Abstract
Objectives
The aim of this study was to analyze the effectiveness of drug-eluting stents (DES) in small vessels in patients with non-insulin-dependent (NIDDM) and insulin-dependent diabetes mellitus (IDDM).
Background
Several randomized trials have shown DES to significantly reduce the angiographic and clinical events in diabetic patients. However, there is insufficient data on similar outcomes in diabetics with small vessels.
Methods
We studied 258 consecutive diabetic patients (173 NIDDM and 85 IDDM) who underwent coronary stenting with DES, divided into 2 cohorts: group A (vessels < 2.7 mm): 163 patients, and group B (vessels ≥ 2.7 mm): 95 patients. We analyzed the major adverse cardiac events (MACE) [death, nonfatal myocardial infarction MI, and target lesion revascularization (TVR)] over a mean follow-up of 78.4 ± 14.8 months.
Results
Group A patients had: smaller reference diameter (2.4 ± 0.31 versus 3.14 ± 0.2 mm, p = 0.0001), longer lesions (19.3 ± 9.5 versus 16.7 ± 7.1 mm, p = 0.023), more complex lesions: (B2/C) (80.7 versus 52.6%, p < 0.033), bifurcation lesions (25.8 versus 11.6%, p = 0.007), diffuse disease (42.9 versus 26.3%, p = 0.008), multivessel (32.5 versus 18.9%, p = 0.019), eccentric lesions (57.1 versus 43.2%, p = 0.031), more stents implanted (1.99 ± 1.6 versus 1.7 ± 1.3, p < 0.0001), more overlapping stents (29.4 versus 13.7%, p = 0.004) and more stents length (25.7 ± 4.9 versus 20.2 ± 2.6, p < 0.003). During the follow-up, both groups had overall similar MACE (10.4 versus 11.7%, p = 0.9) with insignificant higher restenosis (9.2 versus 8.4%, p = 0.832) and TVR (7.4 versus 6.4%, p = 0.75) in group A. There was no difference in death ( p = 0.111) or MI ( p = 0.858). Both groups had similar stent thrombosis rate (1.2 versus 1.1%, p = 0.899), angina events (10.4 versus 16.8%, p = 0.137), abnormal stress thallium (14.1 versus 14.7%, p = 0.890), and hospital days (2.91 versus 3.57, p = 0.886).
Conclusion
Despite complex angiographic characteristics, the use of DES in diabetic patients with small vessels showed favorable clinical outcomes and similar low TVR compared to those with large vessels.
Highlights
- •
Several randomized trials have shown drug-eluting stents (DES) to significantly reduce the angiographic and clinical events in diabetic patients. However, there is insufficient data on similar outcomes in diabetics with small vessels.
- •
This study analyzes the effectiveness of DES in small vessels in patients with non-insulin-dependent (NIDDM) and insulin-dependent diabetes mellitus (IDDM).
- •
In this study DES in diabetic patients with small vessels showed favorable long-term clinical outcomes and similar low target vessel revascularization (TVR) compared to those with large vessels.
1
Introduction
Several clinical trials have demonstrated that diabetes mellitus (DM) is an important risk factor for poor outcomes after percutaneous coronary intervention (PCI) . In particular, diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization .
After stent implantation, patients with DM are more likely to develop restenosis and require repeat revascularization compared with those without DM, and are also at great risk for stent thrombosis, myocardial infarction (MI), and death .
Several randomized trials and meta-analyses have shown that drug-eluting stents (DES) markedly reduce restenosis rates and the need for repeated revascularization procedures compared with bare metal stents (BMS) in patients with diabetes . However, it is still controversial whether DES are equally effective in diabetic patients with small vessel disease as compared with larger vessel in prevention of restenosis and other major cardiac event (MACE) in these patients.
We thought to present this study which compares clinical outcomes and effectiveness of DES in small vessels compared with larger vessels in patients with non-insulin-dependent diabetes mellitus (NIDDM) and insulin-dependent diabetes mellitus (IDDM).
The primary objective of the study was to compare the composite endpoints of death, MI, or target vessel revascularization (TVR) at 6, 12, and 12–84 months in the two groups.
The secondary objective was to analyze the incidence of immediate major and minor bleeding and intermediate rates of angina recurrence, inducible ischemia, and hospitalization for heart failure in both groups.
2
Methods
2.1
Patient selection and procedure
Two hundred fifty eight consecutive diabetic patients who underwent PCI and received DES (Cypher Sirolimus-eluting coronary stent, Cordis Corporation, Miami Lakes, Florida) implantation from July 2002 to March 2009 were identified from our PCI registry and included in the study. The hospital research and ethics advisory council approved the study and all patients signed an informed consent. The patients who did not have at least a 12-month follow-up, who had only balloon angioplasty, BMS, rotablation or coronary bypass graft intervention were excluded from the study. We thought that studying the diabetic patient not just the diabetic lesion would provide more information on periprocedural co-morbidities and outcomes.
2.2
Clinical parameters
Demographic and angiographic data, coronary risk factors, medications, procedure indications, and coronary intervention data were reviewed from our PCI registry, charts and cineangiograms ( Table 1 ).
| Group | A ( n = 163) | B ( n = 95) | p value |
|---|---|---|---|
| Age, mean ± SD | 61.47 ± 11.03 | 59.26 ± 10.37 | 0.068 |
| Male, n (%) | 111 (68.1) | 73 (76.8) | 0.111 |
| BMI kg/m 2 | 30.29 ± 4.0 | 30.42 ± 4.90 | 0.924 |
| Obese, n (%) | 70 (42.9) | 46 (48.4) | 0.394 |
| Hypertension, n (%) | 122 (74.8) | 71 (74.7) | 0.984 |
| Hyperlipidemia, n (%) | 129 (79.1) | 77 (81.1) | 0.712 |
| Smoking, n (%) | 77 (47.2) | 51 (53.7) | 0.318 |
| PVD, n (%) | 57 (35) | 32 (33.7) | 0.834 |
| LVEF, % | 48.35 ± 10.5 | 50.51 ± 8.65 | 0.336 |
| Renal impairment, n (%) | 39 (23.9) | 16 (16.8) | 0.180 |
| Indication, n (%) | |||
| Stable angina | 46 (28.2) | 27 (28.4) | 0.209 |
| ACS/unstable angina | 69 (42.3) | 47 (49.5) | 0.209 |
| ACS/NSTEMI | 38 (23.3) | 12 (12.6) | 0.209 |
| STEMI | 10 (15.7) | 9 (9.5) | 0.209 |
| Cardiogenic shock | 6 (3.7) | 2 (2.1) | 0.481 |
| Prior MI/PCI | 60 (36.8) | 39 (41.1) | 0.499 |
| Prior CABG | 20 (12.3) | 15 (15.8) | 0.426 |
| Medications | |||
| ASA, n (%) | 162 (99.4) | 94 (98.9) | 0.698 |
| β blocker, n (%) | 148 (90.8) | 87 (91.6) | 0.832 |
| Statin, n (%) | 157 (96.3) | 91 (95.8) | 0.832 |
| ACE I, n (%) | 204 (80) | 81 (85.3) | 0.699 |
| Clopidogrel, n (%) | 155 (95.1) | 88 (92.6) | 0.415 |
| Nitrate, n (%) | 121 (74.2) | 62 (65.3) | 0.126 |
| Insulin, n (%) | 56 (34.4) | 29(30.5) | 0.479 |
| OHG, n (%) | 90 (55.2) | 45 (47.4) | 0.224 |
The data were analyzed on immediate and intermediate term outcomes including minor and major bleeding, urgent revascularization, stent thrombosis (ST), MI, death, TVR (driven by symptoms, inducible ischemia, and angiographic restenosis of > 50% of the reference diameter) and hospitalization. Composite endpoints of TVR, death or MI were calculated. Immediate major bleeding was defined using TIMI criteria .
Routine follow-up hemoglobin and diligent examinations to rule out significant bleeding were done in all patients. In-hospital MI was defined as the presence of new significant ST elevation or Q waves in two or more contiguous electrocardiographic leads or an elevation of troponin T or creatine kinase and its MB isoenzyme to at least three times the normal reference in three samples collected at 8-hour intervals. Subsequent MI was defined as the development of new ST elevation or Q-waves or an elevation of creatine kinase or its MB isoenzyme to at least two times the normal reference .
All patients had complete clinic follow-up including stress thallium tests and telephone contact was made if any follow-up data were missing.
2.3
Quantitative coronary angiography
Reference diameter, minimum lumen diameter (MLD), lesion length, and residual stenosis were assessed by quantitative coronary angiography by 2 independent reviewers using an automated computer-based CAAS II system (QCA for Research 1.3, PieMedical Imaging, Maastricht, The Netherlands).
Angiographic success was defined as a final angiographic residual stenosis of < 20%, procedural success was considered in case of angiographic success and if no in hospital major complication (acute MI, need for bypass surgery or repeat PCI, or death) occurred. Quantitative angiography was repeated whenever indicated at follow-up.
A restenosis was defined as an MLD in the treated artery of more than 50% of the reference diameter.
2.4
Statistical analysis
The chi-square or Fisher’s exact test was used to compare the two groups on qualitative variables. The Wilcoxon rank-sum test was used to compare the groups on quantitative variables—age and ejection fraction (comparison of means)—due to nonnormality of these variables in all groups. Logistic regression was used to compare the two groups on outcomes adjusting for significant differences on other factors. A 5% level of significance was used for all statistical tests. SAS version 9.1 was used for statistical computing (SAS Institute, Cary, NC).
2
Methods
2.1
Patient selection and procedure
Two hundred fifty eight consecutive diabetic patients who underwent PCI and received DES (Cypher Sirolimus-eluting coronary stent, Cordis Corporation, Miami Lakes, Florida) implantation from July 2002 to March 2009 were identified from our PCI registry and included in the study. The hospital research and ethics advisory council approved the study and all patients signed an informed consent. The patients who did not have at least a 12-month follow-up, who had only balloon angioplasty, BMS, rotablation or coronary bypass graft intervention were excluded from the study. We thought that studying the diabetic patient not just the diabetic lesion would provide more information on periprocedural co-morbidities and outcomes.
2.2
Clinical parameters
Demographic and angiographic data, coronary risk factors, medications, procedure indications, and coronary intervention data were reviewed from our PCI registry, charts and cineangiograms ( Table 1 ).
| Group | A ( n = 163) | B ( n = 95) | p value |
|---|---|---|---|
| Age, mean ± SD | 61.47 ± 11.03 | 59.26 ± 10.37 | 0.068 |
| Male, n (%) | 111 (68.1) | 73 (76.8) | 0.111 |
| BMI kg/m 2 | 30.29 ± 4.0 | 30.42 ± 4.90 | 0.924 |
| Obese, n (%) | 70 (42.9) | 46 (48.4) | 0.394 |
| Hypertension, n (%) | 122 (74.8) | 71 (74.7) | 0.984 |
| Hyperlipidemia, n (%) | 129 (79.1) | 77 (81.1) | 0.712 |
| Smoking, n (%) | 77 (47.2) | 51 (53.7) | 0.318 |
| PVD, n (%) | 57 (35) | 32 (33.7) | 0.834 |
| LVEF, % | 48.35 ± 10.5 | 50.51 ± 8.65 | 0.336 |
| Renal impairment, n (%) | 39 (23.9) | 16 (16.8) | 0.180 |
| Indication, n (%) | |||
| Stable angina | 46 (28.2) | 27 (28.4) | 0.209 |
| ACS/unstable angina | 69 (42.3) | 47 (49.5) | 0.209 |
| ACS/NSTEMI | 38 (23.3) | 12 (12.6) | 0.209 |
| STEMI | 10 (15.7) | 9 (9.5) | 0.209 |
| Cardiogenic shock | 6 (3.7) | 2 (2.1) | 0.481 |
| Prior MI/PCI | 60 (36.8) | 39 (41.1) | 0.499 |
| Prior CABG | 20 (12.3) | 15 (15.8) | 0.426 |
| Medications | |||
| ASA, n (%) | 162 (99.4) | 94 (98.9) | 0.698 |
| β blocker, n (%) | 148 (90.8) | 87 (91.6) | 0.832 |
| Statin, n (%) | 157 (96.3) | 91 (95.8) | 0.832 |
| ACE I, n (%) | 204 (80) | 81 (85.3) | 0.699 |
| Clopidogrel, n (%) | 155 (95.1) | 88 (92.6) | 0.415 |
| Nitrate, n (%) | 121 (74.2) | 62 (65.3) | 0.126 |
| Insulin, n (%) | 56 (34.4) | 29(30.5) | 0.479 |
| OHG, n (%) | 90 (55.2) | 45 (47.4) | 0.224 |
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