Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events’ outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). Conclusions Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.
Contractions of the vagally innervated guinea pig tracheal tube preparation were induced by 1) stimulation of the preganglionic cervical vagus nerve (PGS), 2) activation of postganglionic intrinsic nerves by use of transmural stimulation (TMS) in the presence of hexamethonium, and 3) exogenous application of spasmogens, acetylcholine (ACh) and histamine. Contractions were recorded as increases in intraluminal pressure of the sealed Krebs-filled tube preparation. In the absence of basal tone, contractions induced by both PGS and TMS were monophasic. When the tone was raised with histamine (1 microM), the rapid contractions were followed by a slow relaxation during TMS but not during PGS. There was no evidence for any involvement of the putative inhibitory nonadrenergic noncholinergic neurotransmitters vasoactive intestinal peptide (VIP) and nitric oxide (NO) in the response to PGS, because neither the peptidase alpha-chymotrypsin nor the NO synthase inhibitor NG-nitro-L-arginine affected PGS-induced contractions. However, both alpha-chymotrypsin and NG-nitro-L-arginine facilitated contractions induced by TMS, suggesting that both VIP and NO are involved in responses to TMS. The facilitation of TMS-induced contractions by NG-nitro-L-arginine was unaffected by epithelium removal. Therefore, neither VIP nor NO appears to be released during PGS, but both are released during TMS, and the generation of NO during TMS is independent of the epithelium.
The effects of brief periods of major coronary artery occlusion on global and regional peak left ventricular (LV) filling rates were studied during angioplasty in 10 patients. No patient had had a previous myocardial infarction. High-fidelity LV pressure and volume were determined by angiography before and 20 and 50 seconds after the onset of transluminal coronary occlusion and soon after the last balloon inflation. Segmental wall motion was analyzed frame by frame along 20 hemiaxes. Global peak filling rate decreased significantly both after 20 (29%, p <0.05) and 50 seconds (27%, p <0.05) from the onset of the occlusion. The term ΣΔt1 was defined as the sum of the absolute values of the time differences from the occurrence of global peak filling rate and the segmental peak filling rate in 20 segments. This variable increased significantly during both periods of transluminal occlusion (by 73% and by 72% [both p <0.005], respectively), indicating asynchrony in the occurrence of regional peak filling rate. Simultaneously, the sum of intervals between aortic valve closure (end systole) and occurrence of peak segmental shortening, ΣΔt2, measured in the 20 segments, increased by 63% after 20 seconds and by 87% after 50 seconds (both p <0.005), showing major asynchrony in segmental contraction. A significant negative correlation was found between global peak filling rate and both ΣΔt1 and ΣΔt2 (r = 0.64, p <0.001 and r = 0.70, p <0.0001, respectively). Our findings suggest that during coronary transluminal occlusion, early asynchrony in regional peak filling rate occurs that appears to be related to delayed and asynchronous peak segmental shortening.
Background Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. Objectives This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. Methods In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. Results The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. Conclusions Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)
