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Editorial

Benefits of complete functional revascularization with PCI: 5 years results of SYNTAX II and ERACI IV trials

Alfredo E Rodríguez

Revista Argentina de Cardioangiologí­a Intervencionista 2021;(4): 0208-0209 | Doi: 10.30567/RACI/20214/0208-0209


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During the last month of September, the long-term 5-year follow-up of the prospective registry SYNTAX II was published. This registry used a new drug-eluting stent (DES2) design followed by a revascularization strategy with FFR (fractional flow reserve) assessment to achieve the complete functional revascularization of every lesion with FFR, that is, all lesions considered “treatable” based on the severity seen on the angiography were assessed using the iFR or FFR indices. If lesions were not ischemic, they never received the DES (1-3).
The SYNTAX II had significant differences compared to the randomized SYNTAX I trial beyond the randomization, or not, of one or the other study and the different stent design. (1,3). In the SYNTAX I, first-generation DESs (DES1) were used, but the most important thing was the functional assessment-guided revascularization strategy of the SYNTAX II. Therefore, the objective was complete functional revascularization that has given us, interventional cardiologists, so many good results over the last 30 years (4) in comparative randomized clinical trials (RCT) with coronary artery bypass graft (CABG). In the SYNTAX I the revascularization strategy attempted to obtain complete angiographic and/or anatomical revascularization with angioplasty (1).
This guided angiography led to a significantly lower number of stents implanted per patient (4.04 vs 2.6 SYNTAX I vs II; P < . 001, respectively); also, to the finding of much less 3-vessel disease (83.3% vs 37.2% in SYNTAX I vs II; P < . 001, respectively).
The retrospective comparison with data from the SYNTAX I made at the 1-year follow-up confirmed a lower rate of major adverse cardiovascular events (MACE), also of each of its components (3).
At the 5-year follow-up (5), the MACE rate dropped 46%, while mortality rate dropped 43% in the SYNTAX II compared to the angioplasty arm of the SYNTAX I.
The fewer acute myocardial infarctions (AMI), new revascularizations (TVR), and stent thromboses reported also favored the SYNTAX II trial significantly (P < . 001).
We should mention that by using fewer DESs we obtain a lower number of revascularizations, which validates the fact that functional revascularization should be the target of coronary angioplasty.
Also, the lesions assessed using functional tests confirmed that the number of patients with severe 3-vessel disease from the SYNTAX I trial was probable overestimated.
The use of second-generation DESs (DES2) could also be associated with better disease progression, although these devices are not always synonym of better results (6) like the recent results from the NOBLE and the EXCEL clinical trials (7-8) and meta-analysis (9) of RCTs of the left main coronary artery (LMCA) reveal. Surprisingly, the first RCTs that used DES1 were associated with better disease progression after 5 years regarding all-cause mortality (OR = 1.19, 0.83-1.71; CABG vs PCI in the PRECOMBAT trial, and LMCA subgroup of the SYNTAX I) compared to the RCTs that used DES2 (OR = 0.78, 0.62-0.99; CABG vs PCI in the NOBLE and the EXCEL trials).
During the recent SOLACI/CACI Congress, the final 5-year results of the still unpublished ERACI IV registry were presented.
This registry also used a functional assessment-guided revascularization strategy while always in observance of the protocol of the ERACI anatomical score (10) where the revascularization of all intermediate lesions (50% to 69% through visual estimation), and lesions found in small vessels is ill-advised.
Similarly, in bifurcation lesions, the investigators were encouraged to use a simple strategy like stenting the main vessel as the first attempt.
This ERACI IV trial has the same limitations as the SYNTAX II since neither one of them is a randomized clinical trial. The actual comparison should be made with the ERACI III trial conducted several years ago where the coadjuvant pharmacological strategy with more powerful thienopyridines (prasugrel or ticagrelor) (11-12) was not available and the stent used was also a first-generation DES (DES1).
Although the mid-term follow-up results have already been published (13), the 5-year data were presented for the first time during the SOLACI/CACI Congress (14). In this presentation it became clear that the final primary endpoint of MACE reduced significantly compared to the ERACI III (33.8% vs 18.7% ERACI III vs IV, respectively; P < . 001), as well as each of the primary endpoint components (like AMI and TVR).
If we analyze the reduction of the primary endpoint in both the SYNTAX II and the ERACI IV registries, we will be able to see that this reduction was 46% and 44% respectively (P < . 001) for both registries compared to previous studies.
Another significant finding of both the SYNTAX II and the ERACI IV trials was that only 21% and 28% of the patients were on a 5-year course of dual antiplatelet therapy, a fact that may very well be associated with noncardiac adverse events at the late follow-up of DES (15).
In conclusion, these findings stress the idea that, although the type of stent used is important, the rational strategy during revascularization seeks a complete functional and non-anatomical revascularization. A strategy that has somehow fallen into oblivion over the last few years but that would be associated with a more favorable late disease progression in patients treated with angioplasty and stenting.
The good results seen in the overall and cardiovascular mortality rates described after 5 years reported by the SYNTAX II trial (3) make us feel optimistic about future randomized comparisons between angioplasty vs CABG and/or optimal medical therapy. In sum,”there seems to be light at the end of the tunnel… after the many obstacles we’ve had to overcome over the last few years…… (6-8,16)”

Dr. Alfredo E. Rodriguez MD, PhD, FACC, FSCAI
Editor-in-chief. The Argentine Journal of Interventional Cardioangiology (RACI)

  1. Head SJ, Davierwala PM, Serruys PW, et al. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J 2014 Oct 21;35(40):2821-30.

  2. Tonino PA, Fearon WF, De Bruyne B, et al. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol 2010;55(25):2816-21.

  3. Escaned J, Collet C, Ryan N, et al, Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study Eur Heart J 2017 Nov 7;38(42):3124-34.

  4. Rodriguez AE, Pavlovsky H, Del Pozo JF. Understanding the Outcome of Randomized Trials with Drug-Eluting Stents and Coronary Artery Bypass Graft in Patients with Multivessel Disease: A Review of a 25-Year Journey. Clin Med Insights Cardiol 2016 Dec 7;10:195-9.

  5. Banning A, Serruys PW,De Maria J, et al. Five years outcome after state-of-the-ar percutaneous coronary revascularization with de novo three vessel coronary artery disease: Final results of the SYNTAX II study Eur Heart Journal 2021,doi 101093/euroheart/ehab703.

  6. Head SJ, Milojevic M, Daemen J, et al. Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data Lancet 2018 Mar 10;391(10124):939-48.

  7. Holm NR, Mäkikallio T, Lindsay MM, et al. NOBLE investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial. Lancet 2020;395(10219):191-9.

  8. Stone GW, Kappetein AP, Sabik JF, et al. EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med 2019;381(19):1820-30.

  9. D’Ascenzo F, De Filippo O, Elia E, et al. Percutaneous vs. surgical revascularization for patients with unprotected left main stenosis: a meta-analysis of 5 years follow-up RCTs. Eur Heart J Qual Care Clin Outcomes 2021Sept 16;7(5).

  10. Rodriguez AE, Fernandez-Pereira C, Mieres J, Santaera O, Antoniucci D; ERACI IV investigators. Modifying angiographic syntax score according to PCI strategy: lessons learnt from ERACI IV Study. Cardiovasc Revasc Med 2015 Oct-Nov;16(7):418-20.

  11. Rodriguez AE, Rodriguez-Granillo AM, Ascarrunz SD, Peralta-Bazan F, Cho MY. Did Prasugrel and Ticagrelor Offer the Same Benefit in Patients with Acute Coronary Syndromes after Percutaneous Coronary Interventions Compared to Clopidogrel? Insights from Randomized Clinical Trials, Registries and Meta-analysis. Curr Pharm Des 2018;24(4):465-77.

  12. Schüpke S, Neumann FJ, Menichelli M, et al. ISAR-REACT 5 Trial Investigators. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med 2019 Oct 17;381(16):1524-34.

  13. Haiek C, Fernández-Pereira C, Santaera O, et al. Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry. Catheter Cardiovasc Interv 2017 Jan;89(1):37-46.

  14. Pavlovsky H. Five-year follow-up of the ERACI IV study: Modified Syntax score for the treatment of multivessel and LMCA. SOLACI/CACI Award Session.SOLACI/CACI Congress, Agosto, 6 2021, Buenos Aires,Argentina.

  15. Palmerini T, Benedetto U, Bacchi-Reggiani L, et al. Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised trials. Lancet 2015;385(9985):2371-82.

  16. Maron DJ, Hochman JS, Reynolds HR, et al. Initial Invasive or Conservative Strategy for Stable Coronary Disease. ISCHEMIA Trial. N Engl J Med 2020 Apr 9;382(15):1395-407.

Autores

Alfredo E Rodríguez
Editor-in-chief The Argentine Journal of Interventional Cardioangiology (RACI).

Autor correspondencia

Alfredo E Rodríguez
Editor-in-chief The Argentine Journal of Interventional Cardioangiology (RACI).

Correo electrónico: arodriguez@centroceci.com.ar

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Revista Argentina de Cardioangiología intervencionista
Issue # 4 | Volumen 11 | Año 2021

Titulo
Benefits of complete functional revascularization with PCI: 5 years results of SYNTAX II and ERACI IV trials

Autores
Alfredo E Rodríguez

Publicación
Revista Argentina de Cardioangiología intervencionista

Editor
Colegio Argentino de Cardioangiólogos Intervencionistas

Fecha de publicación
2021-11-01

Registro de propiedad intelectual
© Colegio Argentino de Cardioangiólogos Intervencionistas

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