ApPropRiateness of myOcardial revascUlarization assessed by SYNTAX Scores in patients with type 2 diabetes melliTus: the PROUST study.

INTRODUCTION: Results of currently available trials have shown divergent outcomes in diabetic patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Current guidelines do not recommend PCI in patients with diabetes and a SYNTAX score ≥ 23. AIM: To compare all-cause 4-year mortality after revascularization for complex coronary artery disease (CAD) in diabetics. MATERIAL AND METHODS: The study group comprised consecutive patients with three-vessel CAD and/or unprotected left main CAD (≥ 50% diameter stenosis) without major hemodynamic instability, who were treated in two institutions with PCI or referred for CABG. RESULTS: Out of 342 diabetics, 177 patients underwent PCI and 165 patients were referred for CABG. The incidence of all-cause death was different between diabetics treated with PCI or CABG at 4 years (16/177, 9.0% vs. 26/165, 15.8%, respectively, p = 0.03). The difference was not evident in non-diabetics (PCI: 41/450, 9.1% vs. CABG: 19/249, 7.6%, p = 0.173). In diabetics, there was a higher incidence of all-cause mortality in PCI patients with intermediate-high (≥ 23) SYNTAX scores compared with those with low (0-22) SYNTAX scores (10/56, 17.9% vs. 6/121, 5.0%, respectively, p < 0.01). On the other hand, diabetics who underwent CABG showed similar mortality rates irrespective of the SYNTAX scores (SYNTAX 0-22: 3/29, 10.3%; SYNTAX ≥ 23: 23/136, 11.9%, p = 0.46). In the subgroup analysis, there was no interaction according to presence or absence of left main CAD (p for interaction = 0.12) as well as according to diabetes status (p for interaction = 0.38), whereas gender and SYNTAX scores were differentiators between PCI and CABG with a p for interaction < 0.1. CONCLUSIONS: Our analysis supports recent evidence that diabetes is not a differentiator between PCI and CABG.

ApPropriateness of myocaRdial RevascularizatiOn assessed by the SYNTAX score II in a coUntry without cardiac Surgery faciliTies; PROUST study.

BACKGROUND/OBJECTIVES: The SYNTAX Score II (SSII) was proposed as a novel approach for objective individualized decision-making for optimal myocardial revascularization i.e. percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. We sought to investigate how many lives may be saved by SSII use. METHODS: A total number of 651 consecutive SSII-naive-patients with complex coronary artery disease who were treated with PCI (n=409) or referred to other institutions for CABG (n=242) were included. All-cause mortality was ascertained in 96% of patients. The SSII was calculated for each patient. RESULTS: Based on the SSII treatment recommendation, CABG would have been the treatment of choice in 257/651 (39.5%) patients, PCI in 7/651 (1.1%) patients and CABG or PCI in 387/651 (59.4%) patients. Out of 257 patients in whom the treatment recommendation by SSII was CABG, 113/257 (44.0%) patients had actually CABG, while the remaining 144/257 (56.0%) underwent PCI. It was shown that 144/257 patients with treatment recommendations in favour of CABG who were treated with PCI had significantly higher mortality at 4years when compared with patients with SSII treatment recommendation for PCI or equally favouring CABG and PCI (12.5% vs. 0.0% vs. 6.9%, respectively, P=0.04). CONCLUSION: The intuitive decision-making for choosing the optimal myocardial revascularization method differed predominantly from the SSII recommendation for CABG. The discordance between the SSII recommended revascularization strategy and the clinical decision was associated with a higher 4-year mortality i.e. one life may be saved if SSII would be calculated and followed consequently in 18 patients.

Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease.

AIMS: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. METHODS AND RESULTS: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. CONCLUSIONS: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena.

Risk stratification in 3-vessel coronary artery disease: Applying the SYNTAX Score II in the Heart Team Discussion of the SYNTAX II trial.

BACKGROUND: Heart Team (HT) and the SYNTAX Score II (SSII) have been integrated to the contemporary guidelines with the aim to provide a multidisciplinary decision-making process between coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). AIMS: To prospectively assess the agreement between the HT decision and the SSII recommendation regarding the revascularization strategy in patients with 3-vessel coronary artery disease (CAD) of the SYNTAX II trial. METHODS: The SSII predicts the 4-year mortality of an individual patient both after PCI and after CABG. Patients were treated by PCI when the SSII predicted a mortality risk favoring PCI or when risk predictions were equipoise between PCI and CABG. However, the HT could overrule the SSII and recommend either CABG or PCI. RESULTS: A total of 202 patients have been screened and 24 did not fulfill inclusion criteria. The median age was 67.0 (IQR 59.0-73.3), and 167 (82.7%) were male. The HT endorsed SSII treatment recommendation, for CABG or PCI, in 152 patients (85.4%). Three patients had preference for PCI, irrespective of the HT decision. The main reason for the HT to overrule the SSII and recommend CABG was the prospect of a more complete revascularization (21 of 25 patients). Patients recommended for CABG by the HT had significantly higher anatomical SYNTAX score (P = 0.03) and higher predicted mortality risk for PCI (P = 0.04) when compared with patients that were enrolled in the trial. CONCLUSION: The SYNTAX score II showed to be a suitable tool for guiding treatment decisions of patients with 3-vessel coronary artery disease being endorsed by the HT in the vast majority of the patients that have been enrolled in the SYNTAX II trial.