Coronary perforation (CP) is a rare but catastrophic event that may be influenced by the procedural anticoagulation regimen. This study compared the consequences of CP in patients who underwent anticoagulation with bivalirudin (BIV; a nonreversible direct thrombin inhibitor with a shorter 1/2-life than heparin) to those in patients who underwent anticoagulation with heparin (HEP) at time of CP. Patients with CP were identified from 33,613 procedures available in our institutional angioplasty registry. The outcome of this group was compared based on anticoagulation regimen (BIV vs HEP). The primary end point for this analysis was the composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Overall a cohort of 69 patients (0.2%) with CP was identified. BIV was the intraprocedural anticoagulant in 41 patients, whereas HEP was used in 28. Baseline characteristics were comparable between groups except for a higher frequency of systemic hypertension and hypercholesterolemia in the BIV group. Procedural characteristics were also similar including lesion complexity and perforation severity. Nearly 1/2 of CPs in each group was managed with prolonged balloon inflation alone. Protamine was used in 46% of HEP-treated patients. Covered stents tended to be used more frequently in the BIV group (p = 0.061). The primary composite end point was similar between groups (odds ratio 1.42, 95% confidence interval 0.47 to 4.29, p = 0.53). However, there was a lower rate of cardiac surgery requirement in BIV-treated patients (p = 0.037). In conclusion, our study suggests that choice of procedural anticoagulant agent does not influence outcome when CP occurs. Therefore, use of BIV should not be discouraged in patients undergoing high-risk intervention for perforations.
Little evidence is available on coronary perforations (CPs) occurring during percutaneous coronary intervention (PCI) with bivalirudin (BIV) anticoagulation. Because a randomized clinical trial is impractical, not to say inappropriate in this context, only small observational case series are available. This study was undertaken to compare the consequences of CP occurring during PCI with BIV anticoagulation to those occurring with heparin (HEP).
Methods
From 33,613 procedures recorded in our prospectively collected angioplasty registry from May 1997 through June 2010, we identified 69 (0.2%) instances of CP. Of those 69, 41 occurred with BIV anticoagulation and 28 with HEP. These 69 patients were included in the analysis. All gave written consent for the procedure and the study was approved by our local institutional review board.
All patients received aspirin 325 mg and ticlopidine 500 mg or clopidogrel 300 to 600 mg before the procedure. During PCI anticoagulation was performed with HEP in all cases before BIV was introduced in our center in 2002. After 2002 regimens were chosen at the operator’s discretion and included unfractionated HEP or BIV. HEP anticoagulation was targeted to achieve and maintain an activated clotting time of 250 to 300 seconds (220 to 250 seconds if a glycoprotein [GP] IIb/IIIa inhibitor was used). In the BIV group a 0.75-mg/kg bolus was given followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure. Adjunctive GP IIb/IIIa inhibitors were used at the discretion of the operator.
The primary end point of the study was a composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Tamponade was defined as the presence of fluid in the pericardial space requiring intervention during the procedure or before hospital discharge. CP grade was classified as previously described by Ellis et al. The Ellis classification of perforations is presented in Table 1 .
| Type I | extraluminal crater without extravasation |
| Type II | pericardial or myocardial blush without contrast jet extravasation |
| Type III | extravasation through frank (>1 mm) perforation |
| Cavity spilling | perforation into anatomic cavity chamber, coronary sinus, etc. |
All data management and analyses were performed by a dedicated coordinating center (Data Center, Cardiovascular Research Institute, Washington, DC). Trained research personnel unaware of the study objectives abstracted from medical records prespecified and predefined demographic, clinical, and procedural data and entered these data into a computer-based registry of PCI procedures. Clinical events during postprocedure hospital course were also recorded. A committee of physicians not involved in the procedures adjudicated the nature of each event. Cine angiograms were reviewed and analyzed by a physician not involved in the procedure.
Statistical analysis was performed using SAS 9.1 (SAS Institute, Cary, North Carolina). Continuous variables are presented as mean ± SD unless otherwise noted. Categorical variables are expressed as frequency and group percentage. Patients’ characteristics were compared using chi-square test (or Fischer’s exact test when appropriate) for categorical variables. Comparisons of continuous variables were made with Wilcoxon rank-sum tests.
Results
Overall 69 (0.2%) CPs occurred in 33,613 procedures. Forty-one CPs occurred during BIV and 28 during HEP anticoagulation. The CP rate was the same in patients treated with BIV and with HEP anticoagulation (0.2%). BIV was introduced in our center in 2002 and subsequently became the primary anticoagulant. Consequently, all CPs with BIV occurred later than 2002, whereas most CPs with HEP were before 2002 (20 of 28, 71%).
Baseline characteristics are presented in Table 2 . Patients in the BIV group more frequently had systemic hypertension and hypercholesterolemia. Procedural and perforations details are presented in Tables 3 and 4 , respectively. Procedures performed with BIV showed a higher activated clotting time peak. GP IIb/IIIa inhibitors tended to be more frequently used in HEP-treated patients (p = 0.074). The vessel most frequently perforated was the left anterior descending coronary artery and 26.1% were long-term total occlusions. Lesion complexity was comparable in the 2 groups; interestingly, there were no perforations in type A lesions. Similarly, there were no differences in severity of perforation between BIV and HEP perforations. Roughly 1/2 the wire perforations were Ellis type I. The device that more frequently caused a CP was an intracoronary guidewire. Atheroablative devices (including laser and Rotablator) caused 7 perforations, most being Ellis type III CPs (57.1%).
| Variable | BIV (n = 41) | HEP (n = 28) | p Value |
|---|---|---|---|
| Age (years) | 71.7 ± 11.7 | 69.2 ± 12.9 | 0.389 |
| Men | 26 (63%) | 17 (61%) | 0.820 |
| European-American | 30 (73%) | 20 (71%) | 0.874 |
| African-American | 9 (22%) | 2 (7%) | 0.179 |
| Body mass index (kg/m 2 ) | 28.0 ± 5.7 | 27.4 ± 5.3 | 0.707 |
| Systemic hypertension ⁎ | 38 (93%) | 18 (64%) | 0.003 |
| Diabetes mellitus | 9 (22%) | 9 (32%) | 0.344 |
| Hypercholesterolemia † | 35 (88%) | 19 (68%) | 0.049 |
| Peripheral vascular disease | 11 (27%) | 4 (14%) | 0.215 |
| Renal failure (creatine clearance <60 ml/min) | 19 (61%) | 9 (38%) | 0.080 |
| Previous coronary artery bypass graft | 13 (34%) | 12 (44%) | 0.403 |
| Previous percutaneous coronary intervention | 14 (38%) | 12 (48%) | 0.426 |
| Current smoker | 7 (17%) | 2 (7%) | 0.294 |
| Acute myocardial infarction admission diagnosis | 5 (12%) | 4 (15%) | 1.000 |
| Left ventricular ejection fraction | 0.48 ± 0.14 | 0.51 ± 0.10 | 0.503 |
| Baseline hematocrit (%) | 38.0 ± 6.1 | 40.1 ± 4.8 | 0.127 |
| Baseline platelet count (×10 9 /L) | 223 ± 103 | 216 ± 55 | 0.730 |
⁎ History of hypertension diagnosed and/or treated with medication or currently being treated with diet and/or medication by a physician.
† Includes patients with previously documented diagnosis of hypercholesterolemia. A patient may be treated with diet or medication. A new diagnosis can be made during this hospitalization with an increased total cholesterol level >160 mg/dl. It does not include increased triglycerides.
| Variable | BIV (n = 41) | HEP (n = 28) | p Value |
|---|---|---|---|
| Peak activated clotting time (seconds) | 355.4 ± 80.0 | 271.78 ± 67.8 | <0.001 |
| Glycoprotein IIb/IIIa inhibitors | 1 (3%) | 5 (19%) | 0.074 |
| Intra-aortic balloon pump | 6 (15%) | 4 (14%) | 1.000 |
| Number of lesions treated with percutaneous coronary intervention | 1.8 ± 1.1 | 1.7 ± 0.9 | 0.707 |
| Procedure length (min) | 96.8 ± 73.1 | 104.9 ± 52.8 | 0.619 |
| Variable | BIV (n = 41) | HEP (n = 28) | p Value |
|---|---|---|---|
| Coronary vessel | 0.156 | ||
| Left anterior descending coronary artery | 13 (32%) | 13 (46%) | |
| Left circumflex coronary artery | 7 (17%) | 5 (18%) | |
| Ramus | 1 (2%) | 3 (11%) | |
| Right coronary artery | 14 (34%) | 3 (11%) | |
| Saphenous vein graft | 6 (15%) | 4 (14%) | |
| Lesion complexity ⁎ | 0.326 | ||
| Type A | 0 | 0 | |
| Type B | 18 (44%) | 9 (32%) | |
| Type C | 23 (56%) | 19 (68%) | |
| Long-term total occlusion | 8 (20%) | 10 (38%) | 0.132 |
| Device causing perforation | 0.798 | ||
| Wire | 19 (46%) | 10 (36%) | |
| Balloon | 9 (22%) | 8 (29%) | |
| Stent | 10 (24%) | 6 (21%) | |
| Rotational atherectomy | 2 (5%) | 3 (11%) | |
| Excimer laser | 1 (2%) | 1 (4%) | |
| Perforation grade † | 0.566 | ||
| Type I | 17 (45%) | 14 (56%) | |
| Type II | 9 (24%) | 6 (24%) | |
| Type III | 10 (26%) | 5 (20%) | |
| Type cavity spilling | 2 (5%) | 0 |
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