Rebuttal: Decreasing bleeding risk in coronary interventions.

Yatskar L, Slater J.

Cardiac Cathterization Laboratory, NYU Medical Center, New York.

Letter to the Editor.

Mann JT 3rd.

Wake Heart Center, Raleigh, NC.

Does IVUS guidance of coronary interventions affect outcome? a prime example of the failure of randomized clinical trials.

There has been a decline in the role of intravascular ultrasound (IVUS) guiding stenting. IVUS has lost favor with interventional cardiologists largely due to the emergence of drug eluting stents (DES). The advent of DES has lowered the need to maximize the final result due to the known low late-loss. This phenomenon has contributed to reduced interest in optimizing results with IVUS guidance. However, current concerns regarding stent thrombosis in relation to DES and its associated significant morbidity and mortality has once more focused attention on optimal stent deployment. Prior to DES, the evidence base was rather ambiguous, as some randomized and observational studies supported IVUS guided bare metal stent insertion in terms of reducing rates of restenosis and clinically driven target lesion revascularisation whereas others demonstrated no such benefit. As there is an additional cost and learning curve with IVUS, it has become difficult to justify its routine use. We present here a oontemporary argument for the resurgence of IVUS optimized stent insertion. We also highlight deficiencies in previously adopted IVUS optimization criteria, which were based on distal and proximal lumen sizes. The new criteria proposed are based on vessel size at different segments of the stented area and therefore take advantage of vessel remodeling. The availability of high pressure, non-compliant balloons have made attainment of these new optimization targets possible without increasing the risk of complications. We hope to demonstrate this statement with the completion of the angiographically versus IVUS optimization (AVIO) study that soon will be initiated. (c) 2008 Wiley-Liss, Inc.

Gerber R, Colombo A.

EMO Centro Cuore Columbus and San Raffaele Hospitals, Milan, Italy.

DES editorial.

Thomas DM.

Clinical Director of Cardiothoracic Services, Guys and St. Thomas NHS Foundation Trust, St. Thomas\’ Hospital, London.

Survival advantage in Medicare patients receiving drug-eluting stents compared with bare metal stents: Real or artefactual?

BACKGROUND:: Concerns have been raised regarding late mortality, particularly from late stent thrombosis, from drug-eluting stents (DES). Randomized clinical trials have shown that DES decrease restenosis but do not decrease mortality compared with bare metal stents (BMS). These studies utilized well-defined clinical and angiographic subsets. In the \”real world\” drug-eluting stents are used in a much broader crosssection of patients. We evaluated mortality in the first year after implantation of DES, specifically the sirolimus-eluting stent (SES), Cypher vs. BMS in \”real world\” older patients using the Medicare claims database. METHODS AND RESULTS:: Data for the years 2002 (n = 6,890; pre-DES) and 2003 (n = 7,566; first year of DES use) (May through December of each year) were analyzed. BMS and DES groups had similar baseline characteristics except for small but significant differences with BMS patients being somewhat older, having more males and African Americans, and a higher percentage of peripheral artery disease and heart failure while DES patients had a higher percentage of diabetics and patients with prior revascularization procedures. A significant improvement in mortality using both unadjusted and adjusted analyses was observed for DES (6.0% vs. 11.4%, P < 0.0001; hazard ratio 1.98, 95% CI 1.68-2.34). Controlling for comorbidity, extent of disease, and other chararacteristics by multivariable analysis or by propensity analysis had little impact on these results. On the other hand, there was no change in overall mortality in all stented patients in 2003 compared with all stented patients in 2002. CONCLUSION:: An observed mortality benefit for DES compared with BMS in 2003 was observed, demonstrating the safety of DES, and suggesting the possibility of superiority in outcome in older patients with DES vs. BMS. However, the lack of improved survival from 2002 to 2003 in all stented patients suggests that the mortality advantage with DES finding may be due to unidentified selection biases. Our data suggest that DES in the Medicare population is as safe as, and possibly superior, to BMS for survival over the first year after implantation. (c) 2008 Wiley-Liss, Inc.

Wang FW, Uretsky BF, Freeman JL, Zhang D, Giordano SH, Goodwin JS.

Division of Cardiology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas.

Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions the DEBIUT (drug-eluting balloon in bifurcaton utrecht) registry.

OBJECTIVES:: To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions. BACKGROUND:: The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry. METHODS:: This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months. RESULTS:: The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported. CONCLUSION:: The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions. (c) 2008 Wiley-Liss, Inc.

Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA.

Department of Heart and Lung, University Medical Center Utrecht, Utrecht, The Netherlands.

Stent strut fracture: Seeing is believing.

Carter AJ.

Cardiology Service and Cardiac Catheterization Laboratories, St. Peter\’s Hospital, Helena, Montana 59601.

Stent fracture, an incidental finding or a significant marker of clinical in-stent restenosis?

BACKGROUND:: The predictors and clinical significance for stent fracture (SF) in drug-eluting stents (DES) remain unknown. We identified procedural factors leading to SF and its clinical consequences in DES. METHODS:: Percutaneous coronary interventions were performed on 3,920 patients with DES over 12 months. In-stent restenosis (ISR) of DES was observed in 188 cases with 121 cases (64.4%) receiving a sirolimus-eluting stent (SES) and 67 (35.6%) a paclitaxol-eluting stent (PES). RESULTS:: SF was identified in 35 (18.6%) of the 188 cases. The 35 cases were then compared with 153 cases of ISR without angiographic evidence of SF. SF was identified in 29 (23.9%) SES compared with 6 (9.0%) in PES (P < 0.05). With univariate analysis, additional factors associated with SF included longer mean stented segment length, male gender, overlapping stents, vessel segment angulation >75 degrees , and more stents (all P < 0.05). With multivariate adjustment, three factors, i.e., stenting on a bend >75 degrees (OR = 13.8, 95%CI 3.7 to 51; P < 0.001), SES (OR = 4.1, 95%CI 1.3 to 13.4; P < 0.018) and overlapping stented segments (OR = 3.9, 95%CI 1.1 to 14.1; P < 0.041) were statistically significant independent predictors of SF while larger stent diameter was protective (OR = 0.14, 95%CI 0.04 to 0.70; P < 0.017). CONCLUSION:: SF proved to be associated with angiographically-documented clinical ISR. Although the exact mechanism is unknown, factors that appear to play a negative role in SF include vessel tortuosity, use of SES and overlapping stents. Larger stent diameter was protective. Further studies are needed to better define the factors important in the mechanism of SF. (c) 2008 Wiley-Liss, Inc.

Shaikh F, Maddikunta R, Djelmami-Hani M, Solis J, Allaqaband S, Bajwa T.

Cardiovascular Disease Section, Aurora Sinai/Aurora St. Luke\’s Medical Centers, University of Wisconsin School of Medicine and Public Health‐Milwaukee Clinical Campus, Milwaukee, Wisconsin.

The paramount importance of 12-lead electrocardiography in the management of patients with acute myocardial infarction.

Zijlstra F.

University Medical Center Groningen.

Prognostic value of ST-segment resolution after rescue percutaneous coronary intervention. Data from the RICO survey.

OBJECTIVES:: The goal of the present study was to test the impact of ST segment resolution (STR) after rescue percutaneous coronary intervention (PCI) on the short-term prognosis. BACKGROUND:: The prognostic value of STR after rescue PCI for acute ST elevation myocardial infarction (STEMI) remains undetermined. METHODS:: From the French regional database, we analyzed 168 consecutive patients with STEMI and failed lysis, defined by <50 percent STR, who underwent rescue PCI. Patients were classified into two groups according to the degree of STR from the maximal ST-elevation measured on the single worst ECG lead before lysis and after rescue PCI: the without STR group (<50% STR) vs. the with STR group (>/=50%). RESULTS:: After rescue PCI, 26 (15%) patients did not have STR and 142 (85%) patients did. No difference was observed between the two groups regarding baseline characteristics, risk factors, and median time delay either from symptom onset to thrombolysis or from failed lysis to rescue PCI. We observed a lower proportion of patients with TIMI 2/3 flow post PCI in the without STR group (respectively 61% vs. 97%, P < 0.001) but an increased use of intra-aortic balloon counterpulsation (34% vs. 8%, P < 0.001) in this group. Thirty-day mortality was markedly higher in the without STR group than in the with STR group (27% vs. 9% respectively, P = 0.025). Moreover, multivariate analysis showed that absence of STR (OR: 5.65; 95% CI: 1.24-25.67), was an independent prognostic factor for mortality. CONCLUSIONS:: We showed for the first time that analysis of ST-segment resolution may be a simple reliable tool to identify patients at high risk after rescue PCI, and may provide useful information for the elaboration of therapeutic strategies. (c) 2008 Wiley-Liss, Inc.

Lorgis L, Zeller M, Dentan G, Laurent Y, Taam JA, L\’huillier I, Vincent-Martin M, Makki H, Cottin Y; on behalf of the RICO survey working group.

Service de Cardiologie, CHU Bocage, Bd Mal de Lattre de Tassigny, Dijon, France.