Original Studies Outcomes of a Dedicated Stent in Coronary Bifurcations with Large Side Branches: A Subanalysis of the Randomized TRYTON Bifurcation Study

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (!2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB 2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB !2.25 mm diameter at Additional Supporting Information may be found in the online version of this article. Catheterization and Cardiovascular Interventions 00:00-00 V C 2015 Wiley Periodicals, Inc

Clinical Outcomes after Percutaneous Coronary Intervention for Cardiogenic Shock Secondary to Total Occlusive Unprotected Left Main Coronary Artery Lesion-Related Acute Myocardial Infarction

Background: Acute myocardial infarction (AMI) with occlusion of an unprotected left main coronary artery (ULMCA) is a rare condition with a high mortality. The literature on clinical outcomes after percutaneous coronary intervention (PCI) for cardiogenic shock secondary to ULMCA-related AMI is scarce. Methods: In this retrospective analysis, all consecutive patients undergoing PCI for cardiogenic shock secondary to total occlusive ULMCA-related AMI were included between January 1998 and January 2017. The primary endpoint was 30-day mortality. The secondary endpoints were long-term mortality and 30-day and long-term major adverse cardiovascular and cerebrovascular events. The differences in clinical and procedural variables were assessed. A multivariable model was created to search for independent predictors of survival. Results: Forty-nine patients were included, and the mean age was 62 ± 11 years. The majority of patients suffered cardiac arrest prior or during PCI (51%). Thirty-day mortality was 78%, of which 55% died within 24 h. The median follow-up of patients who survived 30 days (n = 11) was 9.9 years (interquartile range 4.7–13.6), and long-term mortality was 84%. Long-term all-cause mortality was independently associated with cardiac arrest prior or during PCI (hazard ratio [HR] 2.02, 95% confidence interval 1.02–4.01, p = 0.043). Patients who survived to the 30-day follow-up with severe left ventricular dysfunction had a significantly higher risk of mortality compared to patients with moderate to mild dysfunction (p = 0.007). Conclusions: Cardiogenic shock secondary to total occlusive ULMCA-related AMI carries a very high 30-day all-cause mortality. Thirty-day survivors with a severe left ventricular dysfunction have a poor long-term prognosis

Clinical Outcomes after Percutaneous Coronary Intervention for Cardiogenic Shock Secondary to Total Occlusive Unprotected Left Main Coronary Artery Lesion-Related Acute Myocardial Infarction

Background: Acute myocardial infarction (AMI) with occlusion of an unprotected left main coronary artery (ULMCA) is a rare condition with a high mortality. The literature on clinical outcomes after percutaneous coronary intervention (PCI) for cardiogenic shock secondary to ULMCA-related AMI is scarce. Methods: In this retrospective analysis, all consecutive patients undergoing PCI for cardiogenic shock secondary to total occlusive ULMCA-related AMI were included between January 1998 and January 2017. The primary endpoint was 30-day mortality. The secondary endpoints were long-term mortality and 30-day and long-term major adverse cardiovascular and cerebrovascular events. The differences in clinical and procedural variables were assessed. A multivariable model was created to search for independent predictors of survival. Results: Forty-nine patients were included, and the mean age was 62 ± 11 years. The majority of patients suffered cardiac arrest prior or during PCI (51%). Thirty-day mortality was 78%, of which 55% died within 24 h. The median follow-up of patients who survived 30 days (n = 11) was 9.9 years (interquartile range 4.7–13.6), and long-term mortality was 84%. Long-term all-cause mortality was independently associated with cardiac arrest prior or during PCI (hazard ratio [HR] 2.02, 95% confidence interval 1.02–4.01, p = 0.043). Patients who survived to the 30-day follow-up with severe left ventricular dysfunction had a significantly higher risk of mortality compared to patients with moderate to mild dysfunction (p = 0.007). Conclusions: Cardiogenic shock secondary to total occlusive ULMCA-related AMI carries a very high 30-day all-cause mortality. Thirty-day survivors with a severe left ventricular dysfunction have a poor long-term prognosis

Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up

Aims: Fully bioresorbable Absorb poly-L-lactic-acid (PLLA) scaffolds (Abbott Vascular, Santa Clara, CA, USA) are a novel approach for the treatment of coronary narrowing. Due to the translucency of the material (PLLA), the optical coherence tomography (OCT) measurement methods used in the ABSORB trials were unique but not applicable for permanent metallic stents. When the Absorb scaffold and metallic stents are compared in the context of randomised trials, it is challenging to compare the two devices using the conventional methods. The primary purpose of this report is to explain the biases in conventional methodologies applied for metallic stents and for PLLA scaffolds at baseline and follow-up, and to propose a new standard methodology that enables us to compare two different devices using an almost identical and methodological language. Methods and results: A consensus amongst multiple core labs and expert researchers of OCT was reached on a new standard OCT measurement methodology that enables us to compare these two different devices. In brief, the proposed OCT methods are summarised as follows. 1) Both endoluminal and abluminal scaffold/stent contours should be traced. 2) Consistently, endoluminal and abluminal incomplete stent apposition areas should be measured. 3) The area occupied by scaffold/stent struts should be quantified directly or virtually. 4) The strut area should be systematically excluded from the flow area as well as the neointimal area. 5) Additional information on the degree of embedment could be reported using the interpolated lumen contour. Interobserver variability of the proposed method was excellent (intraclass correlation 0.89-100). Conclusions: A standardised OCT measurement methodology is proposed. This should be implemented in ongoing and future trials comparing the Absorb scaffolds and metallic stent

A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions

Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). Objectives The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. Methods We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. Results We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). Conclusions Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (>= 2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB = 2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB >= 2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P=0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P=0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P=0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB >= 2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs