently by 2 authors. Random‐effects models were used to generate pooled treatment effects. The search yielded 7 randomized controlled trials that randomized 10 797 patients. Median follow‐up was 5 years. Death occurred in 640 of the 5413 patients (11.8%) randomized to revascularization and in 647 of the 5384 patients (12%) randomized to OMT (odds ratio [OR], 0.97; 95% CI, 0.86–1.09; P=0.60). Nonfatal MI was reported in 554 of 5413 patients (10.2%) in the revascularization arms compared with 627 of 5384 patients (11.6%) in the OMT arms (OR, 0.75; 95% CI, 0.57–0.99; P=0.04). In subgroup analysis, nonfatal MI was significantly reduced by CABG (OR, 0.35; 95% CI, 0.21–0.59; P<0.001) but was not reduced by PCI (OR, 0.92; 95% CI, 0.75–1.13; P=0.43) (P‐interaction <0.001).ConclusionsIn patients with chronic coronary syndromes and myocardial ischemia, initial revascularization with PCI or CABG plus OMT did not reduce long‐term mortality compared with OMT alone. CABG plus OMT reduced nonfatal MI compared with OMT alone, whereas PCI did not.

Clinical outcomes of complete versus incomplete revascularization in patients treated with coronary artery bypass grafting: insights from the TiCAB trial.

In this post hoc analysis of the Ticagrelor in coronary artery bypass grafting (CABG) trial, we aimed to analyse patients treated with CABG receiving either complete revascularization (CR) or incomplete revascularization (ICR) independent from random allocation to either ticagrelor or aspirin. Of 1859 patients enrolled in the Ticagrelor in CABG trial, 1550 patients (83.4%) received CR and 309 patients (16.6%) ICR. Outcomes were evaluated regarding all-cause mortality, cardiovascular death, myocardial infarction (MI), repeat revascularization, stroke and bleeding within 12 months after CABG. Baseline parameters revealed significant differences regarding clinical presentation (stable angina pectoris: CR 68.9% vs ICR 71.2%, instable angina pectoris: 14.1% vs 7.8%, non-ST elevation MI: 17.0% vs 21.0%, P ˂ 0.01), lesion characteristics (chronic total occlusion: CR 91.3% vs ICR 96.8%, P ˂ 0.01), operative technique [off-pump coronary artery bypass surgery (OPCAB): CR 3.0% vs ICR 6.1%, P ˂ 0.01] and number of utilized grafts (total number of grafts: 2.69/patient vs 2.49/patient, P ˂ 0.001). ICR patients displayed a significantly increased risk of repeat revascularization [hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.16-3.16; P < 0.01] and percutaneous coronary intervention (HR 1.95, 95% CI 1.13-3.35; P < 0.05) within 12 months after CABG. Higher risk for repeat revascularization in ICR patients was independent from random allocation to either ticagrelor or aspirin and persisted after adjustment for baseline imbalances. Patients with ICR presented more stable at the time of admission, but received less grafts, highly likely due to a higher rate of chronic total occlusion lesions and performed OPCAB. Although mortality presented no difference between groups, our results suggest that patients benefit from CR with regard to prevention of repeat revascularization.

Coronary artery bypass grafting versus percutaneous coronary intervention for myocardial infarction complicated by cardiogenic shock

Myocardial infarction (MI) complicated by cardiogenic shock (CS) is associated with high mortality. Early coronary revascularization improves survival, but the optimal mode of revascularization remains uncertain. We sought to characterize practice patterns and outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with MI complicated by CS. Patients hospitalized for MI with CS between 2002 and 2014 were identified from the United States National Inpatient Sample. Trends in management were evaluated over time. Propensity score matching was performed to identify cohorts with similar baseline characteristics and MI presentations who underwent PCI and CABG. The primary outcome was in-hospital all-cause mortality. A total of 386,811 hospitalizations for MI with CS were identified; 67% were STEMI. Overall, 62.4% of patients underwent revascularization, with PCI in 44.9%, CABG in 14.1%, and a hybrid approach in 3.4%. Coronary revascularization for MI and CS increased over time, from 51.5% in 2002 to 67.4% in 2014 (P for trend < .001). Patients who underwent CABG were more likely to have diabetes mellitus (35.5% vs. 29.2%, P < .001) and less likely to present with STEMI (48.7% vs. 80.9%, P < .001) than those who underwent PCI. CABG (without PCI) was associated with lower mortality than PCI (without CABG) overall (18.9% vs. 29.0%, P < .001) and in a propensity-matched subgroup of 19,882 patients (19.0% vs. 27.0%, P < .001). CABG was associated with lower in-hospital mortality than PCI among patients with MI complicated by CS. Due to the likelihood of residual confounding, a randomized trial of PCI versus CABG in patients with MI, CS, and multi-vessel coronary disease is warranted.

A randomized, double-blind, placebo-controlled trial investigating the effect of ticagrelor on saphenous vein graft patency in patients undergoing coronary artery bypass grafting surgery—Rationale and design of the POPular CABG trial

An estimated 15% of saphenous vein grafts (SVGs) occlude in the first year after coronary artery bypass grafting (CABG) despite aspirin therapy. Graft occlusion can result in symptoms, myocardial infarction, and death. SVG occlusion is primarily caused by atherothrombosis, in which platelet activation plays a pivotal role. Evidence regarding the effect of stronger platelet inhibition on SVG patency after CABG is limited. The main objective of the POPular CABG trial is to determine whether dual antiplatelet therapy with aspirin plus ticagrelor improves SVG patency when compared to aspirin alone. The POPular CABG is a randomized, double-blind, placebo-controlled, multicenter trial investigating the effect of adding ticagrelor to standard aspirin therapy on the rate of SVG occlusion. A total of 500 patients undergoing CABG with ≥ 1 SVG are randomized to ticagrelor or placebo. The primary end point is SVG occlusion rate, assessed with coronary computed tomography angiography at 1 year. Secondary end points are stenoses and occlusions in both SVGs and arterial grafts and SVG failure at 1 year, defined as a composite of SVG occlusion on coronary computed tomography angiography or coronary angiography, SVG revascularization, myocardial infarction in the territory supplied by an SVG, or sudden death. Safety end points are bleeding events at 30 days and 1 year. The POPular CABG trial investigates whether adding ticagrelor to standard aspirin after CABG reduces the rate of SVG occlusion at 1 year.

Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial.

The aim of this study was to assess prospectively the clinical benefits of fractional flow reserve (FFR) in guiding coronary artery bypass grafting (CABG). GRAFFITI is a single-blinded, prospective, multicentre, randomised controlled trial of FFR-guided versus angiography-guided CABG. We enrolled patients undergoing coronary angiography, having a significantly diseased left anterior descending artery or left main stem and at least one more major coronary artery with intermediate stenosis, assessed by FFR. Surgical strategy was defined based on angiography, blinded to FFR values prior to randomisation. After randomisation, patients were operated on either following the angiography-based strategy (angiography-guided group) or according to FFR, i.e., with an FFR ≤0.80 as cut-off for grafting (FFR-guided group). The primary endpoint was graft patency at 12 months. Between March 2012 and December 2016, 172 patients were randomised either to the angiography-guided group (84 patients) or to the FFR-guided group (88 patients). The patients had a median of three [3; 4] lesions; diameter stenosis was 65% (50%; 80%), FFR was 0.72 (0.50; 0.82). Compared to the angiography-guided group, the FFR-guided group received fewer anastomoses (3 [3; 3] vs 2 [2; 3], respectively; p=0.004). One-year angiographic follow-up showed no difference in overall graft patency (126 [80%] vs 113 [81%], respectively; p=0.885). One-year clinical follow-up, available in 98% of patients, showed no difference in the composite of death, myocardial infarction, target vessel revascularisation and stroke. FFR guidance of CABG has no impact on one-year graft patency, but it is associated with a simplified surgical procedure. ClinicalTrials.gov Identifier: NCT01810224.

Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy.

The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG. In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality.

Stable Ischemic Heart Disease: Medical Therapy With or Without Revascularization

Coronary artery disease (CAD) poses a significant global public health burden. Patients with CAD who do not present with acute coronary syndromes are considered to have stable ischemic heart disease (SIHD). Options for the management of SIHD are medical therapy including pharmacologic therapy and lifestyle modification and revascularization with either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Guideline-directed medical therapy is recommended for all patients with SIHD. Aside from severe stenosis in an unprotected left main coronary artery, the role of routine revascularization in the management of SIHD is unclear. Early CABG trials from the 1970s and 1980s demonstrated prognostic benefit with CABG versus medical therapy, but these results have limited applicability in the setting of modern medical therapy, including the widespread use of statins and aspirin and intensive lifestyle interventions. Contemporary strategy trials examining PCI plus medical therapy versus medical therapy alone have not demonstrated prognostic benefit with the addition of PCI. The addition of revascularization offers consistent symptom and quality-of-life benefit compared with medical therapy alone based on trial data, though this benefit may be time limited with PCI. Thus, there is a state of equipoise regarding the addition of revascularization to guideline-directed medical therapy in the management of SIHD. Therefore, shared decision-making is key when determining the best management strategy for a patient with SIHD and should include discussion of expected risks and benefits based on high-quality evidence, costs, and patient preferences. This review contains 6 figures, 8 tables, and 55 references. Key Words: angina, antianginal therapy, coronary artery disease, coronary artery bypass grafting, guideline-directed medical therapy, ischemia, optimal medical therapy, percutaneous coronary intervention, revascularization

Minimally Invasive coronary surgery compared to STernotomy coronary artery bypass grafting: The MIST trial

RationaleMinimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. However, there have been no convincing clinical trials that demonstrate improvement in post-operative quality of life for patients who undergo MICS CABG. Study designThe Minimally Invasive Coronary Surgery compared to Sternotomy Coronary Artery Bypass Grafting (MIST) trial is a multi-centered, prospective randomized controlled trial that compares the quality of life and recovery in the early post-operative period between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients will be randomized either to the MICS CABG group or the sternotomy CABG group, and the target enrollment is 88 patients per group. The primary outcome is quality of life assessment performed by SF-36 questionnaire at 1 month. ConclusionThe MIST trial is the first prospective study that compares the quality of life between MICS CABG and sternotomy CABG patients. The results of this trial may enhance the procedural desirability of MICS CABG by patients and provide an incentive for surgeons and institutions to increase the availability of MICS CABG in suitable patients.

A meta-analysis of ≥5-year mortality in randomized controlled trials of off-pump versus on-pump coronary artery bypass grafting

We sought to determine whether off-pump coronary artery bypass grafting (CABG) increases long-term mortality, by performing a meta-analysis of randomized controlled trials (RCTs) of off-pump versus on-pump CABG with ≥5-year follow-up. MEDLINE and EMBASE, and the Cochrane Central Register of Controlled Trials were searched through July 2018. Hazard, risk, or odds ratios (HRs, RRs, or ORs) of long-term (≥5-year) mortality for off-pump versus on-pump CABG were extracted from each individual trial. Study-specific estimates were combined using inverse variance-weighted averages of logarithmic HRs in the random-effects model. Our search identified eight medium- to large-size RCTs at low risk of bias with long-term follow-up of off-pump versus on-pump CABG enrolling a total of 8780 patients. Combining four RCTs reporting actual HRs generated a statistically significant result favoring on-pump CABG (HR, 1.21; P = 0.02). A pooled analysis of all eight RCTs demonstrated a statistically significant increase in mortality with off-pump CABG (HR/RR, 1.19; P = 0.01). There was no evidence of significant publication bias in the meta-analysis of all eight RCTs. In a sensitivity analysis, extracting RRs or ORs from all eight RCTs and pooling them demonstrated a statistically significant increase in mortality with off-pump CABG (RR, 1.17; P = 0.01; OR, 1.20; P = 0.007). Eliminating 2 RRs and combining six HRs still generated a statistically significant result favoring on-pump CABG (HR, 1.19; P = 0.05). Off-pump CABG increases long-term (≥5-year) mortality compared with on-pump CABG.

DEVELOPMENT OF A PATIENT DECISION AID FOR PATIENTS WHO ARE HIGH RISK CANDIDATES FOR CORONARY ARTERY BYPASS SURGERY

Coronary artery bypass grafting (CABG) carries a risk of morbidity and mortality. These risks are significantly increased in patients with certain pre-existing co-morbidities. Alternative treatments such as PCI or medical management may be considered in these high-risk patients. In Canada, there is no clear framework to support patients' decision-making when faced with such treatment options. A Patient Decision Aid (PtDA) provides structured and evidence-informed decision support, has been shown to decrease decisional conflict or treatment uncertainty, and can meet health-goals that are consistent with the patient’s values. This study focuses on the development and evaluation of a PtDA for higher risk patients considered ineligible for PCI, comparing the option of CABG versus optimal medical management. The development process was guided by the Ottawa Decision Support Framework (ODSF) and the International Patient Decision Aid Standards (IPDAS). The development panel was comprised of health-service researchers, decision science experts, interventional cardiologists, cardiovascular surgeons and intensivists. The first step was to draft the PtDA, which required synthesizing outcome evidence from CABG trials, systematic reviews and meta-analyses. Input from physician experts on local data informed probabilities of risks and benefits to populate the PtDA. The preliminary PtDA data compiled is presented in Figure 1a and 1b. A Needs Assessment survey, currently underway, will help streamline content of the PtDA based on what outcomes patients’ value most, and thus inform value-based clinical decision-making. A patient advisory committee (n=3) will review and evaluate the next draft of the PtDA after incorporation of the findings from the Needs Assessment. Modifications based on patient and family input will be made, if necessary. Finally, the PtDA will be uploaded to the Ottawa Decision Aid Library Inventory for external review. The implementation will be supported and endorsed by the hospital administration as part of their quality improvement initiative to provide integrated, effective and patient-centred care. The aim of this project is to develop a PtDA for patients being considered for CABG, as consistent with the ODSF and IPDAS. This PtDA aims to moderate treatment-related uncertainty, inform patient-centred outcomes and prepare patients to make well-informed decisions. However, additional research is required to improve consensus in defining high-risk patients, and identifying outcomes important to this select group of high-risk patients when faced with a decision of CABG versus optimal medical therapy. Overall, the decision support provided by the PtDA will enhance the decision-making process between patients, physicians, and families.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Surgical Versus Percutaneous Coronary Revascularization in Patients With Diabetes and Acute Coronary Syndromes

BackgroundRandomized trial data support the superiority of coronary artery bypass grafting (CABG) surgery over percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (MV-CAD). However, whether this benefit is seen in a real-world population among subjects with stable ischemic heart disease (SIHD) and acute coronary syndromes (ACS) is unknown. ObjectivesThe main objective of this study was to assess the generalizability of the FREEDOM (Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-vessel Disease) trial in real-world practice among patients with diabetes mellitus and MV-CAD in residents of British Columbia, Canada. Additionally, the study evaluated the impact of mode of revascularization (CABG vs. PCI with drug-eluting stents) in diabetic patients with ACS and MV-CAD. MethodsIn a large population-based database from British Columbia, this study evaluated major cardiovascular outcomes in all diabetic patients who underwent coronary revascularization between 2007 and 2014 (n = 4,661, 2,947 patients with ACS). The primary endpoint (major adverse cardiac or cerebrovascular events [MACCE]) was a composite of all-cause death, nonfatal myocardial infarction, and nonfatal stroke. The risk of MACCE with CABG or PCI was compared using multivariable adjustment and a propensity score model. ResultsAt 30-days post-revascularization, for ACS patients the odds ratio for MACCE favored CABG 0.49 (95% confidence interval [CI]: 0.34 to 0.71), whereas among SIHD patients MACCE was not affected by revascularization strategy (odds ratio: 1.46; 95% CI: 0.71 to 3.01; pinteraction <0.01). With a median follow-up of 3.3 years, the late (31-day to 5-year) benefit of CABG over PCI no longer varied by acuity of presentation, with a hazard ratio for MACCE in ACS patients of 0.67 (95% CI: 0.55 to 0.81) and the hazard ratio for SIHD patients of 0.55 (95% CI: 0.40 to 0.74; pinteraction = 0.28). ConclusionsIn diabetic patients with MV-CAD, CABG was associated with a lower rate of long-term MACCE relative to PCI for both ACS and SIHD. A well-powered randomized trial of CABG versus PCI in the ACS population is warranted because these patients have been largely excluded from prior trials.

Coronary artery disease: New Insights into revascularization treatment of diabetic patients.

Diabetes mellitus is an independent cardiovascular risk factor, considered an equivalent of coronary artery disease in terms of prognosis. A history of acute coronary syndrome is a strong predictor of another coronary episode, and cardiovascular complications are the leading cause of mortality in diabetic patients. Many patients with coronary artery disease suffer from concomitant diabetes or pre-diabetes. There are 3 strategies of coronary artery disease treatment: conservative management, coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). Since drug-eluting stents (DES) were developed, PCI has become one of the most widespread interventional cardiology procedures performed in Europe and worldwide. Among all coronary risk factors, diabetes mellitus remains the most important predictor of unfavorable outcomes of revascularization therapy. This paper reviews the current evidence regarding revascularization in diabetic patients, with particular emphasis on PCI. A systematic analysis of clinical trials of CABG and PCI, especially with DES, was conducted.