PTCA and Stents: Underwriting Perspective
Underwriting Q & A

One third of patients with coronary artery disease (CAD) will undergo coronary artery angioplasty (PTCA) and stenting.

561,000 PTCAs were performed in the United States in 2000.

The primary problem with PTCA is “restenosis,” which is a closing of the coronary artery following balloon dilatation. Approximately 30% of all coronary arteries begin to close up after PTCA. Stents were created to address this complication. Here is how they work:

In 1994 the first stent approved for use in the United States; it was called the Palmaz-Schatz.

While the Palmarz-Schatz stent eliminated many of the complications of PTCA, restenosis still remained a problem, occurring around six months, post-PTCA, in about 25% of the cases.

Why was this happening despite the presence of a stent? The issue came down to the “injury” to the coronary artery wall caused by the PTCA procedure itself. In essence, the body’s response to the balloon expansion of the blocked artery was to grow smooth muscle cells at the PTCA site in an attempt to repair what it saw as an “injury.”

It became clear that a mechanical device alone was not going to solve the biological response of the body. In the 1990’s researchers begin looking to pharmacological coatings on the stents to interrupt the restenosis process. The first attempts were unsuccessful. However, by 2002 two new pharmacological agents dramatically improved the effectiveness of coated stents.

The first was a drug called sirolimus, which is found in the soil of Easter Island. It is used with the Cypher stent (manufactured by Johnson & Johnson). In its first clinical trial, the Cypher stent demonstrated an impressive reduction in the restenosis rate during the first year after PTCA.

The second was a drug called paclitaxel. It is used with the Taxus stent (manufactured by Boston Scientific). Like the Cypher stent, the Taxus stent showed a marked reduction in the rate of restenosis in clinical trials.

Both of these stents, Cypher and Taxus, are called drug-eluting stents.

On April 23, 2003 the FDA approved the Cypher stent for use in the United States. It is the first drug-eluting stent to receive FDA approval.

The Cypher stent was an overwhelming marketing success. Patients wanted it and demand soon exceeded supply. Johnson and Johnson estimates that 450,000 Cypher stents have been implanted since the April 2003 FDA approval.

However, by June 2003 the FDA has issued a warning to physicians regarding possible clotting complications with the Cypher stent.

In October 29,2003 the FDA issued a second warning on the Cypher stent regarding possible “adverse events.” Specifically, the FDA had received more than 290 reports of clotting between one to 30 days of using the Cypher stent. In more than 60 of these reports, use of the Cypher stent was associated with death of the patient.

What does this mean in terms of increased risk to patients undergoing PTCA? In general there is about a 1-2% complication rate for non-drug-eluting stents. The adverse reactions reported with the Cypher stent fits this profile. While there is much more to learn about drug-eluting stents, it appears that the Cypher stent is working well for the vast majority of patients who have received it.

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Underwriting Q & A

Q: Does an applicant for life insurance who has a history of PTCA get a better offer if they have received a stent?

A: No. Receiving or not receiving a stent is only a small piece in the cardiac risk profile. Life expectancy for applicants with a history of PTCA is predicated on many other variables (see below).

Q: Will applicants who have had a Cypher stent implanted be rated higher than applicants with a non-drug-eluting stent?

A: No. The Cypher stent appears to have the same complication rate as non-drug-eluting stents and does not impose an additional mortality risk.

Q: What are the key screening questions for an applicant who has undergone a PTCA?

1) Does the client currently smoke?

Underwriting Comment: Clients who have had coronary angioplasty and continue to smoke may not be insurable. Smoking is a major risk factor for heart disease and one that can have a dramatic impact on outcome (i.e. life expectancy). The good news is that clients who have had coronary angioplasty and quit smoking have better survival rates and better pricing for life insurance.


2) When did the client have the coronary angioplasty?

Underwriting Comment: Clients with an uncomplicated coronary angioplasty are insurable 6 months after the procedure. The "failure rate" (i.e. the closing of the opened coronary artery) can be as high as 30% in the first 6 months following the original procedure.


3) How many blockages were opened via angioplasty?

Underwriting Comment: It is important to know whether the underlying disease of the coronary arteries involves one or more arteries. Clients may not know the exact nature of their coronary disease (i.e. single vessel versus multiple vessel). They may know how many blockages were treated. There is a marked pricing difference between single vessel coronary disease and multiple vessel coronary disease.

4) Did the client have a heart attack before the angioplasty?

Underwriting Comment: It is important to know if the client had a heart attack before the angioplasty procedure. Clients who have not had a heart attack are priced different than clients who have sustained some form of damage to the heart muscle. Both clients may prove insurable, but the pricing will be higher for the prior heart attack clients.

5) Has the client had any chest pain since the coronary angioplasty procedure?

Underwriting Comment: Any reoccurrence of chest pain signals a return of the original problem (i.e. significant blockage of a coronary artery). Clients who experience chest pain in the post-angioplasty period, regardless of the time since the procedure, are uninsurable.

6) Has the client had any follow-up cardiac tests since his or her coronary angioplasty (i.e. treadmill ECG,thallium treadmill, stress-echo treadmill)? If yes, was he or she told the results were “normal?”

Underwriting Comment: Follow-up cardiac testing provides objective evidence that the coronary angioplasty was successful. Thallium treadmills and stress-echo treadmills provide more useful information than a basic treadmill ECG. Any follow-up cardiac testing that is abnormal will result in the client being highly rated or declined for individual coverage.

7) What medications is the client currently taking?

Underwriting Comment: An uncomplicated coronary angioplasty is usually managed with minimal medications following the procedure (i.e. aspirin). A complicated angioplasty is managed with more potent medications such as Lanoxin, Imdur, Isordil or nitroglycerin. The medications will provide a very important pricing insight into not only the insurability of the client, but the actual pricing costs.

8) Is the client currently involved in any form of cardiac rehabilitation or undergone any lifestyle changes (i.e. quit smoking, began an exercise program, changed diet, etc.)?

Underwriting Comment: Lifestyle changes can have an enormous impact on the underwriting outcome for a cardiac case. There are excellent medical studies that verify that mortality outcome is greatly improved with positive lifestyle changes such as quitting smoking or beginning an exercise program. It is important that you document all lifestyle changes that would indicate a decrease in any cardiac risk factors.