Jorge Belardi

Publications (5)34.03 Total impact

• Article: One-year clinical outcome of various doses and pharmacokinetic release formulations of paclitaxel eluted from an erodable polymer - Insight in the Paclitaxel In-Stent Controlled Elution Study (PISCES).

  Jiro Aoki, Andrew T L Ong, Alexandre Abizaid, Peter den Heijer, Hans Bonnier, Dougal R McClean, Stefan Verheye, Jorge Belardi, Jose A Condado, Michel Pieper, J Eduardo Sousa, Marco Bressers, Janette Symons, Frank Litvack, Georgios Sianos, Patrick W Serruys
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  ABSTRACT: Aims: The one year clinical benefit of various doses and release durations of paclitaxel eluted from an erodable polymer has not been evaluated so far.Methods and results: Conor paclitaxel-eluting stents have intra-stent wells in which drug and polymer are deposited. Stents with six different release formulations (dose: 10 microg or 30 microg, duration: 5, 10 or 30 days, direction: mural or bidirectional) were implanted in 6 patient cohorts. Clinical follow-up was conducted at 4 and 12 months. Quantitative angiography and IVUS were performed at 4 months, and additional angiographic and IVUS follow-up were performed for groups D5 (10microg/30days/mural) and D6 (30microg/30days/mural), as they had shown the most favorable results at 4 months. At one year, the lowest major adverse cardiac event rates were observed in the slow release (30 day) group (5.1% in D5 and 6.9% in D6). One-year in-stent late loss was 0.52+/-0.34 mm in D5 and 0.36+/-0.50mm in D6 (p=0.20) while neointimal area was 0.99+/-0.54 mm2 in D5 and 0.77+/-0.92 mm2 in D6 (p=0.42). Corresponding in-stent binary restenosis at one year was 0% and 5.6% respectively (p=0.36). Conclusions: Patients who received the slow release formulation stent had better clinical outcome at one year than those who received the fast release formulation. However, the effect on neointimal suppression requires investigation in a larger population to determine whether the high dose formulation confers an additional clinical benefit.
  EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 08/2005; 1(2):165-72. · 3.29 Impact Factor
• Article: The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES).

  Patrick W Serruys, Georgios Sianos, Alexandre Abizaid, Jiro Aoki, Peter den Heijer, Hans Bonnier, Pieter Smits, Dougal McClean, Stefan Verheye, Jorge Belardi, Jose Condado, Michel Pieper, Louise Gambone, Marco Bressers, Janette Symons, Eduardo Sousa, Frank Litvack
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  ABSTRACT: The aim of this study was to evaluate the effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia. Conventional paclitaxel-eluting stents use a durable polymer coating as a vehicle for drug delivery. The Conor stent (Conor Medsystems, Menlo Park, California) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmacokinetics. Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent (n = 53) or one of six different release formulations that varied in dose (10 or 30 microg) and elution release kinetics (first order, zero order), direction (abluminal, luminal), and duration (5, 10, and 30 days). End points at six months (bare stent group) and at four months (eluting stent groups) were angiographic late loss and neointimal tissue volume by intravascular ultrasound and the rate of major adverse cardiac events (MACE). The lowest in-stent late loss (0.38 mm, p <0.01, and 0.30 mm, p <0.01) and volume obstruction (8%, p <0.01, and 5%, p <0.01) were observed with the 10-microg and 30-microg doses in the 30-day release groups respectively, whereas the highest in-stent late loss (0.88 mm), volume obstruction (26%), and restenosis rate (11.6%) were observed in the bare stent group. The overall MACE rate of the eluting stent group was 8.6%: death 0.5%, myocardial infarction 2.7%, and target lesion revascularization (TLR) 5.3%. Sub-acute thrombosis was 0.5%. The TLR rates in the two 30-day release groups were 0% and 3.4%. This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.
  Journal of the American College of Cardiology 07/2005; 46(2):253-60. · 14.16 Impact Factor
• Article: 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 Hamburger, Eberhard Grube, Matthias Pfisterer, Jorge Belardi, John Webb, Krzysztof Zmudka, Christoph Nienaber, Karl Hauptman, Wolfgang Rutsch, Keith Dawkins, Janusz Drzewiecki, Jörg Koglin, Antonio Colombo
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  ABSTRACT: 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). 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 intravascular 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. 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 paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.
  Herz 04/2004; 29(2):171-80. · 0.92 Impact Factor
• Article: 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 Munzel, Jorge Belardi, Witold Ruzyllo, Luc Bilodeau, Henning Kelbaek, John Ormiston, Keith Dawkins, Louis Roy, Bradley H Strauss, Clemens Disco, Jörg Koglin, Mary E Russell, Antonio Colombo
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  ABSTRACT: 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. 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. 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.
  Circulation 02/2004; 109(2):196-200. · 14.74 Impact Factor
• Source

  Available from: Jaap N Hamburger

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

  Sigmund Silber, Jaap Hamburger, Eberhard Grube, Matthias Pfisterer, Jorge Belardi, John Webb, Krzysztof Zmudka, Christoph Nienaber, Karl Hauptman, Wolfgang Rutsch, Keith Dawkins, Janusz Drzewiecki, Jörg Koglin, Antonio Colombo
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  ABSTRACT: 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 mgliche Vorteile des Direkt-Stentings liegen in einer Reduktion der myokardialen Ischmiezeit, was bei Hochrisikopatienten klinisch relevant sein knnte. Mit der Einfhrung der Medikamente freisetzenden Stents kamen jedoch Bedenken auf, dass ein Direkt-Stenting mglicherweise die Polymerbeschichtung beschdigen knnte und somit die Wirksamkeit vermindert. Auch eine eventuelle Beeintrchtigung 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) durchgefhrt.Ergebnisse:In der TAXUS-Gruppe war nach 6 Monaten zwischen den prdilatierten 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 fr die Patienten, die einen unbeschichteten Kontrollstent erhielten. Im Vergleich zur direkt gestenteten Kontrollgruppe waren die statistisch signifikanten positiven Effekte des TAXUS-Direkt-Stentings unverndert 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, lie 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 durchfhrbar, sicher und genauso wirksam ist wie nach Vordehnung. Randomisierte Studien zum Vergleich des Direkt-Stentings mit Stenting nach Vordehnung fr Medikamente freisetzende Stents sind wichtig.
  Herz 01/2004; 29(2):171-180. · 0.92 Impact Factor