Risk profile and 3-year outcomes from the SYNTAX percutaneous coronary intervention and coronary artery bypass grafting nested registries.
OBJECTIVE
The aim of this study was to evaluate the use of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in "real-world" patients unsuitable for the alternative treatment.


BACKGROUND
No data are available on the risk profile and outcomes of patients that can only undergo PCI or CABG.


METHODS
In the SYNTAX (Synergy between PCI with TAXUS and Cardiac Surgery) trial, a multidisciplinary Heart Team reached a consensus on whether PCI and CABG could result in clinical equipoise; if so, the patient was randomized. If not, the patient was enrolled in a CABG-ineligible PCI registry or PCI-ineligible CABG registry. A proportion (60%) of patients in the CABG registry was randomly assigned to be followed up for 5 years. No statistical comparisons were performed between randomized and registry patients. Major adverse cardiac or cerebrovascular event (MACCE) rates are presented as observational only.


RESULTS
A total of 3,075 patients were treated in the SYNTAX trial; 198 (6.4%) and 1,077 (35.0%) patients were included in PCI and CABG registries, respectively. The main reason for inclusion in the CABG registry was too complex coronary anatomy (70.9%), and the main reason for inclusion in the PCI registry was too high-risk for surgery (70.7%). Three-year MACCE was 38.0% after PCI and 16.4% after CABG. Stratification by SYNTAX score terciles demonstrated a step-wise increase of MACCE rates in both PCI and CABG registries.


CONCLUSIONS
The SYNTAX Heart Team concluded that PCI and CABG remained the only treatment options for 6.4% and 35.0% of patients, respectively. Inoperable patients with major comorbidities that underwent PCI had high MACCE rates. In patients not suitable for PCI, surgical results were excellent. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries, NCT00114972).
Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
Stuart J
SJ
Head
David R
DR
Holmes
Michael J
MJ
Mack
Patrick W
PW
Serruys
Friedrich W
FW
Mohr
Marie-Claude
MC
Morice
Antonio
A
Colombo
A Pieter
AP
Kappetein
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000209:etiology / Q000401:mortality; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006331:Heart Diseases / Q000209:etiology / Q000401:mortality; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome