Unprotected Left Main Stenosis Research Articles

UTILIZATION OF HEMODYNAMIC SUPPORT DEVICES IN HIGH-RISK PCI: EXPERIENCE FROM A HIGH VOLUME CENTER

High-risk candidates for percutaneous coronary intervention (PCI) include patients with severe multi-vessel coronary artery disease (CAD), unprotected left main (LM) coronary artery stenosis, or last remaining patent conduit with a stenosis, especially in patients with a left ventricular ejection

CRT-100.80 Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Unprotected Left Main Coronary Artery Stenosis — Meta-Analysis of Randomized Controlled Trials

Studies comparing outcomes of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) stenosis have shown conflicting results. Electronic databases including MEDLINE, [ClinicalTrials.gov][1] and the Cochrane Library were

Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial

Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009). In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. Biosensors.

TCT-630 The Impact of Diabetes Mellitus in Patients Undergoing Percutaneous Coronary Intervention With a Drug Eluting Stent for Unprotected Left Main Stenosis

TCT-630 The Impact of Diabetes Mellitus in Patients Undergoing Percutaneous Coronary Intervention With a Drug Eluting Stent for Unprotected Left Main Stenosis

Predictors of survival in patients with acute coronary syndrome undergoing percutaneous coronary intervention of unprotected left main coronary artery stenosis.

Aim of this study was to investigate predictors of survival in unstable patients with high SYNTAX-1-score. In significant unprotected left main coronary artery (ULMCA) stenosis, treatment options include percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). While CABG is recommended for stable patients with ULMCA stenosis and a SYNTAX-1-score > 32, PCI may be preferable in unstable or high operative risk patients. Retrospective single-center all-comers registry study. A total of 142 patients underwent ULMCA-PCI (~72.9 years, 23.2% females, 54.2% survival in 2-year follow-up), 84 of whom had a SYNTAX-1 > 32 (37.4 ± 12.8). Patients in the high-SYNTAX-1-group (score > 32) were more often in an acute condition compared to low-SYNTAX-2-group (score ≤ 32) including acute myocardial infarction (76.2% vs. 57.4%, p = .024), cardiogenic shock (48.2% vs. 14.8%, p = .001), or need for mechanical support (36.1% vs. 11.1%, p = .001). Survival was predicted by the acute condition including cardiogenic shock (OR 0.06 and 0.05) and myocardial infarction (OR 0.03 and 0.34) in both groups. Performance of the SYNTAX-1-score was limited in our patient collective in both groups (c-index 0.65 vs. 0.63) while SYNTAX-2-PCI-score performed better (c-index 0.67 vs. 0.67). EuroScore II had the best discriminative ability (c-index 0.87 vs. 0.78). The majority of patients undergoing ULMCA-PCI presented in acute conditions with high SYNTAX-1-score, and is therefore underrepresented in clinical trials. Prognosis was best predicted by the acute condition and the EuroScore II. These data suggest that therapy in unstable patients should be guided by clinical condition over the anatomical SYNTAX-1-score.

Long-term clinical outcomes after a percutaneous coronary intervention with a drug-eluting stent in patients with unprotected left main coronary artery disease excluded from clinical trials.

Major randomized clinical trials assessing clinical outcomes in patients who underwent a percutaneous coronary intervention (PCI) for left main coronary artery disease excluded some high-risk subsets. Whether the effectiveness and safety of a percutaneous approach in this group of patients are comparable with those observed in clinical trials is unclear. We aimed to explore the long-term outcomes of contemporary drug-eluting stent (DES)-based revascularization for left main coronary artery disease in patients presenting with one or more clinical or angiographic characteristics who would have precluded inclusion in randomized trials. Between April 2003 and December 2011, 340 consecutive patients with unprotected left main coronary artery stenosis of at least 50% who underwent successful PCI with DES at Sejong General Hospital (Bucheon, Republic of Korea) were included in this retrospective study. Patients were classified into the exclusion group (group E; n=120) and the inclusion group (group I; n=220) according to the prespecified inclusion and exclusion criteria utilized in clinical trials. During the median follow-up of 86 (52-114) months, major adverse cardiac or cerebrovascular events occurred in 69 (31.4%) patients in group I and 46 (38.3%) patients in group E (P=0.155). In the propensity score-matched population, group E was not associated with a higher incidence of major adverse cardiac or cerebrovascular events (hazard ratio: 1.42, 95% confidence interval: 0.76-2.65, P=0.758). Definite or probable stent thrombosis occurred in five patients of group I, with no cases in group E. In our real-world registry, about a third of patients who underwent PCI for unprotected left main coronary artery stenosis had one or more high-risk characteristics or comorbid conditions that represent exclusion criteria of previous randomized trials. PCI using DES is feasible in these patients.

Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial

It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD. ClinicalTrials.gov Identifier: NCT01471522.

Impact of Final Kissing Balloon and of Imaging on Patients Treated on Unprotected Left Main Coronary Artery With Thin-Strut Stents (From the RAIN-CARDIOGROUP VII Study)

Few data are available about the impact on outcomes of procedural strategies for percutaneous coronary intervention with thin-struts stents on unprotected left main (ULM): 792 patients with an ULM stenosis treated with percutaneous coronary intervention with thin-strut stents were enrolled in the present multicenter registry. Target lesion revascularization (TLR) was the primary end point. MACE (a composite of all-cause death, myocardial infarction, TLR, and stent thrombosis) and its single components, along with target vessel revascularization were the secondary end points. Subgroup analyses were performed according to complex versus noncomplex bifurcation lesions. After 16 months, 5.5% of patients experienced a TLR. At multivariate analysis, provisional stenting (odds ratio [OR] 0.46: 0.85 to 0.23, p = 0.006), use of imaging (OR 0.45: 0.23 to 0.98, p = 0.003) and final kissing balloon (FKB) (OR 0.41: 0.83 to 0.21, p = 0.001) reduced risk of TLR. FKB reduced risk of overall TLR only for 2 stents-strategy (6.2% vs 32.4%, p <0.05), but not for provisional strategy (3.8% vs 3.7%, p = 0.67). Intracoronary imaging reduced risk of overall TLR both for provisional (2.2% vs 5.4%) and for 2-stents strategy (7.3% vs 14.1% p <0.05 for both, all confidence interval 95%). In conclusion, TLR for ULM patients treated with thin-strut stents is infrequent. Provisional stenting was noninferior compared with 2-stents apart from complex lesions. Benefit from intracoronary imaging is consistent for different strategies, whereas that from FKB persists only for 2-stents.

Sirolimus-eluting BiOSS LIM dedicated bifurcation stent in the treatment of unprotected distal left main stenosis.

Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging. To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions. Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed. The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004). Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Unprotected Left Main Coronary Artery Stenosis

BackgroundThe present study performed a meta-analysis of randomized and prospective trials to compare the outcomes of percutaneous coronary intervention (PCI) with stents versus coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (UPLM) stenosis. MethodsThe Cochrane Library, PubMed and EMBASE databases were systematically searched until July 2017. The Newcastle-Ottawa scale was used for quality assessment. ResultsA total of 19 studies with 16,900 participants were included. Pooled analysis showed no significant differences in all-cause mortality (odds ratio [OR] 0.94; 95% CI 0.74-1.20) and cardiac death (OR 1.04; 95% CI 0.74-1.47). However, subgroup analysis showed that PCI was associated with a low all-cause mortality rate at 30-day follow up (OR 0.48; 95% CI 0.26-0.89). The stroke rate in PCI was lower in short-term follow up (OR 0.45; 95% CI 0.23-0.88) and long-term follow up (OR 0.36; 95% CI 0.27-0.47). On the other hand, PCI was associated with higher risk of myocardial infarction (OR 1.59; 95% CI 1.34-1.88), repeat revascularization (OR 2.47; 95% CI 1.80-3.37) and target vessel revascularization (OR 2.10; 95% CI 1.72-2.57) compared to CABG in the pooled analysis. ConclusionsThe current evidence suggests that the risk of stroke was significantly reduced in PCI compared to that in CABG. Therefore, PCI is the preferred treatment for patients with a high risk of stroke. Additionally, in short-term follow up, PCI was reported to be safe and effective for UPLM patients compared to CABG. However, CABG caused fewer complications long term.

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: A Systematic Review and Meta-Analysis.

PCI of ULMS is frequently performed through TFA because of technical complexity and safety concern. Studies have shown comparable efficacy and safety of TRA versus TFA, however, these studies are few in number. We intended to compare the clinical outcomes between transradial access (TRA) and transfemoral access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis (ULMS) by performing a meta-analysis. A systematic search of database, including, PubMed, Web of Science, Google scholar and Cochrane Database were performed by two independent reviewers. Studies were included comparing "TRA" versus "TFA" in patients undergoing PCI in ULMS. The primary outcome was a procedural success rate. Secondary outcomes were major bleeding, access site complications, in-hospital and long term: major adverse cardiac events (MACE), myocardial infarction (MI) and cardiovascular mortality. Eight studies were included in the analysis. The procedural success rate was 97.3% and there was no statistically significant difference between TRA and TFA groups (OR, 1.41 [CI 0.64, 3.12], I2 = 26%). The rates of access site complications (OR, 0.17 [CI 0.07, 0.41], I2 = 16%), major bleeding (OR, 0.39 [CI 0.17, 0.86], I2 = 0%) and all-cause mortality (OR, 0.28 [CI 0.12, 0.64], I2 = 0%) were lower in the TRA group. There were no significant differences in in-hospital and long term cardiovascular mortality, MI and MACE between the two groups. In contrast to TFA, TRA is associated with reduced bleeding and access site complications, with similar procedural success rate in patients undergoing PCI of ULMS.

10-Year Outcomes of Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease

BackgroundComparative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease were previously reported. However, data on very long-term (>10 years) outcomes are limited. ObjectivesThe authors compare 10-year outcomes after PCI and CABG for LMCA disease. MethodsIn this observational study of the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization) registry, the authors evaluated 2,240 patients with unprotected LMCA disease who underwent PCI (n = 1,102) or underwent CABG (n = 1,138) between January 2000 and June 2006. Adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) were compared with the use of propensity scores and inverse-probability-weighting adjustment. The follow-up was extended to at least 10 years of all patients (median 12.0 years). ResultsIn the overall cohort, there was no significant difference in adjusted risks of death and the composite outcome between the groups up to 10 years. The risk of target-vessel revascularization was significantly higher in the PCI group. In the cohort comparing drug-eluting stents and concurrent CABG, the 2 study groups did not differ significantly in the risks of death and the composite outcome at 5 years. However, after 5 years, drug-eluting stents were associated with higher risks of death (hazard ratio: 1.35; 95% confidence interval: 1.00 to 1.81) and the composite outcome (hazard ratio: 1.46; 95% confidence interval: 1.10 to 1.94) compared with CABG. ConclusionsIn patients with significant LMCA disease, as compared with CABG, PCI showed similar rates of death and serious composite outcomes, but a higher rate of target-vessel revascularization at 10 years. However, CABG showed lower mortality and serious composite outcome rates compared with PCI with drug-eluting stents after 5 years. (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization [MAIN-COMPARE]; NCT02791412)

Left Main Disease: What Is the Correct Approach to Revascularization?

Percutaneous coronary intervention of the left main coronary artery has evolved through registries and meta analyses, supported by results from the EXCEL [Everolimus-Eluting Stents (EES) or Bypass Surgery for Left Main Coronary Artery Disease] and NOBLE (Percutaneous Coronary Angioplasty versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis) trials as an acceptable alternative to coronary artery bypass grafting in patients with low and intermediate Syntax scores. Advances in stenting strategies and the availability of larger diameter drug-eluting stents improve patient safety and optimize procedural and patient outcomes.

Long-term results after PCI of unprotected distal left main coronary artery stenosis: the Bifurcations Bad Krozingen (BBK)-Left Main Registry.

Percutaneous coronary intervention (PCI) of unprotected distal left main stenosis (UDLM) is increasingly performed as an alternative to surgical treatment. The optimal strategy for stenting in this setting is still a matter of debate. Therefore, this analysis investigated the long-term clinical outcome of a single- versus a double-stenting strategy for treatment of UDLM. From a large registry, 867 consecutive patients with UDLM undergoing either single or double stenting with drug-eluting stents (DES) were identified. Follow-up was up to 10 (median 3.1, interquartile range 1.1-5.3) years. Primary endpoint was MACE consisting of all-cause death, myocardial infarction, or target lesion re-intervention (TLR). Secondary clinical endpoints included these single endpoints and stent thrombosis. MACE occurred in 41.5% after single and in 49.0% after double stenting (P = 0.03). TLR was lower after single (17.4%) as compared to double stenting (27.2%; P < 0.01). Between single and double stenting, there were no significant differences for death (26.4 versus 23.3%; P = 0.31), death or myocardial infarction (29.1 versus 27.2%; P = 0.55), or definite/probable stent thrombosis (1.3 versus 2.1%; P = 0.42). Compared with single stenting, double stenting was associated with a significantly higher long-term risk of MACE. This was driven by a higher incidence of TLR, whereas the risk of death, MI, or stent thrombosis was similar between the two strategies.

Percutaneous coronary intervention of unprotected left main stenoses - Procedural data and outcome depending on SYNTAX I Score.

We hypothesized that SYNTAX I score is a predictor for procedure complexity in left main PCI. Procedure complexity, duration and contrast load may contribute to adverse outcome of complex left main percutaneous coronary intervention (PCI). In 105 consecutive patients who underwent PCI of unprotected left main coronary artery stenoses between 2014 and 2016, clinical parameters as well as PCI characteristics and follow-up data were analyzed. The mean SYNTAX I score was 29 ± 12, with 66 patients having a SYNTAX I score ≤ 32 and 39 patients a SYNTAX I score > 32. In patients with high SYNTAX I score vs. low-to-intermediate SYNTAX I score, single stent techniques were performed significantly less frequently (18% vs. 68%; p < 0.001), while Crush (44% vs. 5%; p < 0.001) and Culotte techniques (20% vs. 5%; p = 0.003) were performed significantly more frequently. Procedural success was achieved in all 105 cases without periprocedural mortality. During follow up, repeat PCI was necessary significantly more frequently in patients with high compared to patients with low-to-intermediate SYNTAX I score (34% vs.13%; p = 0.003). Nevertheless, overall mortality did not differ between patients with high vs. low-to-intermediate SYNTAX I score (20% vs. 18%). PCI strategies for the treatment of left main coronary artery stenoses get significantly more complex with increasing SYNTAX I scores. While this translates into a significantly longer procedure duration and contrast load, short-term outcome seems not to be influenced by the SYNTAX I score.

Rapamycin-eluting stents for unprotected left main coronary artery stenosis in older adult patients with coronary atherosclerosis: study protocol for a prospective, non-randomized, controlled trial and preliminary results

Background and objectives: Coronary artery bypass grafting (CABG) is the gold standard therapy for unprotected left main coronary artery (ULMCA) stenosis in coronary atherosclerosis. However, ULMCA stenosis has recently been successfully treated with drug-eluting stents. The present study aims to compare the safety and efficacy of CABG versus rapamycin-eluting stents for ULMCA stenosis in older adult patients with degenerative coronary atherosclerosis. Methods: The proposed prospective, non-randomized, controlled trial will include 224 older adult patients with degenerative coronary atherosclerosis with ULMCA stenosis being treated at Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) and Renmin Hospital Affiliated to Hubei University of Medicine, China. Patients will be divided into two groups in accordance with each patient’s treatment choice and indications (n = 112/group): the stent group will receive rapamycin-eluting stents, while the CABG group will undergo CABG. All patients will be followed up at 9, 12, 24, and 36 months postoperatively. Outcome measures and preliminary results: The primary outcome measure will be the rate of repeat revascularizations in the target lesion at 36 months postoperatively. The secondary outcome measures will be the rates of repeat revascularizations in the target lesion at 9, 12, and 24 months postoperatively, the rate of restenosis, mortality, causes of death, and survival at 9, 12, 24, and 36 months postoperatively, and the angiographic appearance of the diseased vessels preoperatively and at 9, 12, 24, and 36 months postoperatively. The safety indicator will be the incidence of major adverse cardiac and cerebrovascular events at 9, 12, 24, and 36 months postoperatively. Pilot study results showed that the stent group (n = 48) had a significantly reduced waiting time for surgery, hospitalization time, and rate of complete revascularizations in the target lesion compared with the CABG group (n = 38) (P Discussion: The results of this study will indicate the medium- and long-term efficacy and safety of rapamycin-eluting stents versus CABG in older adult patients with ULMCA stenosis. Ethics and dissemination: This study was approved by Medical Ethics Committee, Taihe Hospital (approval No. TH0058X), and Shiyan Renmin Hospital (approval No. RM011X), China in July 2017. This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from each patient. The study protocol was designed in January 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2022. The study will end in December 2022. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016413). Protocol version: 1.0.

The DELTA 2 Registry: A Multicenter Registry Evaluating Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents in Patients With Obstructive Left Main Coronary Artery Disease

ObjectivesThe aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a “real world” population. BackgroundPCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients. MethodsAll consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up. ResultsA total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (≈17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p < 0.0001). ConclusionsAfter a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.

Outcomes of primary percutaneous coronary intervention in acute myocardial infarction due to unprotected left main thrombosis: The Asia-Pacific Left Main ST-Elevation Registry (ASTER).

Prior studies of ULM STEMI have been confined to small cohorts. Recent registry data with larger patient cohorts have shown contrasting results. We aim to study the outcomes of patients with unprotected left main (ULM) ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI). The Asia-pacific left main ST-Elevation Registry (ASTER) is a multicenter retrospective registry involving 4 sites in Singapore, South Korea, and the United States. The registry included patients presenting with STEMI due to an ULM coronary artery culprit lesion who underwent emergency PCI. The primary outcome was in-hospital mortality. Secondary outcomes included major adverse cardiovascular events. A total of 67 patients (mean age 64.2 ± 12.8 years, 53 [79.1%] males) were included. The distal left main bifurcation was most commonly involved (85%, n = 57). Fifty one (76%) patients had TIMI 3 flow post-PCI. The in-hospital mortality rate was 47.8% (n = 32); 61% (n = 41) had cardiac failure, 4% (n = 3) had emergency coronary artery bypass grafting, 1% (n = 1) had a re-infarction, 3% (n = 2) had stroke and 55% (n = 37) had malignant ventricular arrhythmias. On multivariate analysis, predictors of in-hospital mortality included older age (odds ratio (OR) 1.085 (95% confidence interval (CI) 1.002-1.175), P = 0.044), diabetes mellitus (OR 10.882 (95%CI 11.074-110.287), P = 0.043) and absence of post-PCI TIMI 3 flow (OR 71.429 (95%CI 2.985-1000), P = 0.008). STEMI from culprit unprotected left main coronary artery stenosis is associated with significant mortality and morbidity. Emergency PCI provides an important treatment option in this high-risk group, but in-hospital mortality remains high.

TCT-81 Hybrid Coronary Revascularization Vs Percutaneous Strategies in Unprotected Left Main Stenosis: A Propensity Match Study

Hybrid coronary revascularization (HCR) has been recently proposed as an effective alternative revascularization strategy in patients with multi-vessel coronary artery disease (CAD). However there is lack of data concerning patients with unprotected left main(ULM) stenosis. Objective of this study

Outcomes of Coronary Artery Bypass and Stents for Unprotected Left Main Coronary Stenosis

This study assessed the short-, medium-, and long-term outcomes of coronary artery bypass grafting vs stenting for patients with unprotected left main coronary artery disease through a meta-analysis of randomized controlled trials. PubMed, Embase, Scopus, Web of Science, Cochrane Library, and major conference proceedings databases were systematically searched for randomized controlled trials of coronary artery bypass grafting compared with stents in unprotected left main coronary artery disease. End points assessed were all-cause death, myocardial infarction, major adverse cardiac and cerebrovascular events, target vessel revascularization, and cerebral stroke. A meta-analysis was conducted according to predefined clinical end points. All-cause death and stroke were similar between stenting and coronary artery bypass grafting at 1 year and at follow-up beyond 1 year. The incidence of myocardial infarction was similar between stenting and coronary artery bypass grafting at each separate time point. The incidence of repeat revascularization was similar between the two groups at 30 days but was higher for stenting at 1 year and beyond. There was a trend toward fewer major adverse cardiac and cerebrovascular events after stenting compared with coronary artery bypass grafting at 30 days, but this difference was no longer significant at 1 year and reversed at follow-up beyond 1 year. The early advantages of stenting over coronary artery bypass grafting have been shown to progressively shift to coronary artery bypass grafting over time. Further larger sample randomized controlled trials are warranted to confirm the results.