Safety and feasibility of minimally invasive coronary artery bypass surgery early after drug-eluting stent implantation due to acute coronary syndrome.

BACKGROUND: The evidence on performing minimally invasive coronary artery surgery early after drug-eluting stent (DES) implantation due to acute coronary syndrome (ACS) is limited. AIM: The study aimed to determine the safety and feasibility of this approach. METHODS: This registry included 115 (78% male) patients treated from 2013 to 2018, who underwent non-left anterior descending (LAD) percutaneous coronary intervention (PCI) due to ACS with contemporary DES implantation (39% diagnosed with myocardial infarction at baseline), followed by endoscopic atraumatic coronary artery bypass (EACAB) surgery within 180 days, after temporary P2Y12 inhibitor discontinuation. Primary composite endpoint of MACCE (major adverse cardiac and cerebrovascular events), defined as death, myocardial infarction (MI), cerebrovascular incident, and repeat revascularization was evaluated in long-term follow-up. The follow-up was collected via a telephone survey and in line with National Registry for Cardiac Surgery Procedures. RESULTS: The median (interquartile range [IQR]) time interval separating both procedures was 100.0 (62.0-136.0) days. Median (IQR) follow-up duration was 1338.5 (753.0-2093.0) days and was completed for all patients with regard to mortality. Eight patients (7%) died; 2 (1.7%) had a stroke; 6 (5.2%) suffered from MI, and 12 (10.4%) required repeat revascularization. Overall, the incidence of MACCE was 20 (17.4%). CONCLUSIONS: EACAB is a safe and feasible method of LAD revascularization in patients who received DES for ACS within 180 days before surgery despite early dual antiplatelet therapy discontinuation. The adverse event rate is low and acceptable.

Del Nido versus cold blood cardioplegia in adult patients with impaired ejection fraction undergoing valvular and complex heart surgery.

BACKGROUND: There is sparse evidence on the efficacy of del Nido cardioplegia in high-risk patients with reduced ejection fraction undergoing valvular or complex heart surgery, and further investigation is required. METHODS: An institutional registry was searched for patients who underwent valvular or complex heart surgery and had an ejection fraction <40%. Subjects who received del Nido cardioplegia (DNC) and cold blood cardioplegia (CBC) were selected. Propensity matching was performed with age, gender, and number of conducted procedures as matching criteria. A comparative analysis was performed on primary endpoints of the troponin rise and changes in ejection fraction (EF). A composite endpoint of a troponin rise of ≥20× baseline or fall of EF≥5% was assessed in a multivariate analysis. Other perioperative complications are reported. RESULTS: One hundred patients from the DNC group were matched to the 100 patients in the CBC group. There were no differences between groups at baseline. Postoperatively, lower troponin values were observed in the DNC group at 12 hours (median; IQR: 523.2;349.1-740.4 pg/mL vs. 787.6;443.6-1689.0 pg/mL; P=0.016) and 36 hours (median; IQR: 426.1;337.2-492.1 pg/mL vs. 653.7;398.8-1737.5 pg/mL; P=0.044). Fewer patients in the DNC group had a fall in EF≥5% (7% vs. 16%; P=0.046). The multivariable analysis did not reveal a significant predictor of composite endpoint. CONCLUSIONS: In patients with impaired contractility undergoing valvular and complex procedures, the use of del Nido cardioplegia as an alternative to cold blood cardioplegia is associated with lower troponin release and improved preservation of ejection fraction.

Use of del Nido cardioplegia in acute coronary syndrome cases with decreased ejection fraction.

BACKGROUND: There has been increasing interest in using del Nido cardioplegia in adult cardiac surgery. However, there is limited evidence for its efficacy in patients with acute coronary syndrome and reduced ejection fraction. METHODS: This study examined patients with decreased ejection fraction (EF < 40%) who were hospitalized due to acute coronary syndrome and received either del Nido (DN) or cold blood cardioplegia (CB). The patients were matched based on age, gender, myocardial infarction at baseline, and number of conducted surgical procedures. An analysis was conducted on postoperative biomarker release (high-sensitivity troponin T and isoenzyme creatine kinase-MB (CK-MB)), changes in myocardial contractility and perioperative outcomes. RESULTS: 62 pairs of patients with similar baseline characteristics were selected. 51.6% of pairs underwent isolated coronary artery bypass grafting, while 48.4% underwent a complex procedure. Postoperative troponin values did not differ significantly at 12 h (median (IQR): 606.7 (381.4-974.8) pg/mL vs. 552 (231.8-1579.5) pg/mL; p = 0.913), nor did CK-MB (median (IQR): 24.3 (12.6-45.5) ng/mL vs. 23.7 (12.3-49.8) ng/mL; p = 0.972). The postoperative EF was similar between groups (median (IQR): 30% (30-35%) vs. 34% (30-38%); p = 0.323). No difference in perioperative mortality, myocardial infarction, stroke, or composite endpoint was noted. In a multivariate analysis, the cardioplegia protocol did not affect biomarker release or changes in ejection fraction. The first stage of acute kidney injury was more frequent in the CB group (28.5% vs. 9.7%, p = 0.033). CONCLUSIONS: Both del Nido and cold blood cardioplegia provide adequate cardioprotection in patients with acute coronary syndrome with decreased ejection fraction.

Del Nido versus Bretschneider cardioplegic solution in valve replacement for severe aortic stenosis - a case-control pilot study.

Introduction: The adequate protection provided by the del Nido cardioplegia has already been proven in trials comparing the solution with blood cardioplegia. However, evidence regarding comparison to the Bretschneider HTK solution is limited. Aim: To determine the efficacy of the del Nido cardioplegia when compared to Bretschneider HTK solution in patients undergoing aortic valve replacement for severe aortic stenosis. Material and methods: Ten patients undergoing isolated aortic valve replacement for severe aortic stenosis using the del Nido solution (group 1) were case-control matched to patients undergoing aortic valve replacement (AVR) using the Bretschneider solution (group 2). The observation included: cardioplegia dosage, time to cardiac arrest, cross-clamp and extracorporeal circulation time, ventricular fibrillation (VF) after removing the cross-clamp, gasometry parameters, creatinine kinase (MB isoenzyme - CK-MB) at 24 and 48 h following the surgery and troponin (highsensitivity troponin T - hsTnT) at 24 and 48 h. Results: Patients were no different in terms of comorbidities. Higher incidence of VF occurred in group 2 (3 vs. 9, 30% vs. 90%; p = 0.02). Blood sodium measurements after removing the cross-clamp were significantly higher in group 1 (median 137.0 vs. 130.0; p = 0.0004). Biomarker release trended toward lower values in group 1, but not significantly (median troponin at 24 h: 223.1 pg/ml vs. 294.8 pg/ml; p = 0.4 and 48 h: 208.0 pg/ml vs. 242.5 pg/ml; p = 0.7, median CK-MB at 24 h: 16.6 ng/ml vs. 17.3 ng/ml; p = 0.6, and 48 h: 6.7 ng/ml vs. 5.08 ng/ml; p = 0.3). Peak creatinine trended towards lower values in group 2, but not significantly (1.35 mg/dl vs. 1.05 mg/dl; p = 0.09). Conclusions: Both del Nido and Bretschneider cardioplegia provide satisfactory myocardial protection. However, del Nido cardioplegia reduces the incidence of VF after declamping the aorta. Further studies are required.

Age- and gender-related differences in the del Nido cardioprotection protocol.

BACKGROUND: The evidence regarding the impact of patient's age and gender on del Nido cardioplegia cadio-protection capability in adults is strongly limited. METHODS: A group of 75 patients undergoing aortic valve replacement (AVR) with del Nido cardioplegia was divided into Group 1 (male) and Group 2 (female). Creatine kinase (CK-MB isoenzyme) and high sensitivity troponin T (hs-TnT) values at 24 hours and 48 hours, occurrence of cardiac activity during crossclamp and ventricular fibrillation (VF) during reperfusion were compared. The impact of age on hs-TnT,CK-MB, VF during reperfusion and cardiac activity during crossclamp was investigated using regression models. RESULTS: No difference between the groups was reported in 24-hour CK-MB (median 15.57 ng/mL; IQR 12.13-22.82 ng/mL vs. 13.97; 12.09-17.147 ng/mL; P=0.168), 48-hour CK-MB (6.19; 4.22-7.71 ng/mL vs. 6.07;4.56-7.06 ng/mL; P=0.707), 24-hour hs-TnT (259.2; 172.0-376.9 pg/mL vs. 193.0; 167.8-351 pg/mL.1; P=0.339), 48-hour hs-TnT (169.1; 124.9-293.0 pg/mL vs. 159.2; 123.12-211.77 pg/mL; P=0.673), VF during reperfusion (25% vs. 18,5%; P=0.774) and cardiac activity during arrest (39.6% vs. 37.1%; p= 1.0). Values of CK-MB at 24 hours, hs-TnT at 24 hours and hs-TnT at 48 hours were not dependent on age. The CK-MB at 48 hours was dependent on age (P=0.039). Probit regression failed to reveal the impact of patients' age on postclamp VF occurrence (P=0.11) or electrical activity during arrest (P=0.57). CONCLUSIONS: Considering our study results, it can be hypothesized that the del Nido cardioplegia provides adequate myocardial protection in AVR patients regardless of age and gender.

Short and long-term results of endoscopic atraumatic coronary artery off-pump bypass grafting in patients with left anterior descending artery stenosis.

BACKGROUND: To perform a retrospective analysis of patients who underwent endoscopic atraumatic coronary artery off-pump bypass grafting (EACAB) in a single center over a period of 11 years. METHODS: Data was acquired from the hospital registry and patient medical records. In order to determine changes in clinical profile, patients were subdivided into three groups regarding year of surgery: 1998-2002 (group 1), 2003-2005 (group 2), 2006-2009 (group 3). In-hospital analysis up to 30 days and long-term observation were conducted. RESULTS: The study cohort consisted of 714 patients (581 male). Procedural success accounted for 99% of all patients. No mortality was observed up to 30 days. Complications in the early period included pleural effusion (7.6%), cardiac arrhythmias (3.6%), bleeding related revision (2.7%) and wound infection (1.6%). Mean follow-up was 6 years (2132 ± 1313 days; median: 1918.5). Nineteen (2.7%) patients died, of which 52.6% (10 patients) were due to heart related conditions. Overall frequency of major adverse cerebral and cardiovascular events (MACCE) was 10.8% (77 patients). The Kaplan-Meyer analysis defined survival rate and event-free survival in long-term observation of 96.1% and 85.3%, respectively. Ejection fraction (EF) < 50% was the only independent factor of mortality (OR: 3.35). Regarding cumulative MACCE, older age (OR: 1.72), lower EF (OR: 3.03), the history of percutaneous coronary intervention (OR: 2.13) and higher New York Heart Association class (OR: 2.63) influenced the incidence rate. CONCLUSIONS: The presented short and very long-term results confirm that EACAB is an efficient alternative for patients requiring revascularization of the left anterior descending artery. The elimination of cardiopulmonary bypass significantly reduces the number of complications.

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.

BACKGROUND: This was the first prospective study to assess the safety and efficiency of MynxGrip vascular closure device (VCD) in peripheral interventions with antegrade access. METHODS AND RESULTS: We enrolled 66 consecutive patients from 1 center. All patients were discharged home on the day of procedure and were observed for adverse events at 1 and 30 days of follow-up. No major complications were observed. The rate of minor complications (conversion to manual or mechanical compression) was 7.6%. Postdischarge, 3% of patients experienced minor complications-small abscess, ipsilateral deep vein thrombosis. In 1 patient, a second VCD was deployed after device failure. The derived device failure rate was 5.9%. No patients required hospitalization. No late bleeding and no hematomas >6 cm were noted. The mean time to discharge was 4 hours and 5 minutes. CONCLUSION: The MynxGrip was safe and effective in sealing access sites after antegrade femoral artery puncture with same-day discharge.

Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for acute coronary syndrome from the DELTA registry: a multicentre registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

AIMS: Our aim was to compare, in a large unprotected left main coronary artery (ULMCA) all-comer registry, the long-term clinical outcome after percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: Of a total of 2,775 patients enrolled in the Drug Eluting Stents for Left Main Coronary Artery Disease (DELTA) multicentre registry, 379 (13.7%) patients with ACS treated with PCI (n=272) or CABG (n=107) were analysed. Baseline demographics were considerably different in the two groups before propensity matching. No significant differences emerged for the composite endpoint of all-cause death, myocardial infarction (MI), and cerebrovascular accident (HR 1.11, 95% CI: 0.63-1.94; p=0.727), all-cause death (HR 1.26, 95% CI: 0.68-2.32; p=0.462), the composite endpoint of all-cause death and MI (HR 1.02, 95% CI: 0.56-1.84; p=0.956), and major adverse cardiac and cerebrovascular events (HR 0.82, 95% CI: 0.50-1.36; p=0.821). However, a higher incidence of target vessel revascularisation (HR 4.67, 95% CI: 1.33-16.47; p=0.008) was observed in the PCI compared with the CABG group, which was confirmed in the propensity score-matched analysis. CONCLUSIONS: In the DELTA all-comer, multinational registry, PCI for ACS in ULMCA is associated with comparable clinical outcomes to those observed with CABG at long-term follow-up, despite the use of first-generation DES.

Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease.

Coronary atherosclerotic disease is highly prevalent in chronic kidney disease (CKD). Although revascularization improves outcomes, procedural risks are increased in CKD, and unbiased data comparing coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in CKD are sparse. To compare outcomes of CABG and PCI in stage 3 to 5 CKD, we identified randomized trials comparing these procedures. Investigators were contacted to obtain individual, patient-level data. Ten of 27 trials meeting inclusion criteria provided data. These trials enrolled 3993 patients encompassing 526 patients with stage 3 to 5 CKD of whom 137 were stage 3b-5 CKD. Among individuals with stage 3 to 5 CKD, mortality through 5 years was not different after CABG compared with PCI (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.67-1.46) or stage 3b-5 CKD (HR 1.29, CI 0.68-2.46). However, CKD modified the impact on survival free of myocardial infarction: it was not different between CABG and PCI for individuals with preserved kidney function (HR 0.97, CI 0.80-1.17), but was significantly lower after CABG in stage 3-5 CKD (HR 0.49, CI 0.29-0.82) and stage 3b-5 CKD (HR 0.23, CI 0.09-0.58). Repeat revascularization was reduced after CABG compared with PCI regardless, of baseline kidney function. Results were limited by unavailability of data from several trials and paucity of enrolled patients with stage 4-5 CKD. Thus, our patient-level meta-analysis of individuals with CKD randomized to CABG versus PCI suggests that CABG significantly reduces the risk of subsequent myocardial infarction and revascularization without affecting survival in these patients.

Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

OBJECTIVES: This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND: The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS: In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS: At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS: In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Therapeutic Potential of Adipose-Derived Therapeutic Factor Concentrate for Treating Critical Limb Ischemia.

Transplantation of adipose-derived stem cells (ADSCs) is an emerging therapeutic option for addressing intractable diseases such as critical limb ischemia (CLI). Evidence suggests that therapeutic effects of ADSCs are primarily mediated through paracrine mechanisms rather than transdifferentiation. These secreted factors can be captured in conditioned medium (CM) and concentrated to prepare a therapeutic factor concentrate (TFC) composed of a cocktail of beneficial growth factors and cytokines that individually and in combination demonstrate disease-modifying effects. The ability of a TFC to promote reperfusion in a rabbit model of CLI was evaluated. A total of 27 adult female rabbits underwent surgery to induce ischemia in the left hindlimb. An additional five rabbits served as sham controls. One week after surgery, the ischemic limbs received intramuscular injections of either (1) placebo (control medium), (2) a low dose of TFC, or (3) a high dose of TFC. Limb perfusion was serially assessed with a Doppler probe. Blood samples were analyzed for growth factors and cytokines. Tissue was harvested postmortem on day 35 and assessed for capillary density by immunohistochemistry. At 1 month after treatment, tissue perfusion in ischemic limbs treated with a high dose of TFC was almost double (p < 0.05) that of the placebo group [58.8 ± 23 relative perfusion units (RPU) vs. 30.7 ± 13.6 RPU; mean ± SD]. This effect was correlated with greater capillary density in the affected tissues and with transiently higher serum levels of the angiogenic and prosurvival factors vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF). The conclusions from this study are that a single bolus administration of TFC demonstrated robust effects for promoting tissue reperfusion in a rabbit model of CLI and that a possible mechanism of revascularization was promotion of angiogenesis by TFC. Results of this study demonstrate that TFC represents a potent therapeutic cocktail for patients with CLI, many of whom are at risk for amputation of the affected limb.

Treatment of symptomatic coronary artery disease in patients with end-stage renal disease on hemodialysis with paclitaxel-eluting TAXUS stent.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1- and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P < 0.05), cardiac death 2.7% vs. 1.9% (P = ns), target vessel revascularization (TVR) 9.1% vs. 6.7% (P = ns), acute myocardial infarction (AMI) 3.8% vs. 2.9% (P = ns), cerebrovascular events (CVA) 0.5% vs. 1.0% (P = ns); and results at 24 months showed: MACE 17.7% vs. 18.3% (P = ns), MACCE 21.5% vs. 26.0% (P = ns), all-cause death 4.3% vs. 14.4% (P < 0.01), cardiac death 3.2% vs. 1.9% (P = ns), TVR 14.0% vs. 16.3% (P = ns), AMI 5.4% vs. 5.8% (P = ns), CVA 3.2% vs. 2.9% (P = ns) for non-end-stage renal disease (ESRD) and dialysis group, respectively. Prior coronary artery bypass graft (CABG) was found to be single risk factor for MACE, TVR, and MACCE in patients with ESRD, while dialysis and prior CABG were found to be single risk factors for death in the entire population. PCI with TAXUS is a feasible procedure and presents promising results in dialysis-dependent patients.

Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.

BACKGROUND: Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events. AIM: To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology. METHODS: All tested stents were implanted with 10% overstretch into 10 carotid segments of Polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, and the treated segments were harvested and evaluated in the independent histopathology laboratory. RESULTS: All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography, all vessels were patent with no signs of thrombi or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage diameter stenosis 10.18 ± 8.1%. There was a 10% increase in the vessel reference diameter when compared to baseline (4.57 ± 0.5 vs. 4.96 ± 0.3 mm, p < 0.01). In the histopathology, mean area stenosis was 17.4% and mean intimal thickness was 0.20 mm. At histopathology, the mean injury, inflammation, and fibrin scores were low. Endothelialisation was complete in all stents, and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralisation. CONCLUSIONS: The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first-in-man application.

Comparison of stenting and surgical revascularization strategy in non-ST elevation acute coronary syndromes and complex coronary artery disease (from the Milestone Registry).

The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In this multicenter, prospective registry, 4,566 patients with non-ST-segment elevation myocardial infarctions, unstable angina, and multivessel coronary disease, including left main disease, were enrolled. After angiography, 3,033 patients were selected for stenting (10.3% received drug-eluting stents) and 1,533 for coronary artery bypass grafting. Propensity scores were used for baseline characteristic matching and result adjustment. Patients selected for percutaneous coronary intervention (PCI) were younger (mean age 64.4±10 vs 65.2±9 years, p=0.03) and more frequently presented with non-ST-segment elevation myocardial infarctions (32.0% vs 14.5%, p=0.01), cardiogenic shock (1.5% vs 0.7%, p<0.01), and history of PCI (13.1% vs 5.5%, p<0.01) or coronary artery bypass grafting (10.6% vs 4.6%, p<0.01). European System for Cardiac Operative Risk Evaluation scores were higher in PCI patients (5.4±2 vs 5.2±2, p<0.01). Patients referred for coronary artery bypass grafting more often presented with triple-vessel disease and left main disease (82.2% vs 33.8% and 13.7% vs 2.4%, respectively, p<0.01). After adjustment, 929 well-matched pairs were chosen. Early mortality was lower after PCI before matching (2.1% vs 3.1%, p<0.01), whereas after balancing, there was no difference (2.5% vs 2.8%, p=0.62). Three-year survival was in favor of PCI compared with surgery before (87.5% vs 82.8%, hazard ratio 1.44, 95% confidence interval 1.2 to 1.7, p<0.01) and after (86.4% vs 82.3%, hazard ratio 1.33, 95% confidence interval 1.05 to 1.7, p=0.01). Stenting was associated with improved outcomes in the following subgroups: patients aged >65 years, women, patients with unstable angina, those with European System for Cardiac Operative Risk Evaluation scores>5, those with Thrombolysis In Myocardial Infarction (TIMI) risk scores >4, those receiving drug-eluting stents, and those with 2-vessel disease. In conclusion, in patients presenting with non-ST-segment elevation acute coronary syndromes and complex coronary artery disease, immediate stenting was associated with lower mortality risk in the long term compared with surgical revascularization, especially in subgroups at high clinical risk.

Peri-strut low-intensity areas in optical coherence tomography correlate with peri-strut inflammation and neointimal proliferation: an in-vivo correlation study in the familial hypercholesterolemic coronary swine model of in-stent restenosis.

BACKGROUND: Peri-strut low-intensity area (PLI) is a common imaging finding during the evaluation of in-stent neointima using optical coherence tomography (OCT). We aimed to determine the biological significance of PLI by comparing in-vivo OCT images with the corresponding histological sections obtained from the familial hypercholesterolemic swine model of coronary stenosis. METHODS: A total of 26 coronary vessels of nine familial hypercholesterolemic swine were injured with 30% balloon overstretch and then immediately followed by everolimus eluting or bare metal stent placement at 20% overstretch. At 30 days, all stented vessels were subjected to in-vivo OCT analysis and were harvested for histological evaluation. For OCT analysis, stent cross-sections (three per stent) were categorized into presence (PLI+) or absence (PLI-) of PLI. In histology, inflammation and fibrin deposition were scored semiquantitatively from 0 (none) to 3 (severe). RESULTS: PLI was found in 64.9% of stent sections. Peri-strut inflammation was more frequently observed in OCT sections PLI (+) compared with PLI (-) (56.0 vs. 7.4%, P=0.01). In contrast, peri-strut fibrin deposits was similar in both groups (PLI+=58.0% vs. PLI-=59.3%, P=0.94). Histological neointimal thickness was significantly higher in PLI (+) sections (mean±SE: 0.68±0.06 vs. 0.34±0.02 mm; P<0.01), yielding a higher percent area stenosis compared with PLI (-) (mean±SE: 59.0±4.4 vs. 34.1±2.2%, P<0.01). The PLI diagnostic sensitivity and specificity for inflammation were 80 and 76.1%, respectively (>56% PLI, area under the curve=0.86, P<0.01), whereas for fibrin deposition, the sensitivity and specificity were 42.2 and 76.1%, respectively (area under the curve=0.56, P=NS). Area under the receiver operating characteristic curve was significantly higher for identifying inflammation than fibrin (0.86 vs. 0.56, P<0.01). The severity of PLI correlated with the neointimal thickness when assessed by OCT (R=0.79, P<0.001). CONCLUSION: The presence of PLI in OCT correlates with neointimal thickness and appears to have a diagnostic value in the recognition of peri-strut inflammation, therefore possibly serving as a surrogate for in-vivo assessment of stent efficacy.

Comparison of percutaneous coronary intervention (with drug-eluting stents) versus coronary artery bypass grafting in women with severe narrowing of the left main coronary artery (from the Women-Drug-Eluting stent for LefT main coronary Artery disease Registry).

Women typically present with coronary artery disease later than men with more unfavorable clinical and anatomic characteristics. It is unknown whether differences exist in women undergoing treatment for unprotected left main coronary artery (ULMCA) disease. Our aim was to evaluate long-term clinical outcomes in women treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG). All consecutive women from the Drug-Eluting stent for LefT main coronary Artery disease registry with ULMCA disease were analyzed. A propensity matching was performed to adjust for baseline differences. In total, 817 women were included: 489 (59.8%) underwent treatment with PCI with drug-eluting stents versus 328 (40.2%) with CABG. Propensity score matching identified 175 matched pairs, and at long-term follow-up there were no differences in all-cause (odds ratio [OR] 0.722, 95% confidence interval [CI] 0.357 to 1.461, p=0.365) or cardiovascular (OR 1.100, 95% CI 0.455 to 2.660, p=0.832) mortality, myocardial infarction (MI; OR 0.362, 95% CI 0.094 to 1.388, p=0.138), or cerebrovascular accident (CVA; OR 1.200, 95% CI 0.359 to 4.007, p=0.767) resulting in no difference in the primary study objective of death, MI, or CVA (OR 0.711, 95% CI 0.387 to 1.308, p=0.273). However, there was an advantage of CABG in major adverse cardiovascular and cerebrovascular events (OR 0.429, 95% CI 0.254 to 0.723, p=0.001), driven exclusively by target vessel revascularization (OR 0.185, 95% CI 0.079 to 0.432, p<0.001). In women with significant ULMCA disease, no difference was observed after PCI or CABG in death, MI, and CVA at long-term follow-up.

Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for ostial/midshaft lesions in unprotected left main coronary artery from the DELTA registry: a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

OBJECTIVES: The aim of this study was to report the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for ostial/midshaft lesions in an unprotected left main coronary artery (ULMCA). BACKGROUND: Data regarding outcomes in these patients are limited. METHODS: Of a total of 2,775 patients enrolled in the DELTA multinational registry, 856 patients with isolated ostial/midshaft lesions in an ULMCA treated by PCI with DES (n = 482) or CABG (n = 374) were analyzed. RESULTS: At a median follow-up period of 1,293 days, there were no significant differences in the propensity score-adjusted analyses for the composite endpoint of all-cause death, myocardial infarction (MI), and cerebrovascular accident (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.79 to 1.86; p = 0.372), all-cause death (HR: 1.35, 95% CI: 0.80 to 2.27; p = 0.255), the composite endpoint of all-cause death and MI (HR: 1.33, 95% CI: 0.83 to 2.12; p = 0.235) and major adverse cardiac and cerebrovascular events (HR: 1.34, 95% CI: 0.93 to 1.93; p = 0.113). These results were sustained after propensity-score matching. However, a higher incidence of target vessel revascularization (HR: 1.94, 95% CI: 1.03 to 3.64; p = 0.039) was observed in the PCI compared with the CABG group, with a trend toward higher target lesion revascularization (HR: 2.00, 95% CI: 0.90 to 4.45; p = 0.090). CONCLUSIONS: This study demonstrates that PCI for ostial/midshaft lesions in an ULMCA is associated with clinical outcomes comparable to those observed with CABG at long-term follow-up, despite the use of older first-generation DES.

Long-term clinical outcomes after percutaneous coronary intervention for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery: the DELTA Registry (drug-eluting stent for left main coronary artery disease): a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

OBJECTIVES: The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis. BACKGROUND: Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites. METHODS: Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry. RESULTS: A total of 1,612 patients were included: 482 were treated for ostial/mid-shaft lesions versus 1,130 for distal bifurcation lesions. At a median follow-up period of 1,250 (interquartile range: 987 to 1,564) days, PCI for distal bifurcation lesions was associated with a higher incidence of major adverse cardiac events (propensity-score adjusted hazard ratio [HR]: 1.48, 95% confidence interval [CI]: 1.16 to 1.89; p = 0.001), largely because of the higher target vessel revascularization rate observed in this group as compared to the ostial/mid-shaft lesions group (propensity-score adjusted HR: 1.68, 95% CI: 1.19 to 2.38; p = 0.003). These results were sustained following propensity-score matched analysis. With regard to all-cause death and the composite endpoint of all-cause death and myocardial infarction, propensity-score adjusted analysis suggested a trend toward higher rates of these in the distal ULMCA PCI group, although this was not observed in the propensity-score matched analysis. CONCLUSIONS: This study demonstrates that PCI for ostial/mid-shaft lesions is associated with better clinical outcomes than are distal bifurcation lesions in ULMCA, largely because there is a lower need for repeat revascularization in ostial/mid-shaft lesions.

Tissue uptake, distribution, and healing response after delivery of paclitaxel via second-generation iopromide-based balloon coating: a comparison with the first-generation technology in the iliofemoral porcine model.

OBJECTIVES: This study sought to evaluate vascular drug uptake, distribution and response of second-generation paclitaxel coated balloon (PCB) (Cotavance, MEDRAD Interventional, Indianola, Pennsylvania) and compare it with first-generation technology, containing identical excipient and drug concentration. BACKGROUND: Original PCB technologies displayed a heterogeneous deposition of crystalline paclitaxel-iopromide inside the balloon folds, whereas second-generation PCBs consisted of more homogeneous, circumferential coatings. METHODS: Paclitaxel tissue uptake was assessed in 20 iliofemoral arteries of a domestic swine. Vascular healing response was assessed in the familial hypercholesterolemic model of iliofemoral in-stent restenosis. Three weeks after bare-metal stent implantation, vascular segments were randomly revascularized with first-generation PCBs (n = 6), second-generation PCBs (n = 6), or plain balloon angioplasty (PBA) (n = 6). At 28 days, angiographic and histological evaluation was performed in all treated segments. RESULTS: One-hour paclitaxel tissue uptake was 42% higher in the second-generation PCBs (p = 0.03) and resulted in more homogeneous segment-to-segment distribution compared with first-generation PCBs. Both angiography (percentage of diameter stenosis: second-generation 11.5 ± 11% vs. first-generation 21.9 ± 11% vs. PBA 46.5 ± 10%; p < 0.01) and histology (percentage of area stenosis: second-generation 50.5 ± 7% vs. first-generation 54.8 ± 18% vs. PBA 78.2 ± 9%; p < 0.01) showed a decrease in neointimal proliferation in both PCB groups. Histological variance of the percentage of area stenosis was lower in second-generation compared with first-generation PCBs (51.7 vs. 328.3; p = 0.05). The presence of peristrut fibrin deposits (0.5 vs. 2.4; p < 0.01) and medial smooth muscle cell loss (0 vs. 1.7; p < 0.01) were lower in the second-generation compared with first-generation PCBs. CONCLUSIONS: In the experimental setting, second-generation PCB showed a comparable efficacy profile and more favorable vascular healing response when compared to first-generation PCB. The clinical implications of these findings require further investigation.

Effects of intracoronary delivery of allogenic bone marrow-derived stem cells expressing heme oxygenase-1 on myocardial reperfusion injury.

Heme oxygenase-1 (HO-1) decreases apoptosis, inflammation and oxidative stress. The aim of the study was to investigate the effects of intracoronary infusion of allogenic bone marrow cells (BMC) overexpressing HO-1 in the porcine model of myocardial infarction (MI). MI was produced by balloon occlusion of a coronary artery. BMC were transduced with adenoviruses encoding for HO-1 (HO-1 BMC) or GFP (GFP-BMC) genes. Prior to reperfusion animals received HO-1 BMC, control BMC (unmodified or GFP-BMC) or placebo. Left ventricular (LV) ejection fraction (EF), shortening fraction (SF), end-systolic and end-diastolic diameters (EDD, ESD) were assessed by echocardiography before, 30 minutes (min) and 14 days after reperfusion. BMC significantly improved LVEF and SF early (30 min) after reperfusion as well as after 14 days. Early after reperfusion HO-1 BMC were significantly more effective than control BMC, but after 14 days, there were no differences. There were no effect of cells on LV remodelling and diastolic function. Both HO-1 BMC and control BMC significantly reduced the infarct size vs. placebo (17.2 ± 2.7 and 18.8 ± 2.5, respectively, vs. 27.5 ± 5.1, p= 0.02) in histomorphometry. HO-1-positive donor BMC were detected in the infarct border area in pigs receiving HO-1-cells. No significant differences in expression of inflammatory genes (SDF-1, TNF-α, IL-6, miR21, miR29a and miR133a) in the myocardium were found. In conclusion, intracoronary delivery of allogeneic BMC immediately prior to reperfusion improved the LVEF and reduced the infarct size. HO-1 BMC were not superior to control cells after 14 days, however, produced faster recovery of LVEF. Transplanted cells survived in the peri-infarct zone.