Limited data are available on the effect of rotational atherectomy plus stenting versus rotational atherectomy plus balloon angioplasty for complex coronary lesions. We compared the early and late clinical outcomes between rotational atherectomy plus stenting (158 patients, 171 lesions) and rotational atherectomy plus balloon angioplasty (165 patients, 186 lesions) for complex lesions. Baseline characteristics were similar between the two groups. The procedural success rate was similar between the 2 groups (94% in rotational atherectomy plus stenting versus 96% in rotational atherectomy plus balloon angioplasty; p = 0.54). There were no significant differences in the in-hospital complications between the 2 groups. During mean follow-up of 40.4 ± 20.2 months, fourteen patients died: 6 in rotational atherectomy plus stenting and 8 in rotational atherectomy plus balloon angioplasty. Target lesion revascularization was similar between the 2 groups (20% in rotational atherectomy plus stenting versus 24% in rotational atherectomy plus balloon angioplasty; p = 0.46). Three-year event (death, nonfatal myocardial infarction and target lesion revascularization)-free survival rate was 79 ± 4% in the rotational atherectomy plus stenting group and 75 ± 3% in the rotational atherectomy plus balloon angioplasty group (p = 0.44). In conclusion, rotational atherectomy followed by stenting or balloon angioplasty is associated with favorable long-term outcomes. Compared with rotational atherectomy plus balloon angioplasty, routine stenting after rotational atherectomy does not provide additional benefits in the clinical outcomes in complex coronary lesions.

       Despite the evolution of interventional techniques and operator experience, percutaneous revascularization of complex coronary lesions (i.e., calcified and long lesions) remains challenging because of lower procedural success rates and higher restenosis rates.1–4 Intravascular ultrasound study has demonstrated that increased coronary calcium is an important determinant of decreased wall compliance,5 and leads to a high incidence of dissections when these lesions are treated with balloon angioplasty. If coronary stenting is performed in this setting, an incomplete and asymmetric stent expansion occurs in up to 50% of cases.6 In addition to a low rate of procedural success and a high rate of late restenosis, long coronary lesions also usually have other clinical or angiographic features, including diabetes mellitus, multi-vessel disease, more calcific lesions and even unsuitable anatomy for coronary bypass surgery. Therefore, percutaneous treatment of long lesions has been a therapeutic challenge.
       Rotational atherectomy abrades fibrocalcific plaque and avoids disruption of soft elastic tissue, and vascular compliance may be improved by removing plaque from the lesions.7 Therefore, rotational atherectomy may be a useful therapeutic option for complex lesions in which the lesion characteristics are unfavorable for balloon angioplasty.8,9 Recently, stenting following rotational atherectomy was shown to be a promising strategy for complex lesions.7,10,11 However, few data are available on the comparison between rotational atherectomy plus stenting and rotational atherectomy plus balloon angioplasty in complex coronary lesions. Therefore, we retrospectively evaluated the early and late clinical outcomes between rotational atherectomy plus stenting versus rotational atherectomy plus balloon angioplasty for complex coronary lesions.

Methods
       Study populations. From November 1997 to November 1999, rotational atherectomy for complex coronary lesions was performed in 323 patients (225 males and 98 females) with 357 lesions. A total of 171 lesions in 158 patients were treated with rotational atherectomy plus stenting and 186 lesions in 165 patients were treated with rotational atherectomy plus balloon angioplasty. All patients had objective evidence of myocardial ischemia and > 70% angiographic diameter stenosis by visual estimate. Informed written consent was obtained from each patient.
       Rotational atherectomy technique. Rotational atherectomy was performed using the standard femoral approach and a step-up burr technique, generally beginning with 1.5 mm or 1.75 mm burrs and increasing to a final burr size corresponding to the reference diameter. The rotational burr was slowly advanced with a high-speed rotation (> 160,000 rpm). Adjunctive balloon angioplasty was performed using balloons sized with balloon-to- artery ratios of 1.1:1. Stents were deployed by inflating the stent delivery balloon with a nominal pressure and, if necessary, adjunctive high-pressure balloon dilatation was performed to achieve angiographic optimization (residual diameter stenosis < 10% by visual estimate). During the procedure, patients received 10,000 units bolus heparin with repeated boluses of 5,000 U to maintain the activated clotting time > 250 seconds. All patients received 200 mg aspirin indefinitely. Stented patients were treated with aspirin (200 mg daily, indefinitely) and ticlopidine (250 mg twice daily for 1 month).
       Quantitative coronary angiographic (QCA) analysis. Coronary angiography was performed after the administration of 0.2 mg intracoronary nitroglycerin. Two experienced investigators who were not aware of the study purpose analyzed the coronary angiogram. Using the guiding catheter for calibration and an online QCA system (Ancor, version 2.0; Siemens, Erlangen, Germany), minimal luminal diameter and reference vessel diameter were measured before and after intervention from diastolic frames in single, matched views showing the smallest luminal diameter. Lesion length was measured as the distance from the proximal to the distal shoulder of the lesion in the least foreshortened projection. Complex lesions were defined as type B2 and type C lesions according to American Heart Association/American College of Cardiology classification.12 Lesion calcification was defined as radiopacity at the site of the target lesion, visible on fluoroscopy.13 Long lesions were defined as >= 20 mm.
       In-hospital outcomes. Procedural success was defined as < 30% final diameter stenosis in the treated lesions and absence of major clinical complications [in-hospital death, Q-wave myocardial infarction (MI) or emergency coronary bypass surgery]. Other procedure-related complications included non-Q wave MI, perforation, abrupt closure and reintervention during hospital stay.
       Long-term clinical follow-up. All patients were requested to visit the outpatient clinics at regular intervals (every 3–4 months after intervention). Follow-up information was obtained by hospital chart review or telephone interview. The occurrence of major adverse cardiac events, including death, nonfatal MI and target lesion revascularization, was recorded. Deaths were classified as either cardiac or noncardiac. Deaths that could not be classified were considered cardiac. The diagnosis of MI was based on CK-MB elevation >= 3 times normal or the appearance of new electrocardiographic or echocardiographic changes.

Figure 1

Cumulative probability of survival free from target lesion revascularization. There were no significant differences between the two groups.

       Statistical analysis. Statistical analysis was performed with SPSS software program (version 9.0). Categorical data are presented as frequencies. Continuous data are presented as means ± standard deviations. Comparisons were performed with unpaired t-tests and Chi-square tests. Survival and event-free survival (freedom from death, nonfatal MI and target lesion revascularization) distributions were estimated according to Kaplan-Meier method, and the overall incidence of major adverse cardiac events was tested using the log-rank test. A two-sided p-value < 0.05 was required for statistical significance.

Results
       There were no significant differences in the baseline clinical characteristics between the 2 groups (Table 1). The baseline angiographic characteristics are shown in Table 2. Preintervention minimal lumen diameter was similar between the 2 groups. However, after therapy, post-intervention minimal lumen diameter was larger with rotational atherectomy plus stenting compared with rotational atherectomy plus balloon angioplasty (2.97 ± 0.98 mm versus 2.87 ± 0.64 mm; p < 0.001). Lesion length and morphology by American Heart Association/American College of Cardiology classification were also similar between the 2 groups. In-hospital complications are shown in Table 3. Procedural success rate was 94% for rotational atherectomy plus stenting and 96% for rotational atherectomy plus balloon angioplasty (p = 0.54). There were no significant differences in the in-hospital complications between the 2 groups. Clinical follow-up was available in all living patients for a mean duration of 40.4 ± 20.2 months after discharge. Long-term clinical outcomes between the 2 groups are shown in Table 4. Death occurred in 14 patients. Target lesion revascularization was required in 71 patients (repeat angioplasty, n = 66; bypass surgery, n = 5). The target lesion revascularization-free survival rate was similar between the 2 groups at 1 year (84 ± 4% in the rotational atherectomy plus stenting group versus 80 ± 3% in the rotational atherectomy plus balloon angioplasty group) and at 3 years (80 ± 4% versus 77 ± 3%, respectively; p = 0.52; Figure 1). There were no significant differences in the adverse cardiac events between the 2 groups (p = 0.58). The cumulative probability of major cardiac event-free survival rate was similar between the two groups (83 ± 4% versus 79 ± 3% at 1 year and 79 ± 4% versus 75 ± 3% at 3 years, respectively; p = 0.44; Figure 2).

Figure 2

Cumulative probability of event-free survival. There were no significant differences between the two groups.

Discussion
       The major findings of this study are: 1) rotational atherectomy, followed by stenting or balloon angioplasty, is associated with favorable long-term outcomes; and 2) we cannot determine the advantage of routine or provisional stenting after rotational atherectomy compared with rotational atherectomy plus balloon angioplasty in terms of the clinical outcomes in complex coronary lesions.
       Several nonrandomized trials have reported that rotational atherectomy shows no obvious difference in the acute success rate or restenosis rate in noncomplex coronary lesions compared with other techniques.14,15 Two previous studies by Kishi and Teirstein reported a disappointing restenosis rate of 57.5–59.0% after rotational atherectomy in patients with diffuse coronary artery disease, which suggested that debulking of excess tissue with rotational atherectomy was not effective therapy for diffuse coronary artery disease.16,17 However, a nonrandomized study demonstrated that rotational atherectomy was an effective treatment modality for complex lesions, e.g., heavily calcified diffuse lesions that were not effectively treated with balloon angioplasty or stents.7,18 Furthermore, several techniques using rotational atherectomy, such as optimal burr size, adjunctive balloon sizing and aggressive atherectomy, can be performed with a high success rate, an acceptable rate of procedural complications and a low rate of angiographic restenosis.19,20 Kiesz et al. reported that modification of rotational atherectomy technique with adjunctive angioplasty resulted in a favorable restenosis rate (28.1%) in long, calcified lesions.8 Recently, the randomized trials comparing rotational atherectomy and balloon angioplasty for complex lesions, including long, calcific, small vessel and bifurcation lesions, showed no differences in terms of procedural success, restenosis rate and clinical outcomes. These results have raised the issue of whether stenting after rotational atherectomy has additional benefits compared to rotational atherectomy with or without balloon angioplasty.21,22 Hoffmann et al. reported that the treatment of the calcific lesions in large coronary arteries (reference vessel diameter >= 3 mm) with rotational atherectomy plus stenting showed a larger post-intervention diameter and more favorable late outcome than either stenting alone or rotational atherectomy plus balloon angioplasty.7 However, they demonstrated advantages of stenting following rotational atherectomy only in large calcific lesions with relatively short lesion lengths. Therefore, on the basis of previous published studies,3,8,20,23,24 stenting or balloon angioplasty following rotational atherectomy may be a therapeutic option for complex coronary lesion such as the long calcific lesion subset. However, limited data are available on the comparison between rotational atherectomy plus stenting and rotational atherectomy plus balloon angioplasty in calcified long coronary lesions.
       We observed that the acute procedural success rate was similar in the 2 groups and the cumulative probability of event-free survival was 79% in rotational atherectomy plus stenting and 75% in rotational atherectomy plus balloon angioplasty at 3 years in complex lesions, including long and calcified lesions. These clinical outcomes appear to be similar to those observed in previous reports.7,8,10 The reported angiographic restenosis rates from prior studies after rotational atherectomy ranged from 23–37%,3,8,10,25 which should result in a similar late clinical event rate as observed in the current study.
       On the basis of our observations, we suggest that if an optimal result is obtained with adjunctive balloon angioplasty after rotational atherectomy in calcific long coronary lesions, routine stenting may not provide additional benefits in terms of long-term clinical outcomes. These findings might be similar to a previous study,26 which showed that for lesions > 20 mm, the incidence of major adverse cardiac events was similar between additional stenting versus balloon angioplasty.
       Study limitations. First, this is a retrospective analysis. Therefore, we may not conclude that there was no difference in outcomes between the two strategies. Second, there was no routine angiographic follow-up. Third, intravascular ultrasound was not used in this study, which may have improved decisions regarding treatment strategy. Fourth, the sample size was modest.

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