Long-Term Outcomes of Patients with Unprotected Left Main Coronary Artery Disease Treated with Percutaneous Angioplasty versus Bypass Grafting: A Meta-Analysis of Randomized Controlled Trials.
ABSTRACT: BACKGROUND AND AIM:Treatment of patients with left main coronary artery disease (LMCA) with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains controversial. The aim of this meta-analysis was to compare the long-term clinical outcomes of patients with unprotected LMCA treated randomly by PCI or CABG. METHODS:PubMed, MEDLINE, Embase, Scopus, Google Scholar, CENTRAL and ClinicalTrials.gov database searches identified five randomized trials (RCTs) including 4499 patients with unprotected LMCA comparing PCI (n = 2249) vs. CABG (n = 2250), with a minimum clinical follow-up of five years. Random effect risk ratios were used for efficacy and safety outcomes. The study was registered in PROSPERO. The primary outcome was major adverse cardiac events (MACE), defined as a composite of death from any cause, myocardial infarction or stroke. RESULTS:Compared to CABG, patients assigned to PCI had a similar rate of MACE (risk ratio (RR): 1.13; 95% CI: 0.94 to 1.36; p = 0.19), myocardial infarction (RR: 1.48; 95% CI: 0.97 to 2.25; p = 0.07) and stroke (RR: 0.87; 95% CI: 0.62 to 1.23; p = 0.42). Additionally, all-cause mortality (RR: 1.07; 95% CI: 0.89 to 1.28; p = 0.48) and cardiovascular (CV) mortality (RR: 1.13; 95% CI: 0.89 to 1.43; p = 0.31) were not different. However, the risk of any repeat revascularization (RR: 1.70; 95% CI: 1.34 to 2.15; p < 0.00001) was higher in patients assigned to PCI. CONCLUSIONS:The findings of this meta-analysis suggest that the long-term survival and MACE of patients who underwent PCI for unprotected LMCA stenosis were comparable to those receiving CABG, despite a higher rate of repeat revascularization.
Project description:Coronary artery bypass graft (CABG) surgery has traditionally represented the standard of care for left main coronary artery (LMCA) disease. However, percutaneous coronary intervention with stent implantation (PCI) has more recently emerged as a valuable alternative. The long-time awaited results of the largest randomized trials on the long-term impact of PCI versus CABG in LMCA disease, the newly published NOBLE and EXCEL studies, revealed contrasting results. Thus, aim of the present meta-analysis was to review the most robust evidence from randomized comparisons of CABG versus PCI for revascularization of LMCA.Randomized studies comparing long-term clinical outcomes of CABG or Stent-PCI for the treatment of LMCA disease were searched for in PubMed, the Chochrane Library and Scopus electronic databases. A total of 5 randomized studies were selected, including 4499 patients.No significant difference between CABG and PCI was found in the primary analysis on the composite endpoint of death, stroke and myocardial infarction (OR = 1·06 95% CI 0·80-1·40; p = 0·70). Similarly, no differences were observed between CABG and PCI for all-cause death (OR = 1·03 95% CI 0·81-1·32; p = 0·81). Although not statistically significant, a lower rate of stroke was registered in the PCI arm (OR = 0·86; p = 0·67), while a lower rate of myocardial infarction was found in the CABG arm (OR = 1·43; p = 0·17). On the contrary, a significantly higher rate of repeat revascularization was registered in the PCI arm (OR = 1·76 95% CI 1·45-2·13; p < 0·001).The present meta-analysis, the most comprehensive and updated to date, including 5 randomized studies and 4499 patients, demonstrates no difference between Stent-PCI and CABG for the treatment of LMCA disease in the composite endpoint of death, stroke and myocardial infarction. Hence, a large part of patients with unprotected left main coronary artery disease can be managed equally well by means of both these revascularization strategies.
Project description:Importance:In patients with left main coronary artery (LMCA) stenosis, coronary artery bypass grafting (CABG) has been the standard therapy for several decades. However, some studies suggest that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative. Objective:To compare the long-term safety of PCI with drug-eluting stent vs CABG in patients with LMCA stenosis. Data Sources:PubMed, Scopus, EMBASE, Web of Knowledge, and ScienceDirect databases were searched from December 18, 2001, to February 1, 2017. Inclusion criteria were randomized clinical trial, patients with LMCA stenosis, PCI vs CABG, exclusive use of drug-eluting stents, and clinical follow-up of 3 or more years. Data Extraction and Synthesis:Trial-level hazard ratios (HRs) and 95% CIs were pooled by fixed-effect and random-effects models with inverse variance weighting. Time-to-event individual patient data for the primary end point were reconstructed. Sensitivity analyses according to drug-eluting stent generation and coronary artery disease complexity were performed. Main Outcomes and Measures:The primary end point was a composite of all-cause death, myocardial infarction, or stroke at long-term follow-up. Secondary end points included repeat revascularization and a composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at long-term follow-up. Results:A total of 4 randomized clinical trials were pooled; 4394 patients were included in the analysis. Of these, 3371 (76.7%) were men; pooled mean age was 65.4 years. According to Grading of Recommendations, Assessment, Development and Evaluation, evidence quality with respect to the primary composite end point was high. Percutaneous coronary intervention and CABG were associated with a comparable risk of all-cause death, myocardial infarction, or stroke both by fixed-effect (HR, 1.06; 95% CI, 0.90-1.24; P?=?.48) and random-effects (HR, 1.06; 95% CI, 0.85-1.32; P?=?.60) analysis. Sensitivity analyses according to low to intermediate Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (random-effects: HR, 1.02; 95% CI, 0.74-1.41; P?=?.89) and drug-eluting stent generation (first generation: HR, 0.90; 95% CI, 0.68-1.20; P?=?.49; second generation: HR, 1.19; 95% CI, 0.82-1.73; P?=?.36) were consistent. Kaplan-Meier curve reconstruction did not show significant variations over time between the techniques, with a 5-year incidence of all-cause death, myocardial infarction, or stroke of 18.3% (319 events) in patients treated with PCI and 16.9% (292 events) in patients treated with CABG. However, repeat revascularization after PCI was increased (HR, 1.70; 95% CI, 1.42-2.05; P?<?.001). Other individual secondary end points did not differ significantly between groups. Finally, pooled estimates of trials with LMCA stenosis tended overall to differ significantly from those of trials with multivessel coronary artery disease without left main LMCA stenosis. Conclusions and Relevance:Percutaneous coronary intervention and CABG show comparable safety in patients with LMCA stenosis and low to intermediate-complexity coronary artery disease. However, repeat revascularization is more common after PCI.
Project description:AIMS?:The optimal method of revascularization for patients with left main coronary artery disease (LMCAD) is controversial. Coronary artery bypass graft surgery (CABG) has traditionally been considered the gold standard therapy, and recent randomized trials comparing CABG with percutaneous coronary intervention (PCI) with drug-eluting stents (DES) have reported conflicting outcomes. We, therefore, performed a systematic review and updated meta-analysis comparing CABG to PCI with DES for the treatment of LMCAD. METHODS AND RESULTS?:We systematically identified all randomized trials comparing PCI with DES vs. CABG in patients with LMCAD. The primary efficacy endpoint was all-cause mortality. Secondary endpoints included cardiac death, myocardial infarction (MI), stroke, and unplanned revascularization. All analyses were by intention-to-treat. There were five eligible trials in which 4612 patients were randomized. The weighted mean follow-up duration was 67.1?months. There were no significant differences between PCI and CABG for the risk of all-cause mortality [relative risk (RR) 1.03, 95% confidence interval (CI) 0.81-1.32; P?=?0.779] or cardiac death (RR 1.03, 95% CI 0.79-1.34; P?=?0.817). There were also no significant differences in the risk of stroke (RR 0.74, 95% CI 0.35-1.50; P?=?0.400) or MI (RR 1.22, 95% CI 0.96-1.56; P?=?0.110). Percutaneous coronary intervention was associated with an increased risk of unplanned revascularization (RR 1.73, 95% CI 1.49-2.02; P?<?0.001). CONCLUSION?:The totality of randomized clinical trial evidence demonstrated similar long-term mortality after PCI with DES compared with CABG in patients with LMCAD. Nor were there significant differences in cardiac death, stroke, or MI between PCI and CABG. Unplanned revascularization procedures were less common after CABG compared with PCI. These findings may inform clinical decision-making between cardiologists, surgeons, and patients with LMCAD.
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:<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:BACKGROUND:Older adults (?70-year-old) are under-represented in the published data pertaining to unprotected left main coronary artery disease (ULMCAD). HYPOTHESIS:Percutaneous coronary intervention (PCI) might be comparable to coronary artery bypass grafting (CABG) for revascularization of ULMCAD. METHODS:We compared PCI versus CABG in older adults with ULMCAD with an aggregate data meta-analyses (4880 patients) of clinical outcomes [all-cause mortality, myocardial infarction (MI), repeat revascularization, stroke and major adverse cardiac and cerebrovascular events(MACCE)] at 30 days, 12-24 months & ?36 months in patients with mean age ?70 years and ULMCAD. A meta-regression analysis evaluated the effect of age on mortality after PCI. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using random-effects model. RESULTS:All-cause mortality between PCI and CABG was comparable at 30-days (OR0.77, 95% CI 0.42- 1.41) and 12-24-months (OR 1.22, 95% CI 0.78-1.93). PCI was associated with a markedly lower rate of stroke at 30-day follow-up in octogenarians (OR 0.14, 95% CI 0.02-0.76) but an overall higher rate of repeat revascularization. At ?36-months, MACCE (OR 1.26,95% CI 0.99-1.60) and all-cause mortality (OR 1.39, 95% CI 1.00-1.93) showed a trend favoring CABG but did not reach statistical significance. On meta-regression, PCI was associated with a higher mortality with advancing age (coefficient=0.1033, p=0.042). CONCLUSIONS:PCI was associated with a markedly lower rate of early stroke in octogenarians as compared to CABG. All-cause mortality was comparable between the two arms with a trend favoring CABG at ?36-months.PCI was however associated with increasing mortality with advancing age as compared to CABG.
Project description:To determine the validity of uric acid as a potential prognostic marker for long-term outcomes of patients with acute myocardial infarction (AMI) and those with AMI undergoing percutaneous coronary intervention (PCI). Methods: Systematic review and meta-analysis were performed. We retrieved data from retrospective and prospective cohort studies that investigated whether serum uric acid (SUA) level affects the prognosis of patients with AMI.Thirteen studies involving 9371 patients were included. High serum uric acid (HSUA) level increased mid/long-term mortality (risk ratio (RR)=2.32, 95% confidence intervals (CI): 2.00-2.70) and had higher short-term mortality (RR=3.09, 95% CI: 2.58-3.71), higher mid/long-term major adverse cardiovascular events (MACE) risk (RR=1.70, 95% CI: 1.54-1.88), and higher short-term MACE risk (RR=2.47, 95% CI: 2.08-2.92) for patients with AMI. In the PCI subgroup, the HSUA level also increased mid/long-term mortality (RR=2.33, 95% CI: 1.89 to 2.87) and had higher mid/long-term MACE risk (RR=1.64, 95% CI: 1.48-1.82), and higher short-term MACE risk (RR 2.43, 95% CI: 2.02-2.93) for patients who were treated with PCI after AMI. Particularly in the PCI subgroup, a higher short-term mortality (RR=6.70, 95% CI: 3.14-14.31) was presented in the group with lower HSUA cut-off level, and the mortality was higher than the group with higher HSUA cut-off level (RR=2.69, 95% CI: 2.09-3.46). Conclusion: The HSUA level significantly increased the mortality and MACE risk of patients with AMI. Mild elevation of SUA levels (normal range) have started to have a significant impact on the short-term mortality of patients who underwent PCI, and has not received the attention of previous studies. However, this condition should be further investigated.
Project description:BACKGROUND:The incidence and prognostic significance of acute kidney injury (AKI) in patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization is not well known. The current analysis included patients randomized to PCI vs. CABG as part of the FREEDOM trial. We sought to examine the impact of AKI and its predictors in diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG. METHODS:We conducted a pre-specified subgroup analysis of the FREEDOM trial to examine the incidence, correlates and impact of AKI according to revascularization strategy. AKI predictors were identified using multivariable logistic regression and associations between AKI and outcomes were examined using Cox regression. The primary endpoint was the composite occurrence of all-cause death, stroke or myocardial infarction at 5?years of follow-up. RESULTS:KI occurred more frequently in patients following CABG (15.6%) compared with PCI (9.1%) (p?<?0.001). AKI was associated with a higher risk for major cardiovascular events (MACE) at 5?years (34.6% vs. 20.5%, p?<?0.001), an effect that remained large and significant irrespective of CABG (HR?=?2.18 95% CI 1.44-3.31, p??0.001) or PCI (HR?=?2.08 95% CI 1.35-3.21, p?<?0.0001). There was a non-significant interaction (p-value?=?0.89) between the revascularization method and AKI, supporting that AKI is a significant risk factor in both revascularization methods. CONCLUSIONS:Although risk for AKI was higher in patients undergoing CABG, the impact of AKI on MACE was substantial irrespective of revascularization strategy. Preventive strategies to identify patients at risk for AKI are warranted to mitigate the long-term effects of this complication.
Project description:The optimal treatment of unprotected left main (UPLM) with either PCI or CABG remains uncertain.The purpose of this study was to determine the comparative safety and efficacy of PCI versus CABG in patients with UPLM disease.Search of BioMedCentral, CENTRAL, mRCT, PubMed, major cardiological congresses proceedings and references cross-check (updated November 2016). Outcomes were the rate of MACE [all cause death, MI, stroke], the rates of the individual components of MACE and the rate of target vessel revascularisation (TVR).We identified 6 Randomised Controlled Trials totalling 4717 patients allocated to PCI or CABG. At 1 year follow up, PCI and CABG were substantially equivalent with respect to the rates of MACE [PCI 8.5% vs CABG 8.9%, OR 1.02,(0.76-1.36), p = 0.9], death [PCI 5.4% vs CABG 6.6%, OR 0.81,(0.63-1.03),p = 0.08] and MI [PCI 3.4% vs CABG 4.3%, OR 0.80(0.59-1.07), p = 0.14]. Notably, PCI was associated with a significantly lower rate of stroke [PCI 0.6% vs CABG 1.8%, OR 0.36,(0.17-0.79), p = 0.01] and with a significantly higher rate of TVR [PCI 8.7% vs CABG 4.5%, OR 2.00(1.46-2.75), p<0.01]. At a median follow up of 5years, the rates of MACE were similar between the two strategies: PCI 14.6% vs CABG 13.8%, OR 1.02(0.76-1.38), p = 0.89. Likewise, the rates of death [PCI 8% and CABG 7.7%, OR 1(0.77-1.31), P = 0.9], MI [PCI 6.1% vs CABG 5%, OR 1.41(0.85-2.34), P = 0.19, I2 59%], and stroke [PCI 2% vs CABG 2.2%, OR 0.85(0.42-1.81), p = 0.65,] were similar while PCI was associated with a significantly higher rate of TVR [14.5% vs CABG 8.9%, OR 1.73(1.41-2.13), p<0.01].In patients with UPLM disease, PCI and CABG are associated with similar rates of MACE and mortality at 1 year as well as after 5 years. Differences can be detected for individual end points at both short and long term FU.
Project description:<h4>Background</h4>Intra-aortic balloon pumps (IABP) have generally been used for patients undergoing high-risk mechanical coronary revascularization. However, there is still insufficient evidence to determine whether they can improve outcomes in reperfusion therapy patients, mainly by percutaneous coronary intervention (PCI) with stenting or coronary artery bypass graft (CABG). This study was designed to determine the difference between high-risk mechanical coronary revascularization with and without IABPs on mortality, by performing a meta-analysis on randomized controlled trials of the current era.<h4>Methods</h4>Pubmed and Embase databases were searched from inception to May 2015. Unpublished data were obtained from the investigators. Randomized clinical trials of IABP and non-IABP in high-risk coronary revascularization procedures (PCI or CABG) were included. In the case of PCI procedures, stents should be used in more than 80% of patients. Numbers of events at the short-term and long-term follow-up were extracted.<h4>Results</h4>A total of 12 randomized trials enrolling 2155 patients were included. IABPs did not significantly decrease short-term mortality (relative risk (RR) 0.66; 95% CI, 0.42-1.01), or long-term mortality (RR 0.79; 95% CI, 0.47-1.35), with low heterogeneity across the studies. The findings remained stable in patients with acute myocardial infarction with or without cardiogenic shock. But in high-risk CABG patients, IABP was associated with reduced mortality (71 events in 846 patients; RR 0.40; 95%CI 0.25-0.67).<h4>Conclusion</h4>In patients undergoing high-risk coronary revascularization, IABP did not significantly decrease mortality. But high-risk CABG patients may be benefit from IABP. Rigorous criteria should be applied to the use of IABPs.