Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents.
We conducted a randomized ...noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups.
After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval CI, -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG.
Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).
There are conflicting data regarding the benefit of intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) over angiography-guided PCI. Since the last meta-analysis was ...published, several new studies have been reported. We performed a comprehensive meta-analysis to evaluate the clinical impact of IVUS-guided PCI with drug-eluting stent compared with conventional angiography-guided PCI. This meta-analysis included 26,503 patients from 3 randomized and 14 observational studies; 12,499 patients underwent IVUS-guided PCI and 14,004 underwent angiography-guided PCI. Main outcome measures were total mortality, myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). IVUS-guided PCI was significantly associated with more stents, longer stents, and larger stents. Regarding clinical outcomes, IVUS-guided PCI was associated with a significantly lower risk of TLR (odds ratio OR 0.81, 95% confidence interval CI 0.66 to 1.00, p = 0.046). In addition, the risk of death (OR 0.61, 95% CI 0.48 to 0.79, p <0.001), MI (OR 0.57, 95% CI 0.44 to 0.75, p <0.001), and stent thrombosis (OR 0.59, 95% CI 0.47 to 0.75, p <0.001) were also decreased. In conclusion, our meta-analysis demonstrated that IVUS-guided PCI was associated with lower risk of death, MI, TLR, and stent thrombosis after drug-eluting stent implantation.
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the ...treatment of choice.
We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups.
The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval CI, -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).
In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).
The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established.
In two trials, we ...randomly assigned a total of 2701 patients who had received drug-eluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis.
The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval CI, 0.80 to 3.36; P=0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P=0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to 3.45; P=0.06).
The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)
Abstract There is limited data comparing effectiveness of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with ...non-ST-elevation acute coronary syndromes (NSTE-ACS). We compared the long-term outcomes of the two revascularization strategies in 1,246 patients presented with NSTE-ACS for left main or multivessel coronary artery disease (CAD). Data were pooled from the BEST, PRECOMBAT, and SYNTAX trials. The primary outcome was a composite of death from any causes, myocardial infarction, or stroke. The baseline characteristics were similar between the two study groups. During the median follow-up of 60 months, the rate of the primary outcome was significantly lower with CABG than with PCI (hazard ratio HR: 0.74; 95% confidence interval CI: 0.56−0.98; P=0.036). This difference was mainly attributed to a significant reduction in the rate of myocardial infarction (HR: 0.50; 95% CI: 0.31−0.82, P=0.006). The superiority of CABG over PCI was consistent across the major subgroups. The individual risks of death from any causes or stroke were not different between the two groups. In contrast, the rate of repeat revascularization was significantly lower in the CABG group than in the PCI group (HR: 0.56; 95% CI: 0.41−0.75, P < 0.001). In this study, among patients with NSTE-ACS for left main or multivessel CAD, CABG significantly reduces the risk of death from any causes, myocardial infarction, or stroke compared to PCI with DES.
Objectives The goal of this study was to identify clinical and lesion-specific local factors affecting visual-functional mismatch. Background Although lesion severity determined by coronary ...angiography has not been well correlated with physiological significance, the mechanism of the discordance remains poorly understood. Methods The authors assessed quantitative coronary angiography, intravascular ultrasound (IVUS), and fractional flow reserve (FFR) in a prospective cohort of 1,000 patients with 1,129 coronary lesions. Three-dimensional computational simulation studies were performed. Results Lesions with angiographic diameter stenosis (DS) ≥50% and FFR >0.80 (“mismatches”) were seen in 57% of non–left main lesions and in 35% of the left main lesions, respectively (p = 0.032). Conversely, among the lesions with DS <50% and FFR <0.80 (“reverse mismatches”) 16% were found in the non–left main lesions and 40% in the left main lesions (p < 0.001). The independent predictors for mismatch were advanced age, non–left anterior descending artery location, absence of plaque rupture, short lesion length, large minimal lumen area, smaller plaque burden, and greater minimal lumen diameter. Conversely, reverse mismatch was independently associated with younger age, left anterior descending artery location, the presence of plaque rupture, a smaller minimal lumen area, and larger plaque burden. In a computational simulation study, FFR was influenced by DS, lesion length, different lesion shape, plaque eccentricity, surface roughness, and various shapes of plaque rupture. Conclusions There were high frequencies of visual-functional mismatch between angiography and FFR. The discrepancy was related to the clinical and lesion-specific factors frequently unrecognizable by angiography, thus suggesting that coronary angiography cannot accurately predict FFR. (Natural History of FFR-Guided Deferred Coronary Lesions IRIS FFR-DEFER; NCT01366404 )
Comparative 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.
The authors compare 10-year outcomes after PCI and CABG for LMCA disease.
In 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).
In 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.
In 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)
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Abstract Objectives This study sought to evaluate the intravascular ultrasound (IVUS) minimal lumen area (MLA) for functionally significant left main coronary artery (LMCA) stenosis using fractional ...flow reserve (FFR) as the standard. Background The evaluation of significant LMCA stenosis remains challenging. Methods We identified 112 patients with isolated ostial and shaft intermediate LMCA stenosis (angiographic diameter stenosis of 30% to 80%) who underwent IVUS and FFR measurement. Results The FFR was ≤0.80 in 66 LMCA lesions (59%); these exhibited smaller reference vessels, smaller minimal lumen diameter, greater diameter of stenosis, longer lesion length, smaller MLA, larger plaque burden, and more frequent plaque rupture. The independent factors of an FFR of ≤0.80 were plaque rupture (odds ratio OR: 4.47; 95% Confidence Interval (CI): 1.35 to 14.8; p = 0.014); body mass index (OR: 1.19; 95% CI: 1.00 to 1.41; p = 0.05), age (OR: 0.95; 95% CI: 0.90 to 1.00; p = 0.031), and IVUS MLA (OR: 0.37; 95% CI: 0.25 to 0.56; p < 0.001). The optimal IVUS MLA cutoff value for an FFR of ≤0.80 was 4.5 mm2 (77% sensitivity, 82% specificity, 84% positive predictive value, 75% negative predictive value, area under the curve: 0.83, 95% CI: 0.76 to 0.96; p < 0.001) overall and 4.1 to 4.5 mm2 in various subgroups. Adjustment for the body surface area, body mass index, and left ventricular mass did not improve the diagnostic accuracy of the IVUS MLA. Conclusions In patients with isolated ostial and shaft intermediate LMCA stenosis, an IVUS-derived MLA of ≤4.5 mm2 is a useful index of an FFR of ≤0.80.
X-ray coronary angiography is a primary imaging technique for diagnosing coronary diseases. Although quantitative coronary angiography (QCA) provides morphological information of coronary arteries ...with objective quantitative measures, considerable training is required to identify the target vessels and understand the tree structure of coronary arteries. Despite the use of computer-aided tools, such as the edge-detection method, manual correction is necessary for accurate segmentation of coronary vessels. In the present study, we proposed a robust method for major vessel segmentation using deep learning models with fully convolutional networks. When angiographic images of 3302 diseased major vessels from 2042 patients were tested, deep learning networks accurately identified and segmented the major vessels in X-ray coronary angiography. The average F1 score reached 0.917, and 93.7% of the images exhibited a high F1 score > 0.8. The most narrowed region at the stenosis was distinctly captured with high connectivity. Robust predictability was validated for the external dataset with different image characteristics. For major vessel segmentation, our approach demonstrated that prediction could be completed in real time with minimal image preprocessing. By applying deep learning segmentation, QCA analysis could be further automated, thereby facilitating the use of QCA-based diagnostic methods.
Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two ...interventions for patients with unprotected left main coronary artery disease.
We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent.
In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval CI, 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents.
In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG.
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