The SYNergy between percutaneous intervention with TAXus drug-eluting stents and cardiac surgery (SYNTAX) score (SS) is an effective angiographic predictor of clinical outcomes in patients with ...multivessel coronary artery disease (MVD) undergoing percutaneous coronary intervention. It is not known whether this relation is independent of the number of diseased vessels. The aim of the present study was to assess the relation between the SS and major adverse cardiac events (MACE) in patients with single-vessel disease (SVD) and MVD undergoing percutaneous coronary intervention. In the ACUITY trial, the SS was determined in 2,627 patients undergoing percutaneous coronary intervention. The relation between the SS and the 1-year clinical outcomes was assessed according to SS tertiles: <5 (n = 441), ≥5 but <10 (n = 525), and ≥10 (n = 495) for SVD and <10 (n = 361), ≥10 but <18 (n = 401), and ≥18 (n = 404) for MVD. At 1 year of follow-up, the rate of MACE was 16.8%, 24.7%, and 23.7% for patients with MVD in the first, second and third tertiles, respectively (p = 0.02). The corresponding rates for those with SVD was 13.3%, 15.3%, and 19.1% (p = 0.01). In the patients with MVD, the SS independently predicted 1-year MACE (hazard ratio 1.02, 95% confidence interval 1.01 to 1.03; p = 0.002), myocardial infarction (hazard ratio 1.02, 95% confidence 1.00 to 1.04; p = 0.02), and cardiac death (hazard ratio 1.05, 95% confidence interval 1.02 to 1.09; p = 0.005). In patients with SVD, the SS independently predicted 1-year MACE (hazard ratio 1.03, 95% confidence interval 1.01 to 1.05; p = 0.0009) and myocardial infarction (hazard ratio 1.05, 95% confidence interval 1.02 to 1.07; p = 0.002). In the overall study cohort, the SS was an independent predictor of MACE and death, and MVD (vs SVD) was not. In conclusion, the SS is a useful angiographic predictive tool for patients with SVD and MVD.
Objectives This study sought to evaluate the impact of chronic kidney disease (CKD) on coronary atherosclerotic plaque composition, morphology, and outcomes in patients with acute coronary syndromes ...(ACS). Background CKD patients presenting with ACS are at increased risk for adverse events. Whether or not this increased risk reflects differences in coronary plaque composition remains unknown. Methods In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, patients presenting with ACS in whom percutaneous coronary intervention was successful underwent 3-vessel grayscale and radiofrequency intravascular ultrasound imaging. Lesions were prospectively characterized, and patients were followed for a median of 3.4 years. We conducted a patient-level and lesion-level analysis of study participants by comparing intravascular ultrasound parameters of untreated nonculprit lesions in patients with and without CKD. Results Patients with CKD (n = 73, 11.3%) were older, more often female and diabetic compared to those without CKD (n = 573). Nonculprit lesions in patients with (n = 280) versus without (n = 2,390) CKD were more likely to have plaque burden ≥70% (11.8% vs. 8.5%, p = 0.05) and minimal luminal area ≤4.0 mm2 (25.9% vs. 19.2%, p = 0.005). The percentage of plaque comprised of necrotic core (15.0% vs. 13.0%, p = 0.0001) and dense calcium (8.2% vs. 6.4%, p < 0.0001) was higher while fibrous tissue (57.7% vs. 59.8%, p < 0.0001) was lower in CKD versus non-CKD lesions. The 3-year composite rate of cardiac death, cardiac arrest, or myocardial infarction (15.1% vs. 3.3%, p < 0.0001) was significantly higher in patients with than in those without CKD, although there were no differences in the rates of events adjudicated to nonculprit lesions. Conclusions Following percutaneous coronary intervention of all culprit lesions in ACS, patients with versus without CKD have more extensive and severe atherosclerosis remaining in their coronary tree with plaque composed of greater necrotic core and less fibrous tissue. These influences resulted in nonsignificantly different rates of non-culprit lesion–related adverse events, although cardiac death, arrest, or myocardial infarction were more common in patients with CKD.
Patients with ST-segment elevation myocardial infarction (STEMI) admitted during nonregular working hours (off-hours) have been reported to have greater mortality than those admitted during regular ...working hours (on-hours), perhaps because of the lower availability of catheterization laboratory services and longer door-to-balloon times. This might not be the case, however, for hospital centers in which primary percutaneous coronary intervention (PCI) is invariably performed. We conducted a substudy using the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction study data to determine whether the STEMI arrival time was associated with differing clinical outcomes. We identified all patients with STEMI admitted to a PCI-capable hospital who underwent primary PCI. Patients presenting during on-hours were compared to those presenting during off-hours. The primary outcome of death, major adverse cardiovascular events, and net adverse clinical events was examined. We identified 2,440 patients (1,205 49% on-hours and 1,235 51% off-hours). Similar baseline characteristics were observed. The off-hour patients had a significantly longer door-to-balloon time (92 vs 75 minutes; p <0.0001) and total ischemic time (209 vs 194 minutes; p <0.0001). Despite these differences, the risk-adjusted all-cause mortality, major adverse cardiovascular events, and net adverse clinical events rates were similar for both groups during the in-hospital, 1-year, and 3-year follow-up. In conclusion, patients with STEMI presenting to primary PCI hospitals during off-hours might have slightly longer delays to revascularization; however, they experienced similar short- and long-term survival and clinical outcomes as those arriving during on-hours.
First-generation DES changed the post-stenting healing process; however, the lack of coverage of a substantial amount of DES struts was shown to contribute substantially to stent thrombosis (1). ......bifurcation lesion was an exclusion criterion in the present study, yet this abundant type of lesion has been difficult to target with metallic stents that usually compromise ("jail") the side branch.
Objectives This study sought to determine the impact of short-term intensive statin therapy on intracoronary plaque lipid content. Background Statin therapy significantly reduces the risk for ...thrombotic events. Whether or not these benefits are attributable to reduction in plaque lipid content remains to be properly documented in human obstructive coronary artery disease (CAD). Methods We randomized 87 patients with multivessel CAD undergoing percutaneous coronary intervention and at least 1 other severely obstructive (fractional flow reserve FFR ≤0.8) nontarget lesion (NTL) to intensive (rosuvastatin 40 mg daily) or standard-of-care lipid-lowering therapy. NTLs were evaluated at baseline and after 7 weeks of therapy with FFR, near-infrared spectroscopy, and intravascular ultrasound. The primary endpoint was the change in lipid-core burden index at the 4-mm maximal segment (LCBI4mm max), wherever this occurred within the lesion. Results Upon follow-up, median reduction (95% confidence interval) in LCBI4mm max was significantly greater in the intensive versus standard group (−149.1 −210.9 to −42.9 vs. 2.4 −36.1 to 44.7; p = 0.01). Results remained consistent after adjustment for baseline differences in LCBI between groups and use of change in LCBI across the entire lesion as the dependent outcome. Conclusions Short-term intensive statin therapy may reduce lipid content in obstructive lesions. These hypothesis-generating findings warrant confirmation in larger studies with longer follow-up. (Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy YELLOW); NCT01567826 )
Definitive pharmacological therapies for COVID-19 have yet to be identified. Several hundred trials are ongoing globally in the hope of a solution. However, nearly all treatments rely on systemic ...delivery but COVID-19 damages the lungs preferentially. The use of a targeted delivery approach is reviewed where engineered products are able to reach damaged lung tissue directly, which includes catheter-based and aerosol-based approaches. In this review we have outlined various target directed approaches which include microbubbles, extracellular vesicles including exosomes, adenosine nanoparticles, novel bio-objects, direct aerosol targeted pulmonary delivery and catheter-based drug delivery with reference to their relative effectiveness for the specific lesions. Currently several trials are ongoing to determine the effectiveness of such delivery systems alone and in conjunction with systemic therapies. Such approaches may prove to be very effective in the controlled and localized COVID-19 viral lesions in the lungs and potential sites. Moreover, localized delivery offered a safer delivery mode for such drugs which may have systemic adverse effects.
In the setting of ST-segment elevation myocardial infarction (STEMI), patients at high risk of systemic emboli who undergo primary percutaneous coronary intervention (PCI) using stents might require ...triple antithrombotic therapy (a combination of aspirin, thienopyridine, and vitamin K antagonist VKA). The risks and benefits of such therapy in the setting of STEMI have been incompletely characterized. We, therefore, assessed the outcomes of patients who received triple therapy after primary PCI in the large-scale, contemporary Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction HORIZONS-AMI trial. Among the 3,320 patients triaged to primary PCI, 126 (3.8%) were prescribed triple therapy and 3,194 (96.2%) were prescribed dual antiplatelet therapy. The most frequent indications for VKA treatment were a severely reduced left ventricular ejection fraction with a large akinetic area, atrial fibrillation (23.8% each), and mural thrombus (23.0%). The assignment to triple therapy was associated with older age, female gender, rhythm disturbances, Killip class >1 on admission, lower left ventricular ejection fraction, left anterior descending artery territory infarcts, and Final Thrombolysis In Myocardial Infarction flow grade <3. Patients treated with triple versus dual therapy had comparable short- and long-term ischemic outcomes but had significantly increased rates of major bleeding during the index hospitalization (17.1% vs 6.5%, p <0.0001), resulting in premature VKA discontinuation in 14.3% of those patients. In conclusion, in the setting of STEMI treated with primary PCI, the combination of aspirin, thienopyridine, and VKA results in an excess of bleeding complications and premature discontinuation of VKA. The risk of adding oral anticoagulation to patients admitted for STEMI should be carefully considered before choosing drug-eluting or bare metal stents.
Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of ...bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non–coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk RR 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non–access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.
Objectives We used intravascular ultrasound (IVUS) to assess incidence, predictors, morphology, and angiographic findings of edge dissections after drug-eluting stent (DES) implantation. Background ...DES implantation strategies differ compared with bare-metal stenting; coronary dissections after DES implantation have not been well studied. Methods We studied 887 patients with 1,045 non–in-stent restenosis lesions in 977 native arteries undergoing DES implantation with IVUS imaging. Results Eighty-two dissections were detected; 51.2% (42 of 82) involved the proximal and 48.8% (40 of 82) the distal stent edge. Residual plaque area (8.0 ± 4.3 mm2 vs. 5.2 ± 3.0 mm2 , p < 0.0001); plaque burden (52.2 ± 11.7% vs. 36.2 ± 15.3%, p < 0.0001); plaque eccentricity (8.4 ± 5.5 vs. 4.0 ± 3.4, p < 0.0001); and stent edge symmetry (1.2 ± 0.1 vs. 1.1 ± 0.1, p = 0.02) were larger; plaque burden ≥50% was more frequent (62.0% vs. 17.2%, p < 0.0001); calcium deposits (52.1% vs. 35.2%, p = 0.03) more common; and lumen-to-stent-edge-area ratio (0.9 ± 0.2 vs. 1.0 ± 0.2, p < 0.0001) was smaller in the edge dissection group compared with the nondissection group. Intramural hematomas occurred in 34.1% (28 of 82) of dissections. When compared with nonhematoma dissections, residual plaque and media area (6.4 ± 2.5 mm2 vs. 8.9 ± 4.6 mm2 , p = 0.04) was smaller, and stent edges less asymmetric (1.1 ± 0.1 vs. 1.2 ± 0.1, p = 0.009) in the dissection with hematoma group. Independent predictors of any stent edge dissection were residual plaque eccentricity (odds ratio OR: 1.4, p = 0.02), lumen-to-stent-edge-area ratio (OR: 0.0, p = 0.007), and stent edge symmetry (OR: 1.2, p = 0.02 for each 0.01 increase). Conclusions IVUS identified edge dissections after 9.2% of DES implantations. Residual plaque eccentricity, lumen-to-stent-edge-area ratio, and stent edge symmetry predicted coronary stent edge dissections. Dissections in less diseased reference segments more often evolved into an intramural hematoma.
Increased creatine kinase-MB levels and ST-segment depression are well-known prognostic factors in the setting of non–ST-elevation acute coronary syndrome (ACS). We hypothesized a relationship ...between virtual histology intravascular ultrasound (VH-IVUS) findings and these prognostic factors. We performed “whole vessel” VH-IVUS analysis in culprit arteries of 225 patients with ACS and measured the 4 basic VH-IVUS coronary plaque components—fibrous, fibrofatty, dense calcium (DC), and necrotic core (NC)—and calculated a NC/DC ratio. Patients’ age was 62 ± 11 years; 72% were men and 23% had diabetes. Only the NC/DC ratio had a positive association with creatine kinase-MB levels (r = 0.21, p = 0.03), and it was significantly higher for patients with ST-depression compared with those with non–ST-depression ACS (1.97 ± 1.46 vs 1.58 ± 1.10, p = 0.02). Sensitivity and specificity curves determined that a NC/DC value ≥2 (odds ratio 3.8, p = 0.01) and percentage of NC ≥6 (odds ratio 3.1, p = 0.04) were thresholds that best separated patients with high-risk non–ST-elevation ACS from those without abnormal creatine kinase-MB or ST depression. Patients with both predictors had significantly higher total cholesterol (204.7 ± 60.5 vs 173.6 ± 44.3 mg/dl, p = 0.01), higher low-density liprotein cholesterol (132.5 ± 49.8 vs 101.3 ± 33.2 mg/dl, p = 0.02), and more myocardial injury (creatine kinase-MB value of 42 ± 38 vs 12 ± 21, p = 0.01) than patients with no predictors. In conclusion, VH-IVUS analysis showed that the percentage of NC and its ratio to DC in diseased coronary segments are positively associated with a high-risk ACS presentation.
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