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Ann Thorac Surg 2002;74:S1334-S1339
© 2002 The Society of Thoracic Surgeons

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Supplement: Cardiothoracic Techniques and Technologies

Primary stenting versus MIDCAB: preliminary report–Comparision of two methods of revascularization in single left anterior descending coronary artery stenosis

Marek Cisowski, MD^a*, Janusz Drzewiecki, MD, PhD^b, Agnieszka Drzewiecka-Gerber, MD^b, Andrzej Jaklik, MD^b, Wojciech Kruczak, MD^c, Micha Szczeklik, MD^a, Andrzej Bochenek, MD, PhD^a

^a First Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland
^b First Department of First Department of Cardiology, Medical University of Silesia, Katowice, Poland
^c Department of Department of Cardiac Anesthesiology, Medical University of Silesia, Katowice, Poland

* Address reprint requests to Dr Cisowski, Zioowa 47, 40-635 Katowice, Poland.
e-mail: marek.cisowski{at}cardiosurg.pl

Presented at the Eighth Annual Cardiothoracic Techniques and Technologies Meeting 2002, Miami Beach, FL, Jan 23–26, 2002.

	Abstract

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BACKGROUND: Percutaneous revascularization is a well-accepted method of treatment for a single left anterior descending coronary artery (LAD) stenosis. With the introduction of primary stenting, it has become the treatment of choice for a LAD lesion. In the last few years however, the introduction of minimally invasive cardiac surgery, video-assisted left internal thoracic artery (LITA) harvesting, and robotic surgery have raised the question as to whether minimally invasive surgical revascularization would be competitive with percutaneous coronary interventions in cases of single-vessel stenoses.

METHODS: A group of 100 patients with Canadian Cardiovascular Society class II to IV, and angiographically confirmed single critical stenosis of the LAD (type A or B), were treated with direct primary stenting (group 1, n = 50), or with endoscopic atraumatic coronary artery bypass grafting (group 2, n =50).

RESULTS: All patients in a group 1, obtained a very good angiographic and clinical effect. No acute postoperative complications were noted at 1 month of follow-up. However, at 1 month of follow-up, 3 patients (6%) developed restenosis of the LAD, and at 6 months follow-up, 6 patients (12%), developed restenosis of the LAD. In these cases, repeated percutaneous coronary interventions of the target vessel were successfully performed. In group 2, very good operative results were observed. In 1 and 6 months of follow-up, all patients remained asymptomatic. Critical stenosis of the left internal thoracic artery–LAD anastomosis was angiographically documented in 1 case (2%). This patient was successfully treated with balloon angioplasty.

CONCLUSIONS: The study results document the superiority of endoscopic atraumatic coronary artery bypass grafting over direct primary stenting in LAD revascularization, along with the slightly higher costs of the surgical procedure.

	Introduction

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The left anterior descending coronary artery (LAD) is usually the largest of all of the epicardial coronary arteries. It supplies about 50% of left heart ventricle with blood. Stenosis of the proximal part of LAD is found in 44% to 47% of patients who qualify for coronary artery bypass grafting (CABG) [1]. These patients are at high risk, and they require a safe method of revascularization that has good and lasting effect.

Bypass surgery and stenting are associated with a similar incidence of death, myocardial infarction, and stroke. However, the need for revascularization during the first year was still higher after stenting. This difference has diminished once the stent implantation has reduced the risk of restenosis [2, 3].

Introduction of direct primary stenting (PS), new generations of stents, and adjunctive treatment with glycoprotein IIb/IIIa inhibitors have significantly improved the results of percutaneous transluminal coronary angioplasty [4]. Still, the risk of in-stent restenosis is quite high (14% to 26%). The following risk factors have so far been identified for in-stent restenosis: B- and C-type lesions (especially in the proximal segment of LAD), insulin-dependent diabetes mellitus, and arterial diameter of less than 3 mm. In cases of complete LAD occlusion, the incidence of restenosis after stenting it is as high as 41% [4–8].

The advantages of percutaneous coronary intervention (PCI) are unquestionable. It is a minimally invasive procedure, with good short-term effect, a small percentage of complications, and relatively low costs.

In cardiac surgery, left internal thoracic artery bypass grafting (LITA-to-LAD) has become the gold standard. This method has proved to have better survival rate and higher percentage of graft patency (92% in 17-year follow-up) than does grafting with other arteries or veins [9–11].

At the end of the last century, minimally invasive cardiosurgical techniques were developed. This was a step forward to meet patients’ expectations in terms of absolute safety, high effectiveness, minimal trauma, and low amount of perceived pain. The other goal of minimally invasive surgery was to eliminate complications, shorten hospital stay, and enhance patient recovery time, thereby reducing the costs of therapy.

Minimally invasive direct coronary artery bypass (MIDCAB) was the first minimally invasive coronary procedure introduced to cardiosurgery. This technique has evolved into endoscopic atraumatic coronary artery bypass (E-ACAB) due to the introduction and improvement of heart stabilizers, thoracic retractors, and endoscopic methods of LITA harvesting. The MIDCAB technique with approach through the left anterior small thoracotomy (LAST, a method of LITA-to-LAD anastomosis), resulted in effective LITA-to-LAD grafting, with 95% to 98% early and midterm graft patency. The MIDCAB technique carries a very low rate of complications and restenosis. It reduces surgical trauma and gives a satisfying cosmetic effect as well [1, 12–18].

To date, there are no published data that compare stenting and minimally invasive LITA-to-LAD bypass grafting with MIDCAB/E-ACAB in the treatment of the isolated proximal LAD lesion. We designed a prospective, randomized clinical study to investigate the efficacy of these two approaches in a selected group of patients to compare early, intermediate, and long-term effects of stenting and LIMA-to-LAD bypass grafting using the E-ACAB technique.

	Material and methods

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The trial was performed between 2000 and 2001, in a group of 100 patients with isolated A- or B-type lesions (American College of Cardiology/American Heart Association) in the proximal part of the LAD (from the ostium to the first diagonal branch). Patients were randomized into two groups: group 1 (n = 50) underwent PCI with direct primary stenting, whereas group 2 (n = 50) underwent minimally invasive LITA-to-LAD bypass grafting (ie, endoscopic atraumatic coronary artery bypass grafting). Inclusion and exclusion criteria are shown in Table 1.

The study was approved by the Bioethical Committee.

Primary stenting protocol
Three days before the planned procedure, all patients were administered antiplatelet treatment (ticlopidin 250 mg once a day, and aspirin 325 mg twice a day). Those who required an urgent PCI because of unstable coronary disease received ticlopidin 500 mg and aspirin 100 mg orally in the catheterization laboratory just before the procedure. The same doses were repeated 8 and 12 hours thereafter, and ticlopidin was also administered for 4 weeks after the procedure. During the procedure, all patients received heparin at a dose of 100 U/kg, until an activated coagulation time of more than 300 seconds was reached. Primary stenting was done by percutaneous insertion of a mother catheter (6F to 8F) through the femoral artery into the left coronary artery and by preliminary injection of contrast medium into the vessel. The leader was then put through the lesion, into which the low-profile stent on balloon (Tristar, Tera, or Penta–Guidant, Inc, Indianapolis, IN) was inserted. Then it was implanted with high inflation pressure with no preliminary dilation. Each time, angiograms were quantitatively analyzed and the minimal lumen diameter calculated. Stent length and width were chosen based on the reference of end–stenotic segment diameter.

Surgical technique
The LITA was harvested thoracoscopically, and the LITA-to-LAD anastomosis was performed on the beating heart through the LAST. The techniques of thoracoscopic LITA harvest and MIDCAB have been described elsewhere, with a few modifications [19]. The LITA is dissected from its bed from the superior border of the first rib to the fifth or sixth rib with low-flow carbon dioxide insufflation, using a Harmonic scalpel (Ethicon Endo-Surgery, Cincinnati, OH) with AESOP assistance (Computer Motion, Inc, Goleta, CA). All tributaries of the LITA are coagulated with the use of the Harmonic scalpel.

A LAST (3 to 5 cm) incision is made through the fourth or fifth intercostal space. We do not advocate the routine excision of costal cartilage, as adequate exposure can be achieved with retraction of the ribs alone. The LAD is incised, and the anastomosis is performed with a single 7-0 polypropylene running suture under mechanical stabilization (CTS, Cuperino, CA, and recently Computer Motion, Inc, Goleta, CA).

Outcome data
Follow-up physical examinations were scheduled at 30 days, 6 months, and 1 and 2 years after procedure. All follow-up examinations include history taking, physical examination, and stress test. In addition, for the 6-month follow-up examination, we scheduled coronary angiography; and with the 2-year follow-up examination, we plan to perform a final analysis of therapy costs.

The trial protocol included preoperative analysis of: age, sex, risk factors, angina pectoris class (according to Canadian Cardiovascular Society), stress test results, echocardiography, and angiography with inclusion of LITA visualization.

After the procedure, electrocardiography and echocardiography were performed. In addition, we calculated procedure costs, hospital costs, and the cost of complications of treatment.

The end points that would show the effectiveness of revascularization were death, myocardial infarction, and reoccurrence of angina pectoris (ie, a major adverse coronary event [MACE]) that required hospital treatment and repeat revascularization of the target vessel.

	Statistical analysis

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Statistical analysis was performed with CSS Statistica software (StatSoft, Tulsa, OK). Categorial variables were compared using Student’s t test, ² methods, or Fisher’s test for small groups.

	Results

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Demographic data
A total of 100 patients, aged 34 to 64 years (mean 54.6 ± 9.4 years) underwent LAD revascularization. The patient groups were similar with respect to base line demographic and angiographic variables. Details are outlined in Tables 2 and 3.

In both groups, there were some minor complications. In group 1, 2 patients (4%) experienced a local hematoma at the place of entry into femoral artery. In group 2, 2 patients (4%) developed left pleural effusion that required treatment with nonsteroidal antiinflammatory drugs only. Three other patients (6%) complained of significant postthoracotomy pain and required a more elaborate pain management approach.

Average PCI time was significantly shorter than E-ACAB time (35 ± 17.8 vs 110 ± 24.5 minutes, respectively; p < 0.001). The average hospital stay was significantly shorter in group 1 than in group 2 (2.3 ± 0.3 versus 4.5 ± 1.3, respectively; p < 0.001). These two factors mainly influenced the cost of treatment, which was lower by 20% in PCI group. Results of the 30-day follow-up are shown in Table 4.

In group 1, one patient (2%) had arteriosclerosis progression in LAD and four others (8%) had arteriosclerosis progression in the right coronary artery and diagonal branch of LAD. In 2 patients (4%) in group 2, such progression was found in the LAD and right coronary artery (Table 6).

	Comment

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In 1998, in certain centers around the world, a new method of LAD, namely, direct primary stenting (PS), was introduced. In this method a low-profile stent, fixed on a balloon is used. This prevents a heart ischemia in the preliminary dilatation. It also reduces the percentage of arterial dissections, since the procedure is limited only to the stenotic part of the artery and is supposed to limit the restenosis rate. The above-mentioned advantages of PS help to reduce the costs associated with the procedure [20].

Coronary stents have continue to evolve, with improved designs and potential for adjunctive therapy, such as intracoronary radiation, which may reduce the rate of restenosis [1, 4, 5].

Two randomized trials Stent vs Internal Mammary Artery Trial (SIMA) and Arterial Revascularization Therapies Study (ARTS) compared stent implantation with bypass surgery (ie, CABG using arterial conduits) [2–4]. The multicenter SIMA compared stent implantation and LITA-to-LAD grafting in a group of 123 patients with primary isolated stenosis of LAD. The study found that the percentage of major complications (death, myocardial infarction, cerebrovascular events, or restenosis) was the same in both groups; however, the complications of the CABG procedure had a significant influence on therapy costs.

Other prospective studies comparing clinical outcomes of stenting and surgical revascularization of isolated proximal LAD stenosis showed a significantly lower percentage of MACE and reinterventions for the CABG group than for the PCI group (5% and 24%, respectively) in long-term follow-up (27 ± 13 months) [1].

The E-ACAB surgery technique is being considered as a less traumatic option for LITA-to-LAD bypass grafting. This technique may reduce the number of complications and costs associated with classic CABG surgery. Early results prove that minimally invasive LITA-to-LAD bypass grafting is safe, effective, and well accepted by patients. It also allows reduction of treatment costs. These observations allowed us to theorize that E-ACAB procedure could be an alternative to PCI, especially for patients with isolated LAD lesions [14, 16, 18, 19, 21]. Further studies concerning long-term graft patency and clinical long-term follow-up are necessary to confirm the efficacy of this approach.

The present study showed that revascularization of isolated proximal LAD stenosis using PS or E-ACAB resulted in low inpatient morbidity and mortality rates as well as good intermediate-term results. Both angiographic analysis and clinical outcome confirmed that repeated revascularization was required significantly more often after PCI than after LIMA-to-LAD bypass grafting (p < 0.05), and was followed by more recurrence of angina pectoris (p < 0.001).

Observed morbidity in both groups in our study did not require reintervention and did not influence the treatment costs. The cost of surgery and longer hospital stay for group 2 was 20% higher (p < 0.01). Keeping in mind the higher incidence of restenosis in the PCI group, completion of the 2-year follow-up study might give a better comparison of the costs.

The results of our randomized study are not yet complete; however, even at this early stage, some trends are clearly visible. Primary stenting is less expensive than E-ACAB and offers the same degree of protection against death and myocardial infarction. On the other hand, PS is associated with a greater need for repeated revascularization. Both techniques have similar risk of complications. The preliminary higher costs of the surgical treatment might be compensated by the costs of treating post-PCI restenosis.

	References

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