Risk profile and 3-year outcomes from the SYNTAX percutaneous coronary intervention and coronary artery bypass grafting nested registries

JACC Cardiovasc Interv. 2012 Jun;5(6):618-25. doi: 10.1016/j.jcin.2012.02.013.

Abstract

Objectives: 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).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary* / adverse effects
  • Angioplasty, Balloon, Coronary* / instrumentation
  • Angioplasty, Balloon, Coronary* / mortality
  • Cerebrovascular Disorders / etiology
  • Cerebrovascular Disorders / mortality
  • Coronary Artery Bypass* / adverse effects
  • Coronary Artery Bypass* / mortality
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / surgery
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents
  • Female
  • Heart Diseases / etiology
  • Heart Diseases / mortality
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Patient Selection
  • Prospective Studies
  • Registries
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00114972