SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

NCT00697372 | Completed Phase 4

• 1 other identifier: P648
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of DES and the technique for stent implantation have not been clarified. The side-branch (SB) is emerging as critical point, accounting for more than a third of the significant restenosis in the DES era. A series of data supports the adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a conservative approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal angiographic result has not been clarified. AIMS OF THE STUDY: The aims of the present study are:

• Group O (optimal SB angiographic result): post-PCI SB area stenosis\<50%
• Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis\>50%. PRIMARY STUDY END-POINTS.
• COMPARISON BETWEEN SES AND EES:
• SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization: inducible ischemia at the early exercise test or occurrence of early spontaneous ischemia related to the SB.

Conditions

Coronary Artery Disease; Coronary Stenosis

Keywords

Angioplasty, Transluminal, Percutaneous Coronary; Drug-Eluting Stents

Outcome Measures

Primary Outcomes (4)

• 6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure)

  18 MONTHS

• ACUTE ANGIOGRAPHIC RESULT

  * "MV acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the MV. * "SB acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the SB.

  7 DAYS

• SIDE BRANCH TROUBLE

  "SB trouble" composite of: 1. occurrence of SB TIMI flow \<3 after MV stenting throughout the procedure; 2. need of guidewire(s) different from BMW to re-wire SB after MV stenting; 3. failure to re-wire the SB after MV stenting; 4. failure to dilate the SB after MV stenting and SB re-wiring.

  7 DAYS

• TARGET BIFURCATION FAILURE

  \- target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.

  18 MONTHS

Secondary Outcomes (1)

• TECHNICAL CHARACTERISTICS

  7 DAYS

Study Arms (2)

SES

ACTIVE COMPARATOR

Patients with coronary bifurcation lesions treated by Sirolimus eluting stent

Device: Sirolimus eluting stent

EES

ACTIVE COMPARATOR

Patients with coronary bifurcation lesions treated by Everolimus eluting stent

Device: Everolimus eluting stent

Interventions

Sirolimus eluting stent DEVICE

Implantation of Sirolimus eluting stent

Also known as: Cypher stent - Cordis (Johnson&Johnson Company)

SES

Everolimus eluting stent DEVICE

Implantation of Everolimus eluting stent

Also known as: Xience stent - Abbot company

EES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• de novo bifurcated lesions
• lesions \>50% located in a major bifurcation point
• TIMI \>2 on both main vessel and side branch
• main vessel visual diameter \>2.5 mm
• side branch visual diameter \>2.0 mm
• \>18 years of age
• signed the informed consent to enter the study

You may not qualify if:

• known hypersensitivity to Sirolimus, Everolimus, cobalt, chromium, nickel, tungsten acrylic and fluoro-polymers
• contraindications to double antiplatelet therapy acute (within 48 hours) ST-elevation acute myocardial infarction

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Institute of Cardiology - Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (16)

• Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.

  PMID: 14981005 BACKGROUND

• Ormiston JA, Webster MW, El Jack S, Ruygrok PN, Stewart JT, Scott D, Currie E, Panther MJ, Shaw B, O'Shaughnessy B. Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies. Catheter Cardiovasc Interv. 2006 Jan;67(1):49-55. doi: 10.1002/ccd.20453.

  PMID: 16003787 BACKGROUND

• Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Mazuelos F, Hernandez E, Melian F, Pavlovic D, Esteban F, Herrador J. Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents. Am Heart J. 2007 Jan;153(1):15.e1-7. doi: 10.1016/j.ahj.2006.10.017.

  PMID: 17174630 BACKGROUND

• Lefevre T, Louvard Y, Morice MC, Loubeyre C, Piechaud JF, Dumas P. Stenting of bifurcation lesions: a rational approach. J Interv Cardiol. 2001 Dec;14(6):573-85. doi: 10.1111/j.1540-8183.2001.tb00375.x.

  PMID: 12053378 BACKGROUND

• Ge L, Tsagalou E, Iakovou I, Sangiorgi GM, Corvaja N, Airoldi F, Chieffo A, Montorfano M, Michev I, Colombo A. In-hospital and nine-month outcome of treatment of coronary bifurcational lesions with sirolimus-eluting stent. Am J Cardiol. 2005 Mar 15;95(6):757-60. doi: 10.1016/j.amjcard.2004.11.030.

  PMID: 15757605 BACKGROUND

• Valgimigli M, Malagutti P, Rodriguez Granillo GA, Tsuchida K, Garcia-Garcia HM, van Mieghem CA, Van der Giessen WJ, De Feyter P, de Jaegere P, Van Domburg RT, Serruys PW. Single-vessel versus bifurcation stenting for the treatment of distal left main coronary artery disease in the drug-eluting stenting era. Clinical and angiographic insights into the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registries. Am Heart J. 2006 Nov;152(5):896-902. doi: 10.1016/j.ahj.2006.03.029.

  PMID: 17070153 BACKGROUND

• Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

  PMID: 16226167 BACKGROUND

• Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64. doi: 10.1016/j.ahj.2004.05.029.

  PMID: 15523318 BACKGROUND

• Ge L, Iakovou I, Cosgrave J, Agostoni P, Airoldi F, Sangiorgi GM, Michev I, Chieffo A, Montorfano M, Carlino M, Corvaja N, Colombo A. Treatment of bifurcation lesions with two stents: one year angiographic and clinical follow up of crush versus T stenting. Heart. 2006 Mar;92(3):371-6. doi: 10.1136/hrt.2005.061531. Epub 2005 Jun 17.

  PMID: 15964941 BACKGROUND

• Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.

  PMID: 17060387 BACKGROUND

• Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.

  PMID: 16098427 BACKGROUND

• Burzotta F, Gwon HC, Hahn JY, Romagnoli E, Choi JH, Trani C, Colombo A. Modified T-stenting with intentional protrusion of the side-branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: the T-stenting and small protrusion technique (TAP-stenting). Report of bench testing and first clinical Italian-Korean two-centre experience. Catheter Cardiovasc Interv. 2007 Jul 1;70(1):75-82. doi: 10.1002/ccd.21194.

  PMID: 17585382 BACKGROUND

• Gradaus R, Mathies K, Breithardt G, Bocker D. Clinical assessment of a new real time 3D quantitative coronary angiography system: evaluation in stented vessel segments. Catheter Cardiovasc Interv. 2006 Jul;68(1):44-9. doi: 10.1002/ccd.20775.

  PMID: 16770813 BACKGROUND

• Burzotta F, Trani C, Todaro D, Lanza GA, Mariani L, Tommasino A, Niccoli G, Porto I, Leone AM, Crea F. Prospective evaluation of myocardial ischemia related to post-procedural side-branch stenosis in bifurcated lesions treated by provisional approach with drug-eluting stents. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):351-9. doi: 10.1002/ccd.23218. Epub 2011 Dec 12.

  PMID: 21735527 DERIVED

• Burzotta F, Trani C, Todaro D, Mariani L, Talarico GP, Tommasino A, Giammarinaro M, Niccoli G, Porto I, Leone AM, Mongiardo R, Mazzari MA, Schiavoni G, Crea F. Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011 Mar;4(3):327-35. doi: 10.1016/j.jcin.2010.12.005.

  PMID: 21435612 DERIVED

• Sgueglia GA, Burzotta F, Trani C, Todaro D, Talarico GP, Niccoli G, Porto I, Leone AM, Coluccia V, Mazzari MA, Mongiardo R, Schiavoni G, Crea F. Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):503-9. doi: 10.1002/ccd.22714.

  PMID: 20602477 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Francesco Burzotta, MD,PhD,FESC

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: April 1, 2010
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

IT (1)