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Pedro A Lemos,
Bruno Moulin,
Marco A Perin,
Ludmilla A R R Oliveira, J Airton Arruda,
Valter C Lima,
Antonio A G Lima,
Paulo R A Caramori,
Cesar R Medeiros,
Mauricio R Barbosa,
Fabio S Brito,
Expedito E Ribeiro
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ABSTRACT: The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known.
A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents.
The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2012; 8(1):117-9. · 3.29 Impact Factor
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Pedro A Lemos,
Bruno Moulin,
Marco A Perin,
Ludmilla A R R Oliveira, J Airton Arruda,
Valter C Lima,
Antonio A G Lima,
Paulo R A Caramori,
Cesar R Medeiros,
Mauricio R Barbosa,
Fabio S Brito,
Expedito E Ribeiro,
Eulógio E Martinez
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ABSTRACT: We describe the rationale and design for the 'PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting or sirolimus-eluting versus bare stents for de novo coronary lesions - PAINT trial'.
To evaluate two novel formulations of paclitaxel-eluting stent and the sirolimus-eluting stent against a stent with the same metallic structure but without polymer coating or drug elution.
The PAINT is a multicenter 3-arm randomized trial, conducted in Brazilian tertiary institutions, which included 275 patients allocated for the InfinniumR paclitaxel-eluting stent, the SupralimusR sirolimus-eluting stent or the Milennium MatrixR bare metal stent in a 2:2:1 ratio. Patients had de novo coronary lesions in native vessels with a diameter between 2.5 and 3.5 mm, amenable for treatment with a single stent of 29 mm or less in length. The primary objective was to compare the in-stent late loss at 9 months of both paclitaxel- and sirolimus-eluting versus the late loss of control bare metal stents. Important secondary objectives included the comparison in outcomes between sirolimus and paclitaxel stents, as well as the analysis of the incidence of major adverse cardiac events.
The PAINT trial had a unique design that allowed for the evaluation of the safety and efficacy profiles of two novel drug-eluting stent formulations, with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). As the drug-eluting stents differed by the drug, but were identical otherwise, the trial also allowed the comparison of the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).
Arquivos brasileiros de cardiologia 12/2009; 93(6):547-53, 590-7. · 1.32 Impact Factor
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Pedro A Lemos,
Bruno Moulin,
Marco A Perin,
Ludmilla A R R Oliveira, J Airton Arruda,
Valter C Lima,
Antonio A G Lima,
Paulo R A Caramori,
Cesar R Medeiros,
Mauricio R Barbosa,
Fabio S Brito,
Expedito E Ribeiro,
Eulógio E Martinez
[show abstract]
[hide abstract]
ABSTRACT: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).
The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.
Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.
Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.
Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.
Catheterization and Cardiovascular Interventions 07/2009; 74(5):665-73. · 2.29 Impact Factor
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ABSTRACT: Sirolimus systemic administration has shown marked inhibition of neointimal hyperplasia (NIH) after balloon angioplasty in porcine models. In this pilot study, we tested the hypothesis that oral sirolimus is safe and effective to inhibit in-stent NIH and therefore to prevent and treat in-stent restenosis (ISR). Twelve patients (18 lesions) with high risk for ISR, including 8 ISR lesions, were admitted. One day before the procedure, patients were given a 15 mg loading dose of oral sirolimus, followed by 5 mg daily for 28 days, with weekly whole blood level measurements. The daily dose was adjusted to keep the concentration at 10-15 ng/ml. Sirolimus was well tolerated by all patients but one, who died at the end of the third week of treatment. The 4- and 8-month follow-up revealed an angiographic late loss of 0.40 +/- 0.24 and 0.67 +/- 0.45 mm (P < 0.01), respectively. At the same time points, the intravascular ultrasound in in-stent relative volumetric obstruction was 14.4% +/- 9.1% and 23.2% +/- 10.1% (P < 0.01), respectively. At 24-month clinical follow-up, adverse events were one (8.3%) death, two (11.1%) target lesion, and four (22.2%) target vessel revascularizations. In conclusion, in this small group of high-risk ISR patients, oral sirolimus inhibited NIH and therefore may be an effective strategy for the prevention and treatment of ISR.
Catheterization and Cardiovascular Interventions 04/2005; 64(4):413-8. · 2.29 Impact Factor
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[show abstract]
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ABSTRACT: Sirolimus systemic administration has shown marked inhibition of neointimal hyperplasia (NIH) after balloon angioplasty in porcine models. In this pilot study, we tested the hypothesis that oral sirolimus is safe and effective to inhibit in-stent NIH and therefore to prevent and treat in-stent restenosis (ISR). Twelve patients (18 lesions) with high risk for ISR, including 8 ISR lesions, were admitted. One day before the procedure, patients were given a 15 mg loading dose of oral sirolimus, followed by 5 mg daily for 28 days, with weekly whole blood level measurements. The daily dose was adjusted to keep the concentration at 10–15 ng/ml. Sirolimus was well tolerated by all patients but one, who died at the end of the third week of treatment. The 4- and 8-month follow-up revealed an angiographic late loss of 0.40 ± 0.24 and 0.67 ± 0.45 mm (P < 0.01), respectively. At the same time points, the intravascular ultrasound in in-stent relative volumetric obstruction was 14.4% ± 9.1% and 23.2% ± 10.1% (P < 0.01), respectively. At 24-month clinical follow-up, adverse events were one (8.3%) death, two (11.1%) target lesion, and four (22.2%) target vessel revascularizations. In conclusion, in this small group of high-risk ISR patients, oral sirolimus inhibited NIH and therefore may be an effective strategy for the prevention and treatment of ISR. Catheter Cardiovasc Interv 2005;64:413–418. © 2005 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 03/2005; 64(4):413 - 418. · 2.29 Impact Factor
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The American Journal of Cardiology 07/2003; 91(11):1363-5. · 3.37 Impact Factor
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Fábio S Brito,
Adriano M Caixeta,
Marco A Perin,
Miguel Rati, J Airton Arruda,
Marcelo Cantarelli,
Hélio Castello,
Bruno M Machado,
Lélio A Silva,
Expedito E Ribeiro,
Protásio L da Luz
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ABSTRACT: Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.
The American Journal of Cardiology 02/2002; 89(2):115-20. · 3.37 Impact Factor
