Correspondence

Coronary-Artery Stenting

N Engl J Med 1996; 335:61July 4, 1996

Article

To the Editor:

Kimura et al. reported (Feb. 29 issue)1 that in patients treated with Palmaz–Schatz coronary-artery stents the rate of survival free of myocardial infarction, bypass surgery, and revascularization of the target lesion was 80.4 percent at one year. This rate is reported to be similar to results reported in the recent Stent Restenosis Study2 and Benestent study3 and markedly higher than the one-year event-free rate of 66 percent given in the 1985–1986 Percutaneous Transluminal Coronary Angioplasty Registry of the National Heart, Lung, and Blood Institute (NHLBI).4 In fact, the definitions of events in the NHLBI registry report and the later trials are not comparable. The registry rate reflects all subsequent procedures, whether for restenosis or new disease, and furthermore involves less stringent criteria for myocardial infarction.

Since 78 percent of the instances of percutaneous transluminal coronary angioplasty repeated within one year in the NHLBI registry involved repeated dilatation of previously treated lesions,5 the conclusion of Kimura et al. that they achieved a comparatively favorable one-year outcome remains valid. Nevertheless, we feel strongly that follow-up reports of new devices should present overall event rates along with device-specific rates. Patency of the target lesion is clearly important, but other outcomes should not be deemphasized.

Richard Holubkov, Ph.D.
Katherine M. Detre, M.D., Dr.P.H.
University of Pittsburgh, Pittsburgh, PA 15261

5 References

1. 1

   Kimura T, Yokoi H, Nakagawa Y, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med 1996;334:561-566
   Full Text | Web of Science | Medline

2. 2

   Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501
   Full Text | Web of Science | Medline

3. 3

   Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994;331:489-495
   Full Text | Web of Science | Medline

4. 4

   Detre KM, Holmes DR Jr, Holubkov R, et al. Incidence and consequences of periprocedural occlusion: the 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1990;82:739-750
   CrossRef | Web of Science | Medline

5. 5

   Detre K, Yeh W, Kelsey S, et al. Has improvement in PTCA intervention affected long-term prognosis? The NHLBI PTCA Registry experience. Circulation 1995;91:2868-2875
   Web of Science | Medline

Author/Editor Response

The authors reply:

To the Editor: Holubkov and Detre argue that follow-up reports of new devices should present overall event rates along with device-specific rates. We did not intend to deemphasize outcomes other than patency of the target lesion. Most randomized trials comparing new devices with balloon angioplasty exclude patients undergoing intervention for multiple lesions. The cohort of patients evaluated for the long-term outcome of Palmaz–Schatz stents represented a consecutive series of patients, including those with multivessel coronary artery disease (53 percent) and those undergoing coronary interventions for multiple lesions (26 percent). When we compare the follow-up outcome in our series with the outcomes in patients enrolled in the randomized trials, it is not appropriate to include repeated procedures for restenosis of nonstented lesions as an end point.

However, we agree that we should include all subsequent procedures as an end point when we are comparing our data with registry data, such as those from the 1985–1986 NHLBI Percutaneous Transluminal Coronary Angioplasty Registry.1

In that registry, the incidences of multivessel coronary artery disease and multiple-lesion coronary angioplasty were roughly similar to ours (51 percent and 38 percent, respectively).2 Our event-free survival rate at one year including all subsequent percutaneous revascularizations still compares favorably with that of the registry data (72 percent vs. 66 percent).

Takeshi Kimura, M.D.
Masakiyo Nobuyoshi, M.D.
Kokura Memorial Hospital, Kitakyushu 802, Japan

2 References

1. 1

   Detre KM, Holmes DR Jr, Holubkov R, et al. Incidence and consequences of periprocedural occlusion: the 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1990;82:739-750
   CrossRef | Web of Science | Medline

2. 2

   Detre K, Yeh W, Kelsey S, et al. Has improvement in PTCA intervention affected long-term prognosis? The NHLBI PTCA Registry experience. Circulation 1995;91:2868-2875
   Web of Science | Medline