The right gastroepiploic artery (RGEA) has advantages for use as an arterial conduit in coronary artery bypass graft surgery but perioperative spasm often develops. This study assessed the spasm and ...occlusion rates of RGEA conduits and elucidated the mechanism of reopening of occluded RGEA conduits.
Patients who received an RGEA conduit in coronary artery bypass graft surgery were studied (n = 976; 700 composite, 276 in situ, 16 free grafts; 16 received both in situ and composite grafts). Early, 1-year, and 5-year angiographies were performed in 961 patients (98.5%), 815 patients (83.5%), and 618 patients (63.3%), respectively.
Graft spasm was demonstrated in early angiograms in 72 proximal graft trunks of 1,608 distal anastomoses (4.5%) constructed using an RGEA conduit. Early occlusion rates of composite, in situ, and free RGEA conduits were 1.1%, 2.5%, and 0%, respectively; 8.5%, 7.5%, and 21.4%, respectively, at 1 year; and 10.5%, 14.1%, and 37.5%, respectively, at 5 years. Nineteen of 23 patients who had RGEA conduit occlusions at early angiography (1 occluded anastomosis per patient) were reevaluated at 1 year, and 9 of them (47.4%) had become patent. Of 83 patients with occluded RGEA composite grafts (90 occluded RGEA conduit anastomoses) at 1-year angiography, 8 were reopened at 5 years (8.9%). Progression of native target coronary artery disease was observed in all 8 patients with reopened occluded RGEA conduits at 5 years but not in 9 patients with reopened RGEA conduits at 1 year.
Reopening of occluded RGEA conduits occurred early and midterm postoperatively. Reopening appeared related to recovery from graft spasm, and could occur as late as midterm if associated with progression of native coronary artery disease.
Summary Background Alectinib, a potent, highly selective, CNS-active inhibitor of anaplastic lymphoma kinase (ALK), showed promising efficacy and tolerability in the single-arm phase 1/2 AF-001JP ...trial in Japanese patients with ALK -positive non-small-cell lung cancer. Given those promising results, we did a phase 3 trial to directly compare the efficacy and safety of alectinib and crizotinib. Methods J-ALEX was a randomised, open-label, phase 3 trial that recruited ALK inhibitor-naive Japanese patients with ALK -positive non-small-cell lung cancer, who were chemotherapy-naive or had received one previous chemotherapy regimen, from 41 study sites in Japan. Patients were randomly assigned (1:1) via an interactive web response system using a permuted-block method stratified by Eastern Cooperative Oncology Group performance status, treatment line, and disease stage to receive oral alectinib 300 mg twice daily or crizotinib 250 mg twice daily until progressive disease, unacceptable toxicity, death, or withdrawal. The primary endpoint was progression-free survival assessed by an independent review facility. The efficacy analysis was done in the intention-to-treat population, and safety analyses were done in all patients who received at least one dose of the study drug. The study is ongoing and patient recruitment is closed. This study is registered with the Japan Pharmaceutical Information Center (number JapicCTI-132316). Findings Between Nov 18, 2013, and Aug 4, 2015, 207 patients were recruited and assigned to the alectinib (n=103) or crizotinib (n=104) groups. At data cutoff for the second interim analysis, 24 patients in the alectinib group had discontinued treatment compared with 61 in the crizotinib group, mostly due to lack of efficacy or adverse events. At the second interim analysis (data cutoff date Dec 3, 2015), an independent data monitoring committee determined that the primary endpoint of the study had been met (hazard ratio 0·34 99·7% CI 0·17–0·71, stratified log-rank p<0·0001) and recommended an immediate release of the data. Median progression-free survival had not yet been reached with alectinib (95% CI 20·3–not estimated) and was 10·2 months (8·2–12·0) with crizotinib. Grade 3 or 4 adverse events occurred at a greater frequency with crizotinib (54 52% of 104) than alectinib (27 26% of 103). Dose interruptions due to adverse events were also more prevalent with crizotinib (77 74% of 104) than with alectinib (30 29% of 103), and more patients receiving crizotinib (21 20%) than alectinib (nine 9%) discontinued the study drug because of an adverse event. No adverse events with a fatal outcome occurred in either treatment group. Interpretation These results provide the first head-to-head comparison of alectinib and crizotinib and have the potential to change the standard of care for the first-line treatment of ALK -positive non-small-cell lung cancer. The dose of alectinib (300 mg twice daily) used in this study is lower than the approved dose in countries other than Japan; however, this limitation is being addressed in the ongoing ALEX study. Funding Chugai Pharmaceutical Co, Ltd.
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 )
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.
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.
Abstract Objectives This study sought to evaluate the long-term prognostic value of coronary computed tomography angiography (CTA) in asymptomatic patients with type 2 diabetes mellitus. Background ...There are limited data on the long-term prognostic impact of coronary CTA in asymptomatic patients with type 2 diabetes mellitus. Methods This study analyzed clinical outcomes of 591 consecutive asymptomatic patients with type 2 diabetes mellitus who underwent coronary CTA (mean age 62.2 ± 8.3 years and 352 men 59.6%). A cardiac event was defined as a composite of cardiac death, nonfatal myocardial infarction, unstable angina requiring hospitalization, or late coronary revascularization. Patients were categorized into 3 groups according to severity of coronary artery disease (CAD) on coronary CTA: normal coronary arteries, nonobstructive CAD (<50%), and obstructive CAD (≥50%). Results One hundred sixty-eight patients (28.4%) had normal coronary arteries, whereas 236 (39.9%) patients had nonobstructive CAD and 187 (31.6%) had obstructive CAD. During the follow-up period (median 5.3 years interquartile range: 4.7 to 5.8 years), 37 cardiac events occurred in 29 patents: 10 cardiac deaths, 2 nonfatal myocardial infarctions, 8 cases of unstable angina, and 17 late coronary revascularizations. The 6-year event-free survival rates were 99.3 ± 0.7% in patients with normal coronary arteries, 96.7 ± 1.2% in patients with nonobstructive CAD, and 86.2 ± 3.0% in patients with obstructive CAD (log-rank p < 0.001). Conclusions Asymptomatic patients with type 2 diabetes mellitus with normal coronary arteries or nonobstructive CAD on coronary CTA show excellent clinical outcomes over a follow-up period of more than 5 years, whereas prognosis is worse in patients with obstructive CAD. These findings suggest long-term prognostic value of coronary CTA for asymptomatic type 2 diabetes mellitus.
Objectives The aim of this study was to evaluate long-term clinical outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTO). Background Despite technical ...advancements, there is a paucity of data on long-term outcomes after PCI of CTO. Methods We evaluated long-term clinical outcomes in 1,791 patients who underwent PCI of 1,852 CTO at 3 tertiary care centers in the United States, South Korea, and Italy between 1998 and 2007. Median follow-up was 2.9 years (interquartile range: 1.5 to 4.6 years). Results Procedural success was obtained in 1,226 (68%) patients. Stents were implanted in 1,160 patients (95%); 396 patients (34%) received bare-metal stents (BMS), and 764 patients (66%) received drug-eluting stents (DES). After multivariable analysis, successful CTO PCI was an independent predictor of a lower cardiac mortality (hazard ratio HR: 0.40, 95% confidence interval CI: 0.21 to 0.75, p < 0.01) and reduced need for coronary artery bypass graft surgery (HR: 0.21, 95% CI: 0.13 to 0.40, p < 0.01); it also correlated with a strong trend toward lower all-cause mortality (HR: 0.63, 95% CI: 0.40 to 1.00, p = 0.05) at 5-year follow-up. Among patients who underwent stent implantation, treatment with DES rather than BMS resulted in less target vessel revascularization at long-term follow-up (17.2% vs. 31.1%, p < 0.01); definite/probable stent thrombosis rates were similar (DES 1.7%, BMS 2.3%, p = 0.58). Within the DES subgroup, patients treated with paclitaxel-eluting stents and sirolimus-eluting stents had similar clinical outcomes. Conclusions Successful CTO PCI is associated with reduced long-term cardiac mortality and need for coronary artery bypass graft surgery. Treatment of CTO with DES rather than BMS is associated with a significant reduction in target vessel revascularization with similar rates of stent thrombosis. Paclitaxel-eluting stents and sirolimus-eluting stents had similar long-term safety and efficacy outcomes.
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.
Abstract Objectives This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. Background The optimal ...bifurcation stenting technique needs to be evaluated. Methods The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non–left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. Results Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p = 0.064), comprising 15.1% versus 3.7% for the main branch (p = 0.004) and 2.8% versus 5.6% for the SB (p = 0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p = 0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p = 0.44), comprising 5.2% versus 4.8% for the main branch (p = 0.90) and 3.9% versus 8.3% for the SB (p = 0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p = 0.84). Conclusions Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non–left main bifurcation lesions once the procedure was performed successfully.
Abstract Objectives This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes. ...Background No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population. Methods The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries. Results In total, 848 patients with mean STS score of 5.2 ± 3.8% were enrolled between March 2010 and September 2014 at 11 centers in 5 countries. The Edwards Sapien or Medtronic CoreValve was implanted in 64.7% and 35.3% of patients, respectively. The procedural success rate was 97.5%. The 30-day and 1-year mortality rates were 2.5% and 10.8%, respectively. There was no difference in 1-year mortality between devices (Sapien: 9.4%; CoreValve: 12.2%; log-rank p = 0.40). The rates of stroke, life-threatening bleeding, major vascular complications and acute kidney injury (stage 2 to 3) were 3.8%, 6.4%, 5.0% and 3.3%, respectively. Moderate or severe paravalvular leakage was significantly more common with the CoreValve than Sapien (14.4% vs. 7.3%; p = 0.001). According to the multivariate model, a higher STS score, lower body mass index, New York Heart Association functional class III–IV symptoms, diabetes mellitus, prior cerebrovascular accident, low mean gradient at baseline, and moderate or severe paravalvular leakage were significantly associated with reduced survival. Conclusions Despite anatomical features of concern, the clinical outcomes of TAVR in our Asian population were favorable in comparison with those of previously published trials and observational studies. (The Asian Transcatheter Aortic Valve Replacement Registry Asian TAVR; NCT02308150 )
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