Atlantic Cardiovascular Patient Outcomes Research Team−E Trial - CPORT E

Description:

Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines list elective percutaneous coronary intervention (PCI) as a Class III indication for institutions without on-site cardiac surgery. Most of this is based on earlier observational data showing worse outcomes in patients undergoing PCI at such institutions. The current trial sought to study this question in a randomized controlled fashion.

Hypothesis:

Outcomes after PCI at sites without on-site cardiac surgery would be noninferior to PCI at sites with 24/7 cardiac surgery.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Stratified
  • Parallel

Patient Populations:

  • Age >18 years
  • >50% stenosis
  • All target lesions approachable at primary hospital
  • Procedures included: Balloon, stent, distal protection, covered stent, cutting balloon for in-stent restenosis
  • >200 PCIs/year at that institution
  • 24/7 primary PCI
  • Complete formal development program
  • Interventionalist meets ACC/AHA competency

    Number of screened applicants: 99,479
    Number of enrollees: 18,867
    Duration of follow-up: 2.2 years
    Mean patient age: 64 years
    Percentage female: 37%
    Ejection fraction: 54.2%

Exclusions:

  • Unprotected left main
  • Ejection fraction <20%
  • MD-judged high risk
  • Atherectomy
  • Cutting balloon de novo lesion

Primary Endpoints:

  • All-cause mortality at 6 weeks
  • MACE at 9 months
    • All-cause mortality
    • Q-wave myocardial infarction
    • Target vessel revascularization

Secondary Endpoints:

  • PCI success rate
  • Incidence of cardiac surgery, bleeding, stroke, renal failure, and subsequent revascularization

Drug/Procedures Used:

Patients undergoing diagnostic catheterization at sites without on-site cardiac surgery and requiring PCI were randomized in 3:1 fashion to either PCI at that institution or transfer to a site with on-site cardiac surgery.

Principal Findings:

A total of 18,867 patients were enrolled at 60 centers, 14,149 to PCI at sites without on-site cardiac surgery, and 4,718 to sites with on-site cardiac surgery (72 were unassigned). The median procedure volume at these institutions was 150. Baseline characteristics were similar between the two arms. About 80% of the patients were white, 39% had diabetes mellitus, 43% had a prior history of myocardial infarction, and 31% had a history of prior PCI. Of these patients, 64% were undergoing PCI for acute coronary syndrome; 23% of the procedures were either urgent or emergent. There was an even distribution between patients with one-, two-, and three-vessel disease (roughly 28-34%); left main PCI was undertaken in 3% of the patients and saphenous vein graft PCI in about 9%. Per study design, there were more lab visits for the index PCI in the patients randomized to PCI at sites with on-site cardiac surgery (1.73 vs. 1.28, p < 0.0001). PCI failure was higher at sites without on-site cardiac surgery, both at a patient level (3.4% vs. 2.5%, p = 0.007), and at a lesion level (6.6% vs. 5.9%, p = 0.04).

The primary endpoint of all-cause mortality at 6 weeks was noninferior between sites without and with on-site cardiac surgery (0.9% vs. 1.0%, p for noninferiority p = 0.004). At 9 months, rates of major adverse cardiac events (MACE) (death, myocardial infarction, target vessel revascularization [TVR]) were noninferior (12.1% vs. 11.2%, p for noninferiority = 0.05). When coronary artery bypass grafting (CABG) was not included in the definition of MACE, sites without on-site cardiac surgery had inferior MACE rates, as compared with sites with on-site cardiac surgery (11.9% vs. 10.5%, p < 0.0001). Similar inferior results were noted on per-protocol analysis at 9 months (12.0% vs. 10.4%, p < 0.001). Individual endpoints at 9 months such as death (3.2% vs. 3.2%) and myocardial infarction (3.1% vs. 3.1%) were similar; rates of TVR (6.5% vs. 5.4%, p = 0.001) were higher at sites without on-site cardiac surgery.  

Other endpoints such as bleeding (3.4% vs. 3.2%), vascular repair (0.4% vs. 0.4%), stroke (0.3% vs. 0.2%), and renal failure (0.5% vs. 0.4%) were similar (p > 0.05 for all). Rates of all CABG (0.6% vs. 1.5%, p < 0.0001) and emergency CABG (0.1% vs. 0.2%, p = 0.05) were lower at sites without on-site cardiac surgery, while rates of unplanned diagnostic catheterization (4.3% vs. 3.2%, p < 0.001) and unplanned emergent PCI (0.2% vs. 0.1%) were higher at sites without on-site cardiac surgery.

Cost-effectiveness: Estimated medical costs per patient were similar between sites without and with on-site cardiac surgery during index hospitalization ($23,343 vs. $20,372, p = 0.16), but higher during the follow-up period ($5,794 vs. $5,040, p = 0.0004). The latter was especially true for low-volume hospitals ($6,126 vs. $4,918, p = 0.0002), but not at high-volume hospitals ($5,529 vs. $5,211, p = 0.18). Cumulative costs were similar at 9 months between sites without and with on-site cardiac surgery ($29,136 vs. $25,412, p = 0.09), with no differences between high- and low-volume hospitals.

Interpretation:

The results of this trial indicate that nonprimary PCI at sites without on-site cardiac surgery (but which perform 24/7 primary PCI) has short-term (6-week) and long-term (9-month) outcomes that are similar to those achieved at sites with on-site cardiac surgery, although PCI success and TVR at 9 months were better at sites with on-site cardiac surgery.

Current ACC/AHA guidelines list PCI at sites without on-site cardiac surgery as a Class III indication, which may need to be reconsidered, as long as they adhere to the strict criteria listed in this trial (minimum procedural volume, quality improvement, participation in outcomes measurement projects). This would thus be similar to the current Class IIb indication for these institutions to carry out emergent primary PCI. One potential advantage is that this could extend PCI coverage to patients living in areas not in close proximity to PCI centers with on-site cardiac surgery. Long-term outcomes are further awaited.

Cost-effectiveness analyses indicate that cumulative costs at 9 months were similar between sites without and with on-site cardiac surgery. However, there was evidence of slight effect modification by hospital volume, in that low-volume hospitals had a higher burden of follow-up medical costs compared with high-volume hospitals.

References:

Aversano T, Lemmon CC, Liu L, on behalf of the Atlantic CPORT Investigators. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med 2012;366:1792-1802.

Presented by Dr. Eric Eisenstein at the American Heart Association Scientific Sessions, Los Angeles, CA, November 4, 2012.

Presented by Dr. Thomas Aversano at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 25, 2012.

Presented by Dr. Thomas Aversano at the American Heart Association Scientific Sessions, Orlando, FL, November 14, 2011.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Interventions and ACS

Keywords: Myocardial Infarction, Stroke, Acute Coronary Syndrome, Constriction, Pathologic, Cost of Illness, Stents, Percutaneous Coronary Intervention, Quality Improvement, Renal Insufficiency, Saphenous Vein, Catheterization, Cardiac Surgical Procedures, Coronary Artery Bypass, Diabetes Mellitus


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