Patients win in LE MANS

Powerful new data emerged yesterday with the first report from the LE MANS substudy of the SYNTAX trial. Patients with left main (LM) disease and a low SYNTAX Score now seem to have two genuine treatment options, thanks to data suggesting that drugeluting stent (DES) revascularisation can achieve 92% patency at 15 months. Session Chairs Marie-Claude Morice and Pieter Kappetein raced through a packed programme beginning with the new LE MANS data. “Our objective is to drive understanding of revascularisation options for left main disease” said Dr Morice "since angiographic patterns, haemodynamic consequences and clinical symptoms of restenosis are not well defined in larger vessels such as the left main."

LE MANS used a new sub-protocol and fresh consent, plus Quantified Coronary Angiography (QCA) and the TAXUS^TM Express2™ stent to better define long-term vascular responses for both CABG and PCI.

Primary end points for PCI were rates of longterm patency (<50% stenosis) and for CABG the ratio of obstructed/occluded (=50% stenosis) grafts / anastomoses. Formal statistical comparisons between the two arms cannot be made, due to differing modalities and primary endpoints, but 92% of PCI-treated LM lesions had <50% stent stenosis at 15 months (98% non-distal / 90% distal). Fifty three percent had complete territory revascularisation compared with 67% at baseline. Far from being an anomaly, Pieter Kappetein pointed out that these comparatively low numbers occurred in both arms and reflected tighter criteria and more accurate quantitative measures than in other less rigidly controlled studies.

In-stent stenosis (46% = 50% diameter) was significantly associated with MACCE (p=0.0003), mainly for repeat interventions. The acute gain was lower for distal left main lesions (1.5/1.2 mm) than for non distal lesions (1.8 mm) but with similar late loss.

For the CABG group the obstruction/occlusion rate at 15 months was higher at 16% of grafts (10% total occlusion plus 6% >50% occluded) but unlike the PCI cohort, graft patency was not significantly associated with MACCE, due to the standard practice of providing for some graft redundancy at operation. Bilateral mammary grafting offers survival benefits in both diabetic and non-diabetic patients, since any restenosis is likely to affect a smaller territory, but it does carry higher risks of deep sternal infection.

During the discussion which ensued, it was agreed that ultimately 5 year survival and Quality of Life for survivors would be the most relevant outcome measures in all cases. Nevertheless, pending those data, the use of PCI in LM disease now seems a much more realistic option than it has to date, subject to team discussions and agreement with complete patient information. However even landmark international studies need to be applied in local daily practice.

There were three case studies using the SYNTAX Score in LM disease presented today. Lief Thuesen presented the first case – a 57 year old non-diabetic male with stable angina CCS II, SYNTAX Score 11 and EuroSCORE 0, Logistic 0.88% - i.e. a low risk case for surgery and therefore suitable for either CABG or PCI. The patient agreed to enter the Nordic-Baltic LMPCI vs. CABG study and was randomised into the PCI arm where angiography showed an ostial upper LM stenosis. The patient underwent PCI lasting 25 minutes using a 4.5 mm balloon inflated to 24 atmospheres. Overall flouro time was 6.1 min and used 85 ml of contrast medium and he was discharged home the following day and had no angina at 1-month clinical follow-up. This uncomplicated case not surprisingly demonstrates the excellent short-term result of non-bifurcational ULM PCI that can be expected in patients with a SYNTAX Score <22.

Two complex registry surgical cases were described by Pieter Kappetein, who commented on the change in practice since SYNTAX began, whereby better than expected results are being achieved, although the rule still applies that the reference therapy for high SYNTAX scoring patients remains CABG.

Adrian Banning presented the third and final case of an overweight 68 year old female (BMI 31) with Type 2 diabetes, hyperlipidaemia and hypertension. She presented with unstable angina, a SYNTAX Score of 29 and EuroSCORE of 3. He described the PCI which evolved due to peri-procedural complications which arose, though thankfully with a good symptomatic and angiographic outcome to date.

During the lively discussion the importance of surgeon/cardiologist cooperation was emphasised, along with the need for longer term data before current guidelines could be formally changed, except possibly to offer PCI nowadays as a valid option to the reference treatment in low SYNTAX Score uncomplicated LM cases.

To practice calculating your patients′ SYNTAX Score go to www.syntaxscore.com. If you have problems or even suggestions how the site might be improved, be sure to email your thoughts.