Japanese Stable Angina Pectoris Study - JSAP

Oct 20, 2008
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Health and Labour Sciences Research Grant from the Japanese Ministry of Health, Labour, and Welfare and the Japanese Heart Foundation
Date Published:
01/01/2008
Date Updated:
10/20/2008
Original Posted Date:
10/20/2008
References

Description:

The goal of the trial was to evaluate a strategy of percutaneous coronary intervention (PCI) plus medical therapy compared with medical therapy alone in patients with low-risk stable coronary artery disease (CAD).

Hypothesis:

PCI plus medical therapy will be more effective in improving long-term prognosis.

Study Design

  • Randomized
  • Parallel

Patients Screened: 469
Patients Enrolled: 384
Mean Follow Up: 3.3 years
Mean Patient Age: 41-75 years, median 65 years
Female: 25%
Mean Ejection Fraction: 65%

Patient Populations:

  • Patients with low-risk stable CAD between the ages of 30 and 75 years
  • Low risk was defined as one- or two-vessel CAD

Exclusions:

  • High-risk coronary anatomy defined as three-vessel, left in trunk, or ostial left anterior descending artery disease
  • Chronic total occlusion
  • Acute coronary syndrome
  • Left ventricular ejection fraction <50%
  • Comorbidities such as renal insufficiency, pneumonia, or bleeding
  • Bypass graft stenosis

Primary Endpoints:

  • Death, plus acute coronary syndrome, plus cerebrovascular accident, plus emergency hospitalization
  • Acute coronary syndrome was defined as acute MI or unstable angina that required emergency hospitalization.
  • Acute MI was defined as the development of new Q waves on ECG or elevation of cardiac biomarkers more than twice the upper limit of normal.

Secondary Endpoints:

  • Independent components of the primary composite outcome

Drug/Procedures Used:

Patients with low-risk stable CAD were randomized to PCI plus medical therapy (n = 192) versus medical therapy alone (n = 192).

Concomitant Medications:

At baseline, for PCI vs. medical therapy, the use of antiplatelet agents was 92% vs. 91%, beta-blockers was 44% vs. 52%, and statins was 49% vs. 45%, respectively. At 3 years, the use of calcium channel blockers was 50% vs. 59%, beta-blockers was 47% vs. 57%, and nitrates was 36% vs. 54%, respectively.

Principal Findings:

Forty percent of the patients had diabetes. The mean delay from randomization to PCI was 33 days. Stents were used in 76% of PCI, of which all were bare-metal stents. In the PCI group, 21.4% of the patients underwent elective revascularization for refractory angina versus 36.5% of the medical therapy group.

The primary outcome of death, plus acute coronary syndrome, plus stroke, plus emergency hospitalization occurred in 22.0% of the PCI groups versus 33% of the medical therapy group (p = 0.04). The individual outcome of all-cause mortality occurred in 2.9% versus 3.9% (p = 0.79), MI occurred in 1.6% versus 3.8% (p = 0.20), and stroke occurred in 0.6% versus 1.1% (p = 0.98), respectively for PCI versus medical therapy.

Interpretation:

Among low-risk patients with stable CAD, PCI and medical therapy compared with medical therapy alone is safe. This strategy resulted in similar cumulative incidences of death, MI, and stroke. PCI significantly reduced the occurrence of acute coronary syndrome defined as acute MI (new Q waves or cardiac enzymes more than twice the upper limit of normal) or emergency hospitalization for unstable angina.

This trial comes on the heels of the much larger COURAGE trial with longer follow-up that also documented similar incidences of death and MI from a strategy of PCI and medical therapy compared with medical therapy alone. In the COURAGE trial, there was no difference in the endpoint of hospitalization for an acute coronary syndrome.

Limitations of the JSAP trial include the fact that patients with refractory angina who were electively revascularized were excluded from analysis, and the definition of an acute coronary syndrome was nonconventional since troponin-positive patients were not analyzed. Also, it is unclear if the adjudication of unstable angina required dynamic electrocardiography changes.

References:

Nishigaki K, Yamazaki T, Kitabatakeet A, al., on behalf of the JSAP (Japanese Stable Angina Pectoris) Study Investigators. Percutaneous coronary intervention plus medical therapy reduces the incidence of acute coronary syndrome more effectively than initial medical therapy only among patients with low-risk coronary artery disease: a randomized comparative multicenter study. J Am Coll Cardiol Intv 2008;1:469-79.

Keywords: Coronary Artery Disease, Stroke, Acute Coronary Syndrome, Follow-Up Studies, Platelet Aggregation Inhibitors, Calcium Channel Blockers, Percutaneous Coronary Intervention, Stents, Prognosis, Metals, Nitrates, Electrocardiography, Ambulatory, Diabetes Mellitus, Troponin


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