Unprotected Left Main Disease Research Articles

New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution

BackgroundWith the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. MethodsAll randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. ResultsNine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2.1-14), whereas first-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) and second-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) were comparable. ConclusionsThe introduction of new-generation drug-eluting stents did not translate into better outcomes for percutaneous coronary intervention when compared with coronary artery bypass grafting.

Coronary artery bypass grafting versus percutaneous coronary intervention in complex coronary artery disease: looking beyond clinical end-points

The choice of optimal revascularization techniques for complex coronary artery disease (CAD), either unprotected left main (UPLM) or multi-vessel disease (MVD), has been a matter of debate for the last two decades. Initially, randomized controlled trials (RCTs) demonstrated a significant mortality benefit of coronary artery bypass grafting (CABG) over medical therapy in patients with complex CAD (1). However, percutaneous coronary intervention (PCI) with balloon angioplasty alone or bare metal stent (BMS) was limited by higher rates of adverse events due to restenosis when compared to CABG (2). Since then, PCI has evolved in both stent technology and delivery techniques, and drug eluting stents (DES) have been shown to decrease risk of revascularization compared with BMS (3). Therefore, further research has focused on comparing PCI using DES versus CABG for patients with complex CAD.

Abstract 21347: Percutaneous Coronary Intervention With Drug Eluting Stents is as Efficacious as Coronary Artery Bypass Grafting in Unprotected Left Main Disease: A Meta Analysis

Background: CABG is the preferred revascularization strategy for unprotected left main disease. Multiple small scale trials and registry data showed that PCI with Drug Eluting Stents is a non-inferior strategy and is a Class IIa ACC/AHA recommendation in a high surgical risk patient with favorable anatomy. However, two recent large scale randomized trials have shown conflicting evidence. We conducted a meta-analysis of the existing data to compare the long term outcomes of PCI with DES vs CABG for left main stenosis. Methods: 4 randomized and 8 non-randomized studies involving 10,284 patients were included. The primary endpoint was a composite of death, stroke or MI at three years or longer. Secondary end points were MACCE (death, stroke, MI or repeat revascularization) and it's individual components. Heterogeneity of the studies was analyzed by Cochran’s Q statistics. The Mantel-Haenszel random effects model was used to calculate the combined odds ratio for outcomes. An independent analysis was performed for the randomized data only. Results: There was no significant difference in the primary composite outcome between PCI and CABG at long term follow up. However the MACCE was significantly higher in PCI, primarily driven by significantly high repeat revascularization. The stroke rate was lower in PCI, although not significant. Analysis of randomized data also yielded similar results. A subgroup analysis stratified by SYNTAX score showed that MACCE and repeat revascularization were not significantly different between PCI and CABG in low to intermediate SYNTAX score (<33) while they were significantly higher in PCI in high SYNTAX score. Conclusion: There was no significant difference in the primary composite outcome between PCI with DES and CABG at long term follow up. Repeat Revascularization in PCI was also not different from CABG in left main stenosis with low SYNTAX score. PCI with DES can be considered as a reasonable alternate strategy in isolated left main stenosis.

Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial

BackgroundThe EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. ObjectivesTo understand the effects of revascularization strategy from the patient’s perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. MethodsBetween September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. ResultsOver 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. ConclusionsAmong selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)

TCT-835 Comparison of Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting for Unprotected Left Main Coronary Artery Disease in Patients with Diabetes: A Meta-Analysis

Improved Percutaneous Coronary Intervention (PCI) techniques for Unprotected Left Main (ULM) disease have led to comparable outcomes to Coronary Artery Bypass Grafting (CABG). Data pertaining specifically to the optimal revascularization strategy for ULM lesions in diabetics is scarce. A

TCT-836 Comparative Efficacy and Safety of Different Types of Drug-Eluting Stents for Unprotected Left Main Coronary Artery Disease: Insights from Stent-Specific, Multi-Center Prospective Registries

Although different types of drug-eluting stents (DES) are currently being used in percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease, limited data are available on the relative efficacy and safety profiles of different types of contemporary DES. To investigate the

TCT-837 Clinical Impact of Complete Coronary Artery Revascularization in Elderly Patients with Unprotected Left Main Disease Treated with Drug-Eluting Stent

TCT-837 Clinical Impact of Complete Coronary Artery Revascularization in Elderly Patients with Unprotected Left Main Disease Treated with Drug-Eluting Stent

Long-term outcomes of coronary artery bypass grafting versus stent-PCI for unprotected left main disease: a meta-analysis

BackgroundCoronary 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.MethodsRandomized 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.ResultsNo 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).ConclusionsThe 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.

Long-term outcomes following left main bifurcation stenting in Indian population—Analysis based on SYNTAX I and II scores

BackgroundSyntax 1 and recently Syntax 2 (SS2) scores are validated risk prediction models in coronary disease. ObjectivesTo find out the long term outcomes following stenting for unprotected left main bifurcation disease (LMD) and to validate and compare the performance of the SYNTAX scores 1 and 2 (SS1 and SS2 PCI) for predicting major adverse cardiac events (MACE) in Indian population. MethodsSingle-center, retrospective, observational study involving patients who underwent percutaneous coronary intervention (PCI) with at least one stent implanted for the LMD. Discrimination and calibration models were assessed by ROC curve and the Hosmer-Lemeshow test. ResultsData of 103 patients were analyzed. The mean SS1 and SS2 scores were 27.9 and 30.7 and MACE was 16.5% at 4 years. The target lesion revascularization (TLR) rate at 4 years was 11(10.7%). There were 4 deaths (3.8%). The mean left ventricular ejection fraction (LVEF) was the only variable in SS2, which predicted cardiac events. ROC curve analysis showed both models to be accurate in predicting TLR and mortality following LM PCI. SS2 score showed a better risk prediction than SSI with AUC for TLR (SSI 0.560 and SS2PCI 0.625) and AUC for mortality (SS1 0.674 and SS2PCI 0.833). Hosmer-Lemeshow test validated the accuracy of both the risk models in predicting the events. ConclusionsBoth risk models were applicable for Indian patients. The SS2 score was a better predictor for mortality and TLR. In the SS2 score, the LVEF was the most useful predictor of events after LM PCI.

P502Twelve-year clinical outcomes in patients with unprotected left main coronary artery disease after percutaneous coronary intervention with bare metal stent

P502Twelve-year clinical outcomes in patients with unprotected left main coronary artery disease after percutaneous coronary intervention with bare metal stent

3120Long-term outcomes of different two-stenting bifurcation techniques for unprotected left main coronary bifurcation disease: a FAILS-2 substudy

3120Long-term outcomes of different two-stenting bifurcation techniques for unprotected left main coronary bifurcation disease: a FAILS-2 substudy

P530Restenosis in simultaneous kissing stents to treat unprotected left main stem coronary artery bifurcation disease: incidence and management

P530Restenosis in simultaneous kissing stents to treat unprotected left main stem coronary artery bifurcation disease: incidence and management

P2071Single- vs two- stenting technique with second generation drug eluting stent for unprotected left main coronary bifurcation disease: insights from FAILS-2 study

P2071Single- vs two- stenting technique with second generation drug eluting stent for unprotected left main coronary bifurcation disease: insights from FAILS-2 study

Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication

Identifying predictive factors for major cardiovascular events and death in patients with unprotected left main coronary artery disease is of great clinical value for risk stratification and possible guidance for tailored preventive strategies. The Interventional Research Incorporation Society-Left MAIN Revascularization registry included 5795 patients with unprotected left main coronary artery disease (percutaneous coronary intervention, n=2850; coronary-artery bypass grafting, n=2337; medication alone, n=608). We analyzed the incidence and independent predictors of major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) and all-cause mortality in each treatment stratum. During follow-up (median, 4.3 years), the rates of MACCE and death were substantially higher in the medical group than in the percutaneous coronary intervention and coronary-artery bypass grafting groups (P<0.001). In the percutaneous coronary intervention group, the 3 strongest predictors for MACCE were chronic renal failure, old age (≥65 years), and previous heart failure; those for all-cause mortality were chronic renal failure, old age, and low ejection fraction. In the coronary-artery bypass grafting group, old age, chronic renal failure, and low ejection fraction were the 3 strongest predictors of MACCE and death. In the medication group, old age, low ejection fraction, and diabetes mellitus were the 3 strongest predictors of MACCE and death. Among patients with unprotected left main coronary artery disease, the key clinical predictors for MACCE and death were generally similar regardless of index treatment. This study provides effect estimates for clinically relevant predictors of long-term clinical outcomes in real-world left main coronary artery patients, providing possible guidance for tailored preventive strategies. URL: https://clinicaltrials.gov. Unique identifier: NCT01341327.

Unprotected left main revascularization: Percutaneous coronary intervention versus coronary artery bypass. An updated systematic review and meta-analysis of randomised controlled trials.

BackgroundThe optimal treatment of unprotected left main (UPLM) with either PCI or CABG remains uncertain.AimThe purpose of this study was to determine the comparative safety and efficacy of PCI versus CABG in patients with UPLM disease.MethodsSearch 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).ResultsWe 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].ConclusionIn 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.

Intravascular Ultrasound Guidance Improves the Long-term Prognosis in Patients with Unprotected Left Main Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

This study compared the long term outcomes in patients with unprotected left main coronary artery (LMCA) disease who underwent stenting under the guidance of intravascular ultrasound (IVUS) or conventional angiography at a large single center. The primary outcome was the composite of all-cause death and myocardial infarction (MI) at 3 years. Target vessel revascularization (TVR) at 3 years was one of the secondary outcomes. Between January 2004 and December 2011, a total of 1,899 patients who underwent IVUS-guided (n = 713, 37.5%) or conventional angiography-guided (n = 1186, 62.5%) stenting were included. At 3 years, the unadjusted primary outcome trended lower in the IVUS-guided group versus the angiography-guided (6.9% vs. 8.4%, p = 0.22) although the TVR was similar between two groups (6.0% vs. 6.0%, p = 0.97). However, after adjustment for differences in baseline risk factors, IVUS-guidance was associated with significantly lower incidence of the composite of all-cause death and MI (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.50 to 0.84; p = 0.001), although there was still no significant difference in TVR between the two groups (HR: 1.09; 95% CI: 0.84 to 1.42; p = 0.53). IVUS guidance has benefits in improving the long-term prognosis for unprotected LMCA stenting.

Clinical outcomes with percutaneous coronary revascularization vs coronary artery bypass grafting surgery in patients with unprotected left main coronary artery disease: A meta-analysis of 6 randomized trials and 4,686 patients

Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Six trials including 4,686 randomized patients were identified. After a median follow-up of 39 months, there were no significant differences between PCI vs CABG in the risk of all-cause mortality (hazard ratio [HR] 0.99, 95% CI 0.76-1.30) or cardiac mortality. However, a significant interaction for cardiac mortality (Pinteraction= .03) was apparent between randomization arm and SYNTAX score, such that the relative risk for mortality tended to be lower with PCI compared with CABG among patients in the lower SYNTAX score tertile, similar in the intermediate tertile, and higher in the upper SYNTAX score tertile. Percutaneous coronary intervention compared with CABG was associated with a similar long-term composite risk of death, myocardial infarction, or stroke (HR 1.06, 95% CI 0.82-1.37), with fewer events within 30 days after PCI offset by fewer events after 30 days with CABG (Pinteraction < .0001). Percutaneous coronary intervention was associated with greater rates of unplanned revascularization compared with CABG (HR 1.74, 95% CI 1.47-2.07). In patients undergoing revascularization for ULMCAD, PCI was associated with similar rates of mortality compared with CABG at a median follow-up of 39 months, but with an interaction effect suggesting relatively lower mortality with PCI in patients with low SYNTAX score and relatively lower mortality with CABG in patients with high SYNTAX score. Both procedures resulted in similar long-term composite rates of death, myocardial infarction, or stroke, with PCI offering an early safety advantage and CABG demonstrating greater durability.

Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients

The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations. To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death (I2>50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio(percutaneous coronary intervention) 2.213; 95% confidence interval, 1.242-3.943; P=0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial (Pinteraction=0.019) but not in the Asian trials (PRECOMBAT Pinteraction=0.469 and BEST Pinteraction=0.472; I2=58%). The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be well recognized and taken into account during the decision making of the treatment strategy. URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT00997828, NCT00422968.

TCTAP A-025 Predictors of Mortality in Acute Myocardial Infarction Patients with Unprotected Left Main Coronary Artery Disease

TCTAP A-025 Predictors of Mortality in Acute Myocardial Infarction Patients with Unprotected Left Main Coronary Artery Disease

Percutaneous coronary intervention or coronary artery bypass grafting for unprotected left main coronary artery disease.

Recent trials comparing PCI with CABG for unprotected left main disease yielded discrepant evidence. To perform an updated meta-analysis of randomized trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease. Randomized trials comparing PCI versus CABG for patients with unprotected left main coronary artery disease were included. Summary estimates risk ratios (RRs) were performed with a DerSimonian and Laird model at short-term, intermediate and long-term follow-up periods (i.e., 30-days, 1-year, and >1-year). Outcomes evaluated were major adverse cardiac and cerebrovascular events (MACCE), all-cause mortality, myocardial infarction, stroke, revascularization and stent thrombosis or symptomatic graft occlusion. Six trials with 4,700 patients and a mean SYNTAX score of 23 were included. At short-term follow-up, the risk of MACCE was lower with PCI (RR 0.55, 95% confidence interval [CI] 0.39-0.76) driven by the lower risk of myocardial infarction (RR 0.67, 95% CI 0.46-0.99), and stroke (RR 0.38, 95% CI 0.16-0.90). The risk of MACCE was similar at the intermediate follow-up (RR 1.21, 95% CI 0.97-1.51). At long-term follow-up, PCI was associated with a higher risk of MACCE (RR 1.19, 95% CI 1.01-1.41), due to a higher risk of revascularization (RR 1.62, 95% CI 1.34-1.94), while the risk of all-cause mortality, myocardial infarction, and stroke were similar. In patients with unprotected left main coronary disease and low to intermediate SYNTAX score, PCI might be an acceptable alternative to CABG. © 2017 Wiley Periodicals, Inc.