Thor Trovik

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial

BACKGROUND Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING Biosensors, Aarhus University Hospital, and participating sites.

Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting The Nordic-Baltic Bifurcation Study III

Background— It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. Methods and Results— We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non–procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. Conclusions— MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

BACKGROUND Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life. METHODS We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life. RESULTS At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups. CONCLUSIONS In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).

Coronary bypass graft patency cannot be determined by multidetector spiral computed tomography

Objectives. Angiography by selective catheterization is the reference standard for coronary bypass graft patency assessment but carries a risk of serious complications. We have investigated whether 16-slice multidetector spiral computed tomography (MDCT) can substitute for selective angiography. Design. Two to three years after coronary artery bypass grafting, 45 patients with a total of 156 bypasses (100 single and 28 sequential grafts) were examined with both MDCT and conventional selective angiography on the same day. The bypasses were classified as patent, stenotic or occluded. Results. The likelihood ratio for MDCT-detected occlusion was 40, reflecting a fairly high combined sensitivity and specificity. However, 24% of the distal anastomoses could not be evaluated by MDCT, mainly because of respiratory movements, artifacts due to metal clips, and small vessel dimensions. Moreover, seven out of 117 bypasses (6%) deemed evaluable by MDCT were wrongly classified by this method. Conclusions. At present, 16-slice MDCT cannot replace selective angiography for assessment of coronary bypass graft patency since 24% of bypasses could not be evaluated by this method, and an error rate of 6% is unacceptable.

Radial artery graft patency relates to gender, diabetes mellitus and angiotensin inhibition

Abstract The radial artery is resistant to atherosclerotic degeneration and therefore appears more attractive for coronary artery bypass grafting than the saphenous vein. However, the patency of radial artery grafts varies widely among studies. Therefore, before deciding whether to adopt this as the conduit of choice second to internal mammary artery grafts, we have prospectively monitored our first cohort of patients with radial-to-coronary bypasses. Design. Angiographic and clinical outcome parameters were registered for the 119 patients receiving radial artery grafts at our institution during April 4, 2001 to October 7, 2003. Results. Reangiography of 102 patients (86%) showed that after two to three years, 79% of the radial artery and 87% of the saphenous vein grafts remained patent. Radial artery harvesting was well tolerated. Patency of radial artery grafts was correlated to diabetes mellitus (detrimental), gender (women had higher occlusion rates), and use of angiotensin inhibiting medication (beneficial). Conclusions. The pre-study assumption that radial artery grafts would out-perform those of saphenous vein at mid-term is not borne out. The propensity of radial artery graft failure in diabetics and the higher patency associated with angiotensin inhibition might both relate to endothelial modulation of the muscular tone of the graft.

Calculating the 30-day Survival Rate in Acute Myocardial Infarction: Should we Use the Treatment Chain or the Hospital Catchment Model?

Introduction Acute myocardial infarction (AMI) is a potentially deadly disease and significant efforts have been concentrated on improving hospital performance. A 30-day survival rate has become a key quality of care indicator. In Northern Norway, some patients undergoing AMI are directly transferred to the Regional Cardiac Intervention Center at the University Hospital of North Norway in Tromsø. Here, coronary angiography and percutaneous coronary intervention is performed. Consequently, local hospitals may be bypassed in the treatment chain, generating differences in case mix, and making the treatment chain model difficult to interpret. We aimed to compare the treatment chain model with an alternative based on patients’ place of living. Methods Between 2013 and 2015, a total of 3,155 patients were registered in the Norwegian Patient Registry database. All patients were categorized according to their local hospitals catchment area. The method of Guo-Romano, with an indifference interval of 0.02, was used to test whether a hospital was an outlier or not. We adjusted for age, sex, comorbidity, and number of prior hospitalizations. Conclusions We revealed the 30-day AMI survival figure ranging between 88.0% and 93.5% (absolute difference 5.5%) using the hospital catchment method. The treatment chain rate ranged between 86.0% and 94.0% (absolute difference 8.0%). The latter figure is the one published as the National Quality of Care Measure in Norway. Local hospitals may get negative attention even though their catchment area is well served. We recommend the hospital catchment method as the first choice when measuring equality of care.

Coronary artery disease cannot be reliably evaluated by 16-slice multidetector spiral computed tomography

Objectives. Angiography by selective catheterization is the standard method for coronary artery imaging but carries a risk of rare, but serious complications. We investigated whether 16-slice multidetector spiral computed tomography (MDCT) could substitute for selective angiography for evaluation of coronary artery disease in surgically revascularized patients. Design. In a setting closely resembling routine clinical practice, 45 patients who had been operated with coronary artery bypass grafting 508–1135 (mean 811) days before were examined with MDCT and conventional selective angiography on the same day. The interpreters were blinded to the results of the parallel imaging modality. Results. Significant pathology (stenosis ≥50% or occlusion) in the larger coronary artery segments was detected by MDCT with a sensitivity of 70–98% (mean 87%) and a specificity of 0–37% (mean 21%). MDCT failed to identify three of ten left main stem stenoses. Conclusion. Sixteen-slice MDCT cannot routinely replace selective angiography for evaluation of coronary artery disease.