A Call for Professional Stenting: The Balloon Is Dead and Buried!
To the Editor:
We read with interest the article by Narins et al entitled “A Call for Provisional Stenting: The Balloon Is Back!”1 but do not agree with their faint-hearted view about primary use of coronary stents.
First, in-stent restenosis is not a malignant disease. In a prospective study, Bauters et al2 demonstrated, in addition to a very low (25%) restenosis rate after stenting, that most patients (64%) with in-stent restenosis could be effectively and easily treated with repeat percutaneous intervention, with a very low (22%) angiographic restenosis rate and a target-vessel revascularization rate of 17% at 6 months.
Next, the efficacy of stenting in lesions that, by design, were excluded from the STRESS and BENESTENT trials, namely, in restenotic lesions (REST), venous bypass grafts (SAVED), chronic total occlusion (SICCO), and acute myocardial infarction (PAMI Stent Pilot), is being demonstrated. Evaluation of stenting in small vessels, long lesions, and other subsets is under way.
Third, the economic costs of stenting can be reduced by many methods (eg, market competition, generic stents, and homemade stents3 ). We believe that a small piece of metal should be more cost-effective than sophisticated adjunctive equipment, such as intravascular ultrasound probes or Doppler flow wires, and than expensive drugs such as glycoprotein IIb/IIIa blockers.4
Fourth, long-term data exist to confirm the lack of late sequelae associated with permanent implantation of metallic devices in the coronary wall. Late improvement in luminal diameter appears to occur even as much as 6 months to 3 years after implantation.5 The first self-expanding and balloon-expandable stents were implanted >10 years ago without any reported late sequelae.
Finally, even if the strategy of planned stent placement has not yet been documented to be superior to one of aggressive balloon angioplasty with provisional stenting in all patient or lesion subsets, coronary stenting, a revolutionary breakthrough, has already become the predominant means of coronary revascularization at the end of this century. Waiting for early recoil for 30 minutes after balloon dilation is certainly a good idea, but because restenosis after balloon angioplasty is mainly due to late remodeling, an alternative and more scientific option would be to leave the patient in the catheterization room for 6 months!
In this era of cost containment, environmentally friendly materials, and low-fat, cholesterol-free, and sugar-free foods, metal-free coronary intervention is certainly politically and ecologically correct, but stent implantation is probably the best way to get a “stentlike” result.
- Copyright © 1998 by American Heart Association
Narins CR, Holmes DR Jr, Topol EJ. A call for provisional stenting: the balloon is back! Circulation.. 1998;97:1298–1305.
Bauters C, Banos J-L, Van Belle E, Mc Fadden EP, Lablanche J-M, Bertrand ME. Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis. Circulation. 1998;97:318–321.
In general, the field of interventional cardiology has distinguished itself from other procedurally based disciplines in demanding that new devices, pharmacological therapies, and strategic approaches be subjected to properly controlled clinical trials before entering into widespread use. We therefore remain intrigued by the seemingly zealous fervor with which many practitioners, apparently on the basis of the allure of the immediate angiographic results and the ease of implantation, support a policy of universal stent implantation. Corcos et al, in their appeal for universal stenting, appear to have misinterpreted and overlooked several important recent studies.
First, in-stent restenosis does indeed remain a highly problematic entity. Despite the study of Bauters et al in which only 22% of 103 patients treated for in-stent restenosis developed recurrent restenosis,R1 among 10 other series involving >600 patients who underwent percutaneous revascularization for in-stent restenosis, recurrent restenosis occurred in 44% (range, 30% to 72%).R2 It is ironic, in light of the claim by Corcos et al that in-stent restenosis is “not a malignant disease,” that we have been forced to enlist the aid of radiation oncologists to approach this condition.
Second, in-stent restenosis remains all too common in the setting of complex (non-STRESS/BENESTENT) lesion types, which constitute the majority (≈80%) of lesions encountered in clinical practice. In the SAVED trial,R3 routine stent implantation for vein graft lesions was not associated with a significant reduction in the primary end point of angiographic restenosis compared with balloon angioplasty. In the REST trial of restenotic lesions, patients in the balloon angioplasty arm in whom “stent-like” results were achieved had an identical low rate of clinical restenosis as patients treated with stent implantation.R4 Recently reported 30-day results from the PAMI stent trial demonstrated a trend toward more frequent restoration of TIMI-3 flow in balloon angioplasty versus stent-treated patients in the setting of acute myocardial infarction. Furthermore, among >2000 patients reported in several series of long stents (>15 mm) or multiple stent implantation, in-stent restenosis developed in 36.7%.R2
Additionally, contrary to the supposition of Corcos et al, 30-day data from the 2399-patient EPILOG-stent trial strongly favors a strategy of provisional stenting with adjunct IIb/IIIa receptor antagonists. Compared with patients assigned to planned stent placement with placebo, the strategy of balloon angioplasty with abciximab was associated with significant reductions in myocardial infarction (5.3% versus 9.6%, P=0.001) and major adverse cardiac events at 30 days (6.9% versus 10.8%, P=0.007) despite a remarkably low (19%) use of provisional stenting. Restenosis and cost-effectiveness data are forthcoming.
As practicing interventional cardiologists, we are aware of the angiographic allure of stent implantation, especially in the presence of long stenoses or diffuse coronary disease. However, given clear improvements in the results of balloon angioplasty, with the availability of stents as backup devices, the presence of provocative early randomized data suggesting that a strategy of provisional stenting may yield short- and long-term results equivalent to universal stenting, and the still unsolved issues of in-stent restenosis and the costliness of stenting, we hope, in the proud tradition of interventional cardiology, that the optimal strategy for stent use is determined by properly designed trials rather than passionate hyperbole.
Bauters C, Banos J-L, Van Belle E, Mc Fadden E, Lablanche J-M, Bertrand M. Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis. Circulation. 1998;97:318–321.
Narins C, Ellis S. Prevention of in-stent restenosis. Semin Intervent Cardiol. In press.
Shah V, Haude M, Erbel R, Hopp HW, Macaya C, Nobuyoshi M, Probst P, Meyer J, for the REST Investigators. Long-term follow-up of “stent-like” post-PTCA results (<30% residual diameter stenosis) in restenotic lesions: results of the REST trial. J Am Coll Cardiol. 1997;29(suppl A):77A. Abstract.