Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

Gennaro Giustino, Alaide Chieffo, Tullio Palmerini, Marco Valgimigli, Fausto Feres, Alexandre Abizaid, Ricardo A. Costa, Myeong Ki Hong, Byeong Keuk Kim, Yangsoo Jang, Hyo Soo Kim, Kyung Woo Park, Martine Gilard, Marie Claude Morice, Fadi Sawaya, Gennaro Sardella, Philippe Genereux, Bjorn Redfors, Martin B. Leon, Deepak L. Bhatt & 2 others Gregg W. Stone, Antonio Colombo

Research output: Contribution to journalArticle

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Abstract

Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

Original languageEnglish (US)
Pages (from-to)1851-1864
Number of pages14
JournalJournal of the American College of Cardiology
Volume68
Issue number17
DOIs
StatePublished - Oct 25 2016

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Percutaneous Coronary Intervention
Safety
Stents
Drug-Eluting Stents
Therapeutics
clopidogrel
Confidence Intervals
Hemorrhage
Aspirin
Thrombosis
Randomized Controlled Trials
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Giustino, G., Chieffo, A., Palmerini, T., Valgimigli, M., Feres, F., Abizaid, A., ... Colombo, A. (2016). Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI. Journal of the American College of Cardiology, 68(17), 1851-1864. https://doi.org/10.1016/j.jacc.2016.07.760
Giustino, Gennaro ; Chieffo, Alaide ; Palmerini, Tullio ; Valgimigli, Marco ; Feres, Fausto ; Abizaid, Alexandre ; Costa, Ricardo A. ; Hong, Myeong Ki ; Kim, Byeong Keuk ; Jang, Yangsoo ; Kim, Hyo Soo ; Park, Kyung Woo ; Gilard, Martine ; Morice, Marie Claude ; Sawaya, Fadi ; Sardella, Gennaro ; Genereux, Philippe ; Redfors, Bjorn ; Leon, Martin B. ; Bhatt, Deepak L. ; Stone, Gregg W. ; Colombo, Antonio. / Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI. In: Journal of the American College of Cardiology. 2016 ; Vol. 68, No. 17. pp. 1851-1864.
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abstract = "Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5{\%}) underwent complex PCI. Overall, 85{\%} of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95{\%} confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95{\%} CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95{\%} CI: 0.75 to 1.35; p interaction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.",
author = "Gennaro Giustino and Alaide Chieffo and Tullio Palmerini and Marco Valgimigli and Fausto Feres and Alexandre Abizaid and Costa, {Ricardo A.} and Hong, {Myeong Ki} and Kim, {Byeong Keuk} and Yangsoo Jang and Kim, {Hyo Soo} and Park, {Kyung Woo} and Martine Gilard and Morice, {Marie Claude} and Fadi Sawaya and Gennaro Sardella and Philippe Genereux and Bjorn Redfors and Leon, {Martin B.} and Bhatt, {Deepak L.} and Stone, {Gregg W.} and Antonio Colombo",
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Giustino, G, Chieffo, A, Palmerini, T, Valgimigli, M, Feres, F, Abizaid, A, Costa, RA, Hong, MK, Kim, BK, Jang, Y, Kim, HS, Park, KW, Gilard, M, Morice, MC, Sawaya, F, Sardella, G, Genereux, P, Redfors, B, Leon, MB, Bhatt, DL, Stone, GW & Colombo, A 2016, 'Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI', Journal of the American College of Cardiology, vol. 68, no. 17, pp. 1851-1864. https://doi.org/10.1016/j.jacc.2016.07.760

Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI. / Giustino, Gennaro; Chieffo, Alaide; Palmerini, Tullio; Valgimigli, Marco; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A.; Hong, Myeong Ki; Kim, Byeong Keuk; Jang, Yangsoo; Kim, Hyo Soo; Park, Kyung Woo; Gilard, Martine; Morice, Marie Claude; Sawaya, Fadi; Sardella, Gennaro; Genereux, Philippe; Redfors, Bjorn; Leon, Martin B.; Bhatt, Deepak L.; Stone, Gregg W.; Colombo, Antonio.

In: Journal of the American College of Cardiology, Vol. 68, No. 17, 25.10.2016, p. 1851-1864.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

AU - Giustino, Gennaro

AU - Chieffo, Alaide

AU - Palmerini, Tullio

AU - Valgimigli, Marco

AU - Feres, Fausto

AU - Abizaid, Alexandre

AU - Costa, Ricardo A.

AU - Hong, Myeong Ki

AU - Kim, Byeong Keuk

AU - Jang, Yangsoo

AU - Kim, Hyo Soo

AU - Park, Kyung Woo

AU - Gilard, Martine

AU - Morice, Marie Claude

AU - Sawaya, Fadi

AU - Sardella, Gennaro

AU - Genereux, Philippe

AU - Redfors, Bjorn

AU - Leon, Martin B.

AU - Bhatt, Deepak L.

AU - Stone, Gregg W.

AU - Colombo, Antonio

PY - 2016/10/25

Y1 - 2016/10/25

N2 - Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

AB - Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

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Giustino G, Chieffo A, Palmerini T, Valgimigli M, Feres F, Abizaid A et al. Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI. Journal of the American College of Cardiology. 2016 Oct 25;68(17):1851-1864. https://doi.org/10.1016/j.jacc.2016.07.760