Avoidance of Adverse Events in Restenotic Lesions With Abciximab?
In-stent restenosis remains a vexing clinical problem. Restenosis rates are known to be reduced with coronary stents compared to balloon angioplasty. The restenotic lesion often does not present a major technical challenge, perhaps because the interventional cardiologist has already challenged and conquered that anatomy once before. The mindset of the interventional cardiologist has usually been to re-address the lesion percutaneously, despite the fact that the restenosis rate in the restenotic lesion remains a potentially worse nemesis than first-time restenosis. Multiple studies have shown that the concomitant use of glycoprotein (GP) IIb/IIIa receptor blockers reduces the incidence of major adverse cardiac events (MACE) during percutaneous coronary intervention (PCI). The concomitant use of stents with abciximab (ReoPro, Centocor, Malvern, Pennsylvania) has actually shown a reduction in mortality compared to balloon angioplasty plus abciximab or stenting alone.
Our colleagues at the Cleveland Clinic retrospectively searched its database and found 284 patients with first-time in-stent restenosis treated from January 1996 to December 1998. Of these 284 patients, 79% were treated with balloon angioplasty (PTCA), 13% with rotational atherectomy (RA), and 8% with repeat stenting. At the discretion of the individual operator, 28% (79) of patients were treated with concomitant abciximab and 72% (205) of patients were not. The two groups were dissimilar with more diabetics (34% vs. 24%; p = 0.04), more hypertensives (65% vs. 52%; p = 0.06) and more hypercholesterolemics (73% vs. 54%; p = 0.02) in the abciximab selected group. The groups were similar with respect to age, gender, LV function, number of vessels involved, history of prior CABG, and unstable clinical symptoms. There were no statistically significant differences with regard to the method of PCI selected in this group of patients, whether balloon angioplasty, rotational atherectomy, or repeat stenting. Again the method of PCI was at the operator's discretion. Follow-up was clinical, obtained by chart reviews, telephone interviews, or outpatient visits. At one-year clinical follow-up, the authors found a statistically significant reduction in both MACE (2.5% vs. 5.3%; p < 0.05) and mortality (1.2% vs. 5.8%; p < 0.01) when abciximab was used in in-stent restenotic lesions.
The findings of this retrospective analysis by the team at the Cleveland Clinic are indeed provocative. The Clinic physicians chose abciximab as an adjunct to PCI in only 28% of restenotic lesions, and neither abciximab nor any other IIb/IIIa receptor blocker in 72% of the cases. Clinically, this strategy seems logical. Traditionally, the restenotic lesion is not thought of as all that technically challenging, if for no other reason than the operator has traveled that road once before. Also, clinically those patients with restenosis often do not present with unstable symptoms, rather, often the more insidious onset of stable angina. Nonetheless, the group of patients who received abciximab had more co-morbidities, including more patients with hypertension, hypercholesterolemia, and most notably, diabetes mellitus. Therefore, abciximab was selected in a higher-sions made by the experts at the Cleveland Clinic probably mimic many clinical practices. During the time frame of this analysis, IIIa/IIIa receptor blockers had often been reserved for those "sicker" patient populations where a poorer PCI outcome would have been anticipated. Despite more co-morbidities, a statistically significant lower incidence of MACE and lower mortality was found at 1-year clinical follow-up in the abciximab group.
Despite the retrospective and observational nature of this study, yet more data on the benefits of abciximab are presented herein. The concomitant use of abciximab in the patient with in-stent restenosis, a group of patients that has traditionally been thought of as relatively "low risk" by the interventional cardiologist, appears to benefit from GP IIb/IIIa receptor blockade. Clearly, to definitely prove or disprove the benefits of abciximab in the restenotic lesion, a randomized trial would be necessary. A trial where a more pure patient population was treated by single PCI, rather than an array of PTCA, RA, or repeat stenting. Certainly both gamma and beta radiation have shown promise in the reduction of restenosis in in-stent restenotic lesions. A future trial combining the promise of brachytherapy in reducing in-stent restenosis with the known benefits of IIb/IIIa receptor blockers would be fascinating, looking at MACE, mortality and target vessel revascularization. Until further data are gathered, the individual patient with in-stent restenosis should be treated with the knowledge at hand. Given these observational data from our colleagues at the Cleveland Clinic in patients with in-stent restenosis, the strategic use of IIb/IIIa receptor blockade makes sense during PCI. Combining this pharmacological therapy with the procedure that obtains the best final minimum lumen diameter may reduce the potential for both acute events and long-term restenosis, until more definitive data and newer treatment options become more widely available.
In-stent restenosis remains a vexing clinical problem. Restenosis rates are known to be reduced with coronary stents compared to balloon angioplasty. The restenotic lesion often does not present a major technical challenge, perhaps because the interventional cardiologist has already challenged and conquered that anatomy once before. The mindset of the interventional cardiologist has usually been to re-address the lesion percutaneously, despite the fact that the restenosis rate in the restenotic lesion remains a potentially worse nemesis than first-time restenosis. Multiple studies have shown that the concomitant use of glycoprotein (GP) IIb/IIIa receptor blockers reduces the incidence of major adverse cardiac events (MACE) during percutaneous coronary intervention (PCI). The concomitant use of stents with abciximab (ReoPro, Centocor, Malvern, Pennsylvania) has actually shown a reduction in mortality compared to balloon angioplasty plus abciximab or stenting alone.
Our colleagues at the Cleveland Clinic retrospectively searched its database and found 284 patients with first-time in-stent restenosis treated from January 1996 to December 1998. Of these 284 patients, 79% were treated with balloon angioplasty (PTCA), 13% with rotational atherectomy (RA), and 8% with repeat stenting. At the discretion of the individual operator, 28% (79) of patients were treated with concomitant abciximab and 72% (205) of patients were not. The two groups were dissimilar with more diabetics (34% vs. 24%; p = 0.04), more hypertensives (65% vs. 52%; p = 0.06) and more hypercholesterolemics (73% vs. 54%; p = 0.02) in the abciximab selected group. The groups were similar with respect to age, gender, LV function, number of vessels involved, history of prior CABG, and unstable clinical symptoms. There were no statistically significant differences with regard to the method of PCI selected in this group of patients, whether balloon angioplasty, rotational atherectomy, or repeat stenting. Again the method of PCI was at the operator's discretion. Follow-up was clinical, obtained by chart reviews, telephone interviews, or outpatient visits. At one-year clinical follow-up, the authors found a statistically significant reduction in both MACE (2.5% vs. 5.3%; p < 0.05) and mortality (1.2% vs. 5.8%; p < 0.01) when abciximab was used in in-stent restenotic lesions.
The findings of this retrospective analysis by the team at the Cleveland Clinic are indeed provocative. The Clinic physicians chose abciximab as an adjunct to PCI in only 28% of restenotic lesions, and neither abciximab nor any other IIb/IIIa receptor blocker in 72% of the cases. Clinically, this strategy seems logical. Traditionally, the restenotic lesion is not thought of as all that technically challenging, if for no other reason than the operator has traveled that road once before. Also, clinically those patients with restenosis often do not present with unstable symptoms, rather, often the more insidious onset of stable angina. Nonetheless, the group of patients who received abciximab had more co-morbidities, including more patients with hypertension, hypercholesterolemia, and most notably, diabetes mellitus. Therefore, abciximab was selected in a higher-sions made by the experts at the Cleveland Clinic probably mimic many clinical practices. During the time frame of this analysis, IIIa/IIIa receptor blockers had often been reserved for those "sicker" patient populations where a poorer PCI outcome would have been anticipated. Despite more co-morbidities, a statistically significant lower incidence of MACE and lower mortality was found at 1-year clinical follow-up in the abciximab group.
Despite the retrospective and observational nature of this study, yet more data on the benefits of abciximab are presented herein. The concomitant use of abciximab in the patient with in-stent restenosis, a group of patients that has traditionally been thought of as relatively "low risk" by the interventional cardiologist, appears to benefit from GP IIb/IIIa receptor blockade. Clearly, to definitely prove or disprove the benefits of abciximab in the restenotic lesion, a randomized trial would be necessary. A trial where a more pure patient population was treated by single PCI, rather than an array of PTCA, RA, or repeat stenting. Certainly both gamma and beta radiation have shown promise in the reduction of restenosis in in-stent restenotic lesions. A future trial combining the promise of brachytherapy in reducing in-stent restenosis with the known benefits of IIb/IIIa receptor blockers would be fascinating, looking at MACE, mortality and target vessel revascularization. Until further data are gathered, the individual patient with in-stent restenosis should be treated with the knowledge at hand. Given these observational data from our colleagues at the Cleveland Clinic in patients with in-stent restenosis, the strategic use of IIb/IIIa receptor blockade makes sense during PCI. Combining this pharmacological therapy with the procedure that obtains the best final minimum lumen diameter may reduce the potential for both acute events and long-term restenosis, until more definitive data and newer treatment options become more widely available.
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