Abstract
Background
There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL).
Methodology
The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR.
Results
The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0 ± 23.0% vs. 55.0 ± 9.0%; p = 0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p = 0.01), shorter stent length (19.9 ± 6.1 mm vs. 22.7 ± 7.3 mm; p = 0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p = 0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p = 1.0), cardiac death (8.5% vs. 2.5%; p = 0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p = 1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p = 1.0). The 1-year MACE-free survival rate was also similar in the two cohorts.
Conclusion
The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.
1
Introduction
Percutaneous intervention upon heavily calcified coronary lesions (HCCL) has been associated with high procedural risks and poor long-term clinical outcomes . Rotational atherectomy (RA) pulverizes rigid calcific plaques and facilitates stent delivery and optimal expansion . In the bare-metal stent (BMS) era, RA improved the procedural success rate, but the rates of restenosis remained high . First generation drug-eluting stents (DES) have led to a dramatic reduction in the rates of restenosis, and several studies have reported improved angiographic and clinical outcomes in calcific lesions that have been prepared using RA .
Second generation DES, with thinner stent strut platforms and more biocompatible polymers, have provided greater long-term safety as compared to first generation DES . The benefit of second generation DES in patients with HCCL treated with RA is unknown. The aim of this study was to compare the clinical outcome of first and second generation DES in patients undergoing RA for HCCL.
2
Methods
This single-center, retrospective study comprised 99 consecutive patients (116 lesions) who had undergone RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions) at the MedStar Washington Hospital Center from October 2003 to January 2013. Patients with mild or moderate calcified lesions, restenotic lesions, previous treatment with any BMS or a combination of first and second-generation DES, and history of prior CABG were excluded. All patients provided written informed consent. The study complied with the Declaration of Helsinki for investigation in human beings and was approved by the institutional ethics committee of the Medstar Washington Hospital Center. Rotational atherectomy (Rotablator system: Boston Scientific-Scimed Corporation, Natick, Massachusetts) was performed according to standard practice. In all cases, the interventional strategy, as well as the use of adjunctive devices and pharmacotherapy, was at the discretion of the operating interventional cardiologist. First-generation DES (sirolimus-eluting stents, Cypher, Cordis, Johnson & Johnson; paclitaxel-eluting stents, Taxus Liberté, Boston Scientific) or second-generation DES (everolimus-eluting stents, Xience V, Abbott Vascular or Promus PREMIER/Element, Boston Scientific; zotarolimus-eluting stents, Endeavor or Resolute, Medtronic Vascular) were implanted after adequate lesion preparation. All patients received aspirin 325 mg pre-procedure and were recommended to continue this regime indefinitely. In addition clopidogrel 75 mg daily following a 300-mg or 600-mg loading dose was commenced pre-procedurally and continued for 12 months. Follow-up data at 1-month, 6-months and 12-months were obtained by telephone contact, mailed questionnaire or outpatient review.
The analyzed clinical parameters were the 1, 6 and 12-month rates of death, Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR.
Heavily calcified coronary lesions were defined visually as the presence of calcium before contrast injection at the site of the lesion and involving both sides of the vessel wall by a senior attending interventional cardiologist blinded to the treatment arm. Q-wave MI was defined as evidence of new Q-waves on the electrocardiogram at the time of MI; the latter being defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml together with symptoms and/or ischemic electrocardiogram changes. Hypercholesterolemia was defined as fasting cholesterol > 250 mg/dl or the use of lipid lowering therapy. Systemic hypertension was defined as blood pressure > 140/90 mmHg or the use of anti-hypertensive therapy. Renal impairment was defined as serum creatinine > 1.2 mg/dL. Congestive heart failure was defined as evidence of fluid retention due to cardiac causes prior to admission. Angiographic success was defined as post-procedural stenosis ≤ 30% and thrombolysis in myocardial infarction flow grade 3. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent. ST was defined in accordance with the Academic Research Consortium definitions as definite, probable, or possible.
Data were analyzed using the Statistical Analysis System version 9.3 (SAS Institute, Cary, NC). Continuous variables are expressed as mean ± SD and analyzed using Student’s t-test. Categorical variables are displayed as percentages and analyzed by chi square or Fisher’s exact test. A p-value < 0.05 was considered significant. 12-month event-free survival curves were constructed with Kaplan–Meier curves.
2
Methods
This single-center, retrospective study comprised 99 consecutive patients (116 lesions) who had undergone RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions) at the MedStar Washington Hospital Center from October 2003 to January 2013. Patients with mild or moderate calcified lesions, restenotic lesions, previous treatment with any BMS or a combination of first and second-generation DES, and history of prior CABG were excluded. All patients provided written informed consent. The study complied with the Declaration of Helsinki for investigation in human beings and was approved by the institutional ethics committee of the Medstar Washington Hospital Center. Rotational atherectomy (Rotablator system: Boston Scientific-Scimed Corporation, Natick, Massachusetts) was performed according to standard practice. In all cases, the interventional strategy, as well as the use of adjunctive devices and pharmacotherapy, was at the discretion of the operating interventional cardiologist. First-generation DES (sirolimus-eluting stents, Cypher, Cordis, Johnson & Johnson; paclitaxel-eluting stents, Taxus Liberté, Boston Scientific) or second-generation DES (everolimus-eluting stents, Xience V, Abbott Vascular or Promus PREMIER/Element, Boston Scientific; zotarolimus-eluting stents, Endeavor or Resolute, Medtronic Vascular) were implanted after adequate lesion preparation. All patients received aspirin 325 mg pre-procedure and were recommended to continue this regime indefinitely. In addition clopidogrel 75 mg daily following a 300-mg or 600-mg loading dose was commenced pre-procedurally and continued for 12 months. Follow-up data at 1-month, 6-months and 12-months were obtained by telephone contact, mailed questionnaire or outpatient review.
The analyzed clinical parameters were the 1, 6 and 12-month rates of death, Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR.
Heavily calcified coronary lesions were defined visually as the presence of calcium before contrast injection at the site of the lesion and involving both sides of the vessel wall by a senior attending interventional cardiologist blinded to the treatment arm. Q-wave MI was defined as evidence of new Q-waves on the electrocardiogram at the time of MI; the latter being defined as a total creatinine kinase increase ≥ 2 × the upper limit of normal and/or creatinine kinase (MB fraction) ≥ 20 ng/ml together with symptoms and/or ischemic electrocardiogram changes. Hypercholesterolemia was defined as fasting cholesterol > 250 mg/dl or the use of lipid lowering therapy. Systemic hypertension was defined as blood pressure > 140/90 mmHg or the use of anti-hypertensive therapy. Renal impairment was defined as serum creatinine > 1.2 mg/dL. Congestive heart failure was defined as evidence of fluid retention due to cardiac causes prior to admission. Angiographic success was defined as post-procedural stenosis ≤ 30% and thrombolysis in myocardial infarction flow grade 3. TLR was defined as ischemia-driven percutaneous or surgical repeat intervention in the stent or within 5 mm proximal or distal to the stent. ST was defined in accordance with the Academic Research Consortium definitions as definite, probable, or possible.
Data were analyzed using the Statistical Analysis System version 9.3 (SAS Institute, Cary, NC). Continuous variables are expressed as mean ± SD and analyzed using Student’s t-test. Categorical variables are displayed as percentages and analyzed by chi square or Fisher’s exact test. A p-value < 0.05 was considered significant. 12-month event-free survival curves were constructed with Kaplan–Meier curves.
3
Results
The baseline characteristics and procedural indication of the patients are summarized in Table 1 . The two groups were well matched for the traditional risk factors for coronary artery disease. The group receiving second generation DES was more commonly men and had a lower left ventricular ejection fraction (46.0 ± 23.0% vs. 55.0 ± 9.0%; p = 0.02).
| Variable | Second generation DES (n = 59) | First generation DES (n = 40) | p value |
|---|---|---|---|
| Male (%) | 69.5 | 50.0 | 0.05 |
| Age (yrs) | 70.8 ± 9.7 | 72.3 ± 10.5 | 0.46 |
| Hypertension (%) | 91.5 | 92.5 | 1.0 |
| Diabetes (%) | 28.8 | 40.0 | 0.25 |
| Hypercholesterolemia (%) | 88.1 | 90.0 | 1.0 |
| Smoker (%) | 50.8 | 50.0 | 0.93 |
| Heart failure (%) | 8.5 | 15.4 | 0.34 |
| Chronic renal insufficiency (%) | 11.9 | 10.0 | 1.0 |
| History of MI (%) | 22.0 | 16.2 | 0.49 |
| LV ejection fraction (%) | 46.0 ± 23.0 | 55.0 ± 9.0 | 0.02 |
| Presentation (%) | |||
| Stable angina | 39.0 | 42.5 | 0.73 |
| Unstable angina | 45.8 | 42.5 | 0.75 |
| Acute MI | 16.9 | 12.8 | 0.58 |
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