Study news

Newsletter 27 October 2015
DATABASE COMPLETION - BASELINE AND 1 MONTH-FOLLOW UP

As we are near the end of the recruitment period, primary focus will shift towards collection of all available data at baseline for all patients. You will receive a weekly update on eCRF completion and received material at your site to make sure that Baseline and 1 month-follow up is completely up to date in December 2015. We would like to ask you to be in close contact with your local CRA in order to achieve this deadline. Thank you in advance.

Cardialysis BV
Westblaak 98, 3012 KM, Rotterdam
attn.:SYNTAX II trial

 

Newsletter 09 April 2015
SAVE THE DATE: EUROPCR 2015 INVESTIGATOR MEETING

On behalf of the Principal Investigators and Steering Committee, it is with great pleasure that we invite you to the investigator meeting for SYNTAX II during EuroPCR 2015!
The investigator meeting will take place on Wednesday 20 May 2015, 08:15am – 09:15am (CEST).
Please save-the-date on your calendar and we will contact you as soon as possible on further details.

 

Newsletter 02 April 2015
IVUS SUBSTUDY UPDATE

We are delighted to report on an interim analysis of the IVUS runs performed in the Syntax 2 study. We have already been able to undertake preliminary assessment in in the first 136 recruited patients. Some trends are already obvious and by pointing these out at this stage we hope to ensure the best data quality for future analysis.

Please take particular care of the very last final IVUS run on each target vessel especially:

• Perform a final motorized IVUS pullback of the stented segment (manual pullback can be performed if it is the preferred approach during the case, but, please ensure that the very last pullback is a motorized pullback)
• Be sure that the final pullback is started beyond the stented segment
• Perform an angiographic acquisition at the beginning, of the pullback in order to verify what length of the stented segment has been assessed
• Label each IVUS pullback specifying
  • vessel or segment according to SYNTAX definition: ex “prox RCA“ or “Segment 1”
  • stage of the procedure: ex “prestenting”, “after stenting”, “after postdilation”
  • label the final run for that segment as “final”: ex “Segment 1 postdilation-final”

Thank you for your ongoing collaboration. The data look very exciting and together we hope to demonstrate the value of IVUS-optimized PCI within the Syntax 2 study.

 

Newsletter 03 March 2015
DUAL ANTIPLATELET REGIMEN IN SYNTAX II

The Syntax II protocol states that dual antiplatelet treatment (DAPT) is mandatory for at least 6 months, keeping aspirin treatment indefinitely. The protocol recommends clopidogrel for loading and maintenance treatment, allowing the use of  prasugrel or ticagrelor as alternative P2Y12 inhibitors to clopidogrel in DAPT.
 
The reason for allowing any of these three agents was that, at the time of writing the SYNTAX II protocol, they all were representative of state-or-the-art DAPT in the context of PCI. Yet, there is growing evidence that ticagrelor or prasugrel are superior to clopidogrel in reducing stent thrombosis. In 2014 the AHA/ACC guidelines for the management of patients with non–ST-elevation acute coronary syndromes issued a class IIa recommendation on the use of ticagrelor over clopidogrel in NSTE-ACS patients treated with coronary stents who are not at high risk of bleeding complications. Data presented by Iqbal et al at the 2014 AHA sessions in Chicago also showed a marked decrease in stent thrombosis in patients with acute coronary syndromes, particularly in the first day after stent implantation. This is important, as the recently published EVOLVE II trial reported no cases of definite/probable stent thrombosis beyond 24 hours of implantation of the Synergy stent. Some of the potential mechanisms by which, compared to clopidogrel, newer P2Y12 inhibitors decrease acute stent thrombosis are 1) a more potent platelet antiaggregant effect, 2) faster platelet antiaggregation, and 3) circumventing the problem of  genetic polymorphisms  affecting the platelet antiaggregant effect of clopidogrel.
 
Based on this growing evidence, the steering committee of SYNTAX II recommends considering the use of prasugrel or ticagrelor as the P2Y12 inhibitors, in conjunction with aspirin, for the loading and maintenance dosages of DAPT in the study. The decision to use clopidogrel as P2Y12 inhibitor in DAPT is left to the operator, understating that there may be individual reasons (including patient characteristics, bleeding risks, drug availability and local regulations) that justify its use instead prasugrel or ticagrelor.

References:

Amsterdam EA et al. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Dec 23;64(24):e139-228.

Iqbal J. Lower mortality and stent thrombosis rates associated with introduction of potent P2Y12 inhibitors in patients with acute coronary syndromes. Presented at: American Heart Association Scientific Sessions; November 17, 2014; Chicago, IL.

Kereiakes DJ et al. EVOLVE II Clinical Trial - Presented at: American Heart Association Scientific Sessions; November 17, 2014; Chicago, IL.

 

Newsletter 19 January 2015
PUBLICATION POLICY

SYNTAX II Publication Policy has been finalized. Local PI’s that are actively participating in the SYNTAXII trial may acquire first authorship of manuscripts concerning additional sub-analyses. One of the criteria is that you need to have enrolled 18 patients within 12 months after site activation and minimally 20 before the end of the trial. An overview on your status, as well as the full Publication Policy will be shared with you early next week.

 

Newsletter 07 January 2015
PROCEDURE SUCCESS

In SYNTAX II we are investigating a new strategy in the  assessment of 3-vessel disease using e.g. the functional SYNTAX Score and the residual SYNTAX Score  in patients that are treated with PCI. It is therefore important to know whether the procedure performed was successful or not. To be able to determine the success of the procedure we apply the so-called Clinical Procedure Success. One of the criteria to consider the procedure successful is if there has been achieved a final in-stent residual stenosis of <30% in ALL lesions treated with the SYNERGY™ stent. This percentage must be determined by you by visual estimation (unfortunately there is no Core Lab involved in SYNTAXII). We understand that there are border cases for which it is difficult to determine. In these cases, please consult your colleagues or staff and try to come to consensus whether the final in-stent residual stenosis is < or > than 30%. There may also be some cases where the percentage has not been determined shortly post-stent implantation. In these cases please find time later to take a look at the index angiography to determine the residual stenosis.

 

Newsletter 12 June 2014
PRESENT ALL 3-VESSEL DISEASE PATIENTS TO THE HEART TEAM

In the SYNTAX II clinical trial we are evaluating the effectiveness of contemporary PCI treatment of de novo 3-vessel disease (3VD) following the heart team selection applying the SYNTAX Score II with pressure wire functional assessment and IVUS guidance. We call this the SYNTAX II strategy. In SYNTAX II it is prescribed that ALL patients with de-novo 3VD, with no left main involvement, must be screened by the local Heart Team using the online SYNTAX Score II calculator. This SYNTAX Score II calculator is exclusively available for your site as part of the SYNTAXII eCRF. 

 

Newsletter 10 April 2014
PERFORMING THE ANATOMICAL SYNTAX SCORE

SCORING TIPS

• You get a more accurate score by doing this in a team (ideally a panel of 3 persons).
• Focus on the coronary anatomy (do not think treatment!).
• For an accurate SYNTAX Score outcome, both the Left Coronary Artery as well as the Right Coronary Artery must be assessed.

WHICH LESIONS SHOULD BE SCORED?

Each coronary lesion with a Diameter Stenosis ≥50% in vessels ≥1.5 mm must be scored. Each lesion can involve ≥1 diseased segments.

If serial stenoses are less than 3 vessel reference diameters apart, they should be scored as one lesion. However, stenoses at a greater distance from each other (more than 3 vessel reference diameters), are considered as separate lesions.

Please refer to www.syntaxscore.com for additional information on the definitions used for the anatomical SYNTAX Score and some example cases.

 

Newsletter 10 April 2014  
SCORING A BIFURCATION

A bifurcation is a division of a main, parent, branch into two daughter branches of at least 1.5mm. Bifurcation lesions may involve the proximal main vessel, the distal main vessel and the side branch according to the Medina classification. The smaller of the two daughter branches should be designated as the ‘side branch’. In case of the main stem either the LCX or the LAD can be designated as the side branch depending on their respective calibres.

Bifurcations are only scored for the following segment junctions: 5/6/11, 6/7/9, 7/8/10, 11/13/12a, 13/14/14a, 3/4/16 and 13/14/15.

In the SYNTAX Score calculator at question ‘Specify which segments are diseased for lesion X’: one should fill out only those segment numbers of the bifurcation that have a Diameter Stenosis ≥50% in direct contact with the bifurcation.

 

Newsletter 10 April 2014
SCORING A TRIFURCATION

A trifurcation is a division of a mainbranch into three branches of at least 1.5mm. Trifurcations are only scored for the following segment junctions: 3/4/16/16a, 5/6/11/12, 11/12a/12b/13, 6/7/9/9a and 7/8/10/10a.

In the SYNTAX Score calculator at question ‘Specify which segments are diseased for lesion X’: one should only fill out those segment numbers of the trifurcation that have a Diameter Stenosis ≥50% in direct contact with the trifurcation

 

Newsletter 07 February 2014
SYNERGY™ and SYNERGY II™ Drug Eluting Stent

It is now also allowed to use the CE-marked SYNERGY II™ stent in the SYNTAXII clinical trial. The current SYNERGY™ stent and the new SYNERGY II™ stent are manufactured by Boston Scientific and used in the SYNTAXII clinical trial within its described intention for use. Ethics Committees will be informed.

In case of any further minor technological improvement of the current SYNERGY™ stents, becoming commercially available (as a new CE marked product), during the course of the study, it will replace the current model and will be provided to the centres participating in the study under the same conditions.

 

Newsletter 07 February 2014
LET’S CELEBRATE

Congratulations to Dr. Escaned and his team at Hospital Clinico San Carlos in Madrid for being the first hospital that has been activated in SYNTAXII AND enrolling the first patient of the study!