Sergio Monaco

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.

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.

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.

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.

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.

Three-Month Therapy with Calcium-Heparin in Comparison with Ticlopidine in Patients with Peripheral Arterial Occlusive Disease at Leriche-Fontaine IIb Class

Forty patients with a mean age of 62.6 ± 6 years, 36 men and 4 women, with peripheral arterial occlusive disease (PAOD) at Leriche-Fontaine IIb class, were randomly allocated to one of two treatment groups, receiving either 12,500 IU/ day of subcutaneous (sc) calcium-heparin (CAE) or 250 mg/day of oral ticlopi dine, each given for ninety days. The following parameters were evaluated be fore the start of the active treatment period and after thirty and ninety days of treatment: pain-free walking distance (PWD), maximum walking distance (WDmax), systolic and diastolic blood pressure (BP), posterior tibial arterial pressure and Winsor index at rest and after exercise (treadmill), transcutaneous oxygen and carbon dioxide pressures at rest (TcPO2 and TcPCO2 respectively), and time to 50% TcPo2 recovery after three-minute ischemia. Both treatments induced an improvement in PWD/WDmax, which, at the end of the study, were increased by 50.7/58.7% and 31.7/36.2%, respectively, for CAE and ticlopidine treatments, respectively. Statistical analysis did not show any difference between treatments, al though a statistically significant difference was found in comparison with basal measurements for both CAE and ticlopidine treatments (p < 0.01). Neverthe less, the effects determined by ticlopidine were, on the whole, less impressive than those of CAE. In fact, interestingly, although not in a statistically significant way, the CAE group walked longer in comparison with the ticlopidine group irrespective of the more critical baseline clinical conditions. Moreover, TcPo2 was favorably modified by CAE (p < 0.01) but not by ticlopidine treatment while the other parameters remained unchanged. In conclusion, CAE, given at the daily dose of 12,500 IU in patients with PAOD at the Leriche-Fontaine IIb class, showed beneficial clinical effects, which, in turn, could be due both to the removal of the thrombophilic im balance and to the restoration of the fibrinolytic-coagulatory hemostasis in the involved microvascular circulation.

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.

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.

Mitral Flexible Annuloplasty Band Displacement: The Role of Three‐Dimensional Echocardiography

Flexible annuloplasty bands have been applied in surgical treatment of degenerative mitral valve disease to obtain an over-reduction of the posterior annulus. Favorable long-term clinical outcomes have been reported, and recurrence of mitral regurgitation is essentially due to a deficient surgical technique, causing immediate or delayed failure, or to the progression of the underlying disease process. This case refers to a 68-year-old male patient who underwent surgical repair of his degenerative mitral valve disease (Barlow’s disease) with the implantation of a Sorin Sovering annuloplasty band (Sovering Mitral Miniband 40 mm; Sorin Biomedica, Salluggia, Italy), to fix the posterior leaflet in a vertical position, and 16 artificial chordae, according to the operator choice. Due to the presence of severe tricuspid regurgitation, tricuspid valve was treated with the implantation of an annuloplasty band (Sovering Tricuspid Miniband 50 mm; Sorin Biomedica). Few months later after valve annuloplasty, severe mitral regurgitation was present secondary to the dislodgment of the mitral flexible band. A comprehensive echocardiographic evaluation was essential to make a correct diagnosis, and the initial description by two-dimensional echo approach (Fig. 1) (Philips iE33, Philips Medical Systems, Andover, MA, USA) was significantly improved using real time three-dimensional transesophageal echocardiography (3D-TEE; Figs. 2 and 3, movie clips S1–S3). An accurate definition of the anatomical relation existing between the displaced band and the surrounding cardiac structures was provided (Figs. 2 and 3, movie clips S1–S3), in accordance with fluoroscopic and surgical descriptions (Fig. 4). Highquality real time 3D-TEE images clearly showed the nearly completely detached mitral band, dislodged from its posterior position and swinging back and forth (Fig. 2 and 3, movie clips S1–S3); Figure 1. A. Two-dimensional transthoracic X-plane view. B. Two-dimensional transesophageal long-axis view of the left ventricle, without and with color Doppler showing mitral valve regurgitation (posterior eccentric regurgitant jet). LA = left atrium; LV = left ventricle; RA = right atrium; RV = right ventricle; AAo = ascending aorta.

MID-TERM CLINICAL OUTCOME OF CATANIA™ CORONARY STENT SYSTEM WITH NANOTHIN POLYZENE®-F IN A REAL WORLD UNSELECTED POPULATION: PRELIMINARY RESULTS: I2 POSTER CONTRIBUTIONS

Background: The recent ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty Stent) first in man study has proven the safety and efficacy of a novel coronary cobalt chromium stent system coated with nanothin ultrapure proprietary formulation of polyphosphazene (CATANIATM stent, CeloNova BioSciences, Inc., Newnan, Georgia, USA) in a rather complex population of patients showing low rate of restenosis and no stent thrombosis at 12 months. This study evaluates the safety and performance of CATANIATM stent in an unselected population of patients, without application of restrictive clinical or angiographic criteria.