In previous randomised trials, coronary artery bypass graft (CABG) had consistently been superior to stenting by doubledigit margins. Irrespective of these results in favour of surgery, the number of percutaneous coronary interventions (PCIs) has increased year on year. This may be due to the fact that many patients prefer the less invasive approach; however, it has also been argued that this is the result of cardiologists being the gatekeepers. The results of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial, which were recently presented at the European Society of Cardiology (ESC) meeting in Munich, had been eagerly awaited by all contributing parties. Interventional cardiologists desired a trial with which they could finally dethrone surgeons in a head-to-head comparison of an all-comer patient population. Surgeons needed facts to ascertain their territory and to prove to patients that bypass surgery is not a method of the past but on the contrary is here to stay – even in times of rapid development of interventional devices, knowledge and skills. The results of the trial were equally anticipated by stent companies, who wanted to boost their sales and secure the interventional market in turbulent economic times.
The primary end-point of this non-inferiority trial – defined as all-cause death, cerebrovascular accident, myocardial infarction or any repeated revascularisation (PCI and/or CABG) at 12 months – occurred in more patients undergoing PCI than CABG (17.8 versus 12.1%; p=0.0015). There was no difference between the two groups in terms of myocardial infarction (PCI 4.8%, CABG 3.2%; p=0.11); however, there was a significantly higher risk of revascularisation in the PCI group (13.7 versus 5.9%; p<0.0001) and a significantly higher risk of stroke during bypass surgery (2.2 versus 0.6%; p=0.003).
In this ongoing era of randomised, controlled trials and the ambitious quest for ‘evidence-based medicine’, we have coincidentally become familiar with ambilateral interpretations of trial results. As the shrinking gap in favour of bypass surgery presented in the SYNTAX trial was welcomed by the interventional community as proof of ongoing progress in interventional cardiology, the Wall Street Journal concurrently reported: ‘Heart Surgery Bests Stents, Study Shows In Sickest Patients Bypass Required Fewer Repeats to Treat Re-clogged Arteries’. This trial contained good news for everyone. As Peter Widimsky of University Hospital Královské Vinohrady in Prague put it, “Surgeons are happy because they are still better, and the interventionalists are happy because they are not so bad.”
SYNTAX did not meet its primary end-point, so the trial could not prove that PCI is not inferior to bypass surgery. Is this a clear message? How will patients and their referring physicians interpret this trial and those to come? Will they prefer the significantly higher risk of reintervention after PCI compared with surgery or the significantly higher risk of stroke during bypass surgery? It is likely that we will again face the fact that patients will look at the results in a different way from the statisticians. We will have to accept that patients are individuals with their own views. Some will prefer surgery and some will prefer a catheter intervention – each patient has his or her own ‘end-point’.
We hope you enjoy this edition of Interventional Cardiology, which is dedicated to the exciting and diverse advances in endovascular interventions. Ôûá