Objectives This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes. Background Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up. Methods We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis. Results At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other). Conclusions In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.
Background The clinical implication of state-of-art PCI at long term follow-up in patients with three vessel disease is undetermined. Purpose The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX-II trial, demonstrated up to 2 years, are maintained at 3-year follow-up. Methods The SYNTAX-II study was a multicentre, single arm study that investigated the impact of a state-of-art PCI strategy on clinical outcomes in patients with de novo three vessel coronary artery disease, without left main disease. State-of-art PCI includes: heart team decision-making utilizing the SYNTAX score II, hybrid iFR-FFR decision-making strategy, intravascular ultrasound guided stent implantation, contemporary chronic total occlusion revascularization techniques and guideline-directed medical therapy. The primary endpoint is major adverse cardiac and cerebrovascular events (MACCE – a composite of all-cause death, any stroke, myocardial infarction, or revascularization) at 3 years. Clinical outcomes in SYNTAX-II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX Trial (SYNTAX-I), selected on the basis of equipoise for long-term (4-year) mortality utilising the SYNTAX Score II. Results Between February 2014 and November 2015, 454 patients out of 708 screened patients were enrolled in SYNTAX-II. In SYNTAX-I, 643 (58.8%) patients with 3VD without left main disease had an equipoise recommendation for CABG or PCI based on the SYNTAX Score II and were used as the comparator. At 2 years, MACCE rate in SYNTAX-II was significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar two-year outcomes for MACCE were evident between SYNTAX II-PCI and SYNTAX-I CABG (13.2 vs. 15.1%, p=0.42). Three-year results will be presented at ESC2019. Conclusions Three-year results of his study may offer an attractive option of revascularization strategy in predefined patients with de novo 3VD (SYNTAX Score II inclusion) even if the patients have moderate to severe anatomical complexity (anatomic SYNTAX score >22). Acknowledgement/Funding European Cardiovascular Research Institute (ECRI) with unrestricted research grants from Volcano and Boston Scientific
Introduction and objectives The relationship between the lumen dimensions obtained in human coronary arteries using intravascular ultrasound (IVUS) and those obtained using optical coherence tomography (OCT) is not well understood. The objectives were to compare the lumen measurement obtained ex vivo in human coronary arteries using IVUS, OCT, and histomorphometry, and in vivo in patients using IVUS and OCT with and without balloon occlusion. Methods Ex vivo study: the lumen areas of matched anatomical sections of human coronary arteries were measured using IVUS, OCT, and histology. In vivo study: the lumen areas in matched sections were measured using IVUS and OCT with and without occlusion. Results Ex vivo: in the 8 specimens studied, the lumen area obtained using OCT and IVUS was larger than that obtained using histomorphometry: mean difference 0.8 (1) mm2 (28%) for OCT and 1.3 (1.1) mm2 (40%) for IVUS. In vivo: in the 5 vessels analyzed, the lumen area obtained using IVUS was larger than that obtained using OCT: mean difference 1.67 (0.54) mm2 (33.7%) for IVUS relative to OCT with occlusion and 1.11 (0.53) mm2 (21.5%) relative to OCT without occlusion. The lumen area obtained using OCT without occlusion was larger than that obtained using OCT with occlusion: mean difference 0.61 (0.23) mm2 (13%). Conclusions In fixed human coronary arteries, both IVUS and OCT overestimated the lumen area compared with histomorphometry. In vivo the lumen dimensions obtained using IVUS were larger than those obtained using OCT, with or without occlusion. Moreover, the OCT image acquisition technique (ie, with or without occlusion) also had an impact on lumen measurement.
No abstract is provided for this article.
Objectives The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. Background Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. Methods A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. Results Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome. Conclusions In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of “scaffold dismantling,” this finding likely has ramifications for all bioresorbable scaffolds.
Nifedipine is a strong calcium antagonist; it blocks the excitation-contraction coupling, yet at therapeutic dosage levels it has few side effects. It is said that a single molecule of nifedipine can neutralize the effects of several thousand calcium ions in the excitation-process. Thus this agent reduces the ability of the cardiac cells to develop mechanical tension yet it does not affect electrical excitation. Calcium antagonists are also potent dilators, particularly of the arteries on the periphery of the human body and in the coronary arterial system. The basic mode of action is thought to be the same, i.e. reduction of the calcium transport, this time into the smooth muscle cells of the arterial wall, thus "forcing' the arteriole to dilate. The resultant action is a reduction in afterload, while there is an increase in perfusion of the coronary vascular bed. Thus there is a dual action, the one centrally, the other peripherally both of which will be particularly effective in patients with unstable angina (UA) in whom excess coronary vascular tone is suspected. Beta-blockers, particularly propranolol and metoprolol, with which we have the most experience, work via beta 2 adrenoceptor blockade in the heart. Cardiac frequency decreases, arrhythmias are suppressed, blood pressure may decrease, all reducing cardiac work. If in UA variations in coronary vascular tone and frank spasm do occur then is would be more logical to use Ca-antagonists instead of beta-blockade. Our clinical experience to date has not shown that patients with UA are worsened by propranolol or metoprolol but there are scores of clinical reports showing worsening of chest pain in Prinzmetal's syndrome, presumably because beta-blockade leads to excessive alpha-adrenergic vascular tone. On the other hand, in one year experience with 73 patients with UA, 52 did not experience relief from adequate beta-blockade until nifedipine was added. Within 2 hours, 42 of the 52 became asymptomatic--thus indicating that in UA the need for spasmolytic therapy prevails over the need for beta-blockade. In many cases of UA both drugs may have a place however, their exact relative value remains to be established.
