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Featured researches published by Jorge A. Belardi.


The New England Journal of Medicine | 1994

A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease

Patrick W. Serruys; Peter de Jaegere; Ferdinand Kiemeneij; Carlos Miguel; Wolfgang Rutsch; Guy R. Heyndrickx; Håkan Emanuelsson; Jean Marco; Victor Legrand; Phillipe Materne; Jorge A. Belardi; Ulrich Sigwart; Antonio Colombo; Jean-Jacques Goy; Paul van den Heuvel; J. Delcan; Marie-Angèle Morel

BACKGROUND Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty. METHODS A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary-artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography. RESULTS After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (+/- SD) minimal luminal diameters immediately after the procedure were 2.48 +/- 0.39 mm in the stent group and 2.05 +/- 0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82 +/- 0.64 mm in the stent group and 1.73 +/- 0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, > or = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P < 0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P < 0.001). CONCLUSIONS Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.


Journal of the American College of Cardiology | 2001

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.

Ferdinand Kiemeneij; Patrick W. Serruys; T. Carlos Macaya; Wolfgang Rutsch; Guy R. Heyndrickx; Per Albertsson; Jean Fajadet; Victor Legrand; Pierre Materne; Jorge A. Belardi; Ulrich Sigwart; Antonio Colombo; Jean-Jacques Goy; Clemens Disco; Marie-Angèle Morel

OBJECTIVES This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.


Circulation | 2004

Chronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents Comparison With Bare Metal Stents by Serial Intravascular Ultrasound Analyses: Data From the Randomized TAXUS-II Trial

Kengo Tanabe; Patrick W. Serruys; Muzaffer Degertekin; Giulio Guagliumi; Eberhard Grube; Charles Chan; Thomas Münzel; Jorge A. Belardi; Witold Rużyłło; Luc Bilodeau; Henning Kelbæk; John A. Ormiston; Keith D. Dawkins; Louis Roy; Bradley H. Strauss; Clemens Disco; Jörg Koglin; Mary E. Russell; Antonio Colombo

Background—Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. Methods and Results—TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA−SA) were measured. NIHA was significantly reduced in SR (0.7±0.9 mm2, P <0.001) and MR (0.6±0.8 mm2, P <0.001) compared with BMS (1.9±1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5±1.7, 1.0±1.8, and 1.4±2.0 mm2, respectively; P <0.001). The increase in peristent area was directly correlated with increases in VA. Conclusions—Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.


European Heart Journal | 2014

Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

Sigmund Silber; Ajay J. Kirtane; Jorge A. Belardi; Minglei Liu; Sandeep Brar; Martin T. Rothman; Stephan Windecker

AIM The optimal duration of dual antiplatelet therapy (DAPT) following the use of new generation drug-eluting stents is unknown. METHODS AND RESULTS The association between DAPT interruption and the rates of stent thrombosis (ST) and cardiac death/target-vessel myocardial infarction (CD/TVMI) in patients receiving a Resolute zotarolimus-eluting stent (R-ZES) was analysed in 4896 patients from the pooled RESOLUTE clinical programme. Daily acetylsalicylate (ASA) and a thienopyridine for 6-12 months were prescribed. A DAPT interruption was defined as any interruption of ASA and/or a thienopyridine of >1 day; long interruptions were >14 days. Three groups were analysed: no interruption, interruption during the first month, and >1-12 months. There were 1069 (21.83%) patients with a DAPT interruption and 3827 patients with no interruption. Among the 166 patients in the 1-month interruption group, 6 definite/probable ST events occurred (3.61%; all long DAPT interruptions), and among the 903 patients in the >1-12 months (60% occurred between 6 and 12 months) interruption group, 1 ST event occurred (0.11%; 2-day DAPT interruption). Among patients with no DAPT interruption, 32 ST events occurred (0.84%). Rates of CD/TVMI were 6.84% in the 1-month long interruption group, 1.41% in the >1-12 months long interruption group, and 4.08% in patients on continuous DAPT. CONCLUSION In a pooled population of patients receiving an R-ZES, DAPT interruptions within 1 month are associated with a high risk of adverse outcomes. Dual antiplatelet therapy interruptions between 1 and 12 months were associated with low rates of ST and adverse cardiac outcomes. Randomized clinical trials are needed to determine whether early temporary or permanent interruption of DAPT is truly safe. ClinicalTrials.gov Identifiers: NCT00617084; NCT00726453; NCT00752128; NCT00927940.


Circulation | 2002

Coronary Flow Velocity Reserve After Percutaneous Interventions Is Predictive of Periprocedural Outcome

Mariano Albertal; Michiel Voskuil; Jan J. Piek; B. De Bruyne; G. Van Langenhove; P.I. Kay; Marco A. Costa; Eric Boersma; T. Beijsterveldt; Je Sousa; Jorge A. Belardi; P. W. Serruys

Background—Because heterogeneous results have been reported, we assessed coronary flow velocity changes in individuals who underwent percutaneous transluminal coronary angioplasty (PTCA) and examined their impact on clinical outcome. Methods and Results—As part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II study, 379 patients underwent Doppler flow–guided angioplasty. All patients were evaluated according to their coronary flow velocity reserve (CFVR) results (≥2.5 or <2.5) at the end of the procedure. A CFVR <2.5 after angioplasty was associated with an elevated baseline blood flow velocity in both the target artery and reference artery. CFVR before PTCA and CFVR in the reference artery were independent predictors of an optimal CFVR after balloon angioplasty (CFVR before PTCA: odds ratio [OR], 2.26; 95% confidence interval [CI], 1.57 to 3.24; CFVR in reference artery: OR, 1.90; 95% CI, 1.21 to 2.98; both P <0.001) and stent implantation (before PTCA: OR, 2.54; 95% CI, 1.47 to 4.36; reference artery: OR, 1.97; 95% CI, 1.07 to 3.87; both P <0.05). A low CFVR at the end of the procedure was an independent predictor of major adverse cardiac events (MACE) at 30 days (OR, 4.71; 95% CI, 1.14 to 25.92;P =0.034) and at 1 year (OR, 2.06; 95% CI, 1.16 to 3.66;P =0.014). After excluding MACE at 30 days, no difference in MACE at 1 year was observed between the patients with and without a CFVR <2.5 at the end of the procedure. Conclusions—A low postprocedural CFVR was associated with a worse periprocedural outcome (which was related to microcirculatory disturbances), but there was no significant difference at late follow-up.


Eurointervention | 2012

One-year outcomes of patients with the zotarolimus-eluting coronary stent: RESOLUTE International Registry.

Franz-Josef Neumann; Petr Widimsky; Jorge A. Belardi

AIMS To provide clinical outcome data from everyday practice for the new generation Resolute zotarolimus-eluting stent (R-ZES). METHODS AND RESULTS Patients were eligible if placement of ≥1 R-ZES was intended. There were no restrictions on clinical indication, number of treated vessels, and lesion characteristics. The primary endpoint was the adjudicated cumulative 1-year incidence of cardiac death and target vessel myocardial infarction. Twenty-five per cent of the patients were randomly selected for monitoring. We recruited 2,349 patients with 3,147 lesions (1.6±1.0 stents per patient); 46.0% of patients had acute coronary syndrome, 30.5% were diabetic, and ≥1 complex criterion for stent placement was present in 67.5% of patients. One-year follow-up was complete in 97.9% of patients. The 1-year incidence of the primary endpoint was 4.3% (95% CI: 3.5% to 5.2%) and for ARC definite and probable stent thrombosis, 0.9% (0.5% to 1.3%). Clinically driven target lesion revascularisation and target lesion failure were 3.4% (2.7% to 4.3%) and 7.0% (6.0% to 8.2%), respectively. These findings were consistent across all lesion and patient subsets analysed. There were no significant differences in outcomes between monitored and unmonitored patients. CONCLUSIONS In everyday practice, the R-ZES performed similarly well as in the RESOLUTE All Comers randomised trial.


Herz | 2004

Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation: A post hoc analysis of TAXUS II

Sigmund Silber; Jaap N. Hamburger; Eberhard Grube; Matthias Pfisterer; Jorge A. Belardi; John G. Webb; Krzysztof Zmudka; Christoph Nienaber; Karl Hauptman; Wolfgang Rutsch; Keith D. Dawkins; Janusz Drzewiecki; Jörg Koglin; Antonio Colombo

Background and Method:Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26).Results:In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 ± 0.36 vs. 0.33 ± 0.30 mm) or intravas- cular ultrasound-(IVUS-)measured volume obstruction (7.95 ± 9.84% vs. 5.61 ± 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 ± 0.30 vs. 0.80 ± 0.62 mm) or IVUS-measured volume obstruction (5.61 ± 7.91% vs. 22.50 ± 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent.Conclusion:Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxeleluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.Hintergrund und Methodik:Obwohl das koronare Direkt-Stenting das angiographische Kurz- und Langzeitergebnis nicht verbessert, macht es dennoch Sinn, da es die Prozedurzeiten, Strahlenexposition und die Kosten reduzieren kann. Andere mögliche Vorteile des Direkt-Stentings liegen in einer Reduktion der myokardialen Ischämiezeit, was bei Hochrisikopatienten klinisch relevant sein könnte. Mit der Einführung der Medikamente freisetzenden Stents kamen jedoch Bedenken auf, dass ein Direkt-Stenting möglicherweise die Polymerbeschichtung beschädigen könnte und somit die Wirksamkeit vermindert. Auch eine eventuelle Beeinträchtigung der Sicherheit und Wirksamkeit durch Malapposition einzelner Stentstreben wurde diskutiert. Ziel dieser Arbeit ist es, die Daten der TAXUS-II Studie (536 Patienten) hinsichtlich des Direkt-Stentings retrospektiv zu analysieren. In dieser Studie war die Vordehnung zwar empfohlen, ein Direkt-Stenting aber nicht unerlaubt. Insgesamt wurde ein Direkt-Stenting bei 49 Patienten (23 in der TAXUS-Gruppe, 26 in der Kontrollgruppe) durchgeführt.Ergebnisse:In der TAXUS-Gruppe war nach 6 Monaten zwischen den prädilatierten und den direkt-gestenteten Patienten kein signifikanter Unterschied hinsichtlich MACE (7,5 % vs. 4,3 %), angiographischer Restenose im analysierten Gesamtsegment (4,8 % vs. 4,3 %), late loss (0,28 ± 36 mm vs. 0,33 ± 30 mm) und in der IVUS-gemessenen prozentualen Obstruktion des Stentvolumens (7,95 ± 9,84 vs. 5,61 ± 7,91) erkennbar. Dasselbe galt auch für die Patienten, die einen unbeschichteten Kontrollstent erhielten. Im Vergleich zur direkt gestenteten Kontrollgruppe waren die statistisch signifikanten positiven Effekte des TAXUS-Direkt-Stentings unverändert erhalten: angiographische Restenose im gesamten analysierten Segment (4,3 % vs. 30,8 %), late loss (0,33 ± 0,30 vs. 0,80 ± 0,62 mm) und IVUS-gemessene Volumenobstruktion (5,61 ± 7,91% vs. 22,50 ± 21,62%). MACE wurde von 19,2 % auf 4,3 % reduziert, allerdings erreichte dieser eindeutige Trend aufgrund der kleinen Patientenzahl keine statistische Signifikanz. Nach Vordehnung waren in der TAXUS-Gruppe alle Parameter signifikant besser als in der Kontrollgruppe.Schlussfolgerung:Der Vergleich von Patienten, die einen TAXUS-Stent mit oder ohne Vordehnung erhielten, ließ keinen Unterschied in den klinischen, angiographischen oder IVUSParametern nach 6-Monaten erkennen. Die Ergebnisse zeigen, dass das Direkt-Stenting mit dem Polymer-basierten, Paclitaxel-freisetzenden TAXUS-Stent gut durchführbar, sicher und genauso wirksam ist wie nach Vordehnung. Randomisierte Studien zum Vergleich des Direkt-Stentings mit Stenting nach Vordehnung für Medikamente freisetzende Stents sind wichtig.


Herz | 2004

Direct Stenting with TAXUS Stents Seems to be as Safe and Effective as with Predilatation

Sigmund Silber; Jaap Hamburger; Eberhard Grube; Matthias Pfisterer; Jorge A. Belardi; John G. Webb; Krzysztof Zmudka; Christoph Nienaber; Karl Hauptman; Wolfgang Rutsch; Keith D. Dawkins; Janusz Drzewiecki; Jörg Koglin; Antonio Colombo

Background and Method:Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26).Results:In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 ± 0.36 vs. 0.33 ± 0.30 mm) or intravas- cular ultrasound-(IVUS-)measured volume obstruction (7.95 ± 9.84% vs. 5.61 ± 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 ± 0.30 vs. 0.80 ± 0.62 mm) or IVUS-measured volume obstruction (5.61 ± 7.91% vs. 22.50 ± 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent.Conclusion:Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxeleluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.Hintergrund und Methodik:Obwohl das koronare Direkt-Stenting das angiographische Kurz- und Langzeitergebnis nicht verbessert, macht es dennoch Sinn, da es die Prozedurzeiten, Strahlenexposition und die Kosten reduzieren kann. Andere mögliche Vorteile des Direkt-Stentings liegen in einer Reduktion der myokardialen Ischämiezeit, was bei Hochrisikopatienten klinisch relevant sein könnte. Mit der Einführung der Medikamente freisetzenden Stents kamen jedoch Bedenken auf, dass ein Direkt-Stenting möglicherweise die Polymerbeschichtung beschädigen könnte und somit die Wirksamkeit vermindert. Auch eine eventuelle Beeinträchtigung der Sicherheit und Wirksamkeit durch Malapposition einzelner Stentstreben wurde diskutiert. Ziel dieser Arbeit ist es, die Daten der TAXUS-II Studie (536 Patienten) hinsichtlich des Direkt-Stentings retrospektiv zu analysieren. In dieser Studie war die Vordehnung zwar empfohlen, ein Direkt-Stenting aber nicht unerlaubt. Insgesamt wurde ein Direkt-Stenting bei 49 Patienten (23 in der TAXUS-Gruppe, 26 in der Kontrollgruppe) durchgeführt.Ergebnisse:In der TAXUS-Gruppe war nach 6 Monaten zwischen den prädilatierten und den direkt-gestenteten Patienten kein signifikanter Unterschied hinsichtlich MACE (7,5 % vs. 4,3 %), angiographischer Restenose im analysierten Gesamtsegment (4,8 % vs. 4,3 %), late loss (0,28 ± 36 mm vs. 0,33 ± 30 mm) und in der IVUS-gemessenen prozentualen Obstruktion des Stentvolumens (7,95 ± 9,84 vs. 5,61 ± 7,91) erkennbar. Dasselbe galt auch für die Patienten, die einen unbeschichteten Kontrollstent erhielten. Im Vergleich zur direkt gestenteten Kontrollgruppe waren die statistisch signifikanten positiven Effekte des TAXUS-Direkt-Stentings unverändert erhalten: angiographische Restenose im gesamten analysierten Segment (4,3 % vs. 30,8 %), late loss (0,33 ± 0,30 vs. 0,80 ± 0,62 mm) und IVUS-gemessene Volumenobstruktion (5,61 ± 7,91% vs. 22,50 ± 21,62%). MACE wurde von 19,2 % auf 4,3 % reduziert, allerdings erreichte dieser eindeutige Trend aufgrund der kleinen Patientenzahl keine statistische Signifikanz. Nach Vordehnung waren in der TAXUS-Gruppe alle Parameter signifikant besser als in der Kontrollgruppe.Schlussfolgerung:Der Vergleich von Patienten, die einen TAXUS-Stent mit oder ohne Vordehnung erhielten, ließ keinen Unterschied in den klinischen, angiographischen oder IVUSParametern nach 6-Monaten erkennen. Die Ergebnisse zeigen, dass das Direkt-Stenting mit dem Polymer-basierten, Paclitaxel-freisetzenden TAXUS-Stent gut durchführbar, sicher und genauso wirksam ist wie nach Vordehnung. Randomisierte Studien zum Vergleich des Direkt-Stentings mit Stenting nach Vordehnung für Medikamente freisetzende Stents sind wichtig.


Herz | 2003

General utilities of multislice tomography in the cardiac field.

Patricia Carrascosa; Carlos Capuñay; Juan Carlos Parodi; Lucio Padilla; Peter C. Johnson; Jorge Carrascosa; Shalabh Chandra; Dava Smith; Jorge A. Belardi

Objects: To show all cardiac evaluations multislice computed tomography (MSCT) can perform. Methods: MSCTs were performed on an MSCT scanner (Mx8000; Philips Medical Systems) with enhanced contrast acquisition. The reconstructed images were sent to a workstation for multiplanar reconstruction, volume rendering, and 3-D reconstruction. A total of 140 patients were studied with MSCT and conventional angiography (CA) to assess coronary artery stenosis. 30 of these patients were also evaluated by intravascular ultrasound (IVUS) for plaque characterization. A group of 20 patients were studied with MSCT, gated single-photon emission computed tomography (SPECT), and echocardiography for myocardial perfusion test and volumetric analysis. Results: The results of MSCT versus CA showed a sensitivity of 79.2% and a specificity of 93.7%, whereas for MSCT versus IVUS the sensitivity was 84.4% and the specificity 91.6%. A total of 156 plaques were detected by both methods. 105 (67%) were soft, 14 (24%) were fibrous and 37 (9%) were calcified. In the evaluation of myocardial perfusion, the cardiac software showed a sensitivity of 55% and a specificity of 80%. However, general evaluation disclosed a sensitivity of 88.5% and a specificity of 96.4%. The volumetric analysis showed a good correlation between MSCT and echocardiography for end-systolic volume (ESV), rS = 0.874, and end-diastolic volume (EDV), rS = 0.828. There was also a good correlation for the evaluation of the left ventricular anatomy: septal wall rS = 0.96, posterior wall rS = 0.81, and diameter of left ventricle rS = 0.69. Conclusion: Nowadays, MSCT allows different cardiologic evaluations with the same acquisition as that for the coronary arteries. These data show a general view of the patient providing information that is obtained by the hand of multiple cardiologic methods such as DA, IVUS, gated SPECT, and echocardiography.Methoden: Die MSCT wurde mit einem Mx8000 (Philips Medical Systems) nach Kontrastmittelgabe durchgeführt. Die rekonstruierten Bilder wurden an eine Workstation zur multiplanaren Rekonstruktion, Volumenrendering und 3-D-Rekonstruktion weitergeleitet. Insgesamt untersuchten wir 140 Patienten mittels MSCT und konventioneller Angiographie (Angio), um die Abschätzung von Koronarstenosen zu evaluieren. 30 dieser Patienten wurden zusätzlich mittels intravaskulärem Ultraschall (IVUS) zur Plaque-Charakterisierung untersucht. 20 Patienten hatten zusätzlich auch eine EKG-gesteuerte Single-Photon-Emissions-Computertomographie (SPECT) sowie eine Echokardiographie zur Beurteilung der Myokardperfusion und zur volumetrischen Analyse. Ergebnisse: Die Ergebnisse für den Vergleich von Angio mit MSCT ergaben eine Sensitivität von 79,2 % und eine Spezifität von 93,7 %. Im Vergleich zum IVUS fand sich für das MSCT eine Sensitiviät von 84,4 % bei einer Spezifität von 91,6%. 156 Plaques wurden von beiden Methoden erkannt, hiervon waren 105 (67%) weich, 14 (24%) fibrös und 37 (9%) kalzifiziert. Bei der Beurteilung der Myokardperfusion ergab sich für das MSCT eine Sensitivität von 55% bei einer Spezifität von 80%. Bei weiterer Analyse zeigte sich eine Senstivität von 88,5% und eine Spezifität von 96,4%. Die volumetrische Analyse zeigte eine gute Korrelation zwischen MSCT und Echokardiographie hinsichtlich der end-systolischen Volumina (ESV), r = 0,874 und enddiastolischen Volumina (EDV), r = 0,828. Hinsichtlich der Beurteilung der linksventrikulären Anatomie ergab sich ebenfalls eine gute Korrelation: Septum r = 0,96, posteriore Wand r = 0,81, LV-Durchmesser r = 0,69. Schlussfolgerung: das MSCT erlaubt heute eine differenzierte kardiologische Abklärung einschließlich der Koronaranatomie. Das MSCT liefert Informationen, die sonst nur mit mehreren Methoden wie IVUS, EKG-gesteuertes SPECT und Echokardiographie erhalten werden können.


Heart | 2013

Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program

Vasim Farooq; Pascal Vranckx; Laura Mauri; Donald E. Cutlip; Jorge A. Belardi; Sigmund Silber; Petr Widimsky; Martin B. Leon; Stephan Windecker; Ian T. Meredith; Manuela Negoita; Frank van Leeuwen; Franz-Joseph Neumann; Alan C. Yeung; Hector M. Garcia-Garcia; Patrick W. Serruys

Background Overlapping first generation sirolimus- and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes—including death and myocardial infarction (MI)—in clinical studies. Objectives To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES). Design Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan–Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial. Setting Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrolment criteria were generally unrestrictive. Patients 5130 patients. Main outcome measures 2-year clinical outcomes and 13-month angiographic outcomes. Results 644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap: 3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES. Conclusions Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes—including repeat revascularisation—to non-overlapping DES. ClinicalTrials.gov Identifiers NCT00248079; NCT00617084; NCT00726453; NCT00752128; NCT00927940.

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Mariano Albertal

Erasmus University Rotterdam

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Lucio Padilla

Cardiovascular Institute of the South

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Gerardo Nau

Cardiovascular Institute of the South

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Marcelo Trivi

Cardiovascular Institute of the South

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Mariano Albertal

Erasmus University Rotterdam

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