Maria Elena Di Salvo

Usefulness of the SYNTAX Score for Predicting Clinical Outcome After Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Disease

Background—The SYNTAX score (SXscore) has been proposed recently as a valuable tool to characterize the coronary vasculature prospectively with respect to the number of lesions and their functional impact, location, and complexity. However, the prognostic value of SXscores in patients undergoing percutaneous coronary intervention of the left main artery has not been validated. Methods and Results—We applied the SXscore in 255 consecutive patients who underwent percutaneous coronary intervention for left main disease and explored its performance with respect to their clinical outcome. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the relation between the SXscore and the incidence of cardiac mortality, the primary end point of the study, and major adverse cardiac events (MACE). At 1 year, the SXscore significantly predicted the risk of cardiac death (hazard ratio, 1.12/unit increase; 95% CI, 1.06 to 1.18; P<0.001) and MACE (hazard ratio, 1.59/unit increase; 95% CI, 1.02 to 2.48; P=0.043). After adjustment for potential confounders, a higher SXscore remained significantly associated with cardiac mortality (adjusted hazard ratio, 1.15; 95% CI, 1.05 to 1.26; P=0.003) and MACE (adjusted hazard ratio, 1.06; 95% CI, 1.02 to 1.10; P=0.005). C-indexes for SXscores in terms of cardiac death and MACE were 0.83 and 0.64, respectively. Using classification tree analysis, discrimination levels of 34 and 37 were identified as the optimal cutoff to distinguish between patients at low and high risk of cardiac death and MACE, respectively. Conclusions—The SXscore is a useful tool to predict cardiac mortality and MACE in patients undergoing percutaneous revascularization of the left main coronary artery.

Usefulness of SYNTAX score to select patients with left main coronary artery disease to be treated with coronary artery bypass graft.

OBJECTIVES The purpose of our study was to investigate the utility of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in aiding patient selection for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in a large contemporary registry of patients undergoing revascularization of left main coronary artery. BACKGROUND The SYNTAX score has been developed as a combination of several validated angiographic classifications aiming to grade the coronary lesions with respect to their functional impact, location, and complexity. METHODS Between March 2002 and December 2008, 819 patients with left main coronary artery disease underwent revascularization in 2 Italian centers. We compared clinical outcomes of PCI versus CABG in patients with SYNTAX score < or =34 and patients with SYNTAX score >34. RESULTS The rates of 2-year mortality were similar between CABG and PCI in the group of patients with SYNTAX score < or =34 (6.2% vs. 8.1%, p = 0.461). Among patients with SYNTAX score >34, those treated with CABG had lower rates of mortality (8.5% vs. 32.7%, p < 0.001) than those treated with PCI. After statistical adjustment, revascularization by PCI resulted in a similar risk of death compared with CABG in patients with SYNTAX score < or =34 (hazard ratio: 0.81, 95% confidence interval: 0.33 to 1.99, p = 0.64) and in a significantly higher risk in patients with SYNTAX score >34 (hazard ratio: 2.54, 95% confidence interval: 1.09 to 5.92, p = 0.031). CONCLUSIONS A SYNTAX score threshold of 34 may usefully identify a cohort of patients with left main disease who benefit most from surgical revascularization in terms of mortality.

Global Risk Classification and Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) Score in Patients Undergoing Percutaneous or Surgical Left Main Revascularization

OBJECTIVES The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). BACKGROUND There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization. METHODS The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated. RESULTS The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029). CONCLUSIONS In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease.

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non- bifurcational left main disease? Insights from a multicentre registry

AIMS To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. METHODS AND RESULTS The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15-0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09-1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). CONCLUSION In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

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.

First-in-Man 1-Year Clinical Outcomes of the Catania Coronary Stent System With Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) Trial

OBJECTIVES This study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging. BACKGROUND Novel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis). METHODS This first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries. RESULTS Acute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 +/- 0.48 mm and the percent neointimal hyperplasia volume was 27.9 +/- 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium-defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55). CONCLUSIONS This first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.

Detection of very early stent healing after primary angioplasty: an optical coherence tomographic observational study of chromium cobaltum and first-generation drug-eluting stents. The DETECTIVE Study

Background Lack of stent coverage appears to be associated with stent thrombosis, a problem of particular concern in patients with ST elevation myocardial infarction (STEMI). Methods The DETECTIVE European Multicenter Registry was set up to address the early modality of stent healing in the setting of STEMI. The Registry compared, with an early optical coherence tomography (OCT) evaluation performed at 3–7 days, the patterns of coverage and apposition of the first generation of drug-eluting stents (DESs) and cobalt chromium non-drug-eluting stents (CCSs) that were deployed in culprit lesions and in non-culprit segments. The Registry included only patients with a multi-vessel disease to allow, at 3–7 days from the first angioplasty, a deferred OCT examination and a staged intervention in another vessel. Results 28 stented lesions (15 patients) eventually entered the final OCT assessment. 13 stents were first-generation DESs, while the remaining 15 were CCSs. 18 stents (64%) were deployed at culprit STEMI lesions, and the remaining 10 (36%) were deployed at non-culprit sites. The distribution of clinical and procedural variables in DES and CCS as well as in culprit and non-culprit sites was not different. In total, 27 019 struts were analysed in 28 stents. The percentage of stent uncoverage in the overall analysis was 11.7%, while the percentage of malapposition and that of struts covered with thrombus were 4.8% and 2.2%, respectively. A low percentage of strut uncoverage was found in all the four studied subgroups: DES 12.8%, CCS 10.9%, stents deployed in culprit lesions 13.2% and stents deployed in non-culprit lesions 8.7%. Conclusions In conclusion, our data show that in patients with STEMI, a very high percentage of stent struts is covered by an early thin rim of tissue within 7 days after stent positioning. The present data bring new insights in the mechanism and timing of strut coverage.

Real world safety and efficacy of the Janus Tacrolimus-Eluting stent: long-term clinical outcome and angiographic findings from the Tacrolimus-Eluting STent (TEST) registry.

We sought to evaluate the safety and performance of the Janus Tacrolimus‐Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria.

Optical Coherence Tomographic Results at Six-Month Follow-Up Evaluation of the CATANIA Coronary Stent System With NanoThin Polyzene-F Surface Modification (from the Assessment of The LAtest Non-Thrombogenic Angioplasty Stent [ATLANTA] Trial)

Drug-eluting stents were devised as an answer to restenosis, but research has shown that the eluting drug can interfere with the blood vessels healing process, thus increasing the risk of stent thrombosis. A stent coated with the new proprietary polymer Polyzene-F, is a novel technical solution that promises to decrease in-stent restenosis and tackle the risk of thrombosis. Fifty-five patients were enrolled in the first clinical human study (ATLANTA registry), addressing the short-term follow-up results of the CATANIA stent with Polyzene-F. As a part of the study protocol, 15 patients were randomly assigned to optical coherence tomographic (OCT) examination at 6-month follow-up. Optical coherence tomograms were obtained using a Lightlab M2 system with a motorized pull-back at 2.0 mm/s. OCT images were acquired at 15.6 frames/s. A total of 1,904 cross-sectional images with 19,028 struts were analyzed. The rate of covered struts was 99.5%, whereas malapposed struts accounted for 0.15%. Area measurements were performed in 476 cross sections. Neointimal hyperplasia (NIH) area and percent NIH area were 3.2 +/- 1.4 mm2 and 38 +/- 17%, respectively. Percent NIH area was comparable between diabetics and nondiabetics. Qualitative assessment of OCT images demonstrated neither occurrence of stent fractures nor thrombus. In conclusion, OCT assessment of the Polyzene-F-covered stent at follow-up showed a small percentage of neointima. Also, almost complete stent strut coverage was revealed by optical coherence tomography. These figures indicate that the CATANIA stent with Polyzene-F is a promising solution for decreasing late stent restenosis and preventing thrombosis.

Percutaneous recanalization of chronic total occlusions: wherein lies the body of proof?

Although interventional technology and skills have markedly advanced, percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) lesions remains challenging. Indeed, CTO PCI is technically complex, carries the potential for a relatively high likelihood of failure and acute complications, and requires specifically skilled operators and a demanding use of resources. In addition, controversy persists surrounding appropriate indications for attempting CTO revascularization. Finally, there is a wide uncertainty on the actual benefits achieved with successful CTO recanalization. A growing number of studies have reported procedural results and/or assessed functional effects and long-term clinical outcomes of CTO PCI. We therefore sought to review and critically appraise the evidence base for procedural outcomes and potential clinical benefits of CTO PCI.