Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)

PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Restenosis
• Intervention / Treatment: Device: Milennium Matrix® (Control); Device: Infinnium®; Device: Supralimus®

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20941-150
    • Rede D'Or de Hospitais
  • São Paulo, Brazil, 04024-002
    • Hospital Sao Paulo - UNIFESP
  • São Paulo, Brazil, 05022-001
    • Hospital São Camilo
  • São Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • São Paulo, Brazil, 05403-900
    • Instituto do Coração - InCor
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-370
      • Hospital Universitario Walter Cantidio
  • Espirito Santo
    • Vitória, Espirito Santo, Brazil, 29156-580
      • Hospital Meridional Intercath
  • Espírito Santo
    • Vitória -, Espírito Santo, Brazil, 29042-755
      • Hospital Universitário Cassiano Antônio de Moraes
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 34000-000
      • Hospital Biocor
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59054-630
      • Hospital Natal Center
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Percutaneous coronary intervention with bare metal stent	Device: Milennium Matrix® (Control); Percutaneous coronary intervention with bare metal stent; Other Names: Milennium Matrix®
Experimental: 2; Percutaneous coronary intervention with paclitaxel-eluting stent	Device: Infinnium®; Percutaneous coronary intervention with paclitaxel-eluting stent
Experimental: 3; Percutaneous coronary intervention with sirolimus-eluting stent	Device: Supralimus®; Percutaneous coronary intervention with sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	1 Year

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Pvt. Ltd.
• Collaborators: CMS Medical
• Investigators: Principal Investigator: Prof. Pedro A. Lemos, MD, Instituto do Coração - InCor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 12, 2008
• First Posted (Estimate): September 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Revascularization; Percutaneous; Restenosis; Techniques; Agents; Platform; Metallic; Supralimus®,; Infinnium®,; Matrix®,; Antiproliferative; Properties
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: The PAINT Trial