Clinical trial NCT00752362: Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)
Official title: PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Restenosis
Keywords: Supralimus®,
Infinnium®,
Matrix®,
Restenosis
Percutaneous
Revascularization
Techniques
Metallic
Platform
Agents
Antiproliferative
Properties
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: CMS Medical
First posted: 2008-09-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

PRIMARY OBJECTIVE:

To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.

SECONDARY OBJECTIVES:

Safety:

To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.

To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the paclitaxel, sirolimus and control study arms.

To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel, sirolimus and control study arms.

Efficacy:

To compare the rate of angiographic success among the study groups To compare the rate of procedural success among the study groups To compare the incidence of clinically driven target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.

To compare the incidence of clinically driven target vessel revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.

To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel, sirolimus and control study arms.

To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study groups To compare the IVUS percent neointimal obstruction among the study groups

Study Design:

In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions in native coronaries. The study will be a multicenter clinical trial and will include patients for the treatment with one of the three study stents. In total, 275 patients will be enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be evaluated at 9 months with IVUS examination.

Treatment:

Patients will be treated, according to the randomization groups, with Infinnium®, Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of 2.5, 3.0, and 3.5 mm.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
3. De novo coronary lesion (non-restenosis);
4. Target lesion located in a native artery;
5. Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
6. Target lesion amenable to treatment with a single stent of up to 29 mm in length;
7. Target lesion with a diameter stenosis \> 50% (visual analysis);
8. Acceptable candidate for surgical revascularization;
9. Signed informed consent term.

Exclusion Criteria:

GENERAL EXCLUSION CRITERIA

1. Q-wave myocardial infarction \< 48 hours before the index procedure
2. Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
3. Left ventricle ejection fraction ≤30%
4. Renal dysfunction (serum creatinine \> 2.0 mg/dl \[\>177 µmol/l\])
5. Platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3
6. White cell count \< 3.000 cells/mm3
7. Suspected or known liver disease (including subclinical hepatitis)
8. Heart transplant recipient
9. Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel
10. Life expectancy \< 12 months
11. Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study
12. Current inclusion in another study to investigate drug or other device, or planned inclusion in another study to investigate drug or other device during the follow-up.
13. Coronary angioplasty (with or without stent) \< 6 months in any segment of the target vessel
14. Previous coronary angioplasty (with or without stent), at any time, in a coronary segment \< 5 mm (proximal or distal) from the target lesion
15. Coronary angioplasty (with or without stent) in any segment of the target vessel planned during the next 12 months following the index procedure.

ANGIOGRAPHIC EXCLUSION CRITERIA

1. Restenotic target lesion
2. Need for treatment of more than one lesion in the target vessel;
3. Diameter of the target vessel \< 2.5 mm or \> 3.5 mm (visual analysis)
4. Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion
5. Significant (\> 50%) unprotected left main lesion
6. Angiographic thrombus
7. Target lesion located in bypass graft
8. Occluded target vessel (antegrade flow TIMI 0 or 1)
9. Target lesion in ostial location;
10. Target lesion in a bifurcation site with a side branch \> 2.5 mm or that may require stent implantation;
11. Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;
12. Severely tortuous target vessel.

Primary outcomes:
measure: compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
timeFrame: 9 months
Secondary outcomes:
measure: MACE at 1,9&12M, SAE & ST until 12M. Rate of angiographic & procedural success, TLR & TVR at 1&9M Instent LL between Supralimus®, Infinnium® & Matrix® Insegment binary restenosis at 9M IVUS% neointimal obstruction cost-effectiveness profile at 12M
timeFrame: 1 Year
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Universitário Walter Cantídio
state: Ceará
city: Vitória
country: Brazil
facility: Hospital Meridional Intercath
state: Espirito Santo
city: Vitória -
country: Brazil
facility: Hospital Universitário Cassiano Antonio de Moraes
state: Espírito Santo
city: Belo Horizonte
country: Brazil
facility: Hospital Biocor
state: Minas Gerais
city: Natal
country: Brazil
facility: Hospital Natal Center
state: Rio Grande do Norte
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Rede D'Or de Hospitais
city: São Paulo
country: Brazil
facility: Hospital São Paulo - UNIFESP
city: São Paulo
country: Brazil
facility: Hospital São Camilo
city: São Paulo
country: Brazil
facility: Instituto do Coração - InCor
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
Study officials:
affiliation: Instituto do Coração - InCor
name: Prof. Pedro A. Lemos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT study. Rationale and design for the PAINT randomized trial. Arq Bras Cardiol. 2009 Dec;93(6):547-53, 590-7. doi: 10.1590/s0066-782x2009001200006. English, Portuguese.
citation: Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT trial investigators. Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):665-73. doi: 10.1002/ccd.22166.
citation: Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE. Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial. EuroIntervention. 2012 May 15;8(1):117-9. doi: 10.4244/EIJV8I1A18.
citation: Marchini JF, Gomes WF, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Lemos PA. Very late outcomes of drug-eluting stents coated with biodegradable polymers: insights from the 5-year follow-up of the randomized PAINT trial. Cardiovasc Diagn Ther. 2014 Dec;4(6):480-6. doi: 10.3978/j.issn.2223-3652.2014.12.05.