Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Registry - SYNTAX Registry

Description:

The goal of this registry was to describe outcomes in patients with severe three-vessel disease (3-VD) or left main (LM) disease, who were not eligible for entry into the SYNTAX randomized trial.

Hypothesis:

This registry describes outcomes in patients who were screened for the SYNTAX trial, and were considered candidates for PCI alone, or CABG alone, but not both.

Study Design

Study Design:

Patients Enrolled: 1,275
Mean Follow Up: 12 months
Mean Patient Age: 71.2 years (PCI), 65.7 years (CABG)

Patient Populations:

  • De novo coronary artery disease
  • Coronary anatomy suitable for either CABG or PCI, not both

Exclusions:

  • Previous PCI
  • Acute MI with creatine-kinase >2 × ULN
  • Concomitant cardiac surgery

Primary Endpoints:

Major adverse cardiovascular events or MACCE

Secondary Endpoints:

  • Death
  • MI
  • CVA
  • Death, MI, or CVA

Drug/Procedures Used:

All patients in the PCI arm received TAXUS (paclitaxel-eluting) stents, whereas all patients in the CABG arm underwent on- or off-pump bypass.

Principal Findings:

Of all the patients who were screened for the SYNTAX trial, a team consisting of a surgeon and an interventionalist decided if the anatomy was suitable for both CABG and PCI, CABG only (technically not feasible for PCI), or PCI only (inoperable). The patients who were amenable to both options constituted the study population for the SYNTAX trial. The outcomes of the other two groups of patients are described here.

A total of 198 patients were enrolled in the PCI only registry, of which 12-month follow-up data were available for 191 patients. The main reasons for being inoperable were the presence of other comorbidities, such as chronic obstructive pulmonary disease (70.7%) unavailability of graft material (9.1%), and patient refusal (5.6%). About 35.4% of the patients had diabetes, with 40.4% having evidence of prior myocardial infarction (MI). Unstable angina was present in about 38% of the patients, and the additive mean EuroSCORE was high (5.8). The total SYNTAX score was 31.6 ± 12.3.

About 64.4% of the patients had bifurcation or trifurcation lesions. The mean number of lesions was about 2.5 ± 1.3, with about 3.1 stents implanted per patient. Long-stenting (>100 mm) was performed in 12.2% of the patients.

A total of 1,077 patients were enrolled in the CABG only registry, of which 12-month follow-up data were available for 633 patients. The main reasons for being not feasible for PCI included complex anatomy (70.9%), untreatable chronic total occlusion (22.0%), and inability to take antiplatelet medications (0.9%). Only a small proportion of patients (0.5%) refused PCI in favor of CABG. About 29.7% of the patients had diabetes, with 33.5% having evidence of prior MI.

Unstable angina was present in about 21.6% of the patients, and the additive mean EuroSCORE was 3.9. The total SYNTAX score was 37.8 ± 13.3. Off-pump CABG was performed in 18.6% of the patients, and 96.7% of the patients had at least one arterial graft, (94.7% with an arterial graft to the left anterior descending).

Twelve-month rates in the PCI registry were as follows: all-cause mortality (7.3%), cerebrovascular accident (CVA) (0%), MI (4.2%), repeat revascularization (12.0%), major adverse cardiac and cerebrovascular events (MACCE) (20.4%) and death, CVA, or MI (10.5%).

Twelve-month rates in the CABG registry were as follows: all-cause mortality (2.5%), CVA (2.2%), MI (2.5%), repeat revascularization (3.0%), MACCE (8.8%) and death, CVA, or MI (6.6%).

Interpretation:

The SYNTAX Registry describes outcomes of the PCI and CABG registries, based on patients who were not eligible to enter the SYNTAX trial. About 6.4% of all-comers with LM and/or 3-VD are considered inoperable, and more than one-third (35%) are deemed not technically feasible for PCI, mainly due to complex anatomy. CABG in these latter patients is associated with good outcomes. Long-term follow-up of these two cohorts may also help ascertain predictors of adverse events in these patient populations.

References:

Serruys PW, Morice MC, Kappatein AP, et al., on behalf of the SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961-72.

The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery: The SYNTAX Registry. Presented by Dr. Friedrich Mohr at the European Society of Cardiology Congress, Munich, Germany, August/September 2008.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Paclitaxel, Registries, Pulmonary Disease, Chronic Obstructive, Coronary Artery Disease, Myocardial Infarction, Stroke, Follow-Up Studies, Drug-Eluting Stents, Comorbidity, Diabetes Mellitus


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