Complex Lesions

The challenges presented by different types of complex lesions in PCI are summarized in the figure below. One of reasons that complex lesions are considered challenging is that they increase the risk of thrombus formation and distal embolization. They do this in two ways: disrupted blood flow and exposure to thrombogenic material. From a procedural perspective, they can be more technically challenging for the physician.

Complex lesions are a challenge in PCI, as evidenced by the following facts:

ReoPro reduces in-lab PCI complications

Abciximab significantly reduced the incidence of angiographic complications during coronary stenting by 29% (P = 0.001) when compared with placebo in all patients in the EPISTENT trial.
Incidence of Angiographic Complications in Abciximab and Placebo Groups3

Angiographic Complications

Placebo
(n=803)

Abciximab
(n=784)

P value

Any angiographic complication

191 (23.8%)

133 (17.0%)

0.001

Major or minor coronary dissection

133 (16.6%)

94 (12.0%)

0.009

Final TIMI flow <3

36 (16.6%)

19 (2.5%)

0.024

Any vessel occlusion

41 (5.1%)

20 (2.6%)

0.008

  Side branch occlusion

36 (4.5%)

19 (2.4%)

0.025

  Other vessel occlusion

5 (0.6%)

1 (0.1%)

0.218*

Transient coronary occlusion

19 (2.4%)

11 (1.4%)

0.159

Residual stenosis >50%

12 (1.5%)

6 (0.8%)

0.170

Referred for urgent coronary
  bypass surgery

4 (0.5%)

5 (0.6.%)

0.750*

Thrombus postintervention

12 (1.5%)

11 (1.4%)

0.879

Distal embolization

10(1.2%)

10 (1.3%)

0.957

Localized perforation

2 (0.2%)

2 (0.3%)

1.0*

*Fisher's exact test used

Chart showing incidence of any angiographic complications

Chart showing incidence of coronary dissection

Chart showing incidence of side branch occlusion

The primary endpoint of the EPISTENT trial was death, MI, or urgent intervention at 30 days (ReoPro + stent 10.8%, P<.001, relative reduction 51%; ReoPro + baloon 6.9%, placebo + stent 10.8%, P=.007, relative reduction 36%)4

ReoPro improves long-term outcomes

One year outcomes

"...patients with complex or non-STRESS/BENESTENT-like lesions have a pronounced benefit from the use of stents with adjunctive abciximab with respect to death, MI, and TVR."5

Chart reflecting one year outcomes

For one year mortality, there was a considerable overall reduction amoung patients assigned to stent and ReoPro compared to stent alone, balloon alone or balloon + ReoPro.

Chart showing MI rates at 1 year in stented patients with complex anatomy

The primary endpoint of the EPILOG trial was death, MI, or urgent revascularization at 30 days (ReoPro + low-dose heparin 5.2%, placebo + standard-dose heparin 11.7%, P<.001, relative reduction 56%; ReoPro + standard-dose heparin 5.4%, placebo + standard-dose heparin 11.7%, P<.001, relative reduction 54%)6

Chart showing mortality rates at 1 year in stented patients with complex anatomy

The primary endpoint of the EPISTENT trial was death, MI, or urgent intervention at 30 days (ReoPro + stent 5.3%, placebo + stent 10.8%, P.001, relative reduction 51%; ReoPro + balloon 6.9%, placebo + stent 10.8%, P=.007, relative reduction 36%)4

Data from earlier studies with balloon angioplasty were not suggestive of the same mortality benefit.

Page references
  1. White JC, Ramee SR, Collins TJ, et al. Coronary thrombi increase PTCA risk. Angioscopy as a clinical tool. Circulation. 1996;93(2):253-258.
  2. Internal Marketing Research, ReoPro White Paper
  3. Islam MA, et al. Am J Cardiol. 2002;90:916-921.
  4. The EPISTENT Investigators. Lancet. 1998;352:87-92.
  5. The EPILOG Investigators. N Engl J Med. 1997;336:1689-96.
  6. Cura FA, et al. Circulation. 2000;102:32-33.

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