Early vessel healing of the Avantgarde cobalt-chromium coronary stent: the ON-GARDE OCT study.

INTRODUCTION: Uncoverage and malapposition of stent struts at optical coherence tomography (OCT) have been associated with stent thrombosis. Stent uncoverage by OCT is being used as a surrogate to address the propensity of a stent to develop thrombosis. We aimed to appraise early vessel healing in patients with ST-elevation myocardial infarction (STEMI) treated with the novel Avantgarde stent. METHODS: Patients with STEMI and multivessel disease were enrolled. The stent deployed on the infarct-related artery was imaged by frequency domain-OCT during deferred intervention (4-7 days apart). The primary end-point was the percentage of uncovered struts. Secondary end-points were the percentage of malapposed struts and struts covered with thrombus. RESULTS: Twenty patients (20 lesions) were enrolled, with 18 (18 stents) achieving a complete OCT pull-back and thus entering the final analysis (1497 cross-sections, 11 446 struts). Uncovered struts were 3.9%, whilst 8.0% of struts were malapposed and 2.6% were covered by thrombus. At per-stent analysis, all stents but two had a homogeneous distribution of strut coverage (i.e. % of uncovered struts ≥10). CONCLUSIONS: This study, originally exploiting OCT data early after stenting in STEMI patients, shows that the Avantgarde stent is associated with favourable vessel healing features.

Prevalence of renal artery stenosis in patients undergoing cardiac catheterization.

To investigate the prevalence of significant renal artery stenosis (RAS ≥50%), and to identify clinical predictors for significant RAS in patients with an elevated cardiovascular risk, such as those affected by ischemic heart disease. In patients with an elevated cardio-vascular risk, both atherosclerotic renovascular disease and coronary artery disease (CAD) are likely to occur. Prospectively from April 2007 to March 2008, all consecutive patients with ischemic heart disease undergoing non-emergent cardiac catheterization were also evaluated for atherosclerotic RAS by renal arteriography. A RAS ≥50% was considered as significant. A total of 1,298 patients underwent cardiac and renal angiography. Significant RAS was found in 70 out of 1,298 patients (5.4%). The presence of peripheral vascular disease, eGFR <67 ml/min/1.73 m(2), age >66 years, dyslipidemia, CAD severity and pulse pressure >52 mmHg were independent clinical predictors of significant RAS, and jointly produced a ROC AUC of 0.79 (95% CI 0.73-0.85, P < 0.001). Based on these data, a prediction rule for significant RAS was developed, and it showed an adequate predictive performance with 64% sensitivity and 82% specificity. In a large cohort of patients undergoing coronary angiography, significant RAS is a relatively rare comorbidity (5.4%). A model based on simple clinical variables may be useful for the clinical identification of high CV risk patients who may be suitable for renal arteriography at the time of cardiac catheterization.

Comparative one-year effectiveness of percutaneous coronary intervention versus coronary artery bypass grafting in patients <75 versus ≥75 years with unprotected left main disease (from the CUSTOMIZE Registry).

There is a lack of knowledge on the interaction between age and left main coronary artery revascularization. The aim of this study was to investigate the comparative effectiveness of percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease aged <75 versus ≥75 years. Of a total of 894 patients included, 692 (77.4%) were aged <75 years and 202 (23.6%) ≥75 years. PCI was found to be significantly different from CABG with respect to the composite of major adverse cardiac events at 1-year follow-up in patients aged <75 years (15.5% vs 8.5%, p = 0.01) but not in those aged ≥75 years (16.4% vs 13.9%, p = 0.65). This finding was consistent after statistical adjustment for baseline confounders in the 2 groups (adjusted hazard ratio [AHR] 2.2, 95% confidence interval 1.2 to 4.1, p = 0.016 in younger patients; AHR 0.9, 95% confidence interval 0.3 to 3.0, p = 0.88 in older patients). In the 2 groups, PCI and CABG showed similar adjusted risks for all-cause death, cardiac death, and myocardial infarction. Target lesion revascularization occurred more frequently in patients aged <75 years treated with PCI compared to CABG (AHR 5.1, 95% confidence interval 1.9 to 13.6, p = 0.001) but not in those aged ≥75 years. A significant interaction between age and treatment with regard to major adverse cardiac events was identified (adjusted p for interaction = 0.034). In conclusion, compared to younger patients, elderly patients with left main disease are likely to derive the maximal gain from a less invasive procedure such as PCI.

Validating the EXCEL hypothesis: a propensity score matched 3-year comparison of percutaneous coronary intervention versus coronary artery bypass graft in left main patients with SYNTAX score ≤32.

OBJECTIVES: The aim of this study is to verify the study hypothesis of the EXCEL trial by comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in an EXCEL-like population of patients. BACKGROUND: The upcoming EXCEL trial will test the hypothesis that left main patients with SYNTAX score ≤ 32 experience similar rates of 3-year death, myocardial infarction (MI), or cerebrovascular accidents (CVA) following revascularization by PCI or CABG. METHODS: We compared the 3-year rates of death/MI/CVA and death/MI/CVA/target vessel revascularization (MACCE) in 556 patients with left main disease and SYNTAX score ≤ 32 undergoing PCI (n = 285) or CABG (n = 271). To account for confounders, outcome parameters underwent extensive statistical adjustment. RESULTS: The unadjusted incidence of death/MI/CVA was similar between PCI and CABG (12.7% vs. 8.4%, P = 0.892), while MACCE were higher in the PCI group compared to the CABG group (27.0% vs. 11.8%, P < 0.001). After propensity score matching, PCI was not associated with a significant increase in the rate of death/MI/CVA (11.8% vs. 10.7%, P = 0.948), while MACCE were more frequently noted among patients treated with PCI (28.8% vs. 14.1%, P = 0.002). Adjustment by means of SYNTAX score and EUROSCORE, covariates with and without propensity score, and propensity score alone did not change significantly these findings. CONCLUSIONS: In an EXCEL-like cohort of patients with left main disease, there seems to be a clinical equipoise between PCI and CABG in terms of death/MI/CVA. However, even in patients with SYNTAX score ≤ 32, CABG is superior to PCI when target vessel revascularization is included in the combined endpoint.

Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry).

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.

Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient.

OBJECTIVES: Strut coverage represents the most powerful morphometric predictor of stent thrombosis and the best surrogate indicator of endothelization. The aim of this study was to get new insights on temporal patterns of vessel healing after stenting with different types of stent. METHODS: Optical coherence tomography (OCT) was used to investigate the early strut coverage of lesions treated with CATANIA (CAT) stent, drug-eluting stent (DES) or cobalt-chromium bare metal stent (BMS). Two cohorts of 10 and 24 patients underwent OCT follow-up at 7-10 and 28-32 days after stenting, respectively. In each cohort, patients were randomly assigned to receive a CAT stent in one lesion and a BMS or a DES in a separate lesion. RESULTS: A total of 7975 and 8406 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 7-10 days, respectively. A total of 21 123 and 25 069 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 28-32 days, respectively. At 7-10 days, the CAT stent showed higher coverage rates compared with DES (90.0 vs. 85.9%, P < 0.0001) and BMS (90.2 vs. 83.6%, P < 0.0001). Similarly, at 28-32 days, the coverage rate was higher with CAT stent compared with DES (97.7 vs. 90.5%, P < 0.0001) and BMS (97.2 vs. 96.5%, P < 0.0001). CONCLUSION: The CAT stent yields quicker and more complete strut coverage than DES and BMS in the early phases of vessel healing following stent implantation.

Long-term outcomes after drug-eluting stent for the treatment of ostial left anterior descending coronary artery lesions.

BACKGROUND: Although drug-eluting stents (DES) have reduced restenosis in a broad range of lesions, there is limited data, from relatively small studies, on the safety and efficacy of DES for isolated ostial left anterior descending (LAD) stenoses. In addition, in the setting of these high-risk lesions, there is the issue of the potential involvement of the left main (LM) bifurcation, requiring subsequent revascularization for a lesion involving this critical location. METHODS: Patients with a de novo isolated unprotected ostial LAD stenoses treated with DES were included. Evaluated end points were cardiac death, nonfatal myocardial infarction, overall target lesion revascularization (TLR), and the reintervention for a restenotic lesion located at the LM segment adjacent to the stent (TLR-LM). RESULTS: A total of 162 patients were included: 95 underwent focal ostial LAD stenting and 67 stenting from the distal LM into the LAD ostium. The 2-year Kaplan-Meier estimates of cardiac death, nonfatal myocardial infarction, overall TLR, and TLR-LM were 2.6%, 2.1%, 8.3%, and 4.7%, respectively. Overall TLR and TLR-LM rates were higher in the focal ostial LAD stenting group. There was a trend toward an independent increased risk of TLR associated with focal ostial stenting. In addition, final minimal luminal diameter trended to be independently associated with TLR. CONCLUSION: The present study showed that DES for isolated ostial LAD lesions is a feasible, safe, and effective treatment strategy. In addition, this study suggested the hypothesis that a default distal LM-LAD stenting, rather than focal ostial stenting, might provide more favorable outcomes. Nevertheless, larger specifically designed studies are needed.

Plaque distribution patterns in distal left main coronary artery to predict outcomes after stent implantation.

OBJECTIVES: The aim of this study was to investigate the association between plaque distribution at left main (LM) bifurcation and target lesion revascularization (TLR) after stenting. BACKGROUND: Despite favorable reported mid- and long-term results, stent implantation on LM bifurcation remains challenging. The role of atherosclerotic plaque distribution in affecting LM bifurcation stenting outcomes has not been explored. METHODS: A total of 329 patients undergoing LM bifurcation stenting in 2 centers were included. A method based on different plaque locations within the bifurcation area was applied. The overall population was divided in 2 groups according to the presence of a specific pattern characterized by plaque occupying (n = 145) or not occupying (n = 184) the whole bifurcation (WB) area. RESULTS: Baseline clinical, angiographic, and procedural characteristics were well-balanced between the 2 groups. The WB group showed a significantly higher risk of 3-year TLR compared with the non-WB group (24.9% vs. 8.3%; unadjusted hazard ratio: 3.12; 95% confidence interval: 1.59 to 6.11; p = 0.001; adjusted hazard ratio: 2.84; 95% confidence interval: 1.43 to 5.64; p = 0.003). The 3-year TLR rate was not significantly different between patients treated with 1-or 2-stent techniques either in the WB or non-WB groups. In the WB group, TLR was similar between patients with lesions classified as 1,1,1 and non-1,1,1 by the Medina classification (20.7% vs. 26.8%, p = 0.57, respectively). CONCLUSIONS: The WB pattern is associated with enhanced TLR risk, regardless of stent technique and plaque severity. This could impact the treatment strategy of high-risk lesions involving the whole bifurcation area.

Long-term outcomes comparison of different types of DES in elderly patients from a real-world experience.

OBJECTIVE: We sought to evaluate the impact on long-term clinical outcomes of different types of drug-eluting stents (DES) in elderly patients. BACKGROUND: Elderly patients constitute a fast-growing portion of cardiovascular patients, however, they are not adequately represented in clinical trials. Moreover, few data comparing different type of DES in elderly patients are available. METHODS: From a total of 2,330 consecutive patients treated at our institution with DES, we selected 207 elderly patients (> or = 75 years of age) who underwent, from May 2002 to December 2006, sirolimus-eluting stent (SES group, 116 patients [pts], 56%) or paclitaxel-eluting stent (PES group, 91 pts, 43.9%) implantation. We evaluated the 24-month incidence of major adverse cardiac events (MACE). RESULTS: Higher rates of hypertension (78.4% vs. 90.1%; p = 0.01), diabetes (37.9 vs. 45.1; p = 0.01) and previous coronary artery bypass grafts (10.3% vs. 19.4%; p = 0.04) in the PES group were observed, whereas in the SES group, there were more smokers (26.6% vs. 12.1%; p = 0.007) and a higher incidence of previous myocardial infarction (MI) (50% vs. 35.2%; p = 0.02). Procedural success and in-hospital MACE were similar in both groups. At follow up, there was a higher incidence of MACE (22.4% vs. 10.9%; p = 0.04) and target lesion revascularization (7.1% vs. 3.0%; p = 0.02) in the SES group compared to the PES group. The incidence of cardiac death and MI were comparable between the two groups, as well as the rate of stent thrombosis. After adjustment for clinical and angiographic characteristics, no significant differences in outcomes were observed between SES and PES. CONCLUSIONS: In this real-word experience, no significant differences were found in the safety and efficacy profiles between SES and PES use in elderly patients.