Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS).
ABSTRACT: Aim:Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI. Methods:Consecutive MV-CAD patients (n?=?155) were randomized (1?:?1?:?1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control. Results:Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% (p=0.71). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days (p < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks (p < 0.001). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority p values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% (p=0.05). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% (p=0.62). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%; p=0.83). Conclusion:In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048.
Project description:<h4>Background</h4>Several updated meta-analyses comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for left main coronary artery disease (LM CAD) have been published recently. However, the risk of false-positive results could be high in conventional updated meta-analyses due to repetitive testing of accumulating data. Therefore, we compared these treatment approaches via trial sequential analysis (TSA).<h4>Methods</h4>The MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched for published randomized controlled trials (RCTs) or subgroups of RCTs comparing PCI and CABG in patients with LM CAD. The primary outcome was major cardiac and cerebrovascular adverse events (MACCE). TSA was used to confirm the conclusions derived from conventional meta-analysis.<h4>Results</h4>Six RCTs with 4700 patients were included. PCI was associated with a greater risk of MACCE compared with CABG (pooled relative risk [RR] 1.21, 95% confidence interval [CI]: 1.05-1.40, P?=?.008). In addition, PCI resulted in a significantly higher risk of revascularization than CABG (pooled RR 1.61, 95% CI: 1.33-1.95, P?<?.0001). TSA provided firm evidence for the reduction of MACCE and revascularization with CABG compared with PCI (cumulative z-curve crossed the monitoring boundary). In the subgroup analysis, CABG was better than PCI in patients with SYNTAX score >32 (pooled RR 1.41, 95% CI: 1.12-1.76, P?=?.003), which was confirmed by the TSA. There was no difference in patients with a SYNTAX score from 0 to 32.<h4>Conclusions</h4>In patients with LM CAD, CABG may be better than PCI for reducing MACCE due to a reduced risk of revascularization. CABG remains the first choice for LM CAD patients with high anatomic complexity, while PCI could be an alternative for those with low-to-moderate anatomic complexity.
Project description:Coronary artery disease (CAD) has typically been treated either medically, with percutaneous coronary intervention (PCI), or with coronary artery bypass grafting (CABG). As advances in stent technology and minimally invasive surgery have developed, a third option has emerged: hybrid coronary revascularization (HCR). In HCR, minimally invasive CABG and PCI are both employed to treat a single patient, often during the same hospital stay. Patients appropriate for this technique vary widely, from low-risk patients with low SYNTAX lesions outside the left anterior descending artery (LAD), to high-risk patients with multiple comorbidities who are felt by the heart team to benefit most by avoiding a sternotomy. Across both our experience and other series in the literature, mortality with HCR is around 1%. Hospital length of stay is less than one week, and typically less than after conventional CABG, but longer than with isolated PCI. Return to baseline activity is substantially shorter after minimally invasive CABG compared to conventional CABG due to the avoidance of a sternotomy; deep sternal wound infections are entirely avoided. Mid-term need for repeat revascularization may be higher with HCR, though randomized data are lacking. In conclusion, HCR is an evolving method to treat multivessel CAD with favorable early results in high volume centers, though growth in the field is limited by surgical experience and success with minimally invasive techniques.
Project description:Aims:The optimal revascularization strategy for left main coronary artery disease (LMD) remains controversial, especially with two recent randomized controlled trials showing conflicting results. We sought to address this controversy with our analysis. Methods and results:Comprehensive literature search was performed. We compared percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for LMD revascularization using standard meta-analytic techniques. A 21% higher risk of long-term major adverse cardiac and cerebrovascular event [MACCE; composite of death, myocardial infarction (MI), stroke, and repeat revascularization] was observed in patients undergoing PCI in comparison with CABG [risk ratio (RR) 1.21, 95% confidence interval (CI) 1.05-1.40]. This risk was driven by higher rate of repeat revascularization in those undergoing PCI (RR 1.61, 95% CI 1.34-1.95). On the contrary, MACCE rates at 30 days were lower in PCI when compared with CABG (RR 0.55, 95% CI 0.39-0.76), which was driven by lower rates of stroke in the PCI arm (RR 0.41, 95% CI 0.17-0.98). At 1 year, lower stroke rates (RR 0.21, 95% CI 0.08-0.59) in the PCI arm were balanced by higher repeat revascularization rates in those undergoing PCI (RR 1.78, 95% CI 1.33-2.37), resulting in a clinical equipoise in MACCE rates between the two revascularization strategies. There was no difference in death or MI between PCI when compared with CABG at any time point. Conclusion:Outcomes of CABG vs. PCI for LMD revascularization vary over time. Therefore, individualized decisions need to be made for LMD revascularization using the heart team approach.
Project description:Cost-effectiveness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES), and coronary artery bypass surgery (CABG) was analyzed in patients with multivessel coronary artery disease over a 5-year follow-up.DES implantation reducing revascularization rate and associated costs might be attractive for health economics as compared to CABG.Consecutive patients with multivessel DES-PCI (n?=?114, 3.3?±?1.2 DES/patient) or CABG (n?=?85, 2.7?±?0.9 grafts/patient) were included prospectively. Primary endpoint was cost-benefit of multivessel DES-PCI over CABG, and the incremental cost-effectiveness ratio (ICER) was calculated. Secondary endpoint was the incidence of major adverse cardiac and cerebrovascular events (MACCE), including acute myocardial infarction (AMI), all-cause death, revascularization, and stroke.Despite multiple uses for DES, in-hospital costs were significantly less for PCI than CABG, with 4551 €/patient difference between the groups. At 5-years, the overall costs remained higher for CABG patients (mean difference 5400 € between groups). Cost-effectiveness planes including all patients or subgroups of elderly patients, diabetic patients, or Syntax score >32 indicated that CABG is a more effective, more costly treatment mode for multivessel disease. At the 5-year follow-up, a higher incidence of MACCE (37.7% vs. 25.8%; log rank P?=?0.048) and a trend towards more AMI/death/stroke (25.4% vs. 21.2%, log rank P?=?0.359) was observed in PCI as compared to CABG. ICER indicated 45615 € or 126683 € to prevent one MACCE or AMI/death/stroke if CABG is performed.Cost-effectiveness analysis of DES-PCI vs. CABG demonstrated that CABG is the most effective, but most costly, treatment for preventing MACCE in patients with multivessel disease.
Project description:Hybrid coronary revascularization (HCR) was developed to combine the advantages of coronary artery bypass graft (CABG) with percutaneous coronary intervention (PCI). However, it is still controversial whether it is more optimal to perform CABG or PCI first. The purpose of this study was to compare the clinical outcomes of these 2 approaches.Eighty patients who underwent HCR from May 2010 to December 2015 were enrolled in this retrospective analysis. The CABG-first group comprised 12 patients and the PCI-first group comprised 68 patients. Outcomes of interest included in-hospital perioperative factors, major adverse cardiac and cerebrovascular events (MACCEs), and the incidence of repeated revascularization, especially for the target vessel lesion.No significant difference was found in the amount of postoperative bleeding (p=0.239). The incidence of MACCEs was similar between the CABG-first and PCI-first groups (1 of 12 [8.3%] vs. 5 of 68 [7.4%], p>0.999). Repeated revascularization was performed on 3 patients (25%) in the CABG-first and 9 patients (13.2%) in the PCI-first group (p=0.376).There were no significant differences in postoperative and medium-term outcomes between the CABG-first and PCI-first groups. Based on these results, it can be inferred that it is safe to opt for either CABG or PCI as the primary procedure in 2-stage HCR.
Project description:Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated.This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial.Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups.Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53).These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263).
Project description:BACKGROUND:Hybrid revascularization, combining percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), may be used differently across hospitals. How outcomes compare with multivessel PCI is unknown. METHODS:We studied hybrid revascularization use in patients in the National Cardiovascular Data Registry from 2009 to 2017 who underwent PCI for multivessel coronary artery disease (CAD) at 711 hospitals, excluding patients with prior CABG, acute ST-elevation myocardial infarction, emergency/salvage CABG, or PCI without stent placement. In-hospital mortality associated with hybrid revascularization versus multivessel PCI was compared using a multivariable logistic model. RESULTS:Among 775,000 patients with multivessel CAD, 1,126 (0.2%) underwent hybrid revascularization and 256,865 (33%) were treated with multivessel PCI. Although 358 (50.4%) hospitals performed hybrid revascularizations, most (97.3%) performed <1 per year. Most patients (68.7%) treated with hybrid revascularization underwent CABG after PCI; only 79.4% of these patients were discharged on P2Y12 inhibitors. Patients who underwent hybrid revascularization were younger and more likely to have significant left main or proximal left anterior descending disease. Unadjusted in-hospital mortality rates were higher among patients treated with hybrid revascularization than multivessel PCI (1.5% vs 0.9%, P?=?.02), a difference that was not significant after multivariable adjustment (odds ratio?=?1.54, 95% CI?=?0.92-2.59). CONCLUSIONS:Hybrid revascularization remains an infrequently used treatment modality for multivessel CAD. Risk-adjusted in-hospital mortality was no different between hybrid revascularization and multivessel PCI; however, patients who underwent hybrid revascularization were less likely to be discharged on P2Y12 inhibitor therapy despite stent implantation.
Project description:Results on the safety and long-term efficacy of drug-eluting stent placement in unprotected left main coronary artery disease (ULMCAD) compared with those of coronary artery bypass surgery (CABG) remain inconsistent across randomized clinical trials and recent meta-analysis studies. We aimed to compare the clinical outcomes and safety over short- and long-term follow-ups by conducting a meta-analysis of large pooled data from randomized controlled trials and up-to-date observational studies.A systematic review of PubMed, Google Scholar, Medline, and reference lists of related articles was performed for studies conducted in the drug-eluting stent era, to compare percutaneous coronary intervention (PCI) with CABG in ULMCAD. The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction (MI), stroke, all-cause mortality, and revascularization after at least 1-year follow-up. In-hospital and 30-day clinical outcomes were considered secondary outcomes. Furthermore, a subgroup analysis of studies with ?5 years follow-up was performed to test the sustainability of clinical outcomes.A total of 29 studies were extracted with 21,832 patients (10,424 in PCI vs 11,408 in CABG). Pooled analysis demonstrated remarkable differences in long-term follow-up (?1 year) MACCE (odds ratio [OR] 1.42, 95% CI 1.27-1.59), P?<?.00001), repeat revascularization (OR 3.00, 95% CI 2.41-3.73, P?<?.00001), and MI (OR 1.32, 95% CI 1.14-1.53, P?=?.0002), favoring CABG over PCI. However, stroke risk was significantly lower in the PCI group. Subgroup analysis of studies with ?5 years follow-up showed similar outcomes except for the noninferiority outcome of MACCE in the PCI arm. However, the PCI group proved good safety profile after a minimum of 30-day follow-up with lower MACCE outcome.PCI for ULMCAD can be applied with attentiveness in carefully selected patients. MI and the need for revascularization remain drawbacks and areas of concern among previous studies. Nonetheless, it has been proven safe during short-term follow-up.
Project description:Aims:Coronary flow reserve (CFR) is an integrated measure of the entire coronary vasculature, and is a powerful prognostic marker in coronary artery disease (CAD). The extent to which coronary revascularization can improve CFR is unclear. This study aimed to evaluate the impact of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on CFR in patients with stable CAD. Methods and results:In a prospective, multicentre observational study, CFR was measured by 15O-water positron emission tomography as the ratio of stress to rest myocardial blood flow at baseline and 6?months after optimal medical therapy (OMT) alone, PCI, or CABG. Changes in the SYNTAX and Leaman scores were angiographically evaluated as indicators of completeness of revascularization. Follow-up was completed by 75 (25 OMT alone, 28 PCI, and 22 CABG) out of 82 patients. The median SYNTAX and Leaman scores, and baseline CFR were 14.5 [interquartile range (IQR): 8-24.5], 5.5 (IQR: 2.5-12.5), and 1.94 (IQR: 1.67-2.66), respectively. Baseline CFR was negatively correlated with the SYNTAX (??=?-0.40, P?<?0.001) and Leaman scores (??=?-0.33, P?=?0.004). Overall, only CABG was associated with a significant increase in CFR [1.67 (IQR: 1.14-1.96) vs. 1.98 (IQR: 1.60-2.39), P?<?0.001]. Among patients with CFR <2.0 (n?=?41), CFR significantly increased in the PCI [1.70 (IQR: 1.42-1.79) vs. 2.21 (IQR: 1.78-2.49), P?=?0.002, P?<?0.001 for interaction between time and CFR] and CABG groups [1.28 (IQR: 1.13-1.80) vs. 1.86 (IQR: 1.57-2.22), P?<?0.001]. The reduction in SYNTAX or Leaman scores after PCI or CABG was independently associated with the percent increase in CFR after adjusting for baseline characteristics (P?=?0.012 and P?=?0.011, respectively). Conclusion:Coronary revascularization ameliorated reduced CFR in patients with obstructive CAD. The degree of improvement in angiographic CAD burden by revascularization was correlated with magnitude of improvement in CFR.
Project description:Background:The safety and efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for stable left main coronary artery disease (LMCAD) remains controversial. Methods:Digital databases were searched to compare the major adverse cardiovascular and cerebrovascular events (MACCE) and its components. A random effect model was used to compute an unadjusted odds ratio (OR). Results:A total of 43 studies (37 observational and 6 RCTs) consisting of 29,187 patients (PCI 13,709 and CABG 15,478) were identified. The 30-day rate of MACCE (OR, 0.56; 95% CI, 0.42-0.76; p?=?0.0002) and all-cause mortality (OR, 0.52; 95% CI, 0.30-0.91; p?=?0.02) was significantly lower in the PCI group. There was no significant difference in the rate of myocardial infarction (MI) (p?=?0.17) and revascularization (p?=?0.12). At 5 years, CABG was favored due to a significantly lower rate of MACCE (OR, 1.67; 95% CI, 1.18-2.36; p?=?<0.04), MI (OR, 1.67; 95% CI, 1.35-2.06; p?=?<0.00001), and revascularization (OR, 2.80; 95% CI, 2.18-3.60; p?=?<0.00001), respectively. PCI was associated with a lower overall rate of a stroke, while the risk of all-cause mortality was not significantly different between the two groups at 1- (p?=?0.75), 5- (p?=?0.72), and 10-years (p?=?0.20). The Kaplan-Meier curve reconstruction revealed substantial variations over time; the 5-year incidence of MACCE was 38% with CABG, significantly lower than 45% with PCI (p?=?<0.00001). Conclusion:PCI might offer early safety advantages, while CABG provides greater durability in terms of lower long-term risk of ischemic events. There appears to be an equivalent risk for all-cause mortality.